Երկիր: Մալայզիա
Լեզու: անգլերեն
Աղբյուրը: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
epoetin zeta
DKSH MALAYSIA SDN BHD
epoetin zeta
1.00 kg; 1.0ml mL; 6x1.0ml mL
STADA Arzneimittel AG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ EPO STADA PREFILLED SYRINGE Epoetin zeta (2 000 IU/0.6 ml, 4 000 IU/0.4ml, 10 000IU/1.0ml) 1 WHAT IS IN THIS LEAFLET 1. What EPO STADA is used for 2. How EPO STADA works 3. Before you use EPO STADA 4. How to use EPO STADA 5. While you are using it 6. Side effects 7. Storage and Disposal of EPO STADA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision This is a biosimilar medicinal product referenced to Epoetin alpha. It is not interchangeable or substitutes with the reference product. WHAT EPO STADA IS USED FOR EPO STADA is used: - in adults, children and adolescents on haemodialysis to treat symptomatic anaemia (low red blood cell counts) associated with chronic renal failure (kidney disease). - in adult patients on peritoneal dialysis to treat symptomatic anaemia associated with chronic renal failure (kidney disease). - in adult patients with renal insufficiency not yet on dialysis to treat severe anaemia associated with kidney disease accompanied by clinical symptoms. - in adult patients with chemotherapy induced anaemia - in adult surgery patients in an autologous predonation programme. HOW EPO STADA WORKS EPO STADA contains a protein called epoetin zeta, that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen). Epoetin zeta is a copy of the human protein erythropoietin and acts in the same way. BEFORE YOU USE EPO STADA - _When you must not use it _ • If you are allergic (hypersensitive) to erythropoietins or any of the other ingredients of this medicine (listed in ingredient). • if you have developed Pure Red Cell Aplasia (PRCA; reduced or stopped production of red blood cells) following treatment with any erythropoietin • if you have high blood pressure, which is not properly controlled with blood pressure-lowering medicines • if you cannot be given medicines to thin blood for the prevention of blood clots • if you are donating your own blood Կարդացեք ամբողջական փաստաթուղթը
EPO STADA 2,000IU/0.6ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE EPO STADA 4,000IU/0.4ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE EPO STADA 10,000IU/1.0ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE This is a biosimilar medicinal product referenced to Eprex®. It is not interchangeable or substitutable with the reference product. NAME AND STRENGTH OF ACTIVE SUBSTANCE Each pre-filled syringe contains epoetin zeta* (recombinant human erythropoietin) solution for injection. The solution contains 3,333IU Epoetin zeta per ml for 2000IU/0.6ml dosage. The solution contains 10,000IU Epoetin zeta per ml for 4,000IU/0.4ml and 10,000IU/1.0ml dosage. *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line. Excipient with known effect: The solution contains 0.50 mg phenylalanine per ml. Each pre-filled syringe of; • 2,000IU/ 0.6ml contains 0.30 mg phenylalanine • 4,000IU/ 0.4ml contains 0.20 mg phenylalanine • 10,000IU/1.0ml contains 0.50 mg phenylalanine LIST OF EXCIPIENTS Disodium phosphate dihydrate Phenylalanine Glycine Sodium dihydrogen phosphate dihydrate Water for injections Leucine Sodium hydroxide (pH adjuster) Sodium chloride Isoleucine Hydrochloric acid (pH adjuster) Glutamic acid Threonine Polysorbate 20 Calcium chloride dihydrate PRODUCT DESCRIPTION Solution for injection in pre-filled syringe. Clear, colourless solution PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Other antianaemic preparations, erythropoietin ATC code: B03XA01 EPO STADA is a biosimilar medicinal product. Detailed information is available on the website of the European Medicines Agency. http://www.ema.europa.eu. _Pharmacodynamic effects_ Erythropoietin is a glycoprotein that stimulates, as a mitosis-stimulating factor and differentiating hormone, the formation of erythrocytes from precursors of the stem cell compartment. The apparent molecular weight of erythropoietin is 32 000-40 000 Dalton. The protein moiety of the molecule contributes about 58% of total molecul Կարդացեք ամբողջական փաստաթուղթը