Streptomycin Sulphate Reig Jofre 1g powder for solution for injection

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

streptomycin (streptomycin sulfate)

Предлага се от:

LABORATORIO REIG JOFRE

АТС код:

J01GA01

INN (Международно Name):

streptomycin (streptomycin sulfate)

дозиране:

1000mg

Лекарствена форма:

powder for solution for injection

Броя в опаковка:

(100) glass vial 10ml

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2016-08-09

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
N
AME OF THE MEDICINAL PRODUCT
_ _
Reig Jofré streptomycin sulphate 1 g powder and solvent for solution
for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains:
-
Streptomycin (sulphate) 1g
-
Excipients:
See section 6.1 for full list of excipients.
3.
PHARMACEUTICAL
FORM
Powder and solvent for solution for injection.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Reig Jofre streptomycin sulphate is indicated for treating the
infections listed below in adults and children
:
- Tuberculosis
in all its forms (in conjunction with other tuberculostatics)
- Brucelosis
- Plague disease (infectious)
- Endocarditis caused by viridans group streptococci o
r
_S. faecalis _
(in conjunction with penicillin)
- Urinary tract infections
- Gonorrhea
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
_ _
1 g per day, which can be administered in two equal doses, 1 every 12
hours
_Children_
_ _
_ _
0.5 g per day, which can be administered in two equal doses, 1 every
12 hours
Children may be administered 20-40 mg/kg/day, in 2-4 doses, 1 every
6-12 hours.
_Elderly patients_
_ _
0.5g -1.5 g per day. Maximum dose: 2 g per day.
_Patients with impaired renal function_
_ _
Adjust dose according to creatinine clearance.
Route of administration
Streptomycin sulphate is administered via intramuscular injection.
4.3
CONTRA
-
INDICA
TIONS
Hypersensitivity
to
the
active
ingredient
or
to
aminoglycosides
in
general , since
there
is
evidence
of crossover allergy between them.
4.4
WARNINGS AND SPECIFIC PRECAUTIONS FOR USE
-
Streptomycin is neurotoxi c and can affect cranial nerve
VIII (particularly its vestibular branch) ,
causing
nausea,
vomiting,
vertigo
and
deafness
. The
incidence
of
these
adverse
effects,
more
pronounced in elderly patients and patients with impaired renal
function , is proportional to
t r e a t m e n t
d u r a t i o n
a n d
t o t a l
d o s e
administered
. Hearing
a n d
b a l a n c e
f u n c t i o n s
m u s t
be
monitored in patients undergoing prolonged periods