Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - binocrit

Document Subject

Generated Narrative: MedicinalProductDefinition mp6f8fb6a1c6179a9554b85e75fc6f0388

identifier: http://ema.europa.eu/identifier/EU/1/07/410/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Binocrit 1,000 IU/0.5 mL solution for injection in a pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6f8fb6a1c6179a9554b85e75fc6f0388

identifier: http://ema.europa.eu/identifier/EU/1/07/410/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - binocrit

Attesters

What is in this leaflet

1. What Binocrit is and what it is used for
2. What you need to know before you use Binocrit
3. How to use Binocrit
4. Possible side effects
5. How to store Binocrit
6. Contents of the pack and other information

Binocrit 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. Binocrit is used to treat symptomatic anaemia caused by kidney disease:

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). Binocrit is prescribed to stimulate your bone marrow to produce more red blood cells. Binocrit is used to treat anaemia in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma (bone marrow cancer) who may have a need for a blood transfusion. Binocrit can reduce the need for a blood transfusion in these patients. Binocrit is used in moderately anaemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation. Because Binocrit stimulates the production of red blood cells, doctors can take more blood from these people. Binocrit is used in moderately anaemic adults about to have major orthopaedic surgery (for example hip or knee replacement operations), to reduce the potential need for blood transfusions. Binocrit is used to treat anaemia in adults with a bone marrow disorder that causes a severe disruption in the creation of blood cells (myelodysplastic syndromes). Binocrit can reduce the need for a blood transfusion.

Do not use Binocrit:

if you are allergic to epoetin alfa or any of the other ingredients of this medicine (listed in section 6).

if you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Binocrit). See section 4.
if you have high blood pressure not properly controlled with medicines.

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.

if you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:

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 Binocrit may not be suitable for you. Please discuss with your doctor. While on Binocrit, 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 Binocrit. Warnings and precautions: Talk to your doctor, pharmacist or nurse before using Binocrit. Binocrit 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 Binocrit is suitable for you. It is important to tell your doctor if any of the following apply to you. You may still be able to use Binocrit, but discuss it with your doctor first. If you know you suffer, or have suffered, from:

high blood pressure;

epileptic seizures or fits;

liver disease;

anaemia from other causes;

porphyria (a rare blood disorder). If you are a cancer patient be aware that products that stimulate red blood cell production (like Binocrit) may act as a growth factor and therefore in theory may affect the progression of your cancer. Depending on your individual situation a blood transfusion may be preferable. Please discuss this with your doctor. If you are a patient with hepatitis C and you receive interferon and ribavirin, you should discuss this with your doctor because a combination of epoetin alfa with interferon and ribavirin has led to a loss of effect and development of a condition called pure red cell aplasia (PRCA), a severe form of anaemia, in rare cases. Binocrit is not approved in the management of anaemia associated with hepatitis C. If you are a patient with chronic renal failure, and particularly if you do not respond properly to Binocrit, your doctor will check your dose of Binocrit because repeatedly increasing your dose of Binocrit if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death. If you are a cancer patient, be aware that use of Binocrit may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy. Take special care with other products that stimulate red blood cell production: Binocrit 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 Binocrit during your treatment, speak to your doctor or pharmacist before using it. Take special care with Binocrit: Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment. 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 Binocrit and contact your doctor or seek medical attention immediately. Other medicines and Binocrit Tell your doctor if you are taking, have recently taken or might take any other medicines. If you are taking a medicine called cyclosporin (used e.g. after kidney transplants), your doctor may order blood tests to check the level of cyclosporin while you are taking Binocrit. Iron supplements and other blood stimulants may increase the effectiveness of Binocrit. Your doctor will decide if it is right for you to take them. If you visit a hospital, clinic or family doctor, tell them you are having Binocrit treatment. It may affect other treatments or test results. Pregnancy and breast-feeding It is important to tell your doctor if any of the following apply to you. You may still be able to use Binocrit, but discuss it with your doctor first:

if you are pregnant, or think you may be pregnant.

if you are breast-feeding. Binocrit contains sodium Binocrit contains less than 1 mmol sodium (23 mg) per dose that is to say essentially sodium free .

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor has carried out blood tests and decided you need Binocrit. Binocrit may be given by injection:

Either into a vein or a tube that goes into a vein (intravenously)

Or under the skin (subcutaneously). Your doctor will decide how Binocrit 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 Binocrit treatment, may later learn how to inject themselves under the skin: see Instructions on how to inject Binocrit yourself at the end of the leaflet. Binocrit 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 Binocrit 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 monitor your blood pressure regularly while you are using Binocrit. People with kidney disease

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.

The usual starting dose of Binocrit for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week. For patients on peritoneal dialysis Binocrit may be given twice a week.

For adults and children Binocrit 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 Binocrit 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 Binocrit 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 Binocrit, your doctor will check your dose and will inform you if you need to change doses of Binocrit.

If you are on a more extended dosing interval (greater than once weekly) of Binocrit, you may not maintain adequate haemoglobin levels and you may require an increase in Binocrit dose or frequency of administration.

You may be given iron supplements before and during Binocrit treatment to make it more effective.

If you are having dialysis treatment when you begin treatment with Binocrit, your dialysis regime may need to be adjusted. Your doctor will decide this. Adults on chemotherapy

Your doctor may initiate treatment with Binocrit 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.

Binocrit 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 Binocrit treatment.

You may be given iron supplements before and during Binocrit treatment to make it more effective.

You will usually continue Binocrit treatment for one month after the end of chemotherapy. Adults donating their own blood

The usual dose is 600 IU per kilogram body weight twice a week.

Binocrit 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 Binocrit treatment to make it more effective. Adults scheduled for major orthopaedic surgery

The recommended dose is 600 IU per kilogram body weight once a week.

Binocrit 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 Binocrit treatment to make it more effective. Adults with myelodysplastic syndrome

Your doctor may initiate treatment with Binocrit 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.

Binocrit 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 Binocrit treatment. Instructions on how to inject Binocrit yourself When treatment starts, Binocrit is usually injected by a medical professional or a nurse. Later, your doctor may suggest that you or your caregiver learn how to inject Binocrit under the skin (subcutaneously) yourself.

Do not attempt to inject yourself unless you have been trained to do so by your doctor or nurse.

Always use Binocrit exactly as instructed by your doctor or nurse.

Ensure that you only inject the amount of liquid as instructed by your doctor or nurse.

Only use Binocrit if it has been stored correctly see section 5, How to store Binocrit.

Before use, leave the Binocrit syringe to stand until it reaches room temperature. This usually takes between 15 and 30 minutes. Use the syringe within 3 days of taking it out of the refrigerator. Only take one dose of Binocrit from each syringe. If Binocrit is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection. Binocrit is given alone and not mixed with other liquids for injection. Do not shake Binocrit syringes. Prolonged vigorous shaking may damage the product. If the product has been shaken vigorously, don t use it. Instructions on how to inject yourself with Binocrit can be found at the end of this leaflet. If you use more Binocrit than you should Tell your doctor or nurse immediately if you think too much Binocrit has been injected. Side effects from an overdose of Binocrit are unlikely. If you forget to use Binocrit 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. Tell your doctor or nurse immediately if you notice any of the effects in this list. Very common side effects These may affect more than 1 in 10 people.

Diarrhoea

Feeling sick in your stomach

Vomiting

Fever

Respiratory tract congestion, such as stuffy nose and sore throat, has been reported in patients with kidney disease not yet on dialysis. Common side effects These may affect up to 1 in 10 people.

Increased blood pressure. Headaches, particularly sudden, stabbing migraine-like headaches, feeling confused or having fits may be signs of a sudden increase in blood pressure. This requires urgent treatment. Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure).

Blood clots (including deep vein thrombosis and embolism) that may require urgent treatment. You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.

Cough.

Skin rashes, which may result from an allergic reaction.

Bone or muscle pain.

Flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, chills, tiredness and dizziness. These may be more common at the start of treatment. If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.

Redness, burning and pain at the site of injection.

Swelling of the ankles, feet or fingers.

Arm or leg pain. Uncommon side effects These may affect up to 1 in 100 people.

High levels of blood potassium which can cause abnormal heart rhythm (this is a very common side effect in patients on dialysis).

Fits.

Nose or airway congestion.

Allergic reaction.

Hives. Rare side effects These may affect up to 1 in 1,000 people.

Symptoms of pure red cell aplasia (PRCA) PRCA means the bone marrow does not make enough red blood cells. PRCA causes sudden and severe anaemia. The symptoms are:

unusual tiredness,

feeling dizzy,

breathlessness. 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:

Blood clots (thrombosis) may form in your dialysis shunt. This is more likely if you have low blood pressure or if your fistula has complications.

Blood clots may also form in your haemodialysis system. Your doctor may decide to increase your heparin dose during dialysis. 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 Binocrit if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2. Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Binocrit. 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. Reporting of side effects 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 Binocrit 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. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Binocrit contains

The active substance is: epoetin alfa (for quantity see the table below).

The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections. What Binocrit looks like and contents of the pack Binocrit 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: 1,000 IU/0.5 mL 2,000 IU/1 mL 10,000 IU/mL: 3,000 IU/0.3 mL 4,000 IU/0.4 mL 5,000 IU/0.5 mL 6,000 IU/0.6 mL 7,000 IU/0.7 mL 8,000 IU/0.8 mL 9,000 IU/0.9 mL 10,000 IU/1 mL 40,000 IU/mL: 20,000 IU/0.5 mL 30,000 IU/0.75 mL 40,000 IU/1 mL 8.4 micrograms 16.8 micrograms 25.2 micrograms 33.6 micrograms 42.0 micrograms 50.4 micrograms 58.8 micrograms 67.2 micrograms 75.6 micrograms 84.0 micrograms 168.0 micrograms 252.0 micrograms 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. Marketing Authorisation Holder Sandoz GmbH Biochemiestr. A-6250 Kundl Austria Manufacturer Sandoz GmbH Biochemiestr. A-6336 Langkampfen Austria For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Sandoz nv/sa T l/Tel: +32 2 722 97 Lietuva Sandoz Pharmaceuticals d.d filialas Tel: +370 5 2636

.: +359 2 970 47 Luxembourg/Luxemburg Sandoz nv/sa T l/Tel.: +32 2 722 97 esk republika Sandoz s.r.o. Tel: +420 225 775 Magyarorsz g Sandoz Hung ria Kft. Tel.: +36 1 430 2Danmark/Norge/ sland/Sverige Sandoz A/S Tlf: +45 63 95 10 Malta Sandoz Pharmaceuticals d.d. Tel: +35699644Deutschland Hexal AG Tel: +49 8024 908 0 Nederland Sandoz B.V. Tel: +31 36 52 41 Eesti Sandoz d.d. Eesti filiaal Tel: +372 665 2 sterreich Sandoz GmbH Tel: +43 5338 2 SANDOZ HELLAS . . : +30 216 600 5Polska Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 Espa a Sandoz Farmac utica, S.A. Tel: +34 900 456 Portugal Sandoz Farmac utica Lda. Tel: +351 21 000 86 France Sandoz SAS T l: +33 1 49 64 48 Rom nia Sandoz Pharmaceuticals SRL Tel: +40 21 407 51 Hrvatska Sandoz d.o.o. Tel: +385 1 23 53 Slovenija Sandoz farmacevtska dru ba d.d. Tel: +386 1 580 29 Ireland Rowex Ltd. Tel: + 353 27 50Slovensk republika Sandoz d.d. - organiza n zlo ka Tel: +421 2 50 70 6Italia Sandoz S.p.A. Tel: +39 02 96Suomi/Finland Sandoz A/S Puh/Tel: +358 10 6133
Sandoz Pharmaceuticals d.d. : +357 22 69 0United Kingdom (Northern Ireland) Sandoz GmbH Tel: +43 5338 2Latvija Sandoz d.d. Latvia fili le Tel: +371 67 892 This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: