Intertrim-480 Oral suspenion oral

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

trimethoprim, sulfadiazine

Beschikbaar vanaf:

Interchemie werken 'De Adelaar' B.V.

ATC-code:

QP01EW10

INN (Algemene Internationale Benaming):

trimethoprim, sulfadiazine

Dosering:

80mg/ml+ 400mg/ml

farmaceutische vorm:

suspenion oral

Eenheden in pakket:

plasstic bottle 1000ml

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2015-09-04

Bijsluiter

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT:
Interchemie werken “De Adelaar” B.V.
Metaalweg 8
5804 CG Venray
The Netherlands
NAME PRODUCT:
Intertrim-480 Oral.
DESCRIPTION APPEARANCE:
A white suspension for oral administration.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each ml contains:
- ACTIVE SUBSTANCE:
sulfadiazine (as sodium)
400 mg.
trimethoprim
80 mg.
- EXCIPIENTS:
benzyl alcohol
10.5 mg.
INDICATIONS:
Intertrim-480 Oral is indicated for gastrointestinal and respiratory
infections caused by trimethoprim and
sulfadiazine
sensitive
micro-organisms
such
as
E.
coli,
Haemophilus,
Pasteurella,
Salmonella,
Staphylococcus and Streptococcus spp. in calves, goats, poultry, sheep
and swine.
CONTRA-INDICATIONS:
Hypersensitivity to trimethoprim and/or sulphonamides.
Administration to animals with a seriously impaired renal and/or
hepatic function or with blood dyscrasias.
TARGET SPECIES:
Calves, goats, sheep, poultry and swine.
ADVERSE REACTIONS:
After long-term treatment and high dosages crystalluria can occur.
When symptoms of crystalluria occur
(haemoturia, kidney colic), treatment has to be stopped immediately
and for example sodium carbonate
(alkalinises) has to be administered for increasing urine solubility
of sulfadiazine. Administration for a
prolonged period also increases the risk for blood dyscrasias.
Anaemia, leucopenia and thrombocytopenia
may occur. Overdoses can result in renal toxicity. Because of possible
sensitisation and contact dermatitis,
direct skin contact has to be avoided during administration.
DOSAGE AND ADMINISTRATION:
For oral administration.
Calves, goats and sheep:
Twice daily, 5 ml per 100 kg body weight for 4 – 7 days.
Poultry and swine:
1 litre per 1500 - 2500 litres of drinking water for 4 - 7 days.
Note: for pre-ruminant calves, lambs and kids only. Shake well before
use.
WITHDRAWAL TIMES:
For meat
- Calves, goats, sheep and swine:
8 days.
- Poultry:
5 days.
PA