Binocrit 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, Epoetin Alfa in a Pre Filled Syringe
1. What Binocrit Is And What Is Binocrit Used For
Binocrit contains the active substance epoetin alfa, a protein that stimulates the bone marrow to form more red blood cells that contain haemoglobin (a substance that carries oxygen). Epoetin alfa is a copy of the human protein et erythropoietin and works similarly.
Binocrit is used to treat symptomatic anaemia caused by kidney disease:
- In children undergoing hemodialysis
- In adults undergoing hemodialysis or peritoneal dialysis
- In adults with severe anaemia not yet undergoing dialysis (given as an injection into a vein)
If you have kidney disease and do 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 anaemia if you are receiving chemotherapy for solid tumours, lymph node tumours (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 anaemia who donate a certain amount of their blood before their operation to 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 injection is used in people with moderate anaemia who need major orthopaedic 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 cannot 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 your blood transfusion during or after the operation.
- If you are going to undergo a major, planned (elective) operation
- Have a serious heart disease
- Severe diseases 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 the injection is right for you.
You must 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
- Anaemia 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.
Suppose you are a patient with hepatitis C and are receiving interferon and ribavirin.
In that case, you should discuss this with your doctor because epoetin alfa in combination with interferon and ribavirin has, in rare cases, led to poor efficacy and development of the condition pure erythrocyte aplasia (PRCA), which is a severe form of anaemia. Binocrit is not approved for the treatment of hepatitis C-associated anaemia.
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 injection as repeated dose increases; 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 have recently taken or might take any other medicines, including medicines obtained without a prescription.
Suppose you take a medicine called ciclosporin (used after a kidney transplant, for example). In that case, your doctor may prescribe blood tests to check your ciclosporin levels while taking it.
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 you are being treated with this medicine. It may affect other treatments or test results.
Pregnancy, Breastfeeding, And Fertility
You must 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
This medicine contains less than 1 mmol sodium (23 mg) per dose, essentially ‘sodium-free’.
3. How To Use Binocrit
Binocrit uses
- 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. You will usually receive the injection from a doctor, nurse, or other healthcare professionals.
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 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 kilograms (kg) body weight. The cause of your anaemia is also included 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 haemoglobin level between 10 and 12 g / dl, as a high haemoglobin 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 anaemia responds to treatment and may adjust dose one, usually no more often than every four weeks.
- Once your anaemia has been corrected, your doctor will regularly 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 your anaemia symptoms.
- 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.
- Suppose you are on an extended dosing interval (less frequently than once a week) with Binocrit. In that case, you may not maintain adequate haemoglobin levels and 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 haemoglobin level is 10 g / dl or lower.
- Your doctor will keep your haemoglobin level between 10 and 12 g / dl, as a high haemoglobin 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 adjust the dose depending on how the anaemia responds to treatment with Binocrit.
- You may receive iron supplements before and during treatment with Binocrit to make it more effective.
- Treatment with this medicine usually continues for one month after chemotherapy treatment.
Adults who donate their blood
- The usual starting dose is 600 IU per kilogram of body weight twice weekly.
- After you donate blood, this medicine 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 orthopaedic 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 and on the day of surgery.
- Suppose there is a medical need to shorten the time until your surgery. In that case, 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 haemoglobin 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.
- Ensure 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 millilitre (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 injecting 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 about the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible Binocrit Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. Please tell your doctor or nurse if you notice any side effects not listed in this leaflet.
Very common side effects are
These may occur in more than 1 in 10 people using Binocrit.
- Diarrhoea
- Nausea
- Vomiting
- Fever
- Narrow airways, e.g.
- Nasal congestion and sore throat have been reported in patients with kidney disease 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) may require immediate treatment. As symptoms, you may experience chest pain, shortness of breath, and painful swelling and redness, usually in the leg.
- Cough
- Skin rash, which is an allergic reaction, can cause
- Skeletal or muscle pain.
- Influenza-like symptoms, such as
- Headache
- Joint pain
- Pain
- Feeling weak
- Chills
- Fatigue
- Dizziness. These may be more common at the beginning of treatment. If you get these symptoms during a vein injection, they can be avoided 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 anaemia. The symptoms are:
- Abnormal fatigue
- Dizziness
- Shortness of breath
Pure erythrocyte plasma has, in 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 ) is normally involved in forming 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 or other side effects with this medicine. If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse, or pharmacist.
Reporting of side effects are
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 medicine’s safety.
Reporting of side effects
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 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.
- There has been something wrong with the refrigerator.
- The liquid is discoloured, 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 that are 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, colourless 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
Läkemedelsverket, Box 26, 751 03 Uppsala
www.lakemedelsverket.se
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 |