Special Instructions for Use, Handling and Disposal: HEMLIBRA solution is a sterile, preservative-free, and ready-to-use solution for subcutaneous injection that does not need to be diluted.
HEMLIBRA solution should be inspected visually to ensure there is no particulate matter or discoloration prior to administration. HEMLIBRA is a colorless to slightly yellow solution. HEMLIBRA solution should be discarded if particulate matter is visible or the product is discolored.
HEMLIBRA solution for injection vials are for single-use only.
A syringe, a transfer needle (or vial adapter) and an injection needle are needed to withdraw HEMLIBRA solution from the vial and inject it subcutaneously.
A 1 mL syringe should be used for an injection up to 1 mL of HEMLIBRA solution. Administer doses of HEMLIBRA greater than 1 mL and up to 2 mL with a 2 mL to 3 mL syringe.
Refer to the HEMLIBRA "Instructions for Use" for handling instructions when combining vials in a syringe. Do not use different HEMLIBRA vial concentrations in a single syringe when combining vials to administer the prescribed dose.
Recommendation criteria for syringes, needles and vial adaptor are defined to ensure correct and safe administration of HEMLIBRA. These criteria are based on handling considerations (e.g., dosing accuracy, subcutaneous injection), HEMLIBRA characteristics (e.g., viscosity), and compatibility between HEMLIBRA and device materials.
1 mL syringe: Criteria: Transparent polypropylene or polycarbonate syringe with Luer-Lock tip (in case not locally available, a syringe with Luer Slip tip can be used), graduation 0.01 mL, sterile, for injection only, single-use, latex-free and non-pyrogenic. When used together with a vial adapter, a low dead space plunger 1 mL syringe fulfilling the previously mentioned criteria must be used.
2 to 3 mL syringe: Criteria: Transparent polypropylene or polycarbonate syringe with Luer-Lock tip (in case not locally available, a syringe with Luer Slip tip can be used), graduation 0.1 mL, sterile, for injection only, single-use, latex-free and non-pyrogenic. When used together with a vial adapter, a low dead space plunger 3 mL syringe fulfilling the previously mentioned criteria must be used.
Transfer needle or vial adapter: Criteria for transfer needle: Stainless steel with Luer-Lock connection (in case not locally available, a needle with Luer Slip connection can be used), sterile, gauge 18 G, length 1" to 1½", blunt (single-bevelled) or semi-blunt tip, single-use, latex-free and non-pyrogenic.
Criteria for vial adapter: Polycarbonate with Luer-Lock connection, sterile, fitting 15 mm vial neck outer diameter, single-use, latex-free and non-pyrogenic.
Injection needle: Criteria: Stainless steel with Luer-Lock connection (in case not locally available, an injection needle with Luer Slip connection can be used), sterile, gauge 26 G (acceptable range: 25-27 G), length preferably 3/8" or maximally ½", single-use, latex-free and non-pyrogenic, preferably including needle safety feature.
Once transferred from the vial to the syringe, the medicinal product should be used immediately since it does not contain any antimicrobial preservative.
Incompatibilities: No incompatibilities between HEMLIBRA and the recommended syringes, vial adaptors and needles have been observed.
Disposal of syringes/sharps: The following procedures should be strictly adhered to regarding the use and disposal of syringes: Needles, syringes and vial adaptors should never be reused.
Place all used needles, syringes and vial adaptors into a sharps container (puncture-proof disposable container).
Disposal of unused/expired medicines: The release of pharmaceuticals in the environment should be minimized. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Use established "collection systems", if available in the location. Local requirements should be followed for the disposal process of unused/expired medicines.