CEFUROXIME - VIT

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

CEFUROXIME AS SODIUM

Disponibil de la:

VITAMED LTD, ISRAEL

Codul ATC:

J01DC02

Forma farmaceutică:

POWDER FOR SOLUTION OR SUSPENSION FOR INJECTION OR INFUSION

Compoziție:

CEFUROXIME AS SODIUM 750 MG

Calea de administrare:

I.M, I.V

Tip de prescriptie medicala:

Required

Produs de:

ACS DOBFAR S.P. A, ITALY

Zonă Terapeutică:

CEFUROXIME

Indicații terapeutice:

CEFUROXIME – VIT is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth):• Community acquired pneumonia• Acute exacerbations of chronic bronchitis• Complicated urinary tract infections, including pyelonephritis• Soft-tissue infections: cellulitis, erysipelas and wound infections• Intra-abdominal infections• Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section)• nose infections for example, sinusitis• septic arthritis

Data de autorizare:

2023-11-30

Caracteristicilor produsului

Page 1 of 14
Cefuroxime - Vit
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cefuroxime - Vit
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 750 mg of cefuroxime (as 789 mg cefuroxime sodium).
Excipients with known effects:
Each vial contains approximately 42 mg sodium (1.8 mmol).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution or suspension for injection or infusion.
Vials containing a white or almost white powder.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Cefuroxime – Vit is indicated for the treatment of the infections
listed below in adults and
children, including neonates (from birth):
• Community acquired pneumonia.
• Acute exacerbations of chronic bronchitis.
• Complicated urinary tract infections, including pyelonephritis.
• Soft-tissue infections: cellulitis, erysipelas and wound
infections.
• Intra-abdominal infections.
• Prophylaxis against infection in gastrointestinal (including
oesophageal), orthopaedic,
cardiovascular, and gynaecological surgery (including caesarean
section).
• Nose infections for example, sinusitis.
• Septic arthritis.
In the treatment and prevention of infections in which it is very
likely that anaerobic organisms will be
encountered, cefuroxime should be administered with additional
appropriate antibacterial agents.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
Posology and method of administration
Posology
_Table 1. Adults and children ≥ 40 kg _
_ _
Indication
Dosage
Community
acquired
pneumonia
and
acute
exacerbations of chronic bronchitis
750 mg every 8 hours
(intravenously or intramuscularly)
Soft-tissue infections: cellulitis, erysipelas and
wound infections.
Page 2 of 14
Intra-abdominal infections
Sinusitis, septic arthritis
750 mg every 8 hours
(intravenously or intramuscularly). For more severe
infections, this dose should be increased to 1.5 g every 8
hours i.v. The frequency of i.m. or i.v. injections can