CEFTRIAXONE S.K.

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

CEFTRIAXONE AS SODIUM

Disponibil de la:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

Codul ATC:

J01DD04

Forma farmaceutică:

POWDER FOR SOLUTION FOR INJECTION

Compoziție:

CEFTRIAXONE AS SODIUM 1000 MG/VIAL

Calea de administrare:

I.M, I.V

Tip de prescriptie medicala:

Required

Produs de:

ANFARM HELLAS S.A., GREECE

Zonă Terapeutică:

CEFTRIAXONE

Indicații terapeutice:

Ceftriaxone S.K. 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 S.K. 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

Data de autorizare:

2022-09-30

Caracteristicilor produsului

Page 1 of 24
CEFTRIAXONE S.K.
POWDER FOR SOLUTION FOR INJECTION
1. NAME OF THE MEDICINAL PRODUCT
Ceftriaxone S.K.
1000 mg
Powder for solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial Ceftriaxone S.K. contains 1,193 mg of ceftriaxone sodium,
equivalent
to 1000 mg of ceftriaxone.
Excipient with known effect: Sodium
1000 mg 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.
Almost white or yellowish powder.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone S.K. 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
Page 2 of 24
−
Bacterial endocarditis
Ceftriaxone S.K. 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 S.K. 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 ADMINISTRAT