BICILLIN L-A-benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL suspension for injection syringe with needle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

benzathine benzylpenicillin tetrahydrate, Quantity: 600000 USP Unit

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: carmellose sodium; lecithin; methyl hydroxybenzoate; povidone; propyl hydroxybenzoate; sodium citrate; water for injections

Administration route:

Intramuscular

Units in package:

10 pre-filled syringes, 5 pre-filled syringes

Prescription type:

(S4) Prescription Only Medicine

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. 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 and acute glomerulonephritis.

Product summary:

Visual Identification: White fluid suspension; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-09-19

Patient Information leaflet

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
•
if you have had an allergic
reaction to cephalosporins if you
are not sure, check with your
pharmacist
You may have an increased
chance of being allergic to
Bicillin L-A if you are allergic to
cephalosporins.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat, or other parts

Summary of Product characteristics

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Superseded: pfpbacii20121
Page 1 of 11
AUSTRALIAN
PRODUCT
INFORMATION
–
BICILLIN

L-A
(BENZATHINE
BENZYLPENICILLIN
TETRAHYDRATE)
SUSPENSION FOR INJECTION
1.
NAME OF THE MEDICINE
Benzathine benzylpenicillin tetrahydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BICILLIN L-A contains benzathine benzylpenicillin (the benzathine salt
of benzylpenicillin)
in aqueous suspension:
600,000
Units/1.17
mL
pre-filled
syringe,
containing
benzathine
benzylpenicillin
tetrahydrate 517 mg/1.17 mL.
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.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Suspension for injection.
_ _
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).
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Superseded: pfpbacii20121
Page 2 of 11
Venereal infections - Syphilis, yaws, bejel and pinta.
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 and acute
glomerulonephritis.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Use a concentration of 442 mg/mL when measuring part