1000 IU / 0.5 ml, 2000 IU / 1 ml, 3000 IU / 0.3 ml, 4000 IU / 0.4 ml, 5000 IU / 0.5 ml, 6000 IU / 0.6 ml, 7000 IU / 0 , 7 mL, 8000 IU / 0.8mL, 9000 IU / 0.9 ml, 10,000 IU / 1 ml, 20,000 IU / 0.5 ml, 30000 IU / 0.75 ml and 40,000 IU / 1 ml injection solution , in a pre-filled syringe 
epoetin alfa

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information See section 4.

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 packaging and other information 

1. What Binocrit is and what it is used for

Binocrit contains the active substance epoetin alfa, a protein that stimulates the bone marrow to form more red blood cells that contain hemoglobin (a substance that carries oxygen). Epoetin alfa is a copy of the human protein et erythropoietin and works in the same way.

Binocrit is used to treat symptomatic anemia ( anemia ) caused by kidney disease:

  • in children undergoing hemodialysis
  • in adults undergoing hemodialysis or peritoneal dialysis
  • in adults with severe anemia not yet undergoing dialysis (given as an injection into a vein)

If you have kidney disease and your kidney does not produce enough erythropoietin, you may have too few red blood cells. Erythropoietin is needed for the production of red blood cells. Binocrit has been prescribed to stimulate your bone marrow to produce more red blood cells.

Binocrit is used to treat anemia if you are receiving chemotherapy for solid tumors, lymph node tumors (malignant lymphoma ), or multiple myeloma (bone marrow cancer) and your doctor thinks you need a blood transfusion. Binocrit may reduce the need for a blood transfusion.

Binocrit is used for patients with moderate anemia who donate a certain amount of their blood before their operation so that they can get it back during or after the operation. Because Binocrit stimulates the production of red blood cells, a larger volume of blood can be taken from these individuals.

Binocrit is used in people with moderate anemia who need major orthopedic surgery (eg hip and knee surgery) to reduce the need for blood transfusions.

2. What you need to know before you use Binocrit

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 erythrocyte aplasia (meaning that your bone marrow is unable to produce enough red blood cells ) after previous treatment with any product that stimulates the formation of red blood cells(including Binocrit), see section 4.
  • if you have high blood pressure, which can not be controlled enough with drugs.
  • to stimulate the production of your red blood cells (so that doctors can take more blood from you)
  • if you can not get a transfusion with your own blood during or after the operation.
  • if you are going to undergo a major, planned (elective) operation
  • have a serious heart disease
  • have severe disease of the veins or arteries are
  • recently had a heart attack or stroke
  • can not take blood thinners

Binocrit may be inappropriate for you. Discuss it with your doctor. Some people who use Binocrit may also need medicines that reduce the risk of blood clots. If you can not take blood-thinning drugs, do not use Binocrit.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Binocrit.

Binocrit and other drugs that stimulate the production of red blood cells 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 (eg if you have a history of blood clots or if you are overweight, have diabetes, have heart disease, or if you are bedridden for a long time as a result of surgery or disease). Tell your doctor if you have any of these. Your doctor will help you determine if Binocrit is right for you.

It is important that you 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 are suffering from or have suffered from:

  • high blood pressure
  • epileptic seizures
  • liver disease
  • anemia of other causes
  • porphyria (a rare blood disease).

If you are a cancer patient, you should be aware that products that stimulate the formation of red blood cells (such as Binocrit) can act as a growth factor and could, therefore, theoretically, affect the development of your cancer.

Depending on your condition, a blood transfusion may be preferable. Discuss this with your doctor.

If you are a patient with hepatitis C and are receiving interferon and ribavirin, you should discuss this with your doctor because epoetin alfa in combination with interferon and ribavirin has in rare cases led to impaired efficacy and development of the condition pure erythrocyte aplasia (PRCA), which is a severe form of anemia. Binocrit is not approved for the treatment of hepatitis C-associated anemia.

If you are a patient with chronic kidney failure, and especially if you do not respond properly to Binocrit, your doctor will check your dose of Binocrit as repeated dose increases of Binocrit, if you do not respond to treatment, may increase the risk of problems with heart or blood vessels and may increase the risk of myocardial infarction, stroke, and death.

Take special care with other drugs that stimulate the production of red blood cells:

Binocrit belongs to a group of products that stimulate the production of red blood cells in the same way as the human protein et erythropoietin does. Your doctor will always note exactly which product you are using. If you get any medicine other than Binocrit that belongs to this group during treatment, talk to your doctor or pharmacist before using it.

Other medicines and Binocrit

Normally, Binocrit does not react with other medicines, but tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

If you are taking a medicine called ciclosporin (used after a kidney transplant, for example), your doctor may prescribe blood tests to check your ciclosporin levels while you are taking Binocrit.

Iron supplements and other blood stimulants can increase the effect of Binocrit. Your doctor will decide if you should take such.

If you go to a hospital, reception, or GP, tell them that you are being treated with Binocrit. It may affect other treatments or test results.

Pregnancy, breastfeeding, and fertility

It is important that you tell your doctor if any of the following apply to you. You may still be able to take Binocrit, but discuss 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, ie essentially ‘sodium-free’.

3. How to use Binocrit

Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Your doctor has taken blood samples and decided that you need Binocrit.

Binocrit is given by injection

  • either in a vein or a tube that enters a vein ( intravenously )
  • or under the skin ( subcutaneously ).

Your doctor will decide how to inject Binocrit. You will usually receive the injection from a doctor, nurse, or other healthcare professional. Depending on why they need Binocrit treatment, some people may later learn to inject themselves under the skin: see Instructions for giving yourself an injection at the end of this leaflet.

Binocrit should not be used:

  • after the expiry date which is stated on the label and the outer carton.
  • if you know, or think it may have been frozen by mistake, or
  • if a fault has occurred with the refrigerator.

Dose one of Binocrit is based on your body weight in kilograms (kg). The cause of your anemia is also included as a factor when your doctor decides which dose is right for you.

Your doctor will monitor your blood pressure regularly while you are using Binocrit.

People with kidney disease

  • Your doctor will keep your hemoglobin level between 10 and 12 g / dl, as a high hemoglobin level may increase the risk of blood clots and death.
  • Usual starting dose
  • Adults and children are provided
  • Your doctor will prescribe regular blood tests to see how your anemia responds to treatment and may adjust dose one, usually no more often than every four weeks.
  • Once your anemia has been corrected, your doctor will regularly continue to check your blood. Your dose of Binocrit and the frequency of administration (how often it is given to you) can be further adjusted to maintain your response to treatment. Your doctor will use the lowest effective dose to control the symptoms of your anemia.
  • If you do not respond properly to Binocrit, your doctor will check your dose and tell you if you need to change the doses of Binocrit.
  • If you are on an extended dosing interval (less frequently than once a week) with Binocrit, you may not maintain adequate hemoglobin levels and you may need to increase the Binocrit- a dose of one or the frequency of administration.
  • You can get iron supplements before and during treatment with Binocrit to make it more effective.
  • If you are undergoing dialysis treatment when you start treatment with Binocrit, your dialysis treatment may need to be adjusted. Your doctor will decide this.

Adults undergoing chemotherapy

  • Your doctor may start treatment with Binocrit if your hemoglobin level is 10 g / dl or lower.
  • Your doctor will keep your hemoglobin level between 10 and 12 g / dl, as a high hemoglobin level may increase the risk of blood clots and death.
  • The usual starting dose is either 150 IU per kg body weight 3 times a week or 450 IU per kilogram body weight once a week.
  • Binocrit is given as an injection under the skin.
  • Your doctor will prescribe blood tests and may adjust the dose depending on how the anemia responds to treatment with Binocrit.
  • You may receive iron supplements before and during treatment with Binocrit to make it more effective.
  • Treatment with Binocrit usually continues for one month after the end of chemotherapy treatment.

Adults who donate their own blood

  • The usual starting dose is 600 IU per kilogram of body weight twice a week.
  • After you donate blood, Binocrit is given immediately by injection into a vein 3 weeks before your operation.
  • You may receive iron supplements before and during treatment with Binocrit to make it more effective.

Adults undergoing major orthopedic surgery

  • The recommended dose is 600 IU per kg of body weight once a week.
  • Binocrit is given as an injection under the skin every week for three weeks before surgery and on the day of surgery.
  • If there is a medical need to shorten the time until your surgery, you will receive a daily dose of 300 IU / kg for up to 10 days before surgery, on the day of surgery, and for 4 days immediately after surgery.
  • If blood tests show that the hemoglobin levels are too high before the operation, treatment will be stopped.
  • You may receive iron supplements before and during treatment with Binocrit to make it more effective.

Instruction for injection of Binocrit under the skin

When starting treatment, Binocrit is usually injected by healthcare professionals. Later, the doctor may suggest that you learn yourself or the person caring for you learn to inject Binocrit under the skin ( subcutaneously ).

Note! If you are a kidney patient, Binocrit must be injected into a vein. Do not inject under the skin ( subcutaneously ).

  • Do not try to give yourself an injection unless your doctor or nurse has trained you to do so.
  • Always use Binocrit exactly as your doctor or nurse has told you.
  • Make sure you only inject the amount of fluid your doctor or nurse has prescribed.
  • Use Binocrit only if it has been stored correctly – see section 5, How to store Binocrit.
  • Before use, the syringe with Binocrit should be taken out and allowed to stand until it reaches room temperature. This usually takes between 15 and 30 minutes. Use the syringe within 3 days after removing it from the refrigerator.

Take only one dose of Binocrit from each syringe.

If Binocrit is injected under the skin ( subcutaneously ), the amount injected is normally no more than one milliliter (1 ml) in one injection.

Binocrit is given alone and should not be mixed with other injections.

Do not shake syringes with Binocrit. Violent shaking for a long time can damage the product. If the product has been shaken violently, it must not be used.

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

Take the next injection as soon as you remember. If it is less than a day until your next injection, you can skip the one you missed and continue according to your usual schedule. Do not inject a double dose.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any side effects not listed in this leaflet, please tell your doctor or nurse .

Very common side effects are

These may occur in more than 1 in 10 people using Binocrit.

  • Diarrhea
  • Nausea
  • Vomiting
  • Fever
  • Narrow airways, e.g. nasal congestion and sore throat, have been reported in patients with kidney disease and who have not yet been treated with dialysis.

Common side effects are

These can occur in up to 1 in 10 people who use Binocrit.

  • Increased blood pressure. Headaches, especially sudden, stabbing migraine-like headaches, feelings of confusion or seizures can be signs of a sudden increase in blood pressure. These require urgent treatment. High blood pressure may require treatment with certain other medicines (or adjustment of any medicines you are already taking for high blood pressure ).
  • Blood clots ( including deep vein thrombosis and embolism) that may require immediate treatment. You may experience chest pain, shortness of breath, and painful swelling and redness, usually in the leg, as symptoms.
  • Cough.
  • Skin rash, which can be caused by an allergic reaction.
  • Skeletal or muscle pain.
  • Influenza-like symptoms, such as headache, joint pain, and pain, feeling weak, chills, fatigue, and dizziness. These may be more common at the beginning of treatment. If you get these symptoms during a vein injection, they can be avoided in the future by giving the injection more slowly.
  • Redness, burning, and pain at the injection site.
  • Swelling of the ankles, feet, or fingers.

Uncommon side effects are

These can occur in up to 1 in 10,000 people who use Binocrit.

  • Symptoms of pure erythrocyte plasma (PRCA)Pure erythrocyte plasma means that the bone marrow does not produce enough red blood cells. Pure erythrocyte plasma leads to sudden and severe anemia. The symptoms are:
  • abnormal fatigue
  • dizziness
  • shortness of breath.

Pure erythrocyte plasma has in very rare cases been reported mainly in patients with kidney disease after months to years of treatment with epoetin alfa and other products that stimulate the formation of red blood cells.

  • An increase in the levels of small blood cells (so-called platelets ), which are normally involved in the formation of a blood clot, especially at the beginning of treatment. Your doctor will check this.

If you are undergoing hemodialysis:

  • Blood clots
  • Blood clots can also form in your hemodialysis system. Your doctor may decide to increase your heparin dose during dialysis.

Tell your doctor or nurse immediately if you notice any of these side effects, or if you notice any other side effects happening 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 ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the information about the safety of the medicine.

Läkemedelsverket, Box 26, 751 03 Uppsala

www.lakemedelsverket.se

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Binocrit

  • 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
    • Store and transport cold (2 ° C ‑ 8 ° C).
    • You can remove Binocrit from the refrigerator and store it at room temperature (up to 25 ° C) for up to 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25 ° C), it must be used within 3 days or discarded.
    • Do not freeze. Do not shake.
    • Store in the original package. Sensitive to light. Do not re-use this medicine
    • the liquid may have been accidentally frozen, or
    • there has been something wrong with the refrigerator,
    • the liquid is discolored or you can see particles floating in it,
    • the seal is broken. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is epoetin alfa (see table below for amounts).

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 the medicine looks like and the contents of the pack

Binocrit is a clear, colorless solution for injection in a pre-filled syringe. The syringes are sealed in a blister pack.

Presentation Corresponding presentations in quantity/volume for each strength Amountepoetin alfa
Pre-filled syringes * 2,000 IU / ml:
1,000 IU / 0.5 ml 8.4 micrograms
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

* Packs of 1, 4, or 6 pre-filled syringes with or without needle guard.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

Contact the representative of the marketing authorization holder to find out more about this medicine:

The representative of the marketing authorization holder:
Belgium / Belgique / BelgienSandoz nv-saTel: +32 2 722 97 97 LithuaniaSandoz Pharmaceuticals dd branchesTel: +370 5 2636 037
BulgariaThe Targovsky presidential agency “Sandoz d.d.”Tel .: +359 2 970 47 47 Luxembourg / LuxemburgSandoz GmbHTel: +43 5338 2000
Czech RepublicSandoz sroTel: +420 221 421 611 HungarySandoz Hungary Kft.Tel .: +36 1 430 2890
MaltaSandoz GmbHTel: +43 5338 2000
GermanyHexal AGTel: +49 8024 908 0 The NetherlandsSandoz BVTel: +31 36 52 41 600
EestiSandoz dd Eesti subsidiaryTel: +372 6652 400 AustriaSandoz GmbHTel: +43 5338 2000
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12ήSandoz Pharmaceuticals dd,:Ηλ: +30 216 600 5000ήDEMO Unified Chemicals in the Humorous State:Ηλ: +30 210 816 18 02
PolandSandoz Polska Sp. z ooTel .: +48 22 209 70 00
SpainSandoz Pharmacéutica, SATel: +34 900 456 856 PortugalSandoz Pharmaceuticals Lda.Tel: +351 21 924 19 11
FranceSandoz SASTel: + 33 1 49 64 48 00 RomaniaSC Sandoz SRLTel: +40 265 208 120
CroatiaSandoz dooTel: +385 1 23 53 111 SloveniaLek farmacevtska družba ddTel: +386 1 580 21 11
IrelandNovartis Ireland LimitedTel: + 353 1 260 12 55 Slovak RepublicSandoz dd – organizational serviceTel: +421 2 48 200 600
ItalySandoz SpATel: +39 02 96541 Finland / FinlandSandoz A / SPuh / Tel: +358 10 6133 415
ΚύπροςPTHadjigeorgiou co ltd:Ηλ: +357 25372425 United KingdomSandoz LtdTel: + 44 1276 69 8020
LatviaSandoz dd Pārstāvniecība LatvijāTel: +371 67 892 006

Muhammad Nadeem

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