Mektix 12.5 mg/125 mg chewable tablets for dogs weighing at least 5 kg

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Milbemycin oxime; Praziquantel

Sẵn có từ:

Krka, d.d., Novo mesto

Mã ATC:

QP54AB51

INN (Tên quốc tế):

Milbemycin oxime; Praziquantel

Liều dùng:

12.5, 125.0 mg/tablet

Dạng dược phẩm:

Chewable tablet

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Khu trị liệu:

milbemycin oxime, combinations

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2018-07-27

Đặc tính sản phẩm

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mektix 12.5 mg/125 mg
chewable tablets for dogs weighing at least 5 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable 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
Chewable tablet.
Yellowish-white with brown spots, round, slightly biconvex 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 case of hypersensitivity to the active substances or to
any of the excipients.
See also section 4.5 Special precautions for use.
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 treat all the animals in the same household
concomitantly.
In order to develop an effective worm control programme local
epidemiological information and the
risk of exposure of the dog should be taken into account, and it is
recommen