Dovato

Land: Europäische Union

Sprache: Englisch

Quelle: EMA (European Medicines Agency)

Wirkstoff:

dolutegravir sodium, lamivudine

Verfügbar ab:

ViiV Healthcare B.V.

ATC-Code:

J05AR

INN (Internationale Bezeichnung):

dolutegravir, lamivudine

Therapiegruppe:

Antivirals for systemic use

Therapiebereich:

HIV Infections

Anwendungsgebiete:

Dovato is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

Produktbesonderheiten:

Revision: 14

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2022-06-10

Gebrauchsinformation

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOVATO 50 MG/300 MG FILM-COATED TABLETS
dolutegravir/lamivudine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 doctor, or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dovato is and what it is used for
2.
What you need to know before you take Dovato
3.
How to take Dovato
4.
Possible side effects
5.
How to store Dovato
6.
Contents of the pack and other information
1.
WHAT DOVATO IS AND WHAT IT IS USED FOR
Dovato is a medicine that contains two active ingredients used to
treat human immunodeficiency virus (HIV)
infection: dolutegravir and lamivudine. Dolutegravir belongs to a
group of anti-retroviral medicines called
_integrase inhibitors _
(INIs), and lamivudine belongs to a group of anti-retroviral medicines
called
_nucleoside _
_analogue reverse transcriptase inhibitors _
(NRTIs).
Dovato is used to treat HIV in adults and adolescents over 12 years
old who weigh at least 40 kg.
Dovato does not cure HIV infection; it keeps the amount of virus in
your body at a low level. This helps
maintain the number of CD4 cells in your blood. CD4 cells are a type
of white blood cells that are important
in helping your body to fight infection.
Not everyone responds to treatment with Dovato in the same way. Your
doctor will monitor the effectiveness
of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOVATO
_ _
DO NOT TAKE DOVATO
•
if you are
ALLERGIC
(
_hypersensitive_
) to dolutegravir or lamivudine or any of the other ingredients of
this medicine (listed in section 6).
•
If you are

Fachinformation

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dovato 50 mg/300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains dolutegravir sodium equivalent to 50
mg dolutegravir and 300 mg
lamivudine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Oval, biconvex, white, film coated tablet, approximately 18.5 x 9.5
mm, debossed with “SV 137” on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dovato is indicated for the treatment of Human Immunodeficiency Virus
type 1 (HIV-1) infection in adults
and adolescents above 12 years of age weighing at least 40 kg, with no
known or suspected resistance to the
integrase inhibitor class, or lamivudine (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dovato should be prescribed by physicians experienced in the
management of HIV infection.
_ _
Posology
_Adults and adolescents (above 12 years of age weighing at least 40_
_kg). _
_ _
The recommended dose of Dovato in adults and adolescents is one 50
mg/300 mg tablet once daily.
_Dose adjustments _
A separate preparation of dolutegravir is available where a dose
adjustment is indicated due to drug-drug
interactions (e.g. rifampicin, carbamazepine, oxcarbazepine,
phenytoin, phenobarbital, St. John’s wort,
etravirine (without boosted protease inhibitors), efavirenz,
nevirapine, or tipranavir/ritonavir, see sections 4.4
and 4.5). In these cases the physician should refer to the individual
product information for dolutegravir.
_Missed doses _
If the patient misses a dose of Dovato, the patient should take Dovato
as soon as possible, providing the next
dose is not due within 4 hours. If the next dose is due within 4
hours, the patient should not take the missed
dose and simply resume the usual dosing schedule.
_Elderly _
There are limited data available on the use of Dovato in patients aged
65 years and over. No dose adjustment
is necessary (see section 5.2).
_ _
3
_Renal impair