CILICAINE SYRINGE 1.5 procaine benzylpenicillin (procaine penicillin) 1.5g injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

procaine benzylpenicillin, Quantity: 1.5 g

Available from:

Viatris Pty Ltd

INN (International Name):

Procaine benzylpenicillin (Procaine penicillin)

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: sodium citrate dihydrate; water for injections; polysorbate 80

Administration route:

Intramuscular

Units in package:

5 X 1.5g (E), 5 X 1.5g

Prescription type:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 18 February 2002: Treatment of moderately severe infections due to penicillin sensitive organisms. Therapy should be guided by bacteriological studies, including sensitivity tests and also by clinical response. Infections which usually respond to adequate dosage are: Group A streptococcal infections including upper respiratory tract infections, skin and skin structure infections and scarlet fever; pneumococcal infections of the respiratory tract; susceptible staphylococcal infections, most gonococcal infections, syphilis, fusospirochaetosis (Vincent's gingivitis and pharyngitis). CILICAINE SYRINGE 1.5 must be administered by the intramuscular route only (see section 4.2 DOSE AND METHOD OF ADMINISTRATION).

Product summary:

Visual Identification: A slightly viscous white suspension, free of excessive aeration. Odour faint and characteristic of penicillin.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 15 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-08-04

Patient Information leaflet

CILICAINE
® SYRINGE 1.5
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CILICAINE SYRINGE 1.5?
CILICAINE SYRINGE 1.5 contains the active ingredient procaine
benzylpenicillin (procaine penicillin). CILICAINE SYRINGE 1.5 is
used to treat infections in different parts of the body caused by
bacteria.
For more information, see Section 1. Why am I using CILICAINE SYRINGE
1.5? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CILICAINE SYRINGE 1.5?
Do not use if you have ever had an allergic reaction to CILICAINE
SYRINGE 1.5 or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CILICAINE SYRINGE 1.5? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CILICAINE SYRINGE 1.5 and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CILICAINE SYRINGE 1.5?
•
CILICAINE SYRINGE 1.5 must only be given by a doctor or nurse.
More instructions can be found in Section 4. How do I use CILICAINE
SYRINGE 1.5? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CILICAINE SYRINGE 1.5?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are
receiving CILICAINE SYRINGE 1.5.
•
If your symptoms do not improve within few days, or if they become
worse, tell your doctor.
•
If you develop any form of skin rash and/or itching or difficulty in
breathing while using CILICAINE
SYRINGE 1.5, contact your doctor immediately.
•
If you develop severe diarrhoea tell your doctor immediately.
THINGS YOU
SHOULD NOT DO
•
Do not use CILICAINE SYRINGE 1.5 to treat any other complaints unless
your

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CILICAINE
® SYRINGE 1.5
_procaine benzylpenicillin (procaine penicillin) injection suspension
_
1
NAME OF THE MEDICINE
Procaine benzylpenicillin (procaine penicillin)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CILICAINE SYRINGE 1.5 injection suspension contains 1.5 g of
procaine benzylpenicillin (as procaine
penicillin) as the active ingredient.
The solution in CILICAINE SYRINGE 1.5 is sterile.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CILICAINE SYRINGE 1.5 injection suspension is a slightly viscous white
suspension, free of excessive
aeration, that has a faint odour characteristic of penicillin.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderately severe infections due to penicillin sensitive
organisms. Therapy should be guided
by bacteriological studies, including sensitivity tests and also by
clinical response.
Infections which usually respond to adequate dosage are:
•
Group A streptococcal infections including:
o
upper respiratory tract infections, skin and skin structure infections
and scarlet fever
o
pneumococcal infections of the respiratory tract
o
susceptible
staphylococcal
infections,
most
gonococcal
infections,
syphilis,
fusospirochaetosis (Vincent’s gingivitis and pharyngitis).
CILICAINE SYRINGE 1.5 must be administered by the intramuscular route
only (see Section 4.2 DOSE
AND METHOD OF ADMINISTRATION).
4.2
DOSE AND METHOD OF ADMINISTRATION
For use by intramuscular injection only.
Before injecting the dose, aspirate to be sure that the needle is not
in a blood vessel (the syringe is designed to
facilitate easy aspiration before injection). If blood appears,
withdraw and inject in another site.
ADULTS
A common dose of procaine benzylpenicillin (procaine penicillin) is
1.5 g daily for two to five days, the fourth
and fifth doses being dependent on the severity of the infection.
Gonorrhoea
Uncomplicated infection with sensitive gonococci: dosage regimen
varies according to treatment plan. Doses