Страна: Израел
Език: английски
Източник: Ministry of Health
LETERMOVIR
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
J05AX18
FILM COATED TABLETS
LETERMOVIR 240 MG
PER OS
Required
MERCK SHARP & DOHME LLC, USA
LETERMOVIR
PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Consideration should be given to official guidance on the appropriate use of antiviral agents.
2020-12-03
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) - 1986 This medicine is marketed upon physician’s prescription only PREVYMIS ® 240 MG FILM- COATED TABLETS PREVYMIS ® 480 MG FILM- COATED TABLETS Each film- coated tablet of PREVYMIS 240 MG contains: letermovir 240 mg Each film- coated tablet of PREVYMIS 480 MG contains: letermovir 480 mg For the list of the inactive ingredients see section 6 . “FURTHER INFORMATION”. See also subsection 2. “Important information about some of the ingredients of the medicine” . READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE. • This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. • This medicine has been prescribed for you . Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours . 1. WHAT PREVYMIS IS INTENDED FOR? PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV- seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). THERAPEUTIC GROUP: Antivirals for systemic use, direct acting antivirals, ATC code: J05AX18 . PREVYMIS is an antiviral medicine that contains the active substance letermovir. The medicine is given upon physician’s prescription only . PREVYMIS is a medicine for adults who have recently had a bone marrow transplant. The medicine helps stop you from getting ill from CMV (‘cytomegalovirus’) . CMV is a virus that a lot of people have without knowing. Normally, CMV just stays in their body and it do es not hurt them. However, if your immune system is weak after you get a bone marrow transplant, you may be at high risk of becoming ill from CMV . 2. BEFORE USING PREVYMIS DO NOT USE PREVYMIS IF: • you are allergic to letermovir or any of the other ingredients of this medicine (listed in section 6). • you take either of these medicines: o pimozide - antipsychotic o ergot alkaloids (suc Прочетете целия документ
1 1. NAME OF THE MEDICINAL PRODUCT PREVYMIS ® 240 mg film- coated tablets PREVYMIS ® 480 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PREVYMIS 240 mg film- coated tablets Each film- coated tablet contains 240 mg of letermovir. PREVYMIS 480 mg film- coated tablets Each film- coated tablet contains 480 mg of letermovir. Excipients with known effect Each 240 mg film- coated tablet contains 4 mg of lactose (as monohydrate). Each 480 mg film- coated tablet contains 6.4 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet) PREVYMIS 240 mg film- coated tablets Yellow oval tablet of dimensions 16.5 mm x 8.5 mm, debossed with “591” on one side and corporate logo on the other side. PREVYMIS 480 mg film- coated tablets Pink oval, bi - convex tablet of dimensions 21.2 mm x 10.3 mm, debossed with “595” on one side and corporate logo on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV- seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). Consideration should be given to official guidance on the appropriate use of antiviral agents. 4.2 POSOL OGY AND METHOD OF ADMINISTRATION PREVYMIS should be initiated by a physician experienced in the management of patients who have had a n allogeneic haematopoietic stem cell transplant. Posology The recommended dose of PREVYMIS is one 480 mg tablet once daily. PREVYMIS should be started after HSCT. PREVYMIS may be started on the day of transplant and no later than 28 days post -transplant. PREVYMIS may be started before or after engraftment. Prophylaxis with PREVYMIS should cont inue through 100 days post -transplant. The safety and efficacy of letermovir use for more than 100 days has not been studied in clinical trials. Prolonged letermovir prophylaxis beyond 100 days post - transplant may be of benefit in some 2 patients at Прочетете целия документ