POM-V
Prescription Required
Companion Animal
Cyclavance 100 mg/ml Oral Solution for Dogs and Cats
Active ingredient: Ciclosporin A
Form
Liquid
Species
Cats
Dogs
Manufacturer
Virbac
VMD MA No.
05653/5045
What it's used for
Treatment of chronic manifestations of atopic dermatitis in dogs. Symptomatic treatment of chronic allergic dermatitis in cats.
Full indications, dosage and side effects ↓The prescription itself has a price. See what practices near you charge for a consultation and the written prescription fee.
Paying less for Ciclosporin A
-
1
Ask your vet for a written prescription
They must provide one on request. Under the CMA Order the fee is capped at £21 from 2027.
-
2
Fill it at a registered online retailer
The CMA found online pharmacies 50–60% cheaper than practice dispensing on common medicines — typically £200–£300 a year.
Done — we'll email you when prices land.
Prescription required
Your vet must provide a written prescription on request. You can then purchase from any licensed online retailer.
Clinical information
Cyclavance 100 mg/ml Oral Solution for Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 18 Mar 2026.
Treatment of chronic manifestations of atopic dermatitis in dogs.
Symptomatic treatment of chronic allergic dermatitis in cats.
Symptomatic treatment of chronic allergic dermatitis in cats.
For oral use.
Before starting treatment, an evaluation of all alternative treatment options should be
made.
Before administration, the body weight of animals has to be accurately determined.
Dogs:
The recommended dose of ciclosporin is 5 mg/kg body weight (0.05 ml of oral solution
per kg BW) and should initially be administered daily. The frequency of administration
should subsequently be reduced depending on the response.
The product should initially be given daily until a satisfactory clinical improvement is
seen. This will generally be the case within 4-8 weeks. If no response is obtained within
the first 8 weeks, the treatment should be stopped.
Once the clinical signs of atopic dermatitis are satisfactorily controlled, the product can
then be given every second day. The veterinarian should perform a clinical
assessment at regular intervals and adjust the frequency of administration to the
clinical response obtained.
In some cases where the clinical signs are controlled with every second day dosing,
the veterinary surgeon can decide to give the product every 3 to 4 days. The lowest
effective frequency of dosing should be used to maintain the remission of clinical signs.
Patients should be regularly re-evaluated and alternative treatment options reviewed.
Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before
reducing the dosing interval.
The duration of treatment should be adjusted according to treatment response.
Treatment may be stopped when the clinical signs are controlled. Upon recurrence of
clinical signs, treatment should be resumed at daily dosing, and in certain cases
repeated treatment courses may be required.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
Dosages for dogs:
At standard dosage of 5mg/kg
Weight (kg) 2345678910Dosage (ml) 0.10.150.20.250.30.350.40.450.5Weight (kg)11121314151617181920Dosage (ml)0.550.60.650.70.750.80.850.90.951Weight (kg)21222324252627282930Dosage (ml)1.051.11.151.21.251.31.351.41.451.5Weight (kg)31323334353637383940Dosage (ml)1.551.61.651.71.751.81.851.91.952Weight (kg)41424344454647484950Dosage (ml)2.052.12.152.22.252.32.352.42.452.5Weight (kg)51525354555657585960Dosage (ml)2.552.62.652.72.752.82.852.92.953Weight (kg)61626364656667686970Dosage (ml)3.053.13.153.23.253.33.353.43.453.5Weight (kg)71727374757677787980Dosage (ml)3.553.63.653.73.753.83.853.93.954
PRIMARY PACKAGING TYPE 1
For the 30 and 60 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or
the 2 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
PRIMARY PACKAGING TYPE 2
For the 30 and 50 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 3 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
Cats:
The recommended dose of ciclosporin is 7 mg/kg body weight (0.07 ml of oral solution
per kg) and should initially be administered daily.
The frequency of administration should subsequently be reduced depending on the
response.
The product should initially be given daily until a satisfactory clinical improvement is
seen (assessed by intensity of pruritus and lesion severity - excoriations, miliary
dermatitis, eosinophilic plaques and/or self-induced alopecia). This will generally be
the case within 4-8 weeks. Severe prolonged pruritus may induce a state of anxiety
and subsequent excessive grooming behaviour. In such cases, despite an
improvement in pruritus upon administration of the treatment, the resolution of self-
induced alopecia may be delayed.
Once the clinical signs of allergic dermatitis are satisfactorily controlled, the product
can then be given every second day. In some cases where the clinical signs are
controlled with every second day dosing, the veterinary surgeon can decide to give
the product every 3 to 4 days. The lowest effective frequency of dosing should be used
to maintain the remission of clinical signs.
Patients should be regularly re-evaluated and alternative treatment options reviewed.
The duration of treatment should be adjusted according to treatment response.
Treatment may be stopped when the clinical signs are controlled. Upon recurrence of
clinical signs, treatment should be resumed at daily dosing, and in certain cases
repeated treatment courses may be required.
The product can be given either mixed with food or directly into the mouth. If given with
food, the solution should be mixed with a small amount of food, preferably after a
sufficient period of fasting to ensure complete consumption by the cat. Should the cat
not accept the product mixed with food, it should be given by inserting the oral syringe
directly into the cat’s mouth and delivering the entire dose. In case the cat only partially
consumes the product mixed with food, administration of the product with the oral
syringe should be resumed only the next day. Any uneaten medicated cat food must
be disposed of immediately and the bowl washed thoroughly.
The efficacy and tolerability of this product was demonstrated in clinical studies with a
duration of 4.5 months.
Dosage for cats:
As the efficacy and safety of ciclosporin have not been assessed in cats weighing less
than 2.3 kg (see section 4.5), administration of the product to cats weighing less than
2.3 kg should be according to a benefit-risk assessment by the responsible
veterinarian.
At standard dosage of 7 mg/kg
Weight (kg)2.12.93.64.35.05.76.47.1Dosage (ml)0.150.200.250.300.350.400.450.50Weight (kg)7.98.69.310.010.711.412.112.813.614.3Dosage (ml)0.550.600.650.700.750.800.850.900.951.00
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 1
For the 30 and 60 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 2 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
PRIMARY PACKAGING TYPE 2
For the 30 and 50 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 3 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
INSTRUCTIONS FOR USE
Dogs: The veterinary medicinal product should be given at least 2 hours before or after
feeding. Insert the oral syringe directly into the dog’s mouth.
Cats: The product can be given either mixed with food or directly into the mouth in
cats.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 1
1 Push and turn the child-resistant screw cap to open the bottle.
Always close the bottle with the child-resistant screw cap after use
2 Keep the bottle upright and insert
the oral dosing syringe firmly into the
plastic adapter.
4 Return the bottle to its upright position and remove
the oral dosing syringe by gently twisting it out of the
plastic adapter.
plunger up so that the oral dosing syringe fills with
the product.
Withdraw the dose of medicine prescribed by your
veterinarian.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
5 You can now introduce the syringe in the mouth
of your animal and push the medicine out of the
syringe.
Do not rinse or clean the oral dosing syringe
between uses.
Note: If the prescribed dose is more than the
maximum volume marked on the oral dosing
syringe, you will need to reload the syringe to
withdraw the full dose.
Note: For cats, you can also give the product
mixed with food
6 Always close the bottle with the
child-resistant screw cap after use.
To provide a child-resistant closure,
push down on the child-resistant
screw cap as you turn it.
Keep out of the sight and reach of
children
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 2
1 Retrieve the plastic cap and insert firmly the plastic dispenser.
The plastic dispenser should remain in place.
2 Keep the bottle upright and insert
the oral dosing syringe firmly into the
plastic dispenser.
4 You can now introduce the syringe in the mouth of
your animal and push the medicine out of the syringe.
Do not rinse or clean the oral dosing syringe between
uses.
Note: If the prescribed dose is more than the
maximum volume marked on the oral dosing syringe,
you will need to reload the syringe to withdraw the full
dose.
Note: For cats, you can also give the product mixed with
food
Keep out of the sight and reach of children
plunger up so that the oral dosing syringe fills with
the product.
Withdraw the dose of medicine prescribed by your
veterinarian.
Return the bottle to its upright position and
remove the oral dosing syringe by gently twisting
it out of the plastic dispenser.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
If necessary, the user can wipe the outside of the oral syringe with a dry tissue and
dispose of used tissue immediately.
Before starting treatment, an evaluation of all alternative treatment options should be
made.
Before administration, the body weight of animals has to be accurately determined.
Dogs:
The recommended dose of ciclosporin is 5 mg/kg body weight (0.05 ml of oral solution
per kg BW) and should initially be administered daily. The frequency of administration
should subsequently be reduced depending on the response.
The product should initially be given daily until a satisfactory clinical improvement is
seen. This will generally be the case within 4-8 weeks. If no response is obtained within
the first 8 weeks, the treatment should be stopped.
Once the clinical signs of atopic dermatitis are satisfactorily controlled, the product can
then be given every second day. The veterinarian should perform a clinical
assessment at regular intervals and adjust the frequency of administration to the
clinical response obtained.
In some cases where the clinical signs are controlled with every second day dosing,
the veterinary surgeon can decide to give the product every 3 to 4 days. The lowest
effective frequency of dosing should be used to maintain the remission of clinical signs.
Patients should be regularly re-evaluated and alternative treatment options reviewed.
Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before
reducing the dosing interval.
The duration of treatment should be adjusted according to treatment response.
Treatment may be stopped when the clinical signs are controlled. Upon recurrence of
clinical signs, treatment should be resumed at daily dosing, and in certain cases
repeated treatment courses may be required.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
Dosages for dogs:
At standard dosage of 5mg/kg
Weight (kg) 2345678910Dosage (ml) 0.10.150.20.250.30.350.40.450.5Weight (kg)11121314151617181920Dosage (ml)0.550.60.650.70.750.80.850.90.951Weight (kg)21222324252627282930Dosage (ml)1.051.11.151.21.251.31.351.41.451.5Weight (kg)31323334353637383940Dosage (ml)1.551.61.651.71.751.81.851.91.952Weight (kg)41424344454647484950Dosage (ml)2.052.12.152.22.252.32.352.42.452.5Weight (kg)51525354555657585960Dosage (ml)2.552.62.652.72.752.82.852.92.953Weight (kg)61626364656667686970Dosage (ml)3.053.13.153.23.253.33.353.43.453.5Weight (kg)71727374757677787980Dosage (ml)3.553.63.653.73.753.83.853.93.954
PRIMARY PACKAGING TYPE 1
For the 30 and 60 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or
the 2 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
PRIMARY PACKAGING TYPE 2
For the 30 and 50 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 3 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
Cats:
The recommended dose of ciclosporin is 7 mg/kg body weight (0.07 ml of oral solution
per kg) and should initially be administered daily.
The frequency of administration should subsequently be reduced depending on the
response.
The product should initially be given daily until a satisfactory clinical improvement is
seen (assessed by intensity of pruritus and lesion severity - excoriations, miliary
dermatitis, eosinophilic plaques and/or self-induced alopecia). This will generally be
the case within 4-8 weeks. Severe prolonged pruritus may induce a state of anxiety
and subsequent excessive grooming behaviour. In such cases, despite an
improvement in pruritus upon administration of the treatment, the resolution of self-
induced alopecia may be delayed.
Once the clinical signs of allergic dermatitis are satisfactorily controlled, the product
can then be given every second day. In some cases where the clinical signs are
controlled with every second day dosing, the veterinary surgeon can decide to give
the product every 3 to 4 days. The lowest effective frequency of dosing should be used
to maintain the remission of clinical signs.
Patients should be regularly re-evaluated and alternative treatment options reviewed.
The duration of treatment should be adjusted according to treatment response.
Treatment may be stopped when the clinical signs are controlled. Upon recurrence of
clinical signs, treatment should be resumed at daily dosing, and in certain cases
repeated treatment courses may be required.
The product can be given either mixed with food or directly into the mouth. If given with
food, the solution should be mixed with a small amount of food, preferably after a
sufficient period of fasting to ensure complete consumption by the cat. Should the cat
not accept the product mixed with food, it should be given by inserting the oral syringe
directly into the cat’s mouth and delivering the entire dose. In case the cat only partially
consumes the product mixed with food, administration of the product with the oral
syringe should be resumed only the next day. Any uneaten medicated cat food must
be disposed of immediately and the bowl washed thoroughly.
The efficacy and tolerability of this product was demonstrated in clinical studies with a
duration of 4.5 months.
Dosage for cats:
As the efficacy and safety of ciclosporin have not been assessed in cats weighing less
than 2.3 kg (see section 4.5), administration of the product to cats weighing less than
2.3 kg should be according to a benefit-risk assessment by the responsible
veterinarian.
At standard dosage of 7 mg/kg
Weight (kg)2.12.93.64.35.05.76.47.1Dosage (ml)0.150.200.250.300.350.400.450.50Weight (kg)7.98.69.310.010.711.412.112.813.614.3Dosage (ml)0.550.600.650.700.750.800.850.900.951.00
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 1
For the 30 and 60 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 2 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
PRIMARY PACKAGING TYPE 2
For the 30 and 50 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 3 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
INSTRUCTIONS FOR USE
Dogs: The veterinary medicinal product should be given at least 2 hours before or after
feeding. Insert the oral syringe directly into the dog’s mouth.
Cats: The product can be given either mixed with food or directly into the mouth in
cats.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 1
1 Push and turn the child-resistant screw cap to open the bottle.
Always close the bottle with the child-resistant screw cap after use
2 Keep the bottle upright and insert
the oral dosing syringe firmly into the
plastic adapter.
4 Return the bottle to its upright position and remove
the oral dosing syringe by gently twisting it out of the
plastic adapter.
plunger up so that the oral dosing syringe fills with
the product.
Withdraw the dose of medicine prescribed by your
veterinarian.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
5 You can now introduce the syringe in the mouth
of your animal and push the medicine out of the
syringe.
Do not rinse or clean the oral dosing syringe
between uses.
Note: If the prescribed dose is more than the
maximum volume marked on the oral dosing
syringe, you will need to reload the syringe to
withdraw the full dose.
Note: For cats, you can also give the product
mixed with food
6 Always close the bottle with the
child-resistant screw cap after use.
To provide a child-resistant closure,
push down on the child-resistant
screw cap as you turn it.
Keep out of the sight and reach of
children
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 2
1 Retrieve the plastic cap and insert firmly the plastic dispenser.
The plastic dispenser should remain in place.
2 Keep the bottle upright and insert
the oral dosing syringe firmly into the
plastic dispenser.
4 You can now introduce the syringe in the mouth of
your animal and push the medicine out of the syringe.
Do not rinse or clean the oral dosing syringe between
uses.
Note: If the prescribed dose is more than the
maximum volume marked on the oral dosing syringe,
you will need to reload the syringe to withdraw the full
dose.
Note: For cats, you can also give the product mixed with
food
Keep out of the sight and reach of children
plunger up so that the oral dosing syringe fills with
the product.
Withdraw the dose of medicine prescribed by your
veterinarian.
Return the bottle to its upright position and
remove the oral dosing syringe by gently twisting
it out of the plastic dispenser.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
If necessary, the user can wipe the outside of the oral syringe with a dry tissue and
dispose of used tissue immediately.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in cases with a history of malignant disorders or progressive malignant
disorders.
Do not vaccinate with a live vaccine during treatment or within a two-week interval
before or after treatment. (see also sections 4.5 “Special precautions for use” and 4.8
“Interaction with other medicinal products”).
Do not use in dogs less than six months of age or less than 2 kg in weight.
Do not use in cats infected with Feline Leukemia Virus (FeLV) or Feline
Immunodeficiency Virus (FIV).
Revised: April 2024
MA split from NI MA following AN: 03937/2022
excipients.
Do not use in cases with a history of malignant disorders or progressive malignant
disorders.
Do not vaccinate with a live vaccine during treatment or within a two-week interval
before or after treatment. (see also sections 4.5 “Special precautions for use” and 4.8
“Interaction with other medicinal products”).
Do not use in dogs less than six months of age or less than 2 kg in weight.
Do not use in cats infected with Feline Leukemia Virus (FeLV) or Feline
Immunodeficiency Virus (FIV).
Revised: April 2024
MA split from NI MA following AN: 03937/2022
Regarding malignancy, please see sections 4.3 “Contraindications” and 4.5 “Special
precautions for use”.
Dogs:
The occurrence of adverse reactions is uncommon. The most commonly observed
undesirable effects are gastrointestinal disturbances such as vomiting, mucoid or soft
faeces and diarrhoea. They are mild and transient and generally do not require the
cessation of the treatment.
Other undesirable effects may be observed uncommonly: lethargy or hyperactivity,
anorexia, mild to moderate gingival hyperplasia, skin reactions such as verruciform
lesions or change of hair coat, red and swollen pinnae, muscle weakness or muscle
cramps.
Mild and transient salivation can be observed following treatment administration.
These effects generally resolve spontaneously after treatment is stopped.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
In very rare cases diabetes mellitus has been observed, especially in West Highland
White Terriers.
Cats:
In cats treated with ciclosporin the following undesirable effects were observed:
Very common: gastrointestinal disturbances such as vomiting and diarrhoea,
accompanied by weight loss. These are generally mild and transient and do not require
the cessation of the treatment. Increased appetite was also commonly observed.
Common: lethargy, anorexia, hypersalivation, hyperactivity, polydipsia, gingival
hyperplasia and lymphopaenia. These effects generally resolve spontaneously after
treatment is stopped or following a decrease in the dosing frequency.
Side effects may be severe in individual animals.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
precautions for use”.
Dogs:
The occurrence of adverse reactions is uncommon. The most commonly observed
undesirable effects are gastrointestinal disturbances such as vomiting, mucoid or soft
faeces and diarrhoea. They are mild and transient and generally do not require the
cessation of the treatment.
Other undesirable effects may be observed uncommonly: lethargy or hyperactivity,
anorexia, mild to moderate gingival hyperplasia, skin reactions such as verruciform
lesions or change of hair coat, red and swollen pinnae, muscle weakness or muscle
cramps.
Mild and transient salivation can be observed following treatment administration.
These effects generally resolve spontaneously after treatment is stopped.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
In very rare cases diabetes mellitus has been observed, especially in West Highland
White Terriers.
Cats:
In cats treated with ciclosporin the following undesirable effects were observed:
Very common: gastrointestinal disturbances such as vomiting and diarrhoea,
accompanied by weight loss. These are generally mild and transient and do not require
the cessation of the treatment. Increased appetite was also commonly observed.
Common: lethargy, anorexia, hypersalivation, hyperactivity, polydipsia, gingival
hyperplasia and lymphopaenia. These effects generally resolve spontaneously after
treatment is stopped or following a decrease in the dosing frequency.
Side effects may be severe in individual animals.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Consideration should be given to the use of other measures and/or treatments to
control moderate to severe pruritus when initiating therapy with ciclosporin
Special precautions for use in animals
Clinical signs of atopic dermatitis in dogs and allergic dermatitis in cats such as pruritus
and skin inflammation are not specific for these diseases. Other causes of dermatitis
such as ectoparasitic infestations, other allergies which cause dermatological signs
(e.g. flea allergic dermatitis or food allergy) or bacterial and fungal infections should
be ruled out before treatment is started. It is good practice to treat flea infestations
before and during treatment of atopic or allergic dermatitis.
A complete clinical examination should be performed prior to treatment. While
ciclosporin does not induce tumours, it does inhibit T-lymphocytes and therefore
treatment with ciclosporin may lead to an increased incidence of clinically apparent
malignancy due to the decrease in antitumour immune response. The potentially
increased risk of tumour progression must be weighed against the clinical benefit. If
lymphadenopathy is observed in animals being treated with ciclosporin, further clinical
investigations are recommended and treatment discontinued if necessary.
It is recommended to clear bacterial and fungal infections before administering the
veterinary medicinal product. However, infections occurring during treatment are not
necessarily a reason for drug withdrawal, unless the infection is severe.
In laboratory animals, ciclosporin is liable to affect the circulating levels of insulin and
to cause an increase in glycaemia. If signs of diabetes mellitus are observed following
the use of the product, e.g. polyuria, polydipsia, the dose should be tapered or
discontinued and veterinary care sought.'
In the presence of suggestive signs of diabetes mellitus, the effect of treatment on
glycaemia must be monitored. The use of ciclosporin is not recommended in diabetic
animals.
Particular attention must be paid to vaccination. Treatment with the veterinary
medicinal product may interfere with vaccination efficacy. In the case of inactivated
vaccines, it is not recommended to vaccinate during treatment or within a two-week
interval before or after administration of the product. For live vaccines see also section
4.3 “Contraindications”.
It is not recommended to use other immunosuppressive agents concomitantly.
Dogs: Closely monitor creatinine levels with severe renal insufficiency.
Cats:
Allergic dermatitis in cats can have various manifestations, including eosinophilic
plaques, head and neck excoriation, symmetrical alopecia and/or miliary dermatitis.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
The immune status of the cats to FeLV and FIV infections should be assessed before
treatment.
Cats that are seronegative for may be at risk of developing clinical
toxoplasmosis if they become infected while under treatment. In rare cases this can
be fatal. Potential exposure of seronegative cats or cats suspected to be seronegative
to should therefore be minimised (e.g. keep indoors, avoid raw meat or
scavenging). However, in a controlled laboratory study, treatment with ciclosporin did
not reactivate oocyst shedding in cats previously exposed to . In cases of
clinical toxoplasmosis or other serious systemic illness, stop treatment with ciclosporin
and initiate appropriate therapy.
Clinical studies in cats have shown that decreased appetite and weight loss may occur
during ciclosporin treatment. Monitoring of body weight is recommended. Significant
reduction in body weight may result in hepatic lipidosis. If persistent, progressive
weight loss occurs during treatment it is recommended to discontinue treatment until
the cause has been identified.
The efficacy and safety of ciclosporin has neither been assessed in cats less than 6
months of age nor weighing less than 2.3 kg.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Accidental ingestion of this product may lead to nausea and/or vomiting. To avoid
accidental ingestion, the product must be used and kept out of reach of children. Do
not leave unattended filled oral syringes in the presence of children. Any uneaten
medicated cat food must be disposed of immediately and the bowl washed thoroughly.
In case of accidental ingestion, particularly by a child, seek medical advice immediately
and show the package leaflet or the label to the physician. Ciclosporin can trigger
hypersensitivity (allergic) reactions. People with known hypersensitivity to ciclosporin
should avoid contact with the product. This product may cause irritation in case of eye
contact. Avoid contact with eyes. In case of contact, rinse thoroughly with clean water.
Wash hands and any exposed skin after use.
control moderate to severe pruritus when initiating therapy with ciclosporin
Special precautions for use in animals
Clinical signs of atopic dermatitis in dogs and allergic dermatitis in cats such as pruritus
and skin inflammation are not specific for these diseases. Other causes of dermatitis
such as ectoparasitic infestations, other allergies which cause dermatological signs
(e.g. flea allergic dermatitis or food allergy) or bacterial and fungal infections should
be ruled out before treatment is started. It is good practice to treat flea infestations
before and during treatment of atopic or allergic dermatitis.
A complete clinical examination should be performed prior to treatment. While
ciclosporin does not induce tumours, it does inhibit T-lymphocytes and therefore
treatment with ciclosporin may lead to an increased incidence of clinically apparent
malignancy due to the decrease in antitumour immune response. The potentially
increased risk of tumour progression must be weighed against the clinical benefit. If
lymphadenopathy is observed in animals being treated with ciclosporin, further clinical
investigations are recommended and treatment discontinued if necessary.
It is recommended to clear bacterial and fungal infections before administering the
veterinary medicinal product. However, infections occurring during treatment are not
necessarily a reason for drug withdrawal, unless the infection is severe.
In laboratory animals, ciclosporin is liable to affect the circulating levels of insulin and
to cause an increase in glycaemia. If signs of diabetes mellitus are observed following
the use of the product, e.g. polyuria, polydipsia, the dose should be tapered or
discontinued and veterinary care sought.'
In the presence of suggestive signs of diabetes mellitus, the effect of treatment on
glycaemia must be monitored. The use of ciclosporin is not recommended in diabetic
animals.
Particular attention must be paid to vaccination. Treatment with the veterinary
medicinal product may interfere with vaccination efficacy. In the case of inactivated
vaccines, it is not recommended to vaccinate during treatment or within a two-week
interval before or after administration of the product. For live vaccines see also section
4.3 “Contraindications”.
It is not recommended to use other immunosuppressive agents concomitantly.
Dogs: Closely monitor creatinine levels with severe renal insufficiency.
Cats:
Allergic dermatitis in cats can have various manifestations, including eosinophilic
plaques, head and neck excoriation, symmetrical alopecia and/or miliary dermatitis.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
The immune status of the cats to FeLV and FIV infections should be assessed before
treatment.
Cats that are seronegative for may be at risk of developing clinical
toxoplasmosis if they become infected while under treatment. In rare cases this can
be fatal. Potential exposure of seronegative cats or cats suspected to be seronegative
to should therefore be minimised (e.g. keep indoors, avoid raw meat or
scavenging). However, in a controlled laboratory study, treatment with ciclosporin did
not reactivate oocyst shedding in cats previously exposed to . In cases of
clinical toxoplasmosis or other serious systemic illness, stop treatment with ciclosporin
and initiate appropriate therapy.
Clinical studies in cats have shown that decreased appetite and weight loss may occur
during ciclosporin treatment. Monitoring of body weight is recommended. Significant
reduction in body weight may result in hepatic lipidosis. If persistent, progressive
weight loss occurs during treatment it is recommended to discontinue treatment until
the cause has been identified.
The efficacy and safety of ciclosporin has neither been assessed in cats less than 6
months of age nor weighing less than 2.3 kg.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Accidental ingestion of this product may lead to nausea and/or vomiting. To avoid
accidental ingestion, the product must be used and kept out of reach of children. Do
not leave unattended filled oral syringes in the presence of children. Any uneaten
medicated cat food must be disposed of immediately and the bowl washed thoroughly.
In case of accidental ingestion, particularly by a child, seek medical advice immediately
and show the package leaflet or the label to the physician. Ciclosporin can trigger
hypersensitivity (allergic) reactions. People with known hypersensitivity to ciclosporin
should avoid contact with the product. This product may cause irritation in case of eye
contact. Avoid contact with eyes. In case of contact, rinse thoroughly with clean water.
Wash hands and any exposed skin after use.
Various substances are known to competitively inhibit or induce the enzymes involved
in the metabolism of ciclosporin, in particular cytochrome P450 (CYP3A4). In certain
clinically justified cases, an adjustment of the dosage of the veterinary medicinal
product may be required.
The compound class of azoles (e.g. ketoconazole) is known to increase the blood
concentration of ciclosporin in dogs and cats, which is considered to be clinically
relevant. Ketoconazole at 5-10 mg/kg is known to increase the blood concentration of
ciclosporin in dogs up to five-fold. During concomitant use of ketoconazole and
ciclosporin the veterinarian should consider as a practical measure to double the
treatment interval if the dog is on a daily treatment regime. Macrolides such as
erythromycin may increase the plasma levels of ciclosporin up to twofold. Certain
Revised: April 2024
MA split from NI MA following AN: 03937/2022
inducers of cytochrome P450, anticonvulsants and antibiotics (e.g. trimethoprim/
sulfadimidine) may lower the plasma concentration of ciclosporin.
Ciclosporin is a substrate and an inhibitor of the MDR1 P-glycoprotein transporter.
Therefore, the co-administration of ciclosporin with P-glycoprotein substrates such as
macrocyclic lactones, e.g. ivermectin and milbemycin, could decrease the efflux of
such drugs from blood-brain barrier cells, potentially resulting in signs of CNS toxicity.
Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and
trimethoprim. The concomitant use of ciclosporin is not recommended with these
active ingredients.
Particular attention must be paid to vaccination (see section 4.3 “Contraindications”
and 4.5 “Special precautions for use”) and to concomitant
immunosuppressive agents (see section 4.5 “Special precautions for use”).
in the metabolism of ciclosporin, in particular cytochrome P450 (CYP3A4). In certain
clinically justified cases, an adjustment of the dosage of the veterinary medicinal
product may be required.
The compound class of azoles (e.g. ketoconazole) is known to increase the blood
concentration of ciclosporin in dogs and cats, which is considered to be clinically
relevant. Ketoconazole at 5-10 mg/kg is known to increase the blood concentration of
ciclosporin in dogs up to five-fold. During concomitant use of ketoconazole and
ciclosporin the veterinarian should consider as a practical measure to double the
treatment interval if the dog is on a daily treatment regime. Macrolides such as
erythromycin may increase the plasma levels of ciclosporin up to twofold. Certain
Revised: April 2024
MA split from NI MA following AN: 03937/2022
inducers of cytochrome P450, anticonvulsants and antibiotics (e.g. trimethoprim/
sulfadimidine) may lower the plasma concentration of ciclosporin.
Ciclosporin is a substrate and an inhibitor of the MDR1 P-glycoprotein transporter.
Therefore, the co-administration of ciclosporin with P-glycoprotein substrates such as
macrocyclic lactones, e.g. ivermectin and milbemycin, could decrease the efflux of
such drugs from blood-brain barrier cells, potentially resulting in signs of CNS toxicity.
Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and
trimethoprim. The concomitant use of ciclosporin is not recommended with these
active ingredients.
Particular attention must be paid to vaccination (see section 4.3 “Contraindications”
and 4.5 “Special precautions for use”) and to concomitant
immunosuppressive agents (see section 4.5 “Special precautions for use”).
Keep the bottle in the outer carton.
Do not refrigerate.
A jelly-like formation may occur below 15°C which is however reversible at
temperatures up to 25°C without affecting the quality of the product.
After first opening: Do not store above 25C.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
Do not refrigerate.
A jelly-like formation may occur below 15°C which is however reversible at
temperatures up to 25°C without affecting the quality of the product.
After first opening: Do not store above 25C.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 1
For the 30 and 60 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 2 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
PRIMARY PACKAGING TYPE 2
For the 30 and 50 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 3 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
INSTRUCTIONS FOR USE
Dogs: The veterinary medicinal product should be given at least 2 hours before or after
feeding. Insert the oral syringe directly into the dog’s mouth.
Cats: The product can be given either mixed with food or directly into the mouth in
cats.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 1
1 Push and turn the child-resistant screw cap to open the bottle.
Always close the bottle with the child-resistant screw cap after use
2 Keep the bottle upright and insert
the oral dosing syringe firmly into the
plastic adapter.
4 Return the bottle to its upright position and remove
the oral dosing syringe by gently twisting it out of the
plastic adapter.
plunger up so that the oral dosing syringe fills with
the product.
Withdraw the dose of medicine prescribed by your
veterinarian.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
5 You can now introduce the syringe in the mouth
of your animal and push the medicine out of the
syringe.
Do not rinse or clean the oral dosing syringe
between uses.
Note: If the prescribed dose is more than the
maximum volume marked on the oral dosing
syringe, you will need to reload the syringe to
withdraw the full dose.
Note: For cats, you can also give the product
mixed with food
6 Always close the bottle with the
child-resistant screw cap after use.
To provide a child-resistant closure,
push down on the child-resistant
screw cap as you turn it.
Keep out of the sight and reach of
children
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 2
1 Retrieve the plastic cap and insert firmly the plastic dispenser.
The plastic dispenser should remain in place.
2 Keep the bottle upright and insert
the oral dosing syringe firmly into the
plastic dispenser.
4 You can now introduce the syringe in the mouth of
your animal and push the medicine out of the syringe.
Do not rinse or clean the oral dosing syringe between
uses.
Note: If the prescribed dose is more than the
maximum volume marked on the oral dosing syringe,
you will need to reload the syringe to withdraw the full
dose.
Note: For cats, you can also give the product mixed with
food
Keep out of the sight and reach of children
plunger up so that the oral dosing syringe fills with
the product.
Withdraw the dose of medicine prescribed by your
veterinarian.
Return the bottle to its upright position and
remove the oral dosing syringe by gently twisting
it out of the plastic dispenser.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
If necessary, the user can wipe the outside of the oral syringe with a dry tissue and
dispose of used tissue immediately.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
There is no specific antidote and in case of signs of overdose the animal should be
treated symptomatically.
Dogs:
No undesirable effects beyond those that were seen under recommended treatment
have been observed in the dog with a single oral dose of up to 6 times of what is
recommended.
In addition to what was seen under recommended dosage, the following adverse
reactions were seen in case of overdose for 3 months or more at 4 times the mean
recommended dosage: hyperkeratotic areas especially on the pinnae, callous-like
lesions of the foot pads, weight loss or reduced weight gain, hypertrichosis, increased
erythrocyte sedimentation rate, decreased eosinophil values. Frequency and severity
of these signs are dose dependent.
The signs are reversible within 2 months following cessation of treatment.
Cats:
The following adverse events were seen in the case of repeated administration for 56
days at 24 mg/kg (more than 3x the recommended dose) or for 6 months at up to 40
mg/kg (more than 5x the recommended dose): loose/soft faeces, vomiting, mild to
moderate increases in absolute neutrophil counts, fibrinogen, activated partial
thromboplastin time (APTT), slight increases in blood glucose and reversible gingival
hypertrophy. Increased appetite was observed for both dose regimens. A transient
increase followed by a decrease in lymphocyte counts was observed in treated cats,
combined with a greater occurrence of palpable small peripheral lymph nodes. This
may reflect immunosuppression following prolonged exposure to ciclosporin. APTT
was prolonged in cats administered at least twice the recommended dose of
ciclosporin. The frequency and severity of these signs were generally dose and time
dependent. At 3x the recommended dose administered daily for nearly 6 months,
changes in ECG (conduction disturbances) commonly occur. They are transient and
not associated with clinical signs. Anorexia, recumbency, loss of skin elasticity, few or
absent faeces, thin and closed eye lids may be observed in sporadic cases at 5x the
recommended dose.
4.11 Withdrawal period(s)
Not applicable.
5.
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 1
For the 30 and 60 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 2 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
PRIMARY PACKAGING TYPE 2
For the 30 and 50 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml)
or the 3 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose
stated above, determined according to bodyweight.
INSTRUCTIONS FOR USE
Dogs: The veterinary medicinal product should be given at least 2 hours before or after
feeding. Insert the oral syringe directly into the dog’s mouth.
Cats: The product can be given either mixed with food or directly into the mouth in
cats.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 1
1 Push and turn the child-resistant screw cap to open the bottle.
Always close the bottle with the child-resistant screw cap after use
2 Keep the bottle upright and insert
the oral dosing syringe firmly into the
plastic adapter.
4 Return the bottle to its upright position and remove
the oral dosing syringe by gently twisting it out of the
plastic adapter.
plunger up so that the oral dosing syringe fills with
the product.
Withdraw the dose of medicine prescribed by your
veterinarian.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
5 You can now introduce the syringe in the mouth
of your animal and push the medicine out of the
syringe.
Do not rinse or clean the oral dosing syringe
between uses.
Note: If the prescribed dose is more than the
maximum volume marked on the oral dosing
syringe, you will need to reload the syringe to
withdraw the full dose.
Note: For cats, you can also give the product
mixed with food
6 Always close the bottle with the
child-resistant screw cap after use.
To provide a child-resistant closure,
push down on the child-resistant
screw cap as you turn it.
Keep out of the sight and reach of
children
Revised: April 2024
MA split from NI MA following AN: 03937/2022
PRIMARY PACKAGING TYPE 2
1 Retrieve the plastic cap and insert firmly the plastic dispenser.
The plastic dispenser should remain in place.
2 Keep the bottle upright and insert
the oral dosing syringe firmly into the
plastic dispenser.
4 You can now introduce the syringe in the mouth of
your animal and push the medicine out of the syringe.
Do not rinse or clean the oral dosing syringe between
uses.
Note: If the prescribed dose is more than the
maximum volume marked on the oral dosing syringe,
you will need to reload the syringe to withdraw the full
dose.
Note: For cats, you can also give the product mixed with
food
Keep out of the sight and reach of children
plunger up so that the oral dosing syringe fills with
the product.
Withdraw the dose of medicine prescribed by your
veterinarian.
Return the bottle to its upright position and
remove the oral dosing syringe by gently twisting
it out of the plastic dispenser.
Revised: April 2024
MA split from NI MA following AN: 03937/2022
If necessary, the user can wipe the outside of the oral syringe with a dry tissue and
dispose of used tissue immediately.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
There is no specific antidote and in case of signs of overdose the animal should be
treated symptomatically.
Dogs:
No undesirable effects beyond those that were seen under recommended treatment
have been observed in the dog with a single oral dose of up to 6 times of what is
recommended.
In addition to what was seen under recommended dosage, the following adverse
reactions were seen in case of overdose for 3 months or more at 4 times the mean
recommended dosage: hyperkeratotic areas especially on the pinnae, callous-like
lesions of the foot pads, weight loss or reduced weight gain, hypertrichosis, increased
erythrocyte sedimentation rate, decreased eosinophil values. Frequency and severity
of these signs are dose dependent.
The signs are reversible within 2 months following cessation of treatment.
Cats:
The following adverse events were seen in the case of repeated administration for 56
days at 24 mg/kg (more than 3x the recommended dose) or for 6 months at up to 40
mg/kg (more than 5x the recommended dose): loose/soft faeces, vomiting, mild to
moderate increases in absolute neutrophil counts, fibrinogen, activated partial
thromboplastin time (APTT), slight increases in blood glucose and reversible gingival
hypertrophy. Increased appetite was observed for both dose regimens. A transient
increase followed by a decrease in lymphocyte counts was observed in treated cats,
combined with a greater occurrence of palpable small peripheral lymph nodes. This
may reflect immunosuppression following prolonged exposure to ciclosporin. APTT
was prolonged in cats administered at least twice the recommended dose of
ciclosporin. The frequency and severity of these signs were generally dose and time
dependent. At 3x the recommended dose administered daily for nearly 6 months,
changes in ECG (conduction disturbances) commonly occur. They are transient and
not associated with clinical signs. Anorexia, recumbency, loss of skin elasticity, few or
absent faeces, thin and closed eye lids may be observed in sporadic cases at 5x the
recommended dose.
4.11 Withdrawal period(s)
Not applicable.
5.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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These products share the same active ingredient and may be suitable alternatives. Always consult your vet.
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Atopica 100 mg/ml Oral Solution for Cats and Dogs
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liquid
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Atopica 100 mg/ml Oral Solution for Cats and Dogs
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liquid
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