Bimoxyl Capsules, 250 mg, Hard Capsules

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Amoxicillin

Available from:

Cross Vetpharm Group Ltd

ATC code:

QJ01CA04

INN (International Name):

Amoxicillin

Authorization status:

Expired

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Bimoxyl Capsules, 250mg, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Active Ingredient
mg per capsule
Amoxicillin
250
(as Amoxicillin trihydrate)
Capsule Body:
Erythrosin (E127)
0.0011
Quinoline yellow (E104)
0.00329
Titanium dioxide (E171)
0.48311
Capsule Cap:
Erythrosin (E127)
0.549
Ferric Oxide Red (E172)
0.244
Titanium dioxide (E171)
0.1952
Ink:
Black Iron Oxide (E172)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Red and white coloured hard gelatine capsule with the logo, AMOX 250,
printed in black ink.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated in the treatment and control of diseases caused by or
associated with
bacterial pathogens sensitive to Amoxicillin. These include the
following
groups of pathogens.
_Pasteurella_ spp.
_Staphylococci _(penicillin sensitive strains)
Bimoxyl Capsules SPC UK page 1 of 6
_Streptococci_
When susceptible organisms are present treatment may be effective in
the
following indications:
localised infections
alimentary tract infections
respiratory infections
urogenital tract infections
secondary bacterial infections
general infections
4.3
CONTRAINDICATIONS
Not to be administered to animals known to be sensitive to beta-lactam
products.
Do not treat dogs less than 10kg bodyweight.
Not to be administered to small herbivores.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As with all penicillins, the product may cause hypersensitivity
(allergy)
following ingestion. It should not be used when the dog is known to be
allergic to penicillins.
As with all other penicillins, bacterial resistance to amoxicillin may
occur.
Thus antibiotic sensitivity testing should be considered if a clinical
condition
fails to respond to treatment within 5 days.
In common with many antibiotics, administration of amoxicillin may
disturb
the gut flora.
4.5
SPECIAL PRECAUTIONS FOR USE
(I)
PRE