HPS Pharmacies wish to advise that Pfizer is experiencing a supply interruption for Bicillin® L-A as follows:
Bicillin L-A
Benzathine benzylpenicillin tetrahydrate 1,200,000 Units / 2.3 mL
ARTG 147169
Bicillin L-A
Benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL
ARTG 293456
This global shortage is due to an unexpected increase in demand as well as manufacturing constraints. Pfizer advises that normal supplies of the higher strength will return by end-June 2024, while normal supplies of the lower strength are expected to return by mid-November 2024.
The Therapeutic Goods Administration (TGA) has authorised the supply of an internationally registered alternative of the 1.2 million IU strength under Section 19A of the Therapeutic Goods Act 1989. This product differs from the Australian version in presentation, storage, final volume, and excipients. Some of the key differences are shown in the table below.
Bicillin® L-A | S19A alternative | |
Expression of active ingredient | Benzathine benzylpenicillin tetrahydrate |
Benzylpenicillin benzathine |
Appearance | White fluid suspension Pre-filled syringe |
Vial of powder + ampoule of solvent for suspension |
Volume required for 1.2 million IU dose | 2.3 mL | 3.5 mL diluent + powder = 4.5 mL (approx.) |
Preparation | Pre-filled single use syringe | Reconstitute immediately before use |
Consumer information | Australian CMI | UK leaflet |
Product information | Australian PI | UK Summary of Product Characteristics |
Storage conditions | 2-8°C (storage at 30°C allowed for single period of 2 months) |
Below 25°C |
During this supply interruption, Pfizer will be closely controlling the supply of very limited quantities of Bicillin® L-A. Bicillin® L-A pre-filled syringes should be conserved for use in neonatal and paediatric patients and in healthcare settings where the S19A product is not appropriate. Advice should be sought from an infectious disease expert, local guidelines, and/or the Australian Therapeutic Guidelines.
For further information, including important safety considerations, please refer to the fact sheet produced by the Australian Commission on Safety and Quality in Health Care.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact Pfizer on 1800 675 229, or your pharmacist at HPS Pharmacies.
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