HPS Pharmacies wish to advise that Pfizer is experiencing a supply interruption for heparin as follows:
Heparin Sodium
Heparin sodium 5000IU/5mL
ARTG 49232
This supply interruption is expected to be resolved by end of December 2024.
Internationally registered alternatives have been approved for supply under Section 19A of the Therapeutic Goods Act 1989. Please note that some products approved under S19A contain benzyl alcohol as a preservative, while the Australian-registered product is preservative-free. A preservative-free option is currently approved for supply under S19A until 30 September 2024.
Benzyl alcohol should not be used in neonates or infants and should be avoided during pregnancy. Clinical review may also be required in other patient groups, depending on the duration of use.
Please note that S19A alternatives are subject to a longer lead time and different pricing as they must be sourced internationally.
Heparin is a high-risk medication. Additional care is recommended when selecting products, particularly when the packaging may be unfamiliar. The following table compares the Australian-registered product with the S19A alternatives.
| Heparin sodium 5000IU/5mL (Pfizer) | Heparin sodium injection, USP 10,000 units/10 mL (Hospira) | Heparin sodium (Wockhardt) – with preservative | Heparin sodium (Wockhardt) preservative-free | |
| Product type | Australian registered | S19A | S19A | S19A |
| Labelled strength | 5000IU/5mL | 10,000 USP units/10 mL (1,000 USP units/mL) | 1,000 I.U./mL (5,000 units in 5 mL) | 1,000 I.U./mL (5,000 units in 5 mL) |
| Excipients | Water for injection | Sodium chloride
Benzyl alcohol Sodium hydroxide Hydrochloric acid Water for injections |
Benzyl alcohol
Methyl parahydroxybenzoate Water for injections Sodium hydroxide solution Hydrochloric acid |
Water for injections
Sodium hydroxide solution Hydrochloric acid |
| Administration route | IV or SC | IV or SC | IV | IV |
| Presentation | 5 mL steriluer ampoule | 10 mL glass vial | 5 mL neutral glass vial | 5 mL glass ampoule |
| Storage | < 25°C | 20°C to 25°C | Do not store > 25°C | Do not store > 25°C |
| Additional information | Single-use only | Multidose vial (use in line with hospital policy). | Multidose vial (use in line with hospital policy). | Single-use only |
*Note: One USP unit is equivalent to one international unit (IU)
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.
Further information from Pfizer is available here (note: Pfizer has since revised the estimated return date to December 2024). 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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