Mirataz 20 mg/ml Transdermal Ointment for Cats
Active ingredient: Mirtazapine
Form
Solution
Species
Manufacturer
Dechra Regulatory B.V.
VMD MA No.
EU/2/19/247/003
What it's used for
Qualitative composition of excipients and other constituents Quantitative composition if that information is essential for proper administration of the vet...
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Mirataz 20 mg/ml Transdermal Ointment for Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
and other constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary
medicinal product
Butylhydroxytoluene (E321)0.01 mgMacrogol 400Macrogol 3350Diethylene glycol monoethyl etherCaprylocaproyl polyoxyglyceridesOleyl alcoholDimethiconeTapioca starch polymethylsilsesquioxane
of the ear) once daily for 14 days, at the dosage of 0.1 g ointment/cat (2 mg
mirtazapine/cat). This corresponds to a 3.8 cm line of ointment (see below).
Alternate the daily application between the left and right ears. If desired, the inner
surface of the cat’s ear may be cleaned by wiping with a dry tissue or cloth
immediately prior to the next scheduled dose. If a dose is missed, apply the
veterinary medicinal product the following day and resume daily dosing.
The recommended fixed dose has been tested in cats weighing between 2.1 kg and
7.0 kg.
To apply the veterinary medicinal product:
Step 1: Put on
impermeable
gloves.
Step 2: Press
down and twist
cap on tube
anticlockwise to
open.
Step 3: Gently
apply even
pressure on tube
and squeeze a 3.8
cm line of ointment
onto your index
finger using the
measured line on
the carton/bottle or
in this
leaflet as a guide.
Step 4: Using your
finger, gently rub
ointment on inside
surface of cat’s ear
(pinna) spreading it
evenly over the
surface. If contact
with your skin
occurs wash with
soap and water.
The line below coincides with the appropriate length of ointment to be applied:
Do not use in animals less than 7.5 months of age or less than 2 kg body weight.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in cats treated with cyproheptadine, tramadol or monoamine oxidase
inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the
veterinary medicinal product as there may be an increased risk of serotonin
syndrome (see section 3.8).
Very common
(>1 animal / 10 animals treated):
Application site reactions
a
(erythema,
crust/scab, residue, skin scaling/dry skin, flaking
skin, dermatitis or irritation, alopecia and
pruritus)
Behavioural disorders
a,b
(vocalisation,
hyperactivity, attention-seeking behaviour,
aggression)
Head shake
a
Disoriented state
a,b
, ataxia
a,b
Lethargy
a,b
Weakness
a,b
Common
(1 to 10 animals / 100 animals
treated):
Vomiting
a,b
Polyuria
a
(associated with a decreased urine
concentration) Elevated blood urea nitrogen
(BUN)
a
Dehydration
a,b
Rare
(1 to 10 animals / 10,000 animals
treated):
Hypersensitivity reaction
c
Hypersalivation
d
Tremor
d
a
Resolved at the end of treatment period with no specific treatment.
b
Depending on the severity, administration of the product may be discontinued
according to the benefit-risk
assessment of the veterinarian.
c
Treatment should be immediately withdrawn.
d
In case of oral ingestion, in addition to effects cited above (except local reactions).
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
than 3 years of age.
The efficacy and safety of the veterinary medicinal product has not been established
in cats with severe renal disease and/or neoplasia.
Proper diagnosis and treatment of the underlying disease is key to managing weight
loss, and treatment options are dependent on the severity of weight loss and
underlying disease(s). The management of any chronic disease associated with
weight loss should include providing appropriate nutrition and monitoring body weight
and appetite.
The therapy with mirtazapine should not replace necessary diagnostics and/or
treatment regimens needed to manage the underlying disease(s) causing unintended
weight loss.
The efficacy of the veterinary medicinal product was only demonstrated with a 14-day
administration corresponding to the current recommendations (see section 3.9).
Repetition of the treatment has not been investigated and as such should only be
done after benefit-risk balance assessment by the veterinarian.
The efficacy and safety of the veterinary medicinal product has not been established
in cats weighing less than 2.1 kg or more than 7.0 kg (see also section 3.9).
Special precautions for safe use in the target species:
The veterinary medicinal product should not be applied on damaged skin.
In the case of hepatic disease, elevated hepatic enzyme levels may be observed.
Kidney disease may cause reduced clearance of mirtazapine, which may result in
higher drug exposure. In these special cases, biochemical hepatic and renal
parameters should be regularly monitored during the treatment.
The effects of mirtazapine on glucose regulation have not been evaluated. In the
case of use in cats with diabetes mellitus, glycaemia should be regularly monitored.
When used in hypovolemic cats, supportive treatment (fluid therapy) should be
implemented.
Care should be taken that other animals in the household do not come in contact with
the application site until it is dry.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
The veterinary medicinal product can be absorbed via cutaneous or oral use and can
cause drowsiness or sedation.
Avoid direct contact with the veterinary medicinal product. Avoid contact with the
treated animal for the first 12 hours after each daily application and until the
application site is dry. It is therefore recommended to treat the animal in the evening.
Treated animals should not be allowed to sleep with owners, especially children and
pregnant women during all the period of the treatment.
Impermeable disposable protective gloves should be provided at the point of sale
with the veterinary medicinal product and must be worn when handling and
administering the veterinary medicinal product.
Thoroughly wash hands immediately after administration of the veterinary medicinal
product or in case of skin contact with the product or the treated cat.
Limited data are available on the reproductive toxicity of mirtazapine. Given that
pregnant women are considered a more sensitive population, it is recommended that
pregnant women or women trying to conceive should avoid handling the veterinary
medicinal product and avoid contact with treated animals throughout the treatment
period.
The veterinary medicinal product may be harmful after ingestion.
Do not leave the child resistant tube out of its carton except during the application
phase. The child resistant tube must be placed in the carton immediately after use.
Children must not be present when applying the treatment to the cat.
Do not eat, drink or smoke while handling the veterinary medicinal product.
The veterinary medicinal product is a skin sensitiser. People with known
hypersensitivity to mirtazapine should avoid contact with the veterinary medicinal
product.
This veterinary medicinal product may cause eye and skin irritation. Avoid hand to
mouth and hand to eye contact until hands have been thoroughly washed. In the
case of contact with eyes, rinse the eyes thoroughly with clean water. In the case of
contact with the skin, wash thoroughly with soap and warm water. If skin or eye
irritation occurs or in case of accidental ingestion, seek medical advice immediately
and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the
veterinary medicinal product as there may be an increased risk of serotonin
syndrome (see section 3.3).
Mirtazapine may increase sedative properties of benzodiazepines and of other
substances with sedative properties (antihistamines H1, opiates). The plasma
concentrations of mirtazapine may be also increased when used concomitantly with
ketoconazole or cimetidine.
The child resistant tube should be closed and returned to the carton immediately
after every use.
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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