CEFTRIAXONE - FRESENIUS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CEFTRIAXONE AS SODIUM

Available from:

NEOPHARM (ISRAEL) 1996 LTD

ATC code:

J01DD04

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

CEFTRIAXONE AS SODIUM 1000 MG/VIAL

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

LABESFAL - LABORATORIOS ALMIRO S.A, FRESENIUS KABI GROUP, PORTUGAL

Therapeutic group:

CEFTRIAXONE

Therapeutic area:

CEFTRIAXONE

Therapeutic indications:

* Ceftriaxone-Fresenius 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-Fresenius 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 infectionsIn the management of neutropenic patients with fever that is suspected to be due to a bacterial infectionIn 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-Fresenius 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:

2018-04-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CEFTRIAXONE
–
FRESENIUS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1000 mg of ceftriaxone (as sodium).
Excipient with known effect: Sodium
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
For I.V/ I.M administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone -Fresenius 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 -Fresenius 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 -Fresenius 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.
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
hepatorenal function of the patient.
The doses recommended in the tables below are the generally
recommend