Gentamicin-K solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

gentamicin (gentamicin sulfate)

Available from:

KRKA d.d.

ATC code:

J01GB03

INN (International Name):

gentamicin (gentamicin sulfate)

Dosage:

80mg/2ml

Pharmaceutical form:

solution for injection

Units in package:

(10/2x5/) ampoules 2ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-05-11

Patient Information leaflet

87 /426
1.3.1
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Summary of Product characteristics

76/426
SPC,
Labeling
and
Packa
e Leaflet
1.3.1
Gentamicin
sui
hate
AM
1.
NAME OF THE MEDICINAL PRODUCT
Gentamicin-K 40 mg/I
ml solution for injection
Gentamicin-K 80 mg/2
lUI
solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
40 mgll
ml solution for injection
1 mi
of solution for injection contains
40 mg gentamicin as 66.65 mg gentamicin sulphate.
One
ampoule (1 tnl of solution for injection)
contains 40 mg gentamicin as 66.65 mg gentamicin sulphate.
_80 mg/2_
tnl solution for injection
I
ml
of solution for injection contains 40 mg gentamicin as 66.65 mg
gentamicin
sulphate.
One
ampoule (2
1111
of solution for injection)
contains 80 mg gentamicin as 133.33 mg gentamicin sulphate.
Excipients:
1
ml of solution
2 ml of solution
methyl
parahydroxybenzoate
1.8
mg
3.6mg
(E218)
propyl
parahydroxybenzoate
0.2 mg
0.4 mg
(E216)
sodium metabisulphite
3.2 mg
6.4 mg
(E223)
3.
PHARMACEUTICAL
FORM
HPROVEO
BY
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.
EXPERT/OAT
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For
a full
list
of excipients,
see section 6.1.
Solution for injection
Clear,
colourless
to slightly yellow solution,
practically free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Gentamicin-K is indicated in adults and children of all age groupS
(pretenn infants,
newborn infants,
infants,
children,
adolescents).
Gentamicin-K (gentamicin)
is used for the treatment
of severe systemic infections
caused by aerobic
Gram-negative
bacteria susceptible to gentamicin.
These infections
include:
sepsis and other severe systemic infections -
meningitis,
peritonitis
(usually in combination
with beta-Iactatn antibiotics),
intra-abdominal
infections:
abscesses,
cholangitis
(usually in combination
with
metronidazole
or c1indamycin),
infections of the urinary tract
and respiratory tract,
secondary infections
of bums,
traumatic and surgical
wounds,
tularaemia,
respiratory infections
(pneumonia,
lung abscess),
SmPCPIL083863
2
20.10.2016-
U
dated:
21.10.2016
Pa e I
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CONFIDENTIAL
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77 /
426
1.3.1
Gentamicin
suI
hate
AM
SPC,
Labelill
e