Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
talimogene laherparepvec
Amgen Europe B.V.
L01XX51
talimogene laherparepvec
Antineoplastic agents
Melanoma
Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.
Revision: 13
Authorised
2015-12-16
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMLYGIC 10 6 PLAQUE FORMING UNITS (PFU)/ML SOLUTION FOR INJECTION IMLYGIC 10 8 PLAQUE FORMING UNITS (PFU)/ML SOLUTION FOR INJECTION talimogene laherparepvec READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your healthcare professional (doctor or nurse). - If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. - Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it. - Always show the Patient Alert Card to your doctor or nurse when you see them or if you go to hospital. WHAT IS IN THIS LEAFLET 1. What Imlygic is and what it is used for 2. What you need to know before and during Imlygic treatment 3. How Imlygic is given 4. Possible side effects 5. How Imlygic is stored 6. Contents of the pack and other information 1. WHAT IMLYGIC IS AND WHAT IT IS USED FOR Imlygic is used to treat adult patients with a type of skin cancer called melanoma that has spread in the skin or to the lymph nodes, when surgery is not an option. The active ingredient of Imlygic is talimogene laherparepvec. This is a weakened form of herpes simplex virus type-1 (HSV-1), which is commonly called the cold sore virus. To get Imlygic from HSV-1, the virus has been changed so that it multiplies more effectively in tumours than in normal cells. This leads to destruction of infected tumour cells. This medicine also works by helping your immune system to recognise and destroy tumours throughout your body. 2. WHAT YOU NEED TO KNOW BEFORE AND DURING IMLYGIC TREATMENT _ _ YOU WILL NOT BE GIVEN IMLYGIC: - if you are allergic to talimogene laherparepvec or any of the other ingredients of this medicine (listed in section 6). - if your healthcare professional has told you that you have a Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Imlygic 10 6 plaque forming units (PFU)/mL solution for injection Imlygic 10 8 plaque forming units (PFU)/mL solution for injection _ _ _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Talimogene laherparepvec is an attenuated herpes simplex virus type-1 (HSV-1) derived by functional deletion of 2 genes (ICP34.5 and ICP47) and insertion of coding sequence for human granulocyte macrophage colony-stimulating factor (GM-CSF) (see section 5.1). _ _ Talimogene laherparepvec is produced in Vero cells by recombinant DNA technology. 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION Imlygic 10 6 plaque forming units (PFU)/mL solution for injection Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 x 10 6 (1 million) plaque forming units (PFU)/mL. Imlygic 10 8 plaque forming units (PFU)/mL solution for injection Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 x 10 8 (100 million) plaque forming units (PFU)/mL. Excipient with known effect Each 1 mL vial contains 7.7 mg sodium and 20 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Imlygic 10 6 plaque forming units (PFU)/mL solution for injection Clear to semi-translucent liquid following thaw from its frozen state. It may contain white, visible, variously shaped, virus-containing particles. Imlygic 10 8 plaque forming units (PFU)/mL solution for injection Semi-translucent to opaque liquid following thaw from its frozen state. It may contain white, visible, variously shaped, virus-containing particles. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with talimoge Прочитать полный документ