Luminaletten vet, 15 mg tablets for dogs
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
18-09-2013
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Active ingredient:
phenobarbital 15 mg
Available from:
Desitin Arzneimittel GmbH
ATC code:
QN03AA02
Pharmaceutical form:
Tablet
Therapeutic group:
Phenobarbital
Therapeutic area:
Dogs Non Food
Authorization date:
2010-09-29
Summary of Product characteristics
Desitin Arzneimittel GmbH
Phenobarbital, 15 mg tablets
DE/V/0141/001
PART 1B: PRODUCT INFORMATION
06/2013
C O N F I D E N T I A L
Page 1/9
1.B.1 SUMMARY
OF
PRODUCT CHARACTERISTICS
_Phenobarbital _
_15 mg _
_tablets _
Desitin Arzneimittel GmbH
Phenobarbital, 15 mg tablets
DE/V/0141/001
PART 1B: PRODUCT INFORMATION
06/2013
C O N F I D E N T I A L
Page 2/9
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
(DE) Luminaletten vet, 15 mg tablets for dogs
(AT, BE, DK, ES, FR, NL, PT, SE) Epirepress 15 mg, tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Phenobarbital 15 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, slightly domed tablets, diameter 5.7 mm, with TC imprinted on one side and a breakline
on the other side. The tablets cannot be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Prevention of seizures due to generalised epilepsy in dogs.
4.3
CONTRAINDICATIONS
Do not use in the case of hypersensitivity to the active substance or to any other barbiturates or to any
of the excipients.
Do not use in animals with severe impaired hepatic function.
Do not use in animals with serious renal and/or cardiovascular/respiratory disorders.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The decision to start antiepileptic drug therapy with phenobarbital should be evaluated for each
individual case and depends on number, frequency, duration and severity of seizures in dogs.
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