PACKAGE LEAFLET FOR:
Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg
Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg
1. NAME AND PERMANENT ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURER, IF DIFFERENT
Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer responsible for batch release:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg
Milbemycin oxime, praziquantel
3. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each tablet contains:
Active substances:
Milbemycin oxime 16 mg
Praziquantel 40 mg
Reddish-brown, oval, biconvex film-coated tablets, with a score line on one side.
The tablet can be divided into equal halves.
4. THERAPEUTIC INDICATIONS
In cats: treatment of mixed infections by larval and adult cestodes and nematodes of the following species:
- Cestodes:
Dipylidium caninum
Taenia spp.
Echinococcus multilocularis
- Nematodes:
Ancylostoma tubaeforme
Toxocara cati
Prevention of heartworm disease (Dirofilaria immitis), if concomitant treatment against cestodes is indicated.
5. CONTRAINDICATIONS
Do not use in cats weighing less than 2 kg.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
6. ADVERSE REACTIONS
In very rare cases, after administration of the combination of milbemycin oxime and praziquantel, particularly in young cats, systemic signs (such as lethargy), neurological signs (such as muscle tremors/ataxia) and/or gastrointestinal signs (such as vomiting and diarrhoea) have been observed.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon immediately.
7. TARGET ANIMAL SPECIES
Cats (weighing at least 2 kg).
8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
For oral administration.
Animals should be accurately weighed to ensure precise dosing.
Minimum recommended dose: 2 mg of milbemycin oxime and 5 mg praziquantel per kg given orally as a single dose.
Depending on the cat's body weight, the practical dosing is as follows:
Body weight Film-coated tablets for
cats (red tablets)
2 – 4 kg ½ tablet
over 4 – 8 kg 1 tablet
over 8 – 12 kg 1½ tablets
9. ADVICE ON CORRECT ADMINISTRATION
The product should be administered with or after food. This ensures optimal protection against heartworm disease.
The product can be incorporated into a heartworm prevention program if concomitant treatment against tapeworms is indicated. The product has a duration of action for heartworm prophylaxis of one month. For regular prevention of the disease, the use of monoproducts is preferred.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store in the original package to protect from moisture. This veterinary medicinal product does not require any special temperature storage conditions.
Shelf life of tablet halves after first opening the immediate packaging: 6 months.
Any half tablets should be stored below 25 °C in the original package and used for the next administration.
Store blister in the carton.
Do not use this veterinary medicinal product after the expiry date which is stated on the blister and carton after "EXP:".
12. SPECIAL WARNINGS
Special precautions for each target species:
It is recommended to treat all animals living in the same household simultaneously.
For effective tapeworm control, epidemiological information (information on the presence and susceptibility of parasites to specific anthelmintic treatment), as well as the living conditions of the cat should be taken into account.
In the case of D. caninum tapeworm infection, concomitant treatment against intermediate hosts such as fleas and lice should be undertaken to prevent re-infection.
Frequent, repeated use of anthelmintics from the same class may lead to the development of parasite resistance to any class of anthelmintics (drugs acting against tapeworms).
Special precautions for use in animals:
No studies have been conducted with severely debilitated cats or those with severely compromised renal or hepatic function. The product is not recommended for such animals or may only be used after a benefit/risk assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental ingestion of tablets, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Echinococcosis is a hazard to humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on treatment and follow-up, as well as human health protection, must be obtained from the relevant competent authority.
Pregnancy and lactation:
The veterinary medicinal product can be used in breeding cats, including pregnant and lactating queens.
Interaction with other veterinary medicinal products and other forms of interaction:
Concomitant use of milbemycin oxime and praziquantel with selamectin is well tolerated.
No interactions were observed when the macrocyclic lactone selamectin, administered at the recommended dose, was given during treatment with the combination of milbemycin oxime and praziquantel at the recommended dose. Due to the lack of further studies, care should be taken in case of concomitant use of the product with other macrocyclic lactones. Also, no studies have been conducted in breeding animals.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose, in addition to the symptoms observed at the recommended dose (see section 6), drooling may be observed. This condition usually resolves spontaneously within one day.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
The product should not be disposed of in waterways as this may be dangerous for fish and other aquatic organisms.
14. DATE OF THE LAST REVISION OF THE TEXT
December 2014
15. ADDITIONAL INFORMATION
Box with 1 blister of 2 tablets.
Box with 1 blister of 4 tablets.
Box with 12 blisters, each blister containing 4 tablets.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Krka Bulgaria EOOD
1164, Sofia, ul. "Yakubitsa" 19, floor 4
Tel 02 962 34 50
Fax: 96235 20
Email: info.bg@krka.biz
