Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Epoetin alfa 336 µg/mL
Sandoz New Zealand Limited
Epoetin alfa 336 µg/mL
336 mcg/mL
Solution for injection
Active: Epoetin alfa 336 µg/mL Excipient: Dibasic sodium phosphate dihydrate Glycine Hydrochloric acid Monobasic sodium phosphate dihydrate Nitrogen Polysorbate 80 Sodium chloride Sodium hydroxide Water for injection
Syringe, glass, 0.5 mL x1, 0.5 mL
Prescription
Prescription
Rentschler Biotechnologie GmbH
Binocrit is indicated for: · the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients with renal insufficiency not yet undergoing dialysis · anaemia associated with chronic renal failure in paediatric and adult patients on dialysis · anaemia in patients with non-myeloid malignancies where anaemia is due to the effect of concomitantly administered chemotherapy · adult patients with mild-to-moderate anaemia (haemoglobin > 100 to < 130 g/L) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 mL) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery · to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients undergoing major surgery who are not expected to pre-deposit their complete peri-operative blood needs.
Package - Contents - Shelf Life: Syringe, glass, 0.5 mL x1 - 0.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.75 mL x1 - 0.75 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 1 mL x1 - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.5 mL x6 - 3 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.75 mL x6 - 4.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 1 mL x6 - 6 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C
2011-07-22
BINOCRIT ® 1 BINOCRIT ® PREFILLED SYRINGES _epoetin alfa (rch) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Binocrit prefilled syringes. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. IT IS IMPORTANT THAT YOU READ THIS LEAFLET. KEEP THIS LEAFLET. You may need to read it again. WHAT BINOCRIT IS USED FOR The prefilled syringes contain the active ingredient epoetin alfa, a protein that stimulates bone marrow to produce more red blood cells. Red blood cells are responsible for carrying oxygen to all parts of your body. A decrease in the number of red blood cells can cause anaemia. Some symptoms of anaemia are tiredness, breathlessness when exercising and feeling cold. Anaemia may have many causes including decreased production of a hormone called erythropoietin by the kidneys due to kidney failure or as a result of chemotherapy treatments for cancer. This medicine is virtually identical to your body’s erythropoietin, and has a similar effect to naturally occurring erythropoietin in your body. This medicine is used to treat: _ _ • anaemia associated with kidney disease. If you have kidney disease, your kidney may not produce enough erythropoietin (necessary for red blood cell production) and your doctor may wish to correct this by prescribing this medicine. This medicine stimulates your bone marrow to produce more red blood cells, helping to treat your anaemia. • anaemia and reduce the need for a blood transfusion if you are receiving chemotherapy for cancer and your doctor decides you may need a blood transfusion. • mildly anaemic patients who are going to have surgery and donate blood before surgery, so that their own blood can be given to t Lesen Sie das vollständige Dokument
NEW ZEALAND DATA SHEET 230320-Binocrit-ds Page 1 of 20 NEW ZEALAND DATA SHEET BINOCRIT (EPOETIN ALFA (RCH)) SOLUTION FOR INJECTION USE IN CANCER In some studies, use of Erythropoiesis Stimulating Agents (ESAs) to treat anaemia in patients with cancer has been associated with increased mortality. ESAs should only be used to treat anaemia that has developed as a result of concomitantly administered chemotherapy, and only when blood transfusion is not considered appropriate. Haemoglobin levels should not exceed 120 g/L (see Section 4.4 Special warnings and precautions for use). 1 PRODUCT NAME Binocrit 1,000 IU/0.5 mL solution for injection in pre-filled syringe. Binocrit 2,000 IU/1.0 mL solution for injection in pre-filled syringe. Binocrit 3,000 IU/0.3 mL solution for injection in pre-filled syringe. Binocrit 4,000 IU/0.4 mL solution for injection in pre-filled syringe. Binocrit 5,000 IU/0.5 mL solution for injection in pre-filled syringe. Binocrit 6,000 IU/0.6 mL solution for injection in pre-filled syringe. Binocrit 7,000 IU/0.7 mL solution for injection in pre-filled syringe. Binocrit 8,000 IU/0.8 mL solution for injection in pre-filled syringe. Binocrit 9,000 IU/0.9 mL solution for injection in pre-filled syringe. Binocrit 10,000 IU/1.0 mL solution for injection in pre-filled syringe. Binocrit 20,000 IU/0.5 mL solution for injection in pre-filled syringe. Binocrit 30,000 IU/0.75 mL solution for injection in pre-filled syringe. Binocrit 40,000 IU/1.0 mL solution for injection in pre-filled syringe. Binocrit is a biosimilar medicine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Binocrit is a sterile, clear and colourless, preservative-free buffered protein solution of epoetin alfa (rch). TABLE 1. BINOCRIT DOSE STRENGTHS AND THE CORRESPONDING QUANTITY OF EPOETIN ALPHA PER ML BINOCRIT DOSE STRENGTH FILLED VOLUME TOTAL CONTENT OF ACTIVE CONCENTRATION 1000 IU 0.5 mL 8.4 microgram 16.8 microgram/mL 2000 IU 1.0 mL 16.8 microgram 16.8 microgram/mL 3000 IU 0.3 mL 25.2 microgram 84.0 microgram/mL 4000 IU 0.4 mL 33.6 microgr Lesen Sie das vollständige Dokument