AAGENT, 50 mg/ml, solution for injection for calves and piglets up to one month old

Land: Kýpur

Tungumál: gríska

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

Virkt innihaldsefni:

GRANTED

Fáanlegur frá:

QJ01GB03

ATC númer:

GENTAMICIN 50 MG/ML (EQUIVALENT TO GENTAMYCIN SULPHATE)

INN (Alþjóðlegt nafn):

GRANTED

Lyfjaform:

FATRO SpA ITALY

Stjórnsýsluleið:

SOLUTION FOR INJECTION

Meðferðarhópur:

N. A. CHANCE TRADING CO

Vörulýsing:

Withdrawal period: CALVES PIGLETS (FIRST MONTH); Distributor: ANTIINFECTIVES FOR SYSTEMIC USE

Vara einkenni

ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ
ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AAGENT, 50 mg/ml, solution for injection for calves and piglets up to
one
month old.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
gentamicin
50 mg
equivalent to gentamicin sulphate
82 mg
EXCIPIENTS:
sodium methyl parahydroxybenzoate (E219)
1.8 mg
sodium propyl parahydroxybenzoate (E217)
0.2 mg
Sodium metabisulphite (E 223)
1.6 mg
Other excipients q.s. to
1 ml
For a complete list of the excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Calves and piglets up to one month old.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
AAGENT is indicated for the treatment of infectious diseases due
to Gram-positive and, principally, Gram-negative bacteria, also
secondary to viral infections, caused in particular by _Enterobacter_
spp., _E. coli_, _Klebsiella_ spp., _Proteus_ spp., _Pseudomonas_
spp.,
_Salmonella_ spp., _Shigella_ spp., _Treponema_ spp., staphylococci
and certain streptococci, in the pathologies of:
-
digestive system (bacterial enteritis, neonatal colibacillosis);
-
respiratory system (bronchopneumonia, pneumonia);
-
integumentary system (pyoderma, abscesses and septic
wounds);
-
septicemia.
4.3.
CONTRAINDICATIONS
Do not administer to animals with known hypersensitivity to
gentamicin.
The use of AAGENT is contraindicated in subjects with severely
compromised renal function.
1
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13
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
To be used exclusively in calves and piglets up to one month old.
4.5.
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Owing to possible variations (over time or geographical) in the
sensitivity of the target microbial species to gentamicin, a
sensitivity test should be performed.
Improper use of the product may increase the incidence of
bacteria resistant to gentamicin and reduce the efficacy of
treatments with other