PENICILLIN G SODIUM SANDOZ 5000000 IUVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

BENZYLPENICILLIN SODIUM EQV BENZYLPENICILLIN

Available from:

SANDOZ SINGAPORE PTE. LTD.

ATC code:

J01CE01

Dosage:

5 mil iu/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

BENZYLPENICILLIN SODIUM EQV BENZYLPENICILLIN 5 mil iu/vial

Administration route:

INTRAVENOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

SANDOZ GMBH

Authorization status:

ACTIVE

Authorization date:

1988-05-04

Summary of Product characteristics

PENICILLIN G SODIUM SANDOZ
®
1,000,000 IU/ 5,000,000 IU – VIALS
Page 1 of 14
1.
NAME OF THE MEDICINAL PRODUCT
Penicillin G Sodium Sandoz 1,000,000 IU/Vial
Penicillin G Sodium Sandoz 5,000,000 IU/Vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PENICILLIN G SODIUM SANDOZ 1,000,000 IU:
One vial contains 1,000,000 IU (equivalent to approximately 0.6 g)
benzylpenicillin as sodium salt
(= 1.68 mmol or 38.6 mg of sodium)
PENICILLIN G SODIUM SANDOZ 5,000,000 IU:
One vial contains 5,000,000 IU (equivalent to approximately 3 g)
benzylpenicillin as sodium salt
(= 8.42 mmol or 193 mg of sodium)
3.
PHARMACEUTICAL FORM
White to off-white powder for solution for injection/infusion.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Penicillin G Sodium is indicated for the treatment of the following
infections in adults, adolescents, children,
newborn infants and pre-term infants, caused by penicillin-sensitive
pathogens (see section 5.1):
•
septicemia
•
skin and wound infections
•
diphtheria (in addition to antitoxin)
•
community acquired pneumonia
•
empyema
•
erysipelas
•
bacterial endocarditis
•
peritonitis
•
meningitis
•
brain abscesses
•
osteomyelitis
•
infections of the genital tract caused by fusobacteria.
Penicillin G Sodium is also used for the treatment of the following
specific infections:
•
anthrax
•
tetanus
•
listeriosis
•
pasteurellosis
•
rat bite fever
•
fusospirochetosis
•
actinomycosis
Furthermore, Penicillin G Sodium is also used for complications in
gonorrhea and syphilis (e.g. gonorrheal
endocarditis or arthritis, congenital syphilis). However, in
uncomplicated cases, preference should be given
to depot penicillins. Penicillin G Sodium is not indicated for the
treatment of syphilis during pregnancy.
Penicillin G Sodium is also used in Lyme borreliosis from the second
stage of the disease onwards
(meningopolyneuritis Garin-Bujadoux-Bannwarth, acrodermatitis chronica
atrophicans, Lyme arthritis, Lyme
carditis) if oral penicillin therapy is no longer indicated. During
p