Tipafar 5 mg/ml Solution for Injection for Dogs and Cats

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Atipamezole Hydrochloride

Inapatikana kutoka:

Vetpharma Animal Health, S.L

ATC kanuni:

QV03AB90

INN (Jina la Kimataifa):

Atipamezole Hydrochloride

Dawa fomu:

Solution for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cats, Dogs

Eneo la matibabu:

Neurological Agent

Idhini hali ya:

Expired

Idhini ya tarehe:

2013-09-19

Tabia za bidhaa

Issued: September 2013
AN: 00695/2012
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TIPAFAR 5 mg/ml Solution for injection for dogs and cats [AT, DE, ES,
FR,
PT, UK]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
ACTIVE SUBSTANCE:
Atipamezole .................................................4.27 mg
(as atipamezole hydrochloride 5.0 mg)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218) ............1.0 mg
For a full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Solution for Injection.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Atipamezole hydrochloride is a selective α2-antagonist and indicated
for reversal
of the sedative effects of medetomidine and dexmedetomidine in dogs
and cats.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance or any
other excipients.
Do not use in breeding animals.
Do not use in animals suffering from hepatic or renal or cardiac
diseases.
See also section 4.7
Issued: September 2013
AN: 00695/2012
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
After administration of the product, the animals should be allowed to
rest
in a quiet place. During the recovery phase, animals should not be
left
unattended. Make sure the animal has regained a normal swallowing
reflex before any food or drink is offered.
Due to different dosing recommendations caution should be taken using
the product off label in animals other than the target species.
If other sedatives different than (dex)medetomidine are administered,
it
must be taken into account that the effects of these other agents are
likely to persist after the reversal of the effects of
(dex)medetomidine.
Atipamezole does not reverse the effect of ketamine, which can cause
seizures in dogs and cause cramps in cats when used alone. Do not
admini