Sanfur - 750 Powder and solvent for solution for injection 750/10 mg/ml

Valsts: Tanzānija

Valoda: angļu

Klimata pārmaiņas: Tanzania Medicinces & Medical Devices Authority

Aktīvā sastāvdaļa:

Cefuroxime Sodium

Pieejams no:

Sance Laboratories Private Limited, INDIA

ATĶ kods:

Cephalosporins

SNN (starptautisko nepatentēto nosaukumu):

Cefuroxime Sodium

Deva:

750/10 mg/ml

Zāļu forma:

Powder and solvent for solution for injection

Ražojis:

Sance Laboratories Private Limited, INDIA

Produktu pārskats:

Physical description: Sterile, White or faintly yellow powder, distributed in sealed containers and which, when shaken with the prescribed volume of sterile liquid, rapidly form clear and practically particle-free solution Sterile water for injection: Clear colourless, odourless liquid; Local technical representative: Moraf Pharmaceuticals Limited (5668)

Autorizācija statuss:

Registered/Compliant

Autorizācija datums:

2021-03-19

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SANFUR – 750 (Cefuroxime for Injection USP 750mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains:
Sterile Cefuroxime Sodium USP equivalent to anhydrous Cefuroxime 750mg
3.
PHARMACEUTICAL FORM
Dry powder for injection,
APPEARANCE OF POWDER: Sterile, white or faintly yellow powder,
distributed in sealed container
and which when shaken with the prescribed volume of sterile liquid,
rapidly form clear and
practically particle-free solution
4.
CLINICAL
PARTICULARS
THERAPEUTIC INDICATIONS
Cefuroxime for Injection 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 gynecological surgery (including
caesarean section)
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.
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.
Intra-abdominal infections
Complicated
urinary
tract
infections,
including pyelonephritis
1.5
g
every
8
hours
(intravenously
or
intramuscularly)
Severe infections
750 mg every 6 hours (intravenously)
1.5 g every 8 hours (intravenously)
Surgical
prophylaxis
for
gastrointestinal,
gynecological
surgery
(includi