Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
lipegfilgrastim, Quantity: 6 mg
Teva Pharma Australia Pty Ltd
lipegfilgrastim
Injection, solution
Excipient Ingredients: acetic acid; polysorbate 20; sorbitol; sodium hydroxide; water for injections
Subcutaneous
6 mg / 0.6 mL solution for injection
(S4) Prescription Only Medicine
Lonquex? is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)
Visual Identification: Lonquex is a sterile preservative free aqueous solution for subcutaneous inj presented in a 1 mL prefilled syringe containing 6 mg of lipegfilgrastim/0.6 mL acetate buffer pH 5.0 (based on protein content); Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-11-12
LONQUEX ® _Lipegfilgrastim (rbe)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS BOOKLET This booklet answers some common questions about Lonquex. Please note that this booklet does not contain everything there is to know about Lonquex. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has prescribed Lonquex after considering its likely benefit to you, as well as the potential risks. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS BOOKLET WITH YOUR MEDICINE. You may need to read this information again. WHAT IS LONQUEX USED FOR Lonquex is used following chemotherapy to help fight infection. Some chemotherapy will reduce the number of neutrophils in your body. Although Lonquex is not a treatment for cancer, it does help the body to make new neutrophils and this may reduce your chance of developing infections that might require antibiotics and/or hospital stays. It may even increase your chance of receiving your chemotherapy on time and at the right dose. _HOW IT WORKS_ Lonquex contains the active substance lipegfilgrastim. Lipegfilgrastim is a long-acting modified protein produced by biotechnology in bacteria called Escherichia coli. It belongs to a group of proteins called cytokines and is similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body. Lipegfilgrastim stimulates the bone narrow (the tissue where new blood cells are made) to produce more white blood cells. White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level, there may not be enough left in the body to fight bacteria and you may have an increased risk of infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only wi Διαβάστε το πλήρες έγγραφο
Teva Pharma Australia Pty Limited Version 5.0 1 AUSTRALIAN PI – LONQUEX ® (LIPEGFILGRASTIM) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Lipegfilgrastim. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lonquex® is the Teva Pharmaceuticals Ltd. trademark for lipegfilgrastim (rbe), a long-acting form of recombinant human granulocyte colony-stimulating factor (G-CSF). Lonquex® contains the active substance lipegfilgrastim (rbe). Lipegfilgrastim is a covalent conjugate of a 19,000 dalton E.Coli produced r-metHuG-CSF and a 20,000 dalton polyethylene glycol (PEG) moiety. The theoretical molecular mass of r-metHuG-CSF is 18,798.9 Da. The molecular mass of the final glycoPEGylated human N-methionyl granulocyte-colony stimulating factor is approximately 39,000 Da. The PEG moiety is attached enzymatically through a glycolinker (glycyl-sialyl-GalNac) to the amino acid Thr134 (which corresponds to the glycosylation site Thr133 in endogenous G-CSF). Lipegfilgrastim is a covalent conjugate of filgrastim with a single methoxy polyethylene glycol (PEG) molecule via a carbohydrate linker consisting of L-Glycine, N-acetylneuraminic acid (Sialic Acid) and a N-acetylgalactosamine (GalNAc) moiety to Threonine134. The average molecular mass is approximately 39,000 dalton of which the protein moiety constitutes approximately 48%. The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. For more information, see SECTION 5, PHARMACOLOGICAL PROPERTIES. Each single-use pre-filled syringe of Lonquex® contains 6 mg of lipegfilgrastim in 0.6 mL solution. Each mL of solution for injection contains 10 mg of lipegfilgrastim. This medicinal product contains 30 mg sorbitol per pre-filled syringe. Patients with rare hereditary problems of fructose intolerance should not use this medicinal product. This medicinal product contains less than 1 mmol sodium (0.14 mg) per pre-filled syringe, i.e. essentially ‘sodium-free’. For the full list of excipients Διαβάστε το πλήρες έγγραφο