Vetremox Fish 100% w/w Powder for Top-Dressing Use

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Amoxicillin Trihydrate

Διαθέσιμο από:

Pharmaq Ltd

Φαρμακολογική κατηγορία (ATC):

QJ01CA04

INN (Διεθνής Όνομα):

Amoxicillin Trihydrate

Φαρμακοτεχνική μορφή:

Powder for top-dressing use

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Salmon (Atlantic)

Θεραπευτική περιοχή:

Antimicrobial

Καθεστώς αδειοδότησης:

Expired

Ημερομηνία της άδειας:

1999-04-12

Αρχείο Π.Χ.Π.

Revised: 24 August 2010
AN: 00737/2010
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetremox Fish 100% w/w Powder for top-dressing use
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin trihydrate
100% w/w
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for top-dressing use
A fine white to cream crystalline powder
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Atlantic salmon
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Furunculosis in Atlantic salmon, caused by Aeromonas salmonicida
4.3
CONTRAINDICATIONS
In common with all other penicillins, Amoxycillin should not be used
orally or
parenterally in rabbits, guinea pigs, hamsters, gerbils or other very
small
herbivores.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None.
Revised: 24 August 2010
AN: 00737/2010
Page 2 of 5
ii.
Special
precautions
for
the
person
administering
the
veterinary
medicinal product to animals
Avoid
skin
contact.
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
EN
149
or
a
non-disposable
respirator to European Standard EN 140 with a filter to EN 143.
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 reaction to these substances
may occasionally be serious.
1.
Do not handle this product if you know you are sensitised, or if
you have been advised not to work with such preparations.
2.
Handle this product with great care to avoid exposure taking all
recommended precautions.
3.
If you develop symptoms following exposure, such as a skin
rash, you should seek medical advice and show the doctor this
warning.
Swelling
of
the
face,
lips
or