CETAFOR Powder and solvent for solution for injection 1000 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Ceftriaxone 1000 mg, Powder for Solvent for Solution for Injection IV

Available from:

Dafra Pharma GmbH, SWITZERLAND

ATC code:

Antibacterials for systemic use, Third-generation

INN (International Name):

Ceftriaxone 1000 mg, Powder for Solvent for Solution for Injection IV

Dosage:

1000 mg

Pharmaceutical form:

Powder and solvent for solution for injection

Manufactured by:

PharmaVision San. Ve Tic. A.S, TURKEY

Product summary:

Physical description: Powder: Sterile white to yellowish crystalline powder Solvent: Clear, colourless sterile solution Solution of powder reconstituted with the solvent: Clear solution; Local technical representative: Harleys (T) Limited (4194)

Authorization status:

Registered/Compliant

Authorization date:

2021-03-29

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1-
NAME OF THE MEDICINAL PRODUCT (FPP)
Cetafor
Ceftriaxone
_ _
1.1
STRENGTH
1000 mg IV, 500 mg IV, 1000 mg IM
1.2
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
2-
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
Cetafor® 1000 mg IV: the vial contains 1193 mg sodium ceftriaxone
equivalent to 1000
mg ceftriaxone. Solvent: 10 ml water for injection.
•
Cetafor® 500 mg IV: the vial contains 596 mg sodium ceftriaxone
equivalent to à 500 mg
ceftriaxone. Solvent: 5 ml water for injection.
•
Cetafor® 1000 mg IM: the vial contains 1193 mg sodium ceftriaxone
equivalent to 1000
mg ceftriaxone. Solvent: 4 ml of Lidocaine hydrochloride 10 mg/ml
(1%).
Excipients with known effect
Cetafor contains approximately 83 mg (3.6 mmol) of sodium per 1000 mg
ceftriaxone.
For the full list of excipients, see section 6.1
3-
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
_Powde_r: Sterile white to yellowish crystalline powder
_Solvents_: Clear, colourless sterile solution
_Solution of powder reconstituted with the solvent: _Clear solution
4-
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cetafor 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
Cetafor 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