Amcofen 16 mg/40 mg chewable tablets for cats weighing at least 2 kg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Milbemycin oxime; Praziquantel

Available from:

Krka, d.d., Novo mesto

ATC code:

QP54AB51

INN (International Name):

Milbemycin oxime; Praziquantel

Dosage:

16, 40 mg/tablet

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

milbemycin oxime, combinations

Authorization status:

Authorised

Authorization date:

2018-07-27

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Milprazon CHEWABLE 16 mg/40 mg film-coated tablets for cats weighing
at least 2 kg (BE, BG,
CZ, DE, IT, LT, LV, NL, PT, RO, SI, SK, UK (NI))
Milprazon a croquer 16 mg/40 mg film-coated tablets for cats weighing
at least 2 kg (FR)
Milprazon Sabor 16 mg/40 mg film-coated tablets for cats weighing at
least 2 kg (ES)
Milprazon Plus 16 mg/40 mg film-coated tablets for cats weighing at
least 2 kg (HR, EE, HU, PL)
Amcofen 16 mg/40 mg chewable tablets for cats weighing at least 2 kg
(IE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCES:
Milbemycin oxime
16 mg
Praziquantel
40 mg
EXCIPIENTS:
Iron Oxide, yellow (E172)
0.03 mg
Iron Oxide, red (E172)
0.12 mg
Iron Oxide, black (E172)
0.05 mg
Titanium dioxide (E171)
0.21 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Brown, oval, biconvex film-coated tablets with score line on one side.
The tablets can be divided into halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats (weighing at least 2 kg).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mixed infections by immature and adult cestodes and
nematodes of the following
species:
- Cestodes:
_Dipylidium caninum_
_Taenia _spp.
_Echinococcus multilocularis_
- Nematodes:
_Ancylostoma tubaeforme_
CONFIDENTIAL
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_Toxocara cati_
Prevention of heartworm disease (_Dirofilaria immitis_) if concomitant
treatment against cestodes is
indicated.
4.3
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is recommended to treat all the animals living in the same
household concomitantly.
In order to develop an effective worm control programme local
epidemiological information and the
risk of exposure of the cat should be t