Profender 85.8 mg/ml + 21.4 mg/ml Multidose Spot-on Solution for Cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Each ml contains:
21.4 mg emodepside and 85.8 mg praziquantel.
Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essentialfor proper
administration of the veterinary
medicinal product
Butylhydroxyanisole (E320; as antioxidant)5.4 mg/mlIsopropylidene glycerolLactic acid
Clear yellow to brown solution.
3. CLINICAL PARTICULARS
3.1 Target species
Cats.
3.2 Indications for use, specifying the target species
For cats suffering from, or at risk from, mixed parasitic infections caused by
roundworms, tapeworms and lungworms of the following species:
Roundworms (nematodes)
Toxocara cati (mature adult, immature adult, L4 and L3)
Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent
lactogenic transmission to the offspring
Toxascaris leonina (mature adult, immature adult and L4)
Ancylostoma tubaeforme (mature adult, immature adult and L4)
Tapeworms (cestodes)
Dipylidium caninum (mature adult and immature adult)
Taenia taeniaeformis (adult)
Echinococcus multilocularis (adult)
Lungworms
Aelurostrongylus abstrusus (adult)
3.3 Contraindications
Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg.
Do not use in cases of hypersensitivity to the active substances or to any of the
excipients.
3.4 Special warnings for each target species
Shampooing or immersion of the animal in water directly after treatment may reduce
the efficacy of the veterinary medicinal product. Treated animals therefore should not
be bathed until the solution has dried.
Parasite resistance to any particular class of anthelmintic may develop following
frequent, repeated use of an anthelmintic of that class.
Unnecessary use of antiparasitics or use deviating from the instructions given in the
SPC may increase the resistance selection pressure and lead to reduced efficacy. The
decision to use the veterinary medicinal product should be based on confirmation of
the parasitic species and burden, or of the risk of infection based on its
epidemiological features, for each individual animal.
The possibility that other animals in the same household can be a source of re-
infection with roundworms, tapeworms and lungworms should be considered, and
these should be treated as necessary with an appropriate veterinary medicinal
product.
3.5 Special precautions for use
Special precautions for use in the target species:
Apply only to the skin surface and on intact skin. Do not administer orally or
parenterally.
Avoid the treated cat or other cats in the household licking the site of application while
it is wet.
There is limited experience on the use of the veterinary medicinal product in sick and
debilitated animals, thus the veterinary medicinal product should only be used based
on a benefit-risk assessment for these animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Read the package leaflet before use.
Do not smoke, eat or drink during application.
Avoid direct contact with application area while it is wet. Keep children away from
treated animals during that time.
Wash hands after use.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the veterinary medicinal product accidentally gets into eyes, they should be
thoroughly flushed with plenty of water.
If skin or eye symptoms persist, or in case of accidental ingestion, seek medical advice
immediately and show the package leaflet or the label to the physician.
Care should be taken not to allow children to have prolonged intensive contact (for
example, by sleeping) with treated cats during the first 24 hours after application of the
product.
Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable
disease to the World Organisation for Animal Health (WOAH), specific guidelines on
the treatment and follow-up, and on the safeguard of persons, need to be obtained
from the relevant competent authority.
Special precautions for the protection of the environment:
Not applicable.
Other precautions
The solvent in this product may stain certain materials including leather, fabrics,
plastics and finished surfaces. Allow the application site to dry before permitting
contact with such materials.
3.6 Adverse reactions (frequency and seriousness)
Cats:
Very rare
(< 1 animal / 10,000 animals
treated, including isolated
reports):
Neurological disorders
1,2,3
(ataxia
1,2,3
, tremor
1,2,3
)
Hypersalivation
, vomiting
, diarrhoea
Application site alopecia
, application site pruritus,
application site inflammation
Behavioural disorders (hyperactivity, anxiety,
vocalisation)
Anorexia, lethargy
Mild
Transient
These effects are thought to occur as a result of the cat licking the application site
immediately after treatment
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 the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
3.8 Interaction with other medicinal products and other forms of interaction
Emodepside is a substrate for P-glycoprotein. Co-treatment with other veterinary
medicinal products that are P-glycoprotein substrates/inhibitors (for example,
ivermectin and other antiparasitic macrocyclic lactones, erythromycin, prednisolone
and cyclosporine) could give rise to pharmacokinetic drug interactions. The potential
clinical consequences of such interactions have not been investigated.
3.9 Amounts to be administered and administration route
Spot-on use.
For external use only.
Dosage and treatment schedule
The recommended minimum doses are 3 mg emodepside / kg body weight and 12 mg
praziquantel / kg body weight, equivalent to 0.14 ml of the veterinary medicinal product
/ kg body weight (bw).
Either calculate the exact dose based on the individual body weight, or use the
following dose volumes recommended for the different weight ranges:
Body
weight
of cat (kg)
Volume
(ml)
EmodepsidePraziquantel(mg)(mg/kg bw)(mg)(mg/kg bw)0.5 - 2.50.357.53 - 153012 - 60>2.5 - 50.70153 - 66012 - 24>5 - 81.12243 - 4.89612 - 19.2>8 Appropriate combination of volumes
For the treatment of roundworms and tapeworms a single administration per treatment
is effective.
For the treatment of queens to prevent lactogenic transmission of Toxocara cati (L3
larvae) to the offspring, a single administration per treatment approximately seven
days prior to expected parturition is effective.
For the lungworm Aelurostrongylus abstrusus, two treatments administered two weeks
apart are effective.
Method of administration
Take the adapter, remove protective cover from the spike and insert spike into the
central area of the stopper. Remove screw cap. Take a standard disposable 1 ml
syringe with luer nozzle and connect it to the adapter. Then turn bottle up-side down,
and withdraw the necessary volume. Replace screw cap after use.
Part the fur on the cat’s neck at the base of the skull until the skin is visible. Place the
tip of the syringe on the skin and empty the contents directly onto the skin.
Application on the base of the skull will minimise the ability of the cat to lick the product
off.
Underdosing could result in ineffective use and may favour resistance development
To ensure a correct dosage, body weight should be determined as accurately as
possible. If animals are to be treated collectively, reasonably homogeneous groups
should be set up, and all animals of a group should be dosed at the rate corresponding
to the heaviest one.
3.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Salivation, vomiting and neurological signs (tremor) were observed occasionally when
the veterinary medicinal product was administered at up to 10 times the recommended
dose in adult cats and up to 5 times the recommended dose in kittens. These
symptoms were thought to occur as a result of the cat licking the application site. The
symptoms were completely reversible.
There is no antidote known.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary medicinal
products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal period(s)
Not applicable.
4.