NeoRecormon therapy is started by a doctor who is an expert on your condition. The first dose is usually given to you under medical supervision, because of the possibility of an allergic reaction.
NeoRecormon injections can then be given by a trained nurse, doctor or other professional.
This multidose preparation can be used for several patients over a period of 1 month after reconstitution. To avoid the risk of cross-infection always follow aseptic techniques and use disposable sterile syringes and needles to administer each dose. Please check that only one vial of NeoRecormon Multidose is in use (i.e. reconstituted) at any one time.
Do not mix NeoRecormon with other injections or infusion solutions.
Use only plastic materials for injection.
Instructions for use
First wash your hands!
Preparation of NeoRecormon Multidose solution (medical care staff)(1) Take the lyophilisate vial 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 you. 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 lyophilisate has dissolved. Do not shake. Check that the solution is clear, colourless and free of particles. If not, do not administer the injection. Put the protective cap on the top of the device.
(10) Before and after reconstitution NeoRecormon Multidose must be stored in a refrigerator at2°C ? 8°C.
Preparation of a single injection (medical care staff)(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 NeoRecormon solution into the syringe, expel air from the syringe into the vial and adjust the amount of NeoRecormon 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 you normally use 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.
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 NeoRecormon solution. Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
NeoRecormon dosing
The dose of NeoRecormon depends on your disease condition, the way the injection is given (under the skin or into a vein) and your body weight. Your doctor will work out the right dose for you.
- Symptomatic anaemia caused by chronic kidney disease
Your injections are given under the skin or into a vein. If the solution is given into your vein it should be injected over about 2 minutes, eg people on haemodialysis will receive the injection via the arterio-venous fistula at the end of dialysis.
People who are not on haemodialysis will usually have injections under the skin.
Treatment with NeoRecormon is divided into two stages:
a) Correcting the anaemia The initial dosefor injections under the skin is 20 IU per injection for every 1 kg of your body weight, given three times per week. After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 40 IU/kg per injection, given three times per week. The doctor may continue to increase your dose at monthly intervals if necessary. The weekly dose can also be divided into daily doses.
The initial dose for injections into veins is 40 IU per injection for every 1 kg of your body weight, given three times per week.
After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 80 IU/kg per injection, given three times per week. The doctor may continue to increase your dose at monthly intervals if necessary.
For both types of injection, the maximum dose should not exceed 720 IU for every 1 kg of your body weight per week.
b) Maintaining sufficient red blood cell levels The maintenance dose: Once your red blood cells reach an acceptable level, the dose is reduced to half of the dose used to correct the anaemia. The weekly dose can be given once per week, or divided into three or seven doses per week. If your red blood cell level is stable on a once weekly dosing regimen, your dose may be switched to once every two weeks administration. In this case dose increases may be necessary.
Every one or two weeks, the doctor may adjust your dose to find your individual maintenance dose. Children will start by following the same guidelines. In trials, children usually needed higher doses of NeoRecormon (the younger the child, the higher the dose).
Treatment with NeoRecormon is normally a long-term therapy. However, it can be interrupted at any time, if necessary.
- Adults with symptomatic anaemia receiving chemotherapy for cancer
Injections are given under the skin.
Your doctor may initiate treatment with NeoRecormon if your haemoglobin level is 10 g/dL or less. After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dL.
The initial weekly dose is 30,000 IU. This may be given as one injection per week, or in divided doses as 3 to 7 injections per week. Your doctor will take regular blood samples. He or she may raise or lower your dose, or interrupt your treatment according to the test results.The haemoglobin values should not exceed a value of 12 g/dL.
The therapy should be continued for up to 4 weeks after the end of chemotherapy.
The maximum dose should not exceed 60,000 IU per week.
- People donating their own blood before surgery
Injections are given into a vein over two minutes, or under the skin.
The dose of NeoRecormon depends on your condition, red blood cell levels and how much blood will be donated before surgery.
The dose worked out by your doctor will be given twice per week for 4 weeks. When you donate blood, NeoRecormon will be given to you at the end of a donation session.
The maximum dose should not exceed
- for injections into veins: 1600 IU for every 1 kg of your body weight per week
- for injections under the skin: 1200 IU for every 1 kg of your body weight per week.
If you inject too much NeoRecormon
Do not increase the dose your doctor has given you. If you think you have injected more NeoRecormon than you should, contact your doctor. It is unlikely to be serious. Even at very high blood levels, no symptoms of poisoning have been observed.
If you forget to take NeoRecormon
If you have missed an injection, or injected too little, talk to your doctor.
Do not take a double dose to make up for any forgotten doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
