Amcofen 2.5 mg/25 mg film-coated tablets for small dogs and puppies weighing at least 0.5 kg

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Milbemycin oxime; Praziquantel

Saadav alates:

Krka, d.d., Novo mesto

ATC kood:

QP54AB51

INN (Rahvusvaheline Nimetus):

Milbemycin oxime; Praziquantel

Annus:

2.5,25 mg/tablet

Ravimvorm:

Film-coated tablet

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline ala:

milbemycin oxime, combinations

Volitamisolek:

Authorised

Loa andmise kuupäev:

2021-09-17

Toote omadused

Health Products Regulatory Authority
17 September 2021
CRN009WHS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Amcofen 2.5 mg/25 mg film-coated tablets for small dogs and puppies
weighing at least 0.5 kg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCES:
Milbemycin oxime 2.5 mg
Praziquantel 25.0 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,
scored on one side.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (small dogs and puppies).
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 puppies of less than 2 weeks of age and/or weighing less
than 0.5 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 followi