CLIVAL Powder for solution for injection 1.2g

البلد: تانزانيا

اللغة: الإنجليزية

المصدر: Tanzania Medicinces & Medical Devices Authority

العنصر النشط:

Amoxicillin , Clavulanic acid

متاح من:

Abacus Pharma Africa Limited, TANZANIA

ATC رمز:

Antibacterials for systemic use, Combinations of

INN (الاسم الدولي):

Amoxicillin and Clavulanic acid

جرعة:

1.2g

الشكل الصيدلاني:

Powder for solution for injection

المصنعة من قبل:

Reyoung Pharmaceutical Co.Ltd, CHINA

ملخص المنتج:

Physical description: white or almost white powder; Local technical representative: Abacus Pharma Africa Limited (8473)

الوضع إذن:

Registered/Compliant

تاريخ الترخيص:

2022-07-19

خصائص المنتج

TECHNICAL LEAFLET
1. NAME OF THE MEDICINAL PRODUCT
Proprietary name: CLIVAL 1.2g Powder for Solution for Injection or
Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1000mg amoxicillin (as sodium salt) and 200mg
clavulanic acid (as potassium salt).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A white or almost white powder.
4. CLINICAL PARTICULARS
_4.1.THERAPEUTIC INDICATIONS _
Co-amoxiclav is indicated for the treatment of the following
infections in adults and children (see
sections 4.2, 4.4 and 5.1):
• Severe infections of the ear, nose and throat (such as
mastoiditis, peritonsillar infections, epiglottitis
and sinusitis when accompanied by severe systemic signs and symptoms)
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
•
Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess with
spreading cellulitis.
• Bone and joint infections, in particular osteomyelitis
• Intra-abdominal infections
• Female genital infections
Prophylaxis against infections associated with major surgical
procedures in adults, such as those
involving the:
• Gastrointestinal tract
• Pelvic cavity
• Head and neck
• Biliary tract surgery
Consideration should be given to the official guidance on the
appropriate use of antibacterial agents.
_4.2.POSOLOGY AND METHOD OF ADMINISTRATION _
_CLIVAL 1.2G _
CO-AMOXICLAV FOR INJECTION 1000MG / 200MG
AMOXICILLIN / CLAVULANIC ACID
STERILE
Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when doses are
stated in terms of an individual component.
The dose of Co-amoxiclav that is selected to treat an individual
infection should take into account:
• The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
• The severity and the site of the infection
• The age, weight and renal fu