Ceftriaxone 500mg powder for solution for injection/infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ceftriaxone (ceftriaxone sodium)

Available from:

Arpimed LLC

ATC code:

J01DD04

INN (International Name):

ceftriaxone (ceftriaxone sodium)

Dosage:

500mg

Pharmaceutical form:

powder for solution for injection/infusion

Units in package:

(10) glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-12-26

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTIC (SPC)
CEFTRIAXONE 500 MG, powder for solution for i/m, i/v injection
and i/v infusion
CEFTRIAXONE 1000 MG, powder for solution for i/m, i/v injection
and i/v infusion
1.
NAME OF THE MEDICINAL PRODUCT
1.1
TRADE NAME – Ceftriaxone 500 mg, Ceftriaxone 1000 mg
1.2
INTERNATIONAL NON-PROPERTY NAME – Ceftriaxone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 500 mg vial contains:
_ACTIVE INGREDIENT_: ceftriaxone (as sodium salt) – 500 mg.
Each 1000 mg vial contains:
_ACTIVE INGREDIENT_: ceftriaxone (as sodium salt) – 1000 mg.
_For a full list of excipients, see section 6.1._
3.
PHARMACEUTICAL FORM
Ceftriaxone 500 mg, powder for solution for i/m, i/v
injection and i/v infusion
Powder for solution for i/m, i/v
injection and i/v infusion.
White to yellowish-orange crystalline powder.
Ceftriaxone 1000 mg, powder for solution for i/m, i/v injection and
i/v infusion
Powder for solution for i/m, i/v
injection and i/v infusion.
White to yellowish-orange crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone is indicated for the treatment of the following infections
in adults and children
including term neonates (from birth):
Bacterial Meningitis
Community acquired pneumonia
Hospital acquired pneumonia
Acute otitis media
Intra-abdominal infections
Complicated urinary tract infections (including pyelonephritis)
Infections of bones and joints
Complicated skin and soft tissue infections
Gonorrhoea
Syphilis
Bacterial endocarditis
Ceftriaxone may be used:
For treatment of acute exacerbations of chronic obstructive pulmonary
disease in adults
For treatment of disseminated Lyme borreliosis (early (stage II) and
late (stage III)) in adults
and children including neonates from 15 days of age.
For Pre-operative prophylaxis of surgical site infections
In the management of neutropenic patients with fever that is suspected
to be due to a bacterial
infection
In the treatment of patients with bacteraemia that occurs in
association with, or is suspected to
be associated with,