CEFTRIAXONE MEDO 1 GR

국가: 이스라엘

언어: 영어

출처: Ministry of Health

지금 구매하세요

제품 특성 요약 제품 특성 요약 (SPC)
27-11-2023
공공 평가 보고서 공공 평가 보고서 (PAR)
28-12-2023

유효 성분:

CEFTRIAXONE AS SODIUM

제공처:

A.L. MEDI-MARKET LTD.

ATC 코드:

J01DD04

약제 형태:

POWDER FOR SOLUTION FOR INJ/INF

구성:

CEFTRIAXONE AS SODIUM 1 G/VIAL

관리 경로:

I.M, I.V

처방전 유형:

Required

Manufactured by:

MEDOCHEMIE LTD (FACTORY C), CYPRUS

치료 영역:

CEFTRIAXONE

치료 징후:

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.

승인 날짜:

2021-03-17

제품 특성 요약

                                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
                                
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