AMOXY-kel 15 150 mg amoxicillin/ml suspension for injection

Negara: Siprus

Bahasa: Yunani

Sumber: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες

Bahan aktif:

GRANTED

Tersedia dari:

QJ01CA04

Kode ATC:

AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 150MG/ML

INN (Nama Internasional):

GRANTED

Bentuk farmasi:

KELA N.V.

Rute administrasi :

SUSPENSION FOR INJECTION

Kelompok Terapi:

N. A. CHANCE TRADING CO

Ringkasan produk:

Withdrawal period: PIGS; Distributor: ANTIBACTERIALS FOR SYSTEMIC USE

Karakteristik produk

ΠΑΡΑΡΤΗΜΑ Ι: ΠΕΡΙΛΗΨΗ ΤΩΝ
ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AMOXY-KEL 15
_150 mg amoxicillin/ml_
_suspension for injection_
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Amoxycillin trihydrate equivalent with 150 mg
amoxycillin anhydrous.
EXCIPIENTS: Butylhydroxytoluene 1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET ANIMAL SPECIES
Pigs
4.2
INDICATIONS FOR USE IN THE SPECIFIED TARGET ANIMAL SPECIES
For the treatment of infections caused by amoxycillin-sensitive
Gram-positive and Gram-
negative pathogens and taking into account the antibiotic’s ability
to reach the site of the
infection in effective concentrations based on its pharmacokinetic
properties.
4.3
CONTRAINDICATIONS
Hypersensitivity to penicillins and cephalosporins.
Do not administer to ruminants, horses, lagomorphs and rodents such as
rabbits, guinea
pigs, hamsters or gerbils.
Do not administer to animals suffering from serious renal failure
associated with anuria
or oliguria.
4.4
SPECIAL WARNINGS FOR EACH ANIMAL SPECIES FOR WHICH THE VETERINARY
MEDICINAL
PRODUCT IS INTENDED
None
4.5
SPECIAL SAFETY PRECAUTIONS FOR USE
SPECIAL SAFETY PRECAUTIONS FOR USE IN ANIMALS
The sensitivity of the target pathogens to amoxycillin can change over
time.
An antibiogram may be necessary for treatment.
SPECIAL SAFETY MEASURES FOR THOSE ADMINISTERING THE MEDICINAL PRODUCT
TO THE
ANIMALS
Penicillins and cephalosporins can cause hypersensitivity (allergies)
after injection,
inhalation, intake or skin contact. Hypersensitivity to penicillins
may lead to cross-
1/11
reactions against cephalosporins and vice versa. Allergic reactions to
these products
can occasionally be serious.
Do not use this product in case of known sensitivity, or when you are
advised not to use
these products.
Be careful when using this product and take all recommended
precautions to prevent
exposure to the prod