Ampimax Plus Injection 250/250

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Ampicillin Trihydrate , Cloxacillin Sodium

Available from:

Abacus Pharma Africa Limited, TANZANIA

ATC code:

Antibacterials for systemic use, beta-lactam anti

INN (International Name):

Ampicillin Trihydrate and Cloxacillin Sodium

Dosage:

250/250

Pharmaceutical form:

Injection

Manufactured by:

Reyoung Pharmaceutical Co., Limited, CHINA

Product summary:

Physical description: Ampicillin and cloxacillin for injection is white or almost white powder or crystalline powder.; Local technical representative: Abacus Pharma Africa Limited (8473)

Authorization status:

Registered/Compliant

Authorization date:

2021-08-20

Summary of Product characteristics

1.5.1 PRESCRIBING INFORMATION (SUMMARY OF PRODUCT CHARACTERISTICS)
1.
NAME OF THE MEDICINAL PRODUCT
Proprietary name: Ampimax Plus Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains Ampicillin Sodium BP equivalent to ampicillin 250mg
and Cloxacillin
Sodium BP equivalent to Cloxacillin 250mg
No any excipients are contained in this product.
3.
PHARMACEUTICAL FORM
Powder for injection.
A white or almost white powder or crystalline powder.
4.
CLINICAL PARTICULARS
_4.1._
_THERAPEUTIC INDICATIONS _
Ampicillin 250mg & Cloxacillin 250mg powder for injection is indicated
for the treatment of
infections in which susceptible organisms have been detected or are
suspected (see Section
5.1):
-
Surgery: post-operative wound infections, post-operative pulmonary
infections
-
Respiratory infections: bronchopneumonia, acute exacerbations of
chronic bronchitis
-
Obstetrics: puerperal fever
-
Bacteraemia when associated with, or suspected to be associated with,
any of the
infections listed in 4.1.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
_4.2._
_POSOLOGY AND METHOD OF ADMINISTRATION _
Intramuscular/
Intravenous
Adult
dosage (including Elderly):
One to two vials every four to six hours.
Children’s dosage:
_Up to two years: _Quarter adult dose
_Two to Ten years: _Half adult dose.
Dosage may be further increased where necessary. ADMINISTRATION
500 mg vials
_Intramuscular _
Dissolve vial contents in 1.5 ml Water for Injections BP.
_Intravenous _
Dissolve vial contents in 10 ml Water for Injections BP and administer
slowly (three to
four minutes). AMPICILLIN AND CLOXACILLIN FOR INJECTION may also be
added to
infusion fluids or injected, suitably diluted, into the drip tube over
a period of three to four
minutes.
Renal Impairment:
In cases of renal failure, the dosage should be adapted in accordance
with the following:
Hepatic impairment
Reduce frequency of administration depending on the severity of the
condition.
_4.3._
_CONTRAINDICATIONS _
Penicillin hyper