Butasal-100 100mg/ml+50mcg/ml solution for injection

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

butafosfan, vitamin B12

Commercializzato da:

Interchemie werken De Adelaar Eesti AS

Codice ATC:

QA13A

INN (Nome Internazionale):

butafosfan, vitamin B12

Dosaggio:

100mg/ml+50mcg/ml

Forma farmaceutica:

solution for injection

Confezione:

glass bottle 100ml

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2015-06-09

Foglio illustrativo

NAME
AND
ADDRESS
OF
THE
MARKETING
AUTHORISATION
HOLDER
AND
OF
THE
MANUFACTURING
AUTHORISATION
HOLDER
RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT:
Marketing authorisation holder:
Manufacturer and batch releaser:
Interchemie werken “De Adelaar” B.V.
Interchemie werken “De Adelaar” Eesti AS
Metaalweg 8
Vanapere tee 14
5804 CG Venray
Viimsi, Harju county
The Netherlands
Estonia
NAME PRODUCT:
Butasal-100.
PHARMACEUTICAL FORM:
A red solution for parenteral administration.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each ml contains:
- ACTIVE SUBSTANCES:
butafosfan
100 mg.
cyanocobalamin (vitamin B
12
)
50 μg.
- EXCIPIENTS:
benzyl alcohol
10.5 mg.
INDICATIONS:
Butasal-100 is indicated for debilitation by acute or chronic
metabolism disorders that result from poor nutrition, inadequate
management or disease (_e.g._ developmental and nutritional disorders
in young animals due to rearing disease, and
(secondary) ketosis in cows). It can be used for metaphylaxis of
infertility, puerperal diseases and in support of sterility
treatment. It acts as a roborant in cases of stress, overexertion,
exhaustion and reduced resistance, and as a tonic in cases of
weakness, secondary anaemia and chilling. Butasal-100 additionally
supports muscular physiology, the treatment of infertility,
and tetany and paresis as an adjunct to calcium and magnesium therapy.
CONTRA-INDICATIONS:
No contra-indications have been identified for Butasal-100 or any of
its constituents.
TARGET SPECIES:
Cattle, calves, horses, foals, goats, kids, sheep, lambs, swine,
piglets, poultry, dogs and cats.
ADVERSE REACTIONS:
No undesirable effects are known for this product.
Butasal-100 is an extremely safe product. It can be used without any
risk
during gestation and lactation, evidenced by a milk withholding period
of 0 days.
There are no known toxic effects of
overexposure to butafosfan or vitamin B12 in the quanities available
in this formulation. Butasal-100 can be considered to be
non-toxic.
Care should be taken to avoid injection throu