Ampicare 250 mg Hard Capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Ampicillin

Inapatikana kutoka:

Cross Vetpharm Group Ltd

ATC kanuni:

amended)

INN (Jina la Kimataifa):

Ampicillin

Dawa fomu:

Capsule, hard

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Dogs

Eneo la matibabu:

Antimicrobial

Idhini hali ya:

Authorized

Idhini ya tarehe:

2000-03-24

Tabia za bidhaa

Revised: April 2010
(ATCVet code amended)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ampicare, 250mg, hard capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
mg per capsule
Ampicillin
250
(as ampicillin trihydrate)
Capsule Body
Erythrosine (E127)
0.952
Quinoline Yellow (E104)
0.004
Patent Blue V (E131)
0.002
Titanium Dioxide (E171)
0.368
Capsule cap
Ferric Oxide black (E172)
0.146
Titanium Dioxide (E171)
0.488
Ink:
Black Iron Oxide (E172)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Red and grey coloured hard gelatine capsule with the logo, AMP 250, 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 ampicillin. These include the
following groups of
pathogens:
_Streptococcus_ spp., _Pasturella haemolitica, P. multocida,
Staphylococcus aureus _
and other pathogenic staphylococci.
Page 1 of 5
Revised: April 2010
(ATCVet code amended)
When susceptible organisms are present treatment may be effective in
the
following indications:
alimentary tract infections
respiratory infections
urinary tract infections
4.3
CONTRAINDICATIONS
Not to be administered to animals known to be sensitive to penicillin.
Not to be administered to small herbivores.
Do not treat dogs of less than 10 kg bodyweight.
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 ampicillin may
occur. Thus
antibiotic sensitivity testing should be considered if a clinical
condition fails to
respond to treatment within 3 to 5 days.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
For oral administration only.
ii.
Special precautions to be taken by the p