Hikma launches Sterile Water for Injection, USP

London, 13 August 2018 – Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody’s / BB+ S&P, both stable) announces that Hikma Pharmaceuticals USA Inc., formerly known as West-Ward Pharmaceuticals, has launched Sterile Water for Injection, USP, 10mL.

Press Release Product 13 August 2018

Hikma’s Sterile Water for Injection, USP is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

IQVIA only captures a small proportion of Water for Injection, USP sales.

Riad Mechlaoui, Chief Executive Officer of Injectables said, “We are very pleased to be bringing Sterile Water for Injection to the market. Sterile water is the critical ingredient for reconstituting dry powders for injection. By launching Sterile Water for Injection, we hope to reduce the shortage of this product which is currently impacting hospitals across the US.”

This new product introduction expands Hikma’s broad offering of more than 90 products and further solidifies our position as one of the top 3 suppliers of generic injectable products to US hospitals.

Important Safety Information for Water for Injection, USP

The following warnings and precautions should be taken when using Sterile Water for Injection, USP:

  • Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
  • Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.
  • Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.
  • Administer to a pregnant woman if only if clearly needed.
  • In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
  • Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.
  • Use aseptic technique for single or multiple entry and withdrawal from all containers.
  • Use only as a diluent or solvent.

Sterile Water for Injection, USP must be made approximately isotonic prior to use.

Adverse reactions may include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. In the event of an adverse reaction, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

Please refer to the Package Insert for full prescribing information. Additional information on Hikma US products is available on www.hikma.com/us.

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