Amcofen 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 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:

12.5.125.0 mg/tablet

Pharmaceutical form:

Film-coated tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

milbemycin oxime, combinations

Authorization status:

Authorised

Authorization date:

2021-09-17

Summary of Product characteristics

Health Products Regulatory Authority
17 September 2021
CRN009WHS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Amcofen 12.5 mg/125 mg film-coated tablets for dogs weighing at least
5 kg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
​
ACTIVE SUBSTANCES:
​
​
Milbemycin oxime
​
12.5 mg
​
Praziquantel
​
125.0 mg
​
​
​
EXCIPIENTS:
​
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pale yellowish brown, oval, biconvex, mottled, film coated tablets.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (weighing at least 5 kg).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mixed infections by adult cestodes and nematodes of the
following species:
- Cestodes:
_Dipylidium caninum_
_Taenia_ spp.
_Echinococcus_ spp.
_Mesocestoides_ spp.
- Nematodes:
_Ancylostoma caninum_
_Toxocara canis_
_Toxascaris leonina_
_Trichuris vulpis_
_Crenosoma vulpis_ (Reduction of the level of infection)
_Angiostrongylus vasorum_ (Reduction of the level of infection by
immature adult (L5) and adult parasite stages; see specific
treatment and disease prevention schedules under section 4.9 Amounts
to be administered and administration route)
_Thelazia callipaeda_ (see specific treatment schedule under section
4.9 Amounts to be administered and administration route)
The product can also be used in the prevention of heartworm disease
(_Dirofilaria immitis_) if concomitant treatment against
cestodes is indicated.
4.3 CONTRAINDICATIONS
Do not use in dogs weighing less than 5 kg.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
See also section 4.5 Special precautions for use.
Health Products Regulatory Authority
17 September 2021
CRN009WHS
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Parasite resistance to any particular class of anthelmintic may
develop following frequent, repeated use of an anthelmintic of
that class.
It is recommended to trea