DELSTRIGO TABLET

Valsts: Dienvidāfrikas Republika

Valoda: angļu

Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)

Pieejams no:

MSD (Pty) Ltd

Deva:

See ingredients

Zāļu forma:

TABLET

Kompozīcija:

EACH TABLET CONTAINS DORAVIRINE 100,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg

Autorizācija statuss:

Registered

Lietošanas instrukcija

DELSTRIGO®
APPLICANT: MSD (PTY) LTD
DOSAGE FORM: FILM-COATED TABLETS
VERSION: FINAL
APPROVED PATIENT INFORMATION LEAFLET
1.3.2
APPROVED BY SAHPRA: 31 AUGUST 2021
REGISTRATION APPROVED BY SAHPRA
Original date of filing: 30 April 2019.
Date of registration approval: 31 August 2021
Initials: TP
PAGE 1 OF 15
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
DELSTRIGO 100 MG, 300 MG, 245 MG FILM-COATED TABLETS
doravirine/ lamivudine/ tenofovir disoproxil
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, pharmacist.
•
DELSTRIGO has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What DELSTRIGO is and what it is used for
2.
What you need to know before you take DELSTRIGO
3.
How to take DELSTRIGO
4.
Possible side effects
5.
How to store DELSTRIGO
6.
Contents of the pack and other information
1.
WHAT DELSTRIGO IS AND WHAT IT IS USED FOR
S4
DELSTRIGO®
APPLICANT: MSD (PTY) LTD
DOSAGE FORM: FILM-COATED TABLETS
VERSION: FINAL
APPROVED PATIENT INFORMATION LEAFLET
1.3.2
APPROVED BY SAHPRA: 31 AUGUST 2021
REGISTRATION APPROVED BY SAHPRA
Original date of filing: 30 April 2019.
Date of registration approval: 31 August 2021
Initials: TP
PAGE 2 OF 15
WHAT DELSTRIGO IS AND WHAT IT IS USED FOR
DELSTRIGO is used to treat HIV (‘human immunodeficiency virus’)
infection. It belongs to a group of
medicines called ‘antiretroviral medicines’.
DELSTRIGO contains the active substances:
•
Doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI)
•
Lamivudine - a nucleoside analogue reverse transcriptase inhibitor
(NRTI)
•
Tenofovir disoproxil - a nucleoside analogue reverse transcriptase
inhibitor (NRTI)
DELSTRIGO is used to treat HIV infection in people 18 years of age and
older. HIV is the virus that
ca

Produkta apraksts

DELSTRIGO®
APPLICANT: MSD (PTY) LTD
DOSAGE FORM: FILM-COATED TABLETS
VERSION: FINAL
APPROVED PROFESSIONAL INFORMATION
1.3.1.1
APPROVED BY SAHPRA: 31 AUGUST 2021
REGISTRATION APPROVED BY SAHPRA
Original date of filing: 30 April 2019
Date of registration approval: 31 August 2021
Initials: TP
Page 1 of 61
SCHEDULING STATUS
S4
1.
NAME OF THE PRODUCT
Delstrigo 100 mg, 300 mg, 245 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of doravirine, 300 mg of
lamivudine, and 300 mg of tenofovir
disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil.
Excipient with known effect
Each film-coated tablet contains 8.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, oval-shaped, tablet of dimensions 21.59 mm x 11.30 mm,
debossed with the corporate logo and
776 on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Delstrigo is indicated for the treatment of adults infected with HIV-1
without past or present evidence of
resistance to the non-nucleoside reverse transcriptase inhibitor
(NNRTI) class, lamivudine, or tenofovir
(see sections 4.4 and 5.1).
DELSTRIGO®
APPLICANT: MSD (PTY) LTD
DOSAGE FORM: FILM-COATED TABLETS
VERSION: FINAL
APPROVED PROFESSIONAL INFORMATION
1.3.1.1
APPROVED BY SAHPRA: 31 AUGUST 2021
REGISTRATION APPROVED BY SAHPRA
Original date of filing: 30 April 2019
Date of registration approval: 31 August 2021
Initials: TP
Page 2 of 61
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a medical practitioner experienced in
the management of HIV infection.
Posology
The recommended dose of Delstrigo is one 100/300/245 mg tablet taken
orally once daily with or without
food._ _
_Dose adjustment _
If Delstrigo is co-administered with rifabutin, the doravirine dose
should be increased to 100 mg twice
daily. This is achieved by adding one 100 mg tablet of doravirine (as
a single agent), to be taken
approximately 12 h