CEFTRIAXONE PANPHARMA 1 G

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CEFTRIAXONE AS SODIUM

Available from:

PHARMALOGIC LTD

ATC code:

J01DD04

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

CEFTRIAXONE AS SODIUM 1 G/VIAL

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

PANPHARMA LABORATORIES, FRANCE

Therapeutic group:

CEFTRIAXONE

Therapeutic area:

CEFTRIAXONE

Therapeutic indications:

Ceftriaxone PANPHARMA 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 endocarditisCeftriaxone PANPHARMA 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 ceftriaxone- susceptible 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 PANPHARMA should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Authorization date:

2023-08-31

Summary of Product characteristics

CEFTRIAXONE PANPHARMA 1 G
POWDER FOR SOLUTION FOR INJECTION/INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Ceftriaxone Panpharma 1 g
Powder for solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Ceftriaxone contains 1.196 g of ceftriaxone sodium,
equivalent to 1g of
ceftriaxone.
Excipient with known effect: Sodium
1g vial contains 3.6 mmol (or 83 mg) of sodium per vial.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to pale yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone Panpharma 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 Panpharma 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 ceftriaxone-susceptible 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 Panpharma 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 guidelines on the
appropriate use of antibacterial
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depe