Amoxicure, 30% w/w Powder for Oral Solution

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
09-12-2022

Viambatanisho vya kazi:

Amoxicillin

Inapatikana kutoka:

Oropharma n.v

ATC kanuni:

QJ01CA04

INN (Jina la Kimataifa):

Amoxicillin

Dawa fomu:

Powder for oral solution

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Pigeon (non-food producing)

Eneo la matibabu:

Antimicrobial

Idhini hali ya:

Authorized

Idhini ya tarehe:

2000-04-02

Tabia za bidhaa

                                Revised 23 October 2008
AN: 00491/2008
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxicure, 30% w/w powder for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Amoxicillin (as amoxicillin trihydrate)
For full list of excipients, see section 6.1.
30.0 % w/w
3.
PHARMACEUTICAL FORM
Powder for oral solution.
Very fine, microcrystalline, white or almost white, almost odourless
or with a
faint characteristic odour of amoxicillin powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigeons.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the treatment of infections caused by micro-organisms
sensitive
to amoxicillin such as _Streptococcus gallolyticus._
4.3
CONTRA-INDICATIONS
Pigeons with a known hypersensitivity for penicillins should not be
treated
with the product.
Do not administer when β-lactamase producing bacteria are present.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised 23 October 2008
AN: 00491/2008
4.5
SPECIAL PRECAUTIONS FOR USE
I.
SPECIAL PRECAUTIONS FOR USE IN TARGET ANIMALS
Official, national and regional antimicrobial policies should be taken
into account when the product is used.
During treatment pigeons should not be allowed to drink from other
sources.
The drinking fountains have to be cleaned and disinfected in order to
prevent reinfections.
The medicated drinking water should not be prepared and held in
metal drinkers.
II.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Avoid
skin
contact
and
accidental
ingestion.
Whilst
handling
the
product wear coveralls, protective goggles and chemically resistant
impermeable gloves at all times.
Avoid
inhalation
of
dust.
Wear
either
a
disposable
half-mask
respirator
conforming
to
European
Standard
EN149
or
a
non-
disposable respirator to European Standard EN140 with a filter to
EN143.
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following
injection,
inhalation,
ingestion
or
skin
contact.

                                
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