Betamox 200mg Palatable Tablets

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

AMOXICILLIN TRIHYDRATE

Διαθέσιμο από:

Borneosew Medical Trading (M) Sdn Bhd

INN (Διεθνής Όνομα):

AMOXICILLIN TRIHYDRATE

Μονάδες σε πακέτο:

250.00 mcg/mL; 100.00 mcg/mL

Κατασκευάζεται από:

Norbrook Laboratories Limited

Αρχείο Π.Χ.Π.

PACKAGE INSERT
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Betamox 200mg Palatable Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS:
ACTIVE SUBSTANCE:
Amoxicillin
200 mg
(as Amoxicillin Trihydrate
229.7 mg)
EXCIPIENTS:
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
Off-white circular tablets scored on one face
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use in the treatment of bacterial infections of the alimentary,
respiratory and
urogenital tracts and in the eye, ear, skin and wound infections
caused by
susceptible organisms. _In vitro_, amoxicillin is effective against a
range of Gram-
positive and Gram-negative bacteria, including:
_Bacillus cereus _
_ _
_Bordetella bronchiseptica _
_ _
_Corynebacterium_ spp_ _
_ _
_Chromobacter_ spp
_ _
_Citrobacter freundii _
_ _
_Escherichia coli _
_ _
_Flavobacter_ spp_ _
_ _
_Proteus mirabilis _
_ _
_Pasteurella _spp_ including Pasteurella multocida _
_ _
_Salmonella_ spp
_ _
_Staphylococci _(penicillin sensitive strains)
_ _
_Streptococci _
_ _
4.3
CONTRAINDICATIONS
Betamox 200mg Palatable Tablets should not be given to penicillin
sensitive
animals. As with other penicillins, amoxicillin should not be used
orally or
parenterally in rabbits, guinea pigs, hamsters or gerbils. Caution is
advised when
used in other very small herbivores.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
No special precautions for use
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following injection, inhalation, ingestion or 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 sensitise