Penicillin G Sodium

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Benzylpenicillin sodium 5988mg equivalent to 10 MIU benzylpenicillin sodium salt

Available from:

Sandoz New Zealand Limited

INN (International Name):

Benzylpenicillin sodium 5988 mg (equivalent to 10 MIU benzylpenicillin sodium salt)

Dosage:

5988 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Benzylpenicillin sodium 5988mg equivalent to 10 MIU benzylpenicillin sodium salt

Units in package:

Vial, glass, clear, colourless type III (EP) with butyl rubber stopper and aluminium crimp seal., 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sandoz GmbH

Product summary:

Package - Contents - Shelf Life: Vial, glass, clear, colourless type III (EP) with butyl rubber stopper and aluminium crimp seal. - 5 dose units - 5 years from date of manufacture stored at or below 25°C protect from light. Use immediately after reconstitution - Vial, glass, clear, colourless type III (EP) with butyl rubber stopper and aluminium crimp seal. 1 vial - 10 mL - 5 years from date of manufacture stored at or below 25°C protect from light. Use immediately after reconstitution - Vial, glass, clear, colourless type III (EP) with butyl rubber stopper and aluminium crimp seal. 10ml vials - 10 dose units - 5 years from date of manufacture stored at or below 25°C protect from light. Use immediately after reconstitution

Authorization date:

2005-01-06

Patient Information leaflet

PENICILLIN G SODIUM
®
1
PENICILLIN G
SODIUM
®
_benzylpenicillin (as benzylpenicillin sodium) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Penicillin G Sodium.
It does not contain all the available
information. It does not take the
place of talking to your pharmacist or
doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Penicillin G
Sodium against the benefits this
medicine expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT PENICILLIN G
SODIUM IS USED FOR
Penicillin G Sodium is an antibiotic
used to treat some infections in
different parts of the body caused by
bacteria.
Penicillin G Sodium may also be
used to prevent infections before,
during and after surgery.
Penicillin G Sodium will not work
against infections caused by viruses,
such as colds or the flu.
Penicillin G Sodium is an antibiotic
that belongs to a group of medicines
called penicillins. These antibiotics
work by killing the bacteria that are
causing your infection.
Your doctor may have prescribed
Penicillin G Sodium for another
reason.
Ask your doctor why Penicillin G
Sodium has been prescribed for you.
This medicine is available only with
a doctor’s prescription.
There is no evidence that Penicillin G
Sodium is addictive.
BEFORE YOU ARE GIVEN
PENICILLIN G SODIUM
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT TAKE PENICILLIN G SODIUM IF:
•
YOU HAVE ALLERGY TO PENICILLIN G
SODIUM OR OTHER PENICILLINS.
Some of the symptoms of an
allergic reaction may include skin
rash, itching and difficult
breathing.
•
YOU HAVE HAD AN ALLERGIC
REACTION TO CEPHALOSPORINS.
•
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
•
THE EXPIRY DATE PRINTED ON THE
PACK OR VIAL, HAS PASSED. IF YOU
TAKE THIS MEDICINE AFTER THE
EXPIRY DATE HAS PASSED, IT MAY
NOT WORK.
If you are not sure whether you
should be given Penicillin G Sodium,
talk to your doctor.
_

Summary of Product characteristics

230320-penicillin-g-sodium-ds
Page 1 of 12
NEW ZEALAND DATA SHEET
PENICILLIN G SODIUM (BENZYLPENICILLIN SODIUM)
1.
PRODUCT NAME
PENICILLIN G SODIUM INJECTION 1 million IU, 5 million IU and 10
million IU
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 million IU (equivalent to approximately 0.6 g benzylpenicillin
sodium or Penicillin G
Sodium),
5 million IU (equivalent to approximately 3 g benzylpenicillin sodium
or Penicillin G Sodium)
10 million IU (equivalent to approximately 6 g benzylpenicillin sodium
or Penicillin G
Sodium).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
Penicillin G Sodium injection is a white to whitish crystalline, water
soluble powder aseptically
filled into glass vials. Reconstitution yields a clear solution of
Benzylpenicillin Injection BP.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Penicillin G Sodium is indicated in the following infections caused by
penicillin-sensitive
pathogens: septicaemia; skin and wound infections; diphtheria (in
addition to antitoxin);
pneumonia; empyema; erysipela; pericarditis; bacterial endocarditis;
mediastinitis; peritonitis;
meningitis; brain abscesses; arthritis; osteomyelitis; infections of
the genital tract caused by
fusobacteria. Sensitivity should be tested wherever possible.
SPECIFIC INFECTIONS
Penicillin G Sodium is effective in infections such as anthrax,
clostridial infections including
tetanus, listeriosis, pasteurellosis, rat bite fever,
fusospirochaetosis, actinomycosis. In addition,
it has a place in the treatment of complications secondary to
gonorrhoea and syphilis (e.g.
gonorrhoeal endocarditis or arthritis, and congenital syphilis). If
uncomplicated, gonorrhoea
and syphilis should preferably be treated with long-acting
penicillins.
Penicillin G Sodium is also beneficial in patients with Lyme
borreliosis after the first stage of
the
disease
(meningopolyneuritis
Garin-Bujadoux-Bannwarth,
acrodermatitis
chronica
atrophicans, Lyme arthritis, Lyme carditis), if oral p