Amoxicure, 30% w/w Powder for Oral Solution

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Amoxicillin

Διαθέσιμο από:

Oropharma n.v

Φαρμακολογική κατηγορία (ATC):

QJ01CA04

INN (Διεθνής Όνομα):

Amoxicillin

Φαρμακοτεχνική μορφή:

Powder for oral solution

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Pigeon (non-food producing)

Θεραπευτική περιοχή:

Antimicrobial

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2000-04-02

Αρχείο Π.Χ.Π.

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.