Ceftriaxone 1g powder for solution for injection powder for solution for injection

देश: आर्मेनिया

भाषा: अंग्रेज़ी

स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

सक्रिय संघटक:

ceftriaxone (ceftriaxone sodium)

थमां उपलब्ध:

CP Pharmaceuticals Ltd.

ए.टी.सी कोड:

J01DD04

INN (इंटरनेशनल नाम):

ceftriaxone (ceftriaxone sodium)

डोज़:

1000mg

फार्मास्यूटिकल फॉर्म:

powder for solution for injection

पैकेज में यूनिट:

(10) glass vials

प्रिस्क्रिप्शन प्रकार:

Prescription

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2019-10-30

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftriaxone 1g Powder for solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains ceftriaxone sodium equivalent to 1g of ceftriaxone.
Excipient with known effect
Each gram of ceftriaxone contains approximately82 mg (3.6mmol) of
sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for solution for injection (Powder for injection).
White to pale yellow crystalline powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone is indicated in 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
Ceftriaxone should be co-administered with other antibacterial agents
whenever
the possible range of causative bacteria would not fall within its
spectrum (see
section 4.4).
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depends on the severity, susceptibility, site and type of
infection and
on the age and hepato-renal function of the patient.
The doses recommend