Bicillin L-A

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Benzathine benzylpenicillin tetrahydrate 442 mg/mL (1,200,000U/2.3mL)

Available from:

Pfizer New Zealand Limited

INN (International Name):

Benzathine benzylpenicillin tetrahydrate 442 mg/mL (1,200,000U/2.3mL)

Dosage:

1,200,000 U/2.3 mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Benzathine benzylpenicillin tetrahydrate 442 mg/mL (1,200,000U/2.3mL) Excipient: Carmellose sodium Lecithin Methyl hydroxybenzoate Povidone Propyl hydroxybenzoate Sodium citrate dihydrate Water for injection

Units in package:

Cartridge, glass, 2 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sandoz GmbH

Therapeutic indications:

Intramuscular benzathine benzylpenicillin is indicated in the treatment of infections due to penicillin-sensitive micro-organisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate dosage of intramuscular benzathine benzylpenicillin: · Streptococcal infections (Group A - without bacteraemia). Mild-to-moderate infections of the upper respiratory tract (eg., pharyngitis). · Venereal infections - Syphilis, yaws, bejel and pinta.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, Pre-filled 2.3 mL in cardboard carton - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months not refrigerated stored at or below 30°C. Do not return to refrigerated storage.

Authorization date:

1996-03-20

Patient Information leaflet

New Zealand Consumer Medicine Information
BICILLIN L-A
®
1
BICILLIN® L-A
_benzathine benzylpenicillin tetrahydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Bicillin L-A. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you receiving Bicillin L-
A against the benefits they expect it
will have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BICILLIN L-A IS
USED FOR
Bicillin L-A is used to treat
infections in different parts of the
body caused by bacteria. Bicillin L-
A is also used to prevent certain
infections such as rheumatic fever.
Bicillin L-A will not work against
infections caused by viruses such as
colds or flu.
Bicillin belongs to the group of
penicillin antibiotics. It works by
killing bacteria or preventing their
growth. This particular type of
Bicillin is called Bicillin L-A
because it is long-acting. It is
supplied in a syringe for once-only
use.
Your doctor may have prescribed
Bicillin L-A for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BICILLIN L-A
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
BICILLIN L-A
_WHEN YOU MUST NOT BE GIVEN _
_IT: _
DO NOT HAVE BICILLIN L-A IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
benzathine benzylpenicillin
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines such
as other penicillin antibiotics
•
cephalosporins. You may have an
increased chance of being allergic
to Bicillin L-A if you are allergic
to cephalosporins.
If you are not sure, check with your
pharmacist.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongu

Summary of Product characteristics

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Superseded: pfdbicii11120
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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
BICILLIN L-A
®
Benzathine Benzylpenicillin 1,200,000 Units/2.3 mL suspension for
injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BICILLIN L-A contains benzathine benzylpenicillin (the benzathine salt
of benzylpenicillin)
in aqueous suspension
1,200,000
Units/2.3
mL
pre-filled
syringe,
containing
benzathine
benzylpenicillin
tetrahydrate 1016.6 mg/2.3 mL.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Methyl hydroxybenzoate
•
Propyl hydroxybenzoate.
BICILLIN L-A
contains
approximately
0.11 mEq
of
sodium
per
600,000 units
of
benzylpenicillin (approximately 2.59 mg of sodium per 600,000 units of
benzylpenicillin).
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Suspension for injection pre-filled syringe with needle.
BICILLIN L-A in the disposable pre-filled syringe formulation is a
viscous and opaque white
suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intramuscular benzathine benzylpenicillin is indicated in the
treatment of infections due to
penicillin-sensitive micro-organisms that are susceptible to the low
and very prolonged serum
levels common to this particular dosage form. Therapy should be guided
by bacteriological
studies (including sensitivity tests) and by clinical response.
The following infections will usually respond to adequate dosage of
intramuscular benzathine
benzylpenicillin:
Streptococcal infections (Group A - without bacteraemia).
Mild-to-moderate infections of the
upper respiratory tract (e.g. pharyngitis).
Venereal infections - Syphilis, yaws, bejel and pinta.
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Superseded: pfdbicii11120
Page 2 of 11
Medical conditions in which benzathine benzylpenicillin therapy is
indicated as prophylaxis:
Rheumatic fever and/or chorea - Prophylaxis with benzathine
benzylpenicillin has proven
effective in preventing recurrence of these conditions. It has also
been used as follow-up
prophylactic therapy for rheumatic heart disease