Recormon Caution For Usage

Special Instructions for Use, Handling and Disposal: Lyophilisate and solvent for solution for injection: Instructions for use and handling: Recormon Multidose is supplied as a powder for solution for injection in vials. This is dissolved with the contents of the accompanying solvent ampoule by means of a reconstitution and withdrawal device according to the instructions given as follows. Only solutions which are clear or slightly opalescent, colorless and practically free of visible particles may be injected. Do not use glass materials for injection, use only plastic materials.
This is a multidose preparation from which different single doses can be withdrawn over a period of 1 month after dissolution. To avoid the risk of contamination of the contents always observe aseptic techniques (i.e. use disposable sterile syringes and needles to administer each dose) and strictly follow the handling instructions below. Before withdrawing each dose disinfect the rubber seal of the withdrawal device with alcohol to prevent contamination of the contents by repeated needle insertions.
Preparation of Recormon Multidose solution: 1. Take the vial with the freeze-dried substance out of the package. Write the date of reconstitution and expiry on the label (expiry is 1 month after reconstitution).
2. Remove the plastic cap from the vial.
3. Disinfect the rubber seal with alcohol.
4. Take the reconstitution and withdrawal device (which allows sterile air exchange) out of the blister and remove the protective cover from the spike.
5. Attach the device to the vial until the snap lock clicks home.
6. Put the green needle on the syringe contained in the package and remove the needle cover.
7. Hold the OPC (One-Point-Cut) ampoule with the blue point upwards. Shake or tap the ampoule to get any fluid in the stem into the body of the ampoule. Take hold of the stem and snap off away from the patient. Withdraw all the solvent into the syringe. Disinfect the rubber seal of the device with alcohol.
8. Penetrate the seal with the needle to a depth of about 1 cm and slowly inject the solvent into the vial. Then disconnect the syringe (with needle) from the device.
9. Swirl the vial gently until the powder has dissolved. Do not shake. Check that the solution is clear, colorless and practically free from particles. Put the protective cap on the top of the device.
10. Before and after reconstitution Recormon Multidose must be stored at +2° to +8°C (refrigerator).
Preparation of a single injection: 1. Before withdrawing each dose disinfect the rubber seal of the device with alcohol.
2. Place a 26G needle onto an appropriate single-use syringe (max.1 ml).
3. Remove the needle cover and insert the needle through the rubber seal of the device. Withdraw Recormon solution into the syringe, expel air from the syringe into the vial and adjust the amount of Recormon solution in the syringe to the dose prescribed. Then disconnect the syringe (with needle) from the device.
4. Replace the needle by a new one (the new needle should have the size which the patient normally uses for injections).
5. Remove the needle cover and carefully expel air from the needle by holding the syringe vertically and gently pressing the plunger upwards until a bead of liquid appears at the needle tip.
For subcutaneous injection, clean the skin at the site of injection using an alcohol wipe. Form a skin fold by pinching the skin between the thumb and the forefinger. Hold the syringe near to the needle and insert the needle into the skin with a quick, firm action. Inject Recormon solution. Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Any unused product or waste material should be disposed of in accordance with local requirements.
Solution for injection in pre-filled syringes: Instructions for use and handling: First wash the hands!
Remove one syringe from the pack and check that the solution is clear, colorless and practically free from visible particles. Remove the cap from the syringe.
Remove one needle from the pack, fix it on the syringe and remove the protective cap from the needle.
Expel air from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards. Keep pressing the plunger until the amount of Recormon in the syringe is as prescribed.
Clean the skin at the site of injection using an alcohol wipe. Form a skin fold by pinching the skin between thumb and forefinger. Hold the syringe barrel near to the needle, and insert the needle into the skin fold with a quick, firm action. Inject the Recormon solution.
Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
This medicinal product is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Disposal: The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps: Needles and syringes should never be reused.
Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Keep this container out of the reach of children.
Placing used sharps containers in the household waste should be avoided.
Dispose of the full container according to local requirements or as instructed by a healthcare provider.
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.
Incompatibilities: Lyophilisate and solvent for solution for injection: This medicinal product must not be diluted or mixed with other medicinal products except those mentioned as follows (content of accompanying solvent ampoule).
Solution for injection in pre-filled syringes: In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.