BIMASTAT 150 + 25 MG/ML ORAL SUSPENSION

Country: Kýpur

Tungumál: gríska

Heimild: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Virkt innihaldsefni:

SULFADIAZINE; NEOMYCIN SULFATE

Fáanlegur frá:

PANCHRIS FEEDS (VETERINARY) LTD (0000003032) INDUSTRIAL ZONE ARADIPPOU, 7100 LARNACA, P O BOX 40261

ATC númer:

QJ01RA02

INN (Alþjóðlegt nafn):

SULFONAMIDES, COMB WITH OTHER ANTIBACTERIALS EXCL TRIMETHOPRIM

Skammtar:

150 + 25 MG/ML

Lyfjaform:

ORAL SUSPENSION

Samsetning:

SULFADIAZINE (0000068359) 150MG; NEOMYCIN SULFATE (0001405103) 25MG

Stjórnsýsluleið:

ORAL USE

Gerð lyfseðils:

Εθνική Διαδικασία

Lækningarsvæði:

SULFONAMIDES, COMB WITH OTHER ANTIBACTERIALS EXCL TRIMETHOPRIM

Vörulýsing:

Νομικό καθεστώς: Με Ιατρική Συνταγή; VIAL X 250 ML (20V037301) 250 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή

Upplýsingar fylgiseðill

ΠΑΡΑΡΤΗΜΑ 2: ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ
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1/1

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ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ
ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimastat
Oral Suspension for pre-ruminant calves
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Sulfadiazine
150 mg/ml
Neomycin (as neomycin sulphate)
25 mg/ml
EXCIPIENTS:
Methyl parahydroxybenzoate
2.0 mg/ml
Propyl parahydroxybenzoate
0.2 mg/ml
Carmoisine E122
0.05 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pre-ruminant calves.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of diarrhoea in pre-ruminant calves associated with
infections caused by organisms known to be, or suspected of being,
susceptible to the combination of sulfadiazine and neomycin.
4.3
CONTRAINDICATIONS
Do not use in animals with know hypersensitivity to the active
ingredient.
Do not exceed the recommended dosage or the period of treatment.
Do not use local anesthetics of the procaine group during treatment as
they
are antagonistic to the sulphonamide component.
Do not use in calves with functional rumens.
Do not use in lactating cows.
Do not use in foals and horses.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Concurrent intravenous fluid therapy should be considered in
dehydrated
calves. Parenteral antibiotic treatment should be considered if a
clinical
response is not seen after 48 hours treatment.
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4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing of the
bacteria
isolated from the animal. If this is not possible, therapy should be
based on
local (regional, farm level) epidemiological information about
susceptibility of
the target bacteria.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Avoid contact with skin.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Chronic usage of oral neomycin may result