Country: Israel
Language: English
Source: Ministry of Health
LIPEGFILGRASTIM
ABIC MARKETING LTD, ISRAEL
L03AA14
SOLUTION FOR INJECTION
LIPEGFILGRASTIM 6 MG / 0.6 ML
S.C
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
LIPEGFILGRASTIM
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).
2020-03-19
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only LONQUEX ® Solution for injection in a pre-filled syringe For subcutaneous injection only Composition Each syringe contains: Lipegfilgrastim 6 mg/0.6 ml Corresponding to lipegfilgrastim 10 mg per 1 ml solution. For information on the inactive and allergenic ingredients, see section 2 – “Important information about some of the ingredients of the medicine” and section 6 – “Further information”. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. This medicine is intended for subcutaneous injection only. This medicine is not intended for use in children or adolescents under 18 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended to reduce the duration of neutropenia (low white blood cell count) and the incidence of febrile neutropenia that may be caused by chemotherapy treatment. If you would like to find out why this medicine was prescribed for you, please ask your doctor or pharmacist. Therapeutic group: A G-CSF-type protein that stimulates production of white blood cells called neutrophils. 2. BEFORE USING THE MEDICINE Do not use this preparation if: ∙ You are sensitive (allergic) to the active ingredient or to any of the additional ingredients contained in the medicine (see section 6 in this leaflet – “Further information”). Special warnings regarding use of the medicine Before treatment with Lonquex, tell the doctor if: ∙ you experience left upper abdominal pain or pain at the tip of the shoulder. This could indicate impaired spleen function (see section 4 – “Side effects”). ∙ you Read the complete document
Lonquex SPC Minor Updates 11/2023 SUMMARY OF PRODUCT CHARACTERISTICS LONQUEX ® Solution for injection 1. NAME OF THE MEDICINAL PRODUCT Lonquex ® 6 mg solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of lipegfilgrastim* in 0.6 ml solution. Each ml of solution for injection contains 10 mg of lipegfilgrastim. The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker. *This is based on protein content only. The concentration is 20.9 mg/ml (i.e. 12.6 mg per pre-filled syringe) if the PEG moiety and the carbohydrate linker are included. **Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor [G-CSF]) is produced in _Escherichia coli _ cells by recombinant DNA technology. 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 5.1. _Excipients with known effect_ Each pre-filled syringe contains 30 mg sorbitol. Sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (injection). Clear, colourless solution 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Lonquex is indicated in adults 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). _ _ 4.2 Posology and method of administration _ _ Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology. _ _ Lonquex SPC Minor Updates 11/2023 _Posology _ One 6 mg dose of lipegfilgrastim (a single pre-filled syringe of Lonquex) is recommended for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy. _ _ _ _ Special populations _Elderly patients _ In clinical Read the complete document