Milaxyn Plus XL Tablets For Dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Praziquantel; Pyrantel embonate ; Febantel

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP52AA51

INN (International Name):

Praziquantel; Pyrantel embonate ; Febantel

Dosage:

175,504,525 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

CAM: Companion Animal Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

praziquantel, combinations

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2013-04-12

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Milaxyn Plus XL Tablets For Dogs (IE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Praziquantel 175 mg
Pyrantel Embonate 504 mg (equivalent to 175 mg pyrantel)
Febantel
525 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF
EXCIPIENTS AND OTHER CONSTITUENTS
Lactose monohydrate,
Microcrystalline cellulose,
Magnesium stearate,
Colloidal anhydrous silica,
Croscarmellose sodium,
Sodium laurilsulfate
Pork flavour
A yellow-coloured oblong tablet with a breakline on both sides.
The tablets can be divided into equal halves.
3. CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of mixed infections by nematodes and cestodes of the
following species
NEMATODES:
ASCARIDS:
_Toxocara canis_
,
_Toxascaris leonina_
(adult and late immature forms).
HOOKWORMS:
_Uncinaria stenocephala_
,
_Ancylostoma caninum_
(adults).
WHIPWORMS:
_Trichuris vulpis_
(adults).
CESTODES:
TAPEWORMS:
_Echinococcus_
species
_(E. granulosus, E. multilocularis), Taenia_
species
_(T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum_
(adult and immature forms).
3.3
CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
Do not use during the 1st and 2nd trimester of pregnancy (Refer to
section 3.7).
3.4
SPECIAL WARNINGS
2
Fleas serve as intermediate hosts for one common type of tapeworm –
_Dipylidium caninum_
.
Tapeworm infestation is certain to reoccur unless control of
intermediate hosts such as fleas, mice, etc.
is undertaken.
To minimise the risk of reinfestation and new infestation, excreta
should be collected and properly
disposed of for 24 hours following treatment.
Parasite resistance to any particular class of anthelmintic may
develop following frequent, repeated
use of an anthelmintic of that class.
Unnecessary use of antiparasitics or use deviating from the
instructions given in the SPC may increase