Marion 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:

Anfarm Hellas S.A.

ATC code:

J01DD04

INN (International Name):

ceftriaxone (ceftriaxone sodium)

Dosage:

1000mg

Pharmaceutical form:

powder for solution for injection/infusion

Units in package:

(1) glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-03-17

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT

MARION
Powder and Solvent for solution for I.M. injection 1g

MARION
Powder for solution for injection or infusion 1g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

MARION
Powder and Solvent for solution for I.M. injection 1g:
Each vial contains ceftriaxone sodium equivalent to ceftriaxone 1g.
Each
ampoule of solvent contains lidocaine hydrochloride 35mg, water for
injection qs 3.5ml

MARION Powder for solution for injection or infusion 1g:
Each vial contains ceftriaxone sodium equivalent to ceftriaxone 1g
3. PHARMACEUTICAL FORM
Powder and solvent for solution for I.M. injection
Powder for solution for injection or infusion
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, any of the infections listed above.
Treatment may be started before the results of susceptibility tests
are known.
Ceftriaxone should be co-administered with other antibacterial agents
whenever the
possible range of causative bacteria would not fall within