Drontal Oral Suspension for Puppies

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Febantel; Pyrantel

Dostopno od:

Bayer Limited

Koda artikla:

QP52AF02

INN (mednarodno ime):

Febantel; Pyrantel

Odmerek:

15 / 5 milligram(s)/millilitre

Farmacevtska oblika:

Oral suspension

Tip zastaranja:

CAM: Companion Animal Medicine as defined in relevant national legislation

Terapevtska skupina:

Dogs

Terapevtsko območje:

pyrantel

Terapevtske indikacije:

Endoparasiticide

Status dovoljenje:

Authorised

Datum dovoljenje:

2008-05-23

Lastnosti izdelka

Health Products Regulatory Authority
27 November 2018
CRN008RNV
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Oral Suspension for Puppies
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES
Febantel
15.0
mg
Pyrantel
5.0
mg (as pyrantel embonate 14.4mg)
EXCIPIENTS:
Sodium benzoate (E211)
2.05
mg
Sodium propionate (E281)
2.05
mg
Ponceau 4R (E124)
0.25
mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
Pale red suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (puppies and young dogs up to one year of age)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of roundworm infections in puppies and young dogs up
to one
year of age caused by:
Ascarids: Toxocara canis
Toxascaris leonina
Hookworms: Ancylostoma caninum
Uncinaria stenocephala
Whipworm: Trichuris vulpis
4.3 CONTRAINDICATIONS
Do not use simultaneously with compounds containing piperazine. See
sections 4.7
and 4.8.
Health Products Regulatory Authority
27 November 2018
CRN008RNV
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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The safety of the product has not been assessed in puppies younger
than 2 weeks
and weighing less than 0.600 kg.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Wash hands after use.
Avoid direct contact with the skin and eyes. In case of accidental
spillage wash the
affected area immediately with clean running water.
OTHER PRECAUTIONS
None
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In very rare cases mild transient digestive tract signs (e.g.,
vomiting diarrhoea) may
occur.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Do not use in pregnant and lactating bitches.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FO