Milbetrin 12.5 mg/125 mg Tablets for Dogs

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Milbemycin oxime; Praziquantel

Доступно од:

Chanelle Pharmaceuticals Manufacturing Limited

АТЦ код:

QP54AB51

INN (Међународно име):

Milbemycin oxime; Praziquantel

Дозирање:

12.5, 125 mg/tablet

Фармацеутски облик:

Tablet

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска област:

milbemycin oxime, combinations

Статус ауторизације:

Authorised

Датум одобрења:

2019-06-14

Карактеристике производа

Health Products Regulatory Authority
17 June 2019
CRN000WL3
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbetrin 12.5 mg/125 mg Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each 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
Tablet
A brown flat round shaped tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (weighing more than 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 SPC point "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")
Health Products Regulatory Authority
17 June 2019
CRN000WL3
Page 2 of 5
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 case of hypersensitivity to the active substances or to
any of the excipients.
See section 4.5 Special precautions for use.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The use of the product should follow the implementation of appropriate
diagnostic measures towards mixed infections by
nematodes and cestodes with consideration of animal history and
characteristics (e.g. age, health status), en