PENIBRIN 500 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMPICILLIN AS SODIUM

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

J01CA01

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

AMPICILLIN AS SODIUM 500 MG/VIAL

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

SANDOZ GmbH, AUSTRIA

Therapeutic group:

AMPICILLIN

Therapeutic area:

AMPICILLIN

Therapeutic indications:

Penibrin injection is recommended in serious infections when prompt, effective levels of the antibiotic must reach the site of infection.Such infections include meningitis, subacute bacterial endocarditis, peritonitis, septicemia, severe forms of chronic bronchitis, osteomyelitis, pneumonia and pyelonephritis due to susceptible organisms.

Authorization date:

2021-12-31

Patient Information leaflet

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Summary of Product characteristics

SUMMARY OF PRODUCT
CHARACTERISTICS
PENIBRIN
® 500 MG
PENIBRIN
® 1 G
PENIBRIN
® 2 G
POWDER FOR SOLUTION FOR INJECTION/INFUSION
FOR I.M. OR I.V. INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
PENIBRIN
®
500 mg
PENIBRIN
®
1 g
PENIBRIN
®
2 g
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
PENIBRIN 500 MG:
One vial contains 531.4 mg of ampicillin sodium
(equivalent to 500 mg ampicillin).
PENIBRIN 1 G:
One vial contains 1063 mg of ampicillin sodium
(equivalent to 1000 mg ampicillin).
PENIBRIN 2 G:
One vial contains 2126 mg of ampicillin sodium
(equivalent to 2000 mg ampicillin).
Excipient with known effect:
PENIBRIN 500 MG: Each vial contains approximately
33 mg sodium.
PENIBRIN 1 G: Each vial contains approximately
66 mg sodium.
PENIBRIN 2 G: Each vial contains approximately
132 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Penibrin injection is recommended in serious
infections when prompt, effective levels of the
antibiotic must reach the site of infection. Such
infections include meningitis, subacute bacterial
endocarditis, peritonitis, septicemia, severe forms
of chronic bronchitis, osteomyelitis, pneumonia
and pyelonephritis due to susceptible organisms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Parenteral drug products should be inspected _
_visually for particulate matter and discoloration, _
_prior to administration, whenever solution and _
_container permit._
The recommended dosages are given below:
In stubborn, severe infections, a higher dosage
may be administered.
_Adults_
250-500 mg every 6 hours, by intramuscular or
intravenous injection.
_Gonorrhea_
2 doses of 500 mg spaced 12 hours apart. Treatment
may be repeated if necessary.
_Children_
12.5 mg/kg body weight every 6 hours, by
intramuscular or intravenous injection.
_NOTE:_ Larger doses may be required for stubborn or
severe infections. The children’s dosage is intended
for individuals whose