DIAZIGAL PREMIX VETERINARY

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

SULPHADIAZINE; TRIMETHOPRIM

Disponibbli minn:

BIOVAC LTD., ISRAEL

Għamla farmaċewtika:

POWDER

Kompożizzjoni:

SULPHADIAZINE 25 %W/W; TRIMETHOPRIM 5 %W/W

Rotta amministrattiva:

PER OS IN FOOD

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

BIOVAC LTD., ISRAEL

Indikazzjonijiet terapewtiċi:

For the treatment of infections caused by susceptible bacteria in broiler chicken, turkeys, preruminating calves and fish.

Data ta 'l-awtorizzazzjoni:

2023-11-30

Fuljett ta 'informazzjoni

CONSUMER LEAFLET FOR A VETERINARY PRODUCT
This medicine is marketed according to a veterinarian’s prescription
only.
For animal use only
1.
NAME OF THE VETERINARY MEDICINE, FORM AND STRENGTH
Diazigal premix veterinary
Powder for mixing in feed mixture
2. ACTIVE INGREDIENTS:
Sulfadiazine 25 % w/w
Trimethoprim 5 % w/w
For the list of excipients see section 13 "Additional information"
3. WHAT IS THE MEDICINE INTENDED FOR
For the treatment of infections caused by susceptible bacteria in
broiler chicken, turkeys,
Pre-ruminating calves and fish.
Therapeutic group: anti microbial product containing sulfonamide and
trimethoprim combination
4. CONTRAINDICATIONS
Do not use in calves with mature rumen. Do not use in animals with
severe disorders in the liver,
kidneys or blood system.
Do not use in cases of known sensitivity to sulfonamides or to any
other ingredient of the medicine.
5. SIDE EFFECTS
Precipitation of crystals in the kidneys is a theoretical risk and was
rarely reported. Hypersensitivity
to sulfonamides is also possible but rare.
Side effects can be reported to the Ministry of Health by clicking on
the link "Adverse Drug
Reactions Repot" that appears on the home page of the Ministry of
Health web site
(www.health.gov.il), which leads to an online form for reporting side
effects. Alternatively you can
use the following link: https://sideeffects.health.gov.il/
6. TARGET ANIMALS
Broiler chickens
Turkeys
Pre-ruminating calves
Fish
7. DOSAGE AND ADMINISTRATION
The recommended dosage in turkeys and broiler chickens is 1 kg of
Diazigal Premix in 1000 kg of
feed mixture for 5-7 days.
Calves: 3 kg of Diazigal Premix in 1000 kg of feed for 7 days.
Fish: 240 gram of Diazigal Premix per 1 ton of fish live weight, for
7-10 days. The consumption
of feed in fish varies according to the water temperature. Therefore,
consult the veterinarian for
adjusting the dosage. 8. HOW TO USE THE PRODUCT
To be administered in the feed mixture according to the veterinarian
instructions.
9. WITHDRAWAL TIME
Broiler chickens: 8 days
Turkeys

Karatteristiċi tal-prodott

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DiazigalPremix Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulfadiazine 25% w/w
Trimethoprim 5% w/w
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for feed.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens, turkeys, calves (pre-ruminating) and fish.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by susceptible bacteria in
broiler
chicken, turkeys, pre-ruminating calves and fish.
4.3
CONTRA-INDICATIONS
Do not administer to animals with known sulphonamide hypersensitivity
or to
any of the other ingredients of this medication .
Do not administer to calves with functionally mature rumens.
Do not administer to animals with severe hepatic or renal impairment
or with
blood dyscrasias.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Chickens and Turkeys: where appetite is depressed the inclusion rate
should be increased to achieve the correct dosage.
To avoid possible crystalluria, adequate water intake is essential.
Particular care is needed with animals suffering from renal damage.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animal
Incorporation into the feed must be performed by a suitably approved
manufacturer. Persons handling this product should avoid inhalation of
Page 2 of 4
any dust and contact with skin. Wear either a disposable half-mask
respirator conforming to European Standard EN 149 or a non-
disposable respirator to European Standard EN 140 with a filter to EN
143 when mixing or handling this product. Rubber gloves should be
worn when mixing or handling this product.
Hands should be washed thoroughly after use. Sulphonamides may
cause hypersensitivity (allergy) following injection, inhalation,
ingestion
or skin contact. Hypersensitivity to sulphonamides may lead to cross
reactions with other anti