Prevymis

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

Letermovir

Beschikbaar vanaf:

Merck Sharp & Dohme B.V.

ATC-code:

J05

INN (Algemene Internationale Benaming):

letermovir

Therapeutische categorie:

Antivirals for systemic use

Therapeutisch gebied:

Cytomegalovirus Infections

therapeutische indicaties:

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.

Product samenvatting:

Revision: 15

Autorisatie-status:

Authorised

Autorisatie datum:

2018-01-08

Bijsluiter

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

Productkenmerken

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