Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Letermovir
Merck Sharp & Dohme B.V.
J05
letermovir
Antivirals for systemic use
Cytomegalovirus Infections
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.
Revision: 15
Authorised
2018-01-08
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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, debosse d 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). PREVYMIS is indicated for prophylaxis of CMV disease in CMV - seronegative adults who have received a kidney transplant from a CMV- seropositive donor [D+/R-]. Consideration should be given to official guidance on the appropriate use of antiviral agents. 4.2 POSOLOGY 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 or kidney transplant . 3 Posology PREVYMIS is also available as concentrate for solution for infusion (240 mg and 480 mg). PREVYMIS tablets and concentrate for solution for infusion may be used interchangeably at the discretion of the physician, and no dose adjustment is necessary. The recommend ed dose of PREVYMIS is one 480 mg tablet once daily. HSC Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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, debosse d 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). PREVYMIS is indicated for prophylaxis of CMV disease in CMV - seronegative adults who have received a kidney transplant from a CMV- seropositive donor [D+/R-]. Consideration should be given to official guidance on the appropriate use of antiviral agents. 4.2 POSOLOGY 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 or kidney transplant . 3 Posology PREVYMIS is also available as concentrate for solution for infusion (240 mg and 480 mg). PREVYMIS tablets and concentrate for solution for infusion may be used interchangeably at the discretion of the physician, and no dose adjustment is necessary. The recommend ed dose of PREVYMIS is one 480 mg tablet once daily. HSC Lesen Sie das vollständige Dokument