AMOXYGAL VETERINARY

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

AMOXICILLIN TRIHYDRATE

Fáanlegur frá:

BIOVAC LTD., ISRAEL

Lyfjaform:

POWDER

Samsetning:

AMOXICILLIN TRIHYDRATE 100 %W/W

Stjórnsýsluleið:

PER OS IN DRINKING WATER

Gerð lyfseðils:

Required

Framleitt af:

BIOVAC LTD., ISRAEL

Ábendingar:

For the treatment in bacterial infections sensitive to amoxicillin in broilers.

Leyfisdagur:

2023-10-31

Upplýsingar fylgiseðill

Page 1 of 3
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
AMOXYGAL VETERINARY, powder for dissolution in drinking water
2.
ACTIVE INGREDIENT AND QUANTITY IN A SINGLE DOSE
Amoxicillin trihydrate 100% w/w
3.
WHAT IS THE MEDICINE INTENDED FOR
For the treatment of bacterial infections sensitive to amoxicillin in
broilers.
Therapeutic group: antibiotic belonging to the semisynthetic
penicillin group.
4.
CONTRA-INDICATIONS
Do not administer the product to rabbits, hamsters, gerbils and guinea
pigs.
Do not treat animals with known sensitivity to penicillin or
beta-lactams.
5.
SIDE EFFECTS
No side effects were reported for the product.
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: Broilers.
Not for use in laying birds producing eggs for human consumption.
7.
DOSAGE AND ADMINISTRATION
The following formula may be used to calculate the amount of product
required per
day (in grams):
Number of birds x average live weight (kg)
66 (for dosage of 15 mg/kg)
To ensure a correct dosage, bodyweight should be determined as
accurately as
possible to avoid underdosing. The uptake of medicated water depends
on the
clinical condition of the birds. In order to obtain the correct dosage
the concentration
of amoxicillin has to be adjusted taking into account water intake.
The recommended dosage is 15 mg amoxicillin trihydrate per kg
bodyweight.
The total period of treatment should be for 3 consecutive days or in
severe cases for
5 consecutive days.
Page 2 of 3
8.
HOW TO USE THE PRODUCT
The product is administered in the drinking water. Prepare the
solution with fresh tap
water immediately befo

Vara einkenni

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AMOXYGAL VETERINARY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin trihydrate 100% w/w
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for oral solution. A white powder to almost white.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Broilers
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment in bacterial infections sensitive to amoxicillin in
broilers.Not
effective against beta-lactamase producing organisms.
Use of the product should be based on susceptibility testing and it
should take into
account official and local antimicrobial policies.
4.3
CONTRA-INDICATIONS
Amoxinsol 100 should not be administered to rabbits, hamsters, gerbils
and
guinea pigs.
Hyperseneitivity to the active substance.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in animals known to be hypersensitive to the active
ingredient
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None
ii.
Special precautions to be taken by the person administering the
veterinary
Page 2 of 4
medicinal product to animals
Avoid inhalation of dust.
Wash hands after use.
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following injection, inhalation, ingestion and skin contact.
Hypersensitivity
to penicillins may lead to cross reactions to cephalosporins and vice
versa.
Allergic reactions to these substances may occasionally be serious.
1) Do not handle this product if you know you are sensitised or if you
have
been advised not to work with such preparations.
2) Handle this product with great care to avoid exposure, taking all
recommended precautions.
3) If you develop symptoms following exposure such as a skin rash, you
should seek medical advice and show the doctor this warning. Swelling
of the face, lips or eyes or difficulty with breathing are more
serious
symptoms and require urgent medical attention.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None reported