Gentamicin-K solution for injection

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

gentamicin (gentamicin sulfate)

Sẵn có từ:

KRKA d.d.

Mã ATC:

J01GB03

INN (Tên quốc tế):

gentamicin (gentamicin sulfate)

Liều dùng:

40mg/ml

Dạng dược phẩm:

solution for injection

Các đơn vị trong gói:

(10/2x5/) ampoules 1ml

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2017-05-11

Tờ rơi thông tin

87 /426
1.3.1
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Đặc tính sản phẩm

76/426
SPC,
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and
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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
SCO~.h
.
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