Abseamed
epoetin alfa
Epoetin alfa
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What Abseamed is and what it is used for
What you need to know before you use Abseamed
How to use Abseamed
Possible side effects
How to store Abseamed
Contents of the pack and other information
Abseamed contains the active substance epoetin alfa, a protein that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen). Epoetin alfa is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way.
in children on haemodialysis
in adults on haemodialysis or peritoneal dialysis
in severely anaemic adults not yet undergoing dialysis
If you have kidney disease, you may be short of red blood cells if your kidney does not produce enough erythropoietin (necessary for red cell production). Abseamed is prescribed to stimulate your bone marrow to produce more red blood cells.
to stimulate the production of your red blood cells (so that doctors can take more blood from you) if you cannot have transfusions with your own blood during or after surgery.
have severe heart disease
have severe disorders of the veins and arteries
have recently had a heart attack or stroke
can’t take medicines to thin the blood
Abseamed may not be suitable for you. Please discuss with your doctor. While on Abseamed, some people need medicines to reduce the risk of blood clots. If you can’t take medicines that prevent blood clotting, you must not have Abseamed.
Talk to your doctor, pharmacist or nurse before using Abseamed.
Abseamed and other products that stimulate red cell production may increase the risk of developing blood clots in all patients. This risk may be higher if you have other risk factors for developing blood clots (for example, if you have had a blood clot in the past or are overweight, have diabetes, have heart disease or you are off your feet for a long time because of surgery or illness). Please tell your doctor about any of these things. Your doctor will help you to decide if Abseamed is suitable for you.
Abseamed is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does. Your healthcare professional will always record the exact product you are using. If you are given a product in this group other than Abseamed during your treatment, speak to your doctor or pharmacist before using it.
SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications.
If you develop a serious rash or another of these skin symptoms, stop taking Abseamed and contact your doctor or seek medical attention immediately.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Abseamed contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.
Your doctor will decide how Abseamed will be injected. Usually the injections will be given to you by a doctor, nurse or other health care professional. Some people, depending on why they need Abseamed treatment, may later learn how to inject themselves under the skin: see Instructions on how to inject Abseamed yourself at the end of the leaflet.
Abseamed should not be used:
after the expiry date on the label and outer carton
if you know, or think that it may have been accidentally frozen, or
if there has been a refrigerator failure.
The dose of Abseamed you receive is based on your body weight in kilograms. The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Your doctor will maintain your haemoglobin level between 10 and 12 g/dL as a high haemoglobin level may increase the risk of blood clots and death. In children the haemoglobin level should be maintained between 9.5 and 11 g/dL.
For adults and children Abseamed is given as an injection either into a vein (intravenously) or a tube that goes into a vein. When this access (via a vein or tube) is not readily available, your doctor may decide that Abseamed should be injected under the skin (subcutaneously). This includes patients on dialysis and patients not yet on dialysis.
Your doctor will order regular blood tests to see how your anaemia is responding and may adjust the dose, usually no more frequently than every four weeks. A rise in haemoglobin of greater than 2 g/dL over a four week period should be avoided.
Once your anaemia has been corrected, your doctor will continue to check your blood regularly.
Your Abseamed dose and frequency of administration may be further adjusted to maintain your response to treatment. Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
If you do not respond adequately to Abseamed, your doctor will check your dose and will inform you if you need to change doses of Abseamed.
If you are on a more extended dosing interval (greater than once weekly) of Abseamed, you may not maintain adequate haemoglobin levels and you may require an increase in Abseamed dose or frequency of administration.
You may be given iron supplements before and during Abseamed treatment to make it more effective.
If you are having dialysis treatment when you begin treatment with Abseamed, your dialysis regime may need to be adjusted. Your doctor will decide this.
Your doctor may initiate treatment with Abseamed if your haemoglobin is 10 g/dL or less.
Your doctor will maintain your haemoglobin level between 10 and 12 g/dL as a high haemoglobin level may increase the risk of blood clots and death.
The starting dose is either 150 IU per kilogram body weight three times a week or 450 IU per kilogram body weight once a week.
Abseamed is given by injection under the skin.
Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Abseamed treatment.
You may be given iron supplements before and during Abseamed treatment to make it more effective.
You will usually continue Abseamed treatment for one month after the end of chemotherapy.
Abseamed is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
You may be given iron supplements before and during Abseamed treatment to make it more effective.
Abseamed is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
If there is a medical need to reduce the time before your operation, you will be given a daily dose of 300 IU/kg for up to ten days before surgery, on the day of surgery and for four days immediately afterwards.
If blood tests show your haemoglobin is too high before the operation, the treatment will be stopped.
You may be given iron supplements before and during Abseamed treatment to make it more effective.
Your doctor may initiate treatment with Abseamed if your haemoglobin is 10 g/dL or less. The aim of treatment is to maintain your haemoglobin level between 10 and 12 g/dL as a higher haemoglobin level may increase the risk of blood clots and death.
Abseamed is given by injection under the skin.
The starting dose is 450 IU per kilogram bodyweight once a week.
Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Abseamed treatment.
When treatment starts, Abseamed is usually injected by a medical professional or a nurse. Later, your doctor may suggest that you or your caregiver learn how to inject Abseamed under the skin (subcutaneously) yourself.
If Abseamed is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Abseamed is given alone and not mixed with other liquids for injection.
Instructions on how to inject yourself with Abseamed can be found at the end of this leaflet.
Tell your doctor or nurse immediately if you think too much Abseamed has been injected. Side effects from an overdose of Abseamed are unlikely.
Make the next injection as soon as you remember. If you are within a day of your next injection, forget the missed one and carry on with your normal schedule. Do not double up the injections to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects
These may affect more than 1 in 10 people.
Common side effects
These may affect up to 1 in 10 people.
You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.
Uncommon side effects
These may affect up to 1 in 100 people.
Rare side effects
These may affect up to 1 in 1,000 people.
PRCA means the bone marrow does not make enough red blood cells. PRCA causes sudden and severe anaemia. The symptoms are:
PRCA has been very rarely reported mostly in patients with kidney disease after months to years of treatment with epoetin alfa and other products that stimulate red blood cell production.
An increase in levels of small blood cells (called platelets), which are normally involved in the formation of a blood clot may occur, particularly when starting treatment. Your doctor will check on this.
Severe allergic reaction that may include:
a swollen face, lips, mouth, tongue or throat,
difficulty swallowing or breathing,
itchy rash (hives).
Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
If you are receiving haemodialysis:
Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Abseamed if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Store and transport refrigerated (2°C-8°C).
You may take Abseamed out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 3 days or disposed of.
Do not freeze or shake.
Store in the original package in order to protect from light.
Do not use this medicine if you notice that
it may have been accidentally frozen, or
if there has been a refrigerator failure,
the liquid is coloured or you can see particles floating in it,
the seal is broken.
Abseamed is presented as a clear, colourless solution for injection in a pre-filled syringe. The syringes are sealed in a blister.
Presentation | Corresponding Presentations in Quantity/Volume for each Strength | Amount of epoetin alfa |
Pre-filled syringes* | 2,000 IU/mL: | 8.4 micrograms |
1,000 IU/0.5 mL | ||
2,000 IU/1 mL | 16.8 micrograms | |
10,000 IU/mL: | ||
3,000 IU/0.3 mL | 25.2 micrograms | |
4,000 IU/0.4 mL | 33.6 micrograms | |
5,000 IU/0.5 mL | 42.0 micrograms | |
6,000 IU/0.6 mL | 50.4 micrograms | |
7,000 IU/0.7 mL | 58.8 micrograms | |
8,000 IU/0.8 mL | 67.2 micrograms | |
9,000 IU/0.9 mL | 75.6 micrograms | |
10,000 IU/1 mL | 84.0 micrograms | |
40,000 IU/mL: | ||
20,000 IU/0.5 mL | 168.0 micrograms | |
30,000 IU/0.75 mL | 252.0 micrograms | |
40,000 IU/1 mL | 336.0 micrograms |
*Pack size of 1, 4 or 6 pre-filled syringe(s) with or without a needle safety guard. Not all pack sizes may be marketed.
Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37
D-58638 Iserlohn
Germany
Sandoz GmbH Biochemiestr. 10
A-6336 Langkampfen Austria
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This section contains information on how to give yourself an injection of Abseamed. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. Abseamed is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse. If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Wash your hands.
Remove one syringe from the pack and remove the protective cap from the injection needle.
Syringes are embossed with graduation rings in order to enable partial use if required. Each graduation ring corresponds to a volume of 0.1 mL. If partial use of a syringe is required, remove unwanted solution before injection.
Clean the skin at the injection site using an alcohol wipe.
Form a skin fold by pinching the skin between thumb and forefinger.
Insert the needle into the skin fold with a quick, firm action. Inject the Abseamed solution as you have been shown by your doctor. You should check with your doctor or pharmacist if you are not sure.
Pre-filled syringe without needle safety guard
Always keeping your skin pinched, depress the plunger slowly and evenly.
After injecting the liquid, remove the needle and let go of your skin. Apply pressure over the injection site with a dry, sterile pad.
Discard any unused product or waste material. Only use each syringe for one injection.
Pre-filled syringe with needle safety guard
Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger!
After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin. Apply pressure over the injection site with a dry, sterile pad.
Let go of the plunger. The needle safety guard will rapidly move to cover the needle.
Discard any unused product or waste material. Only use each syringe for one injection.