CEFTRIAXONE MEDO 1 GR

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CEFTRIAXONE AS SODIUM

Available from:

A.L. MEDI-MARKET 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:

MEDOCHEMIE LTD (FACTORY C), CYPRUS

Therapeutic area:

CEFTRIAXONE

Therapeutic indications:

Ceftriaxone 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 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 aboveCeftriaxone 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:

2021-03-17

Summary of Product characteristics

Page 1 of 18
CEFTRIAXONE MEDO 1 GR
Powder for solution for injection/infusion
1.
Name of the medicinal product
CEFTRIAXONE MEDO 1 GR
Powder for solution for injection/infusion
2.
Qualitative and quantitative composition
Each vial of Ceftriaxone Medo 1 Gr contains 1 gr ceftriaxone as
ceftriaxone sodium
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.
Almost white or yellowish crystalline powder, slightly hygroscopic.
4.
Clinical particulars
4.1
Therapeutic Indications
Ceftriaxone Medo 1 Gr 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 MEDO 1 GR 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.
Page 2 of 18
Ceftriaxone Medo 1 Gr 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 metho