Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
LENALIDOMIDE
K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL
L04AX04
HARD CAPSULE
LENALIDOMIDE 20 MG
PER OS
Required
LOTUS PHARMACEUTICAL CO., LTD NANTOU PLANT, TAIWAN
LENALIDOMIDE
Multiple Myeloma (MM)Lenalidomide S.K. is indicated for the treatment of multiple myeloma. Myelodysplastic Syndromes Lenalidomide S.K. is indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Lenalidomide S.K. 7.5 mg is not indicated for treatment in MDS. Mantle Cell Lymphoma Lenalidomide S.K. is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL). Follicular lymphomaLenalidomide S.K. in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma.
2020-06-22
2 Contents Page Introduction 3 Personal Information 4 Summary 6 You must never take Lenalidomide S.K. if 7 Info for women who are able to become pregnant 8 Info for women who are not able to become pregnant 11 Information for men 12 Pregnancy Prevention Program Initiation & Reports 13 Prescription information 14 End of Treatment Requirements 15 Additional information 16 3 Lenalidomide S.K. was found to be harmful to foetuses or cause birth defects in animals and is likely to have similar effects in humans. Your doctor has registered you to a Risk Management Plan (RMP), Pregnancy Prevention Program (PPP). The aim of this program is to assist your doctor to inform you regarding the risks related to an unborn child associated with Lenalidomide S.K. treatment and to ensure that you are aware of the precautions you need to take before, during and after the treatment. You must understand and consent to the program conditions to receive the treatment with Lenalidomide S.K. Disclaimer: This information pack only refers to Risk Management Plan (RMP), Pregnancy Prevention Program (PPP). To find out more about the medication, side-effects and warnings please speak with your healthcare professional and read the patient information leaflet. 4 Personal Information Information for patients, doctors, caregivers & pharmacists about the use of personal information – risk management program relating to the administration of the drug Lenalidomide K.S. Kim International Ltd. (hereinafter: “K.S. Kim” or “we”) respects your right to privacy. Your ability to make informed decisions about the use of information belonging to you is important to us. In this document, we specify the information that we collect from you, how we protect it and what uses we make of the information. Information that we collect “Personal information” is information that can be attributed to a person or entity, such as a name, address or medical information. The personal information that we collect from patients includes name/ initials, identity car Přečtěte si celý dokument