LIVTENCITY

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

MARIBAVIR

Tilgængelig fra:

TAKEDA ISRAEL LTD

ATC-kode:

J05AX10

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

MARIBAVIR 200 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

TAKEDA IRELAND LTD., IRELAND

Terapeutisk område:

MARIBAVIR

Terapeutiske indikationer:

LIVTENCITY is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

Autorisation dato:

2023-05-31

Indlægsseddel

-
Regulations (Preparations)
Patient leaflet in accordance with the Pharmacists'
1986
This medicine is dispensed with a doctor’s prescription only
Livtencity
Film-coated tablets
Active ingredient:
maribavir 200 mg
Inactive ingredients and allergens in this medicine: see section 2
under ‘Important
information about some of this medicine’s ingredients’, and
section 6 ‘Additional information'.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1. What is this medicine intended for?
Livtencity is indicated for the treatment of adults and pediatric
patients (12 years of age and
older weighing at least 35 kg) with post-transplant cytomegalovirus
(CMV) infection/disease,
that is refractory to treatment (with or without genotypic resistance)
with ganciclovir,
valganciclovir, cidofovir or foscarnet.
Therapeutic group: Antivirals
Livtencity is an antiviral medicine against the CMV virus.
2. Before using this medicine
Do not use this medicine if:

You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients in this medicine (see section 6).
Special warnings about using this medicine
Before using Livtencity, tell your doctor if:

You are taking anticonvulsants

You are using ganciclovir or valganciclovir. Concomitant use with
Livtencity is not
recommended. See section 'Interactions with other medicines'.
Additional warnings

Treatment failure due to resistance may occur during and after
treatment with Livtencity.
Disease relapse after treatment discontinuation may occur within 4-8
weeks after
treatment discontinuation. In case of lack of response to treatment or
disease relapse,
your doctor should monitor CMV levels and check for viral resistance
to the medicine.

Produktets egenskaber

1
1 NAME OF THE MEDICINAL PRODUCT
LIVTENCITY
®
1.1 DOSAGE FORMS AND STRENGTHS
Each film coated Tablet contains 200 mg maribavir. The film coated
tablet is blue, oval shaped convex tablet
debossed with “SHP” on one side and “620” on the other side.
2
THERAPUTIC INDICATION
LIVTENCITY is indicated for the treatment of adults and pediatric
patients (12 years of age and older and
weighing at least 35 kg) with post-transplant cytomegalovirus (CMV)
infection/disease that is refractory to
treatment (with or without genotypic resistance) with ganciclovir,
valganciclovir, cidofovir or foscarnet
_[see _
_Use in Specific Populations (8.4) and Clinical Studies (14)]_
.
3
DOSAGE AND ADMINISTRATION
3.1 Recommended Dosage
The recommended dosage in adults and pediatric patients (12 years of
age and older and weighing at least 35
kg) is 400 mg (two 200 mg tablets) taken orally twice daily with or
without food
_[see Use in Specific _
_Populations (8.4), Clinical Pharmacology (12.3) and Clinical Studies
(14)]_
.
3.2 Dosage Adjustment When Coadministered with Anticonvulsants
If LIVTENCITY is coadministered with carbamazepine, increase the
dosage of LIVTENCITY to 800 mg (four
200 mg tablets) twice daily
_[see Drug Interactions (7.3)]. _
If LIVTENCITY is coadministered with phenytoin
or phenobarbital, increase the dosage of LIVTENCITY to
1,200 mg (six 200 mg tablets) twice daily
_[see Drug Interactions (7.3)]. _
3.3_ _Administration
The immediate-release tablets can be taken as whole, dispersed or
crushed tablets by mouth, or as dispersed
tablets through a nasogastric or orogastric tube (French size 10 or
larger). The suspension may be prepared
ahead of time and stored under 25
°C
for up to 8 hours.
Administration of Dispersed Tablets or Crushed Tablets by Mouth
1.
Place the appropriate number of tablets for the prescribed dose into a
suitable container. If desired, the
tablets may be crushed. Add the appropriate volume of drinking water
(other liquids have not been tested) to
make a suspension
_(see Table 1 below)_
.
Table 1