DALIDUO TABLET

Valsts: Dienvidāfrikas Republika

Valoda: angļu

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

Pieejams no:

Cipla Medpro Manufacturing (Pty) Ltd

Deva:

See ingredients

Zāļu forma:

TABLET

Kompozīcija:

EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM 50,0 mg RILPIVIRINE HYDROCHLORIDE 25,0 mg

Autorizācija statuss:

Registered

Lietošanas instrukcija

Cipla Medpro (Pty) Ltd
DALIDUO
1.3.2
Film-coated tablets
09 November 2021 Version 3
Page 1 of 11
PATIENT INFORMATION LEAFLET FOR DALIDUO
SCHEDULING STATUS:
DALIDUO (50/ 25 film coated tablets)
Dolutegravir sodium and rilpivirine hydrochloride
Contains sugar and sweetener such as 145 mg mannitol and 52 mg lactose
monohydrate.
READ ALL OF THIS LEAFLET CAREFULLY 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 or
nurse.
• DALIDUO 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 is DALIDUO and what is used for:
2.
What you need to know before you take DALIDUO.
3.
How to take DALIDUO.
4.
Possible side effects
5.
How to store DALIDUO
6.
Contents of the pack and other information.
S4
Cipla Medpro (Pty) Ltd
DALIDUO
1.3.2
Film-coated tablets
09 November 2021 Version 3
Page 2 of 11
1.WHAT IS DALIDUO AND WHAT IS USED FOR
DALIDUO is indicated for the treatment of immunodeficiency
virus-1(HIV-1) infection in adults
who are virologically suppressed (HIV-1 RNA ˂ 50 copies/ml), for at
least 6 months on a stable
PI, NI or NNRTI plus NRTI based regimens, without known or suspected
resistance to either
antiretroviral component. Co- administration with any other NNRTI
medicines is not
recommended.
2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE DALIDUO.
DO NOT TAKE DALIDUO:
•
If you are hypersensitive (allergic) to rilpivirine, dolutegravir or
any of the excipients
•
with other medicines used to treat HIV which fall under the class of
Non-Nucleoside
Reverse Transcriptase Inhibitors (NNRTIs) such as delavirdine,
efavirenz, etravirine,
nevirapine
•
in combination with carbamazepine, oxcarbazepine, phenobarbitone,
phenytoin,
systemic dexamethasone (except as a single dose treatment) rifabutin,
rifampicin,
rifapentine, St. Johns Wort, proton-pump inhibitors (PPIs) such as
l

Produkta apraksts

Cipla Medpro (Pty) Ltd
DALIDUO
1.3.1.1
(film-coated tablets)
09 November 2021
Version 3
Page 1 of 48
PROFESSIONAL INFORMATION FOR:
DALIDUO
SCHEDULING STATUS
1. NAME OF THE MEDICINE
DALIDUO 50/ 25 film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DALIDUO (film-coated tablet): Each tablet contains rilpivirine
hydrochloride
equivalent to 25 mg rilpivirine and dolutegravir sodium equivalent to
50 mg dolutegravir
Each tablet contains sugar and sweeteners 145 mg mannitol and 52 mg
lactose monohydrate
For full list of excipients, see SECTION 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink coloured, capsule shaped biconvex film-coated tablet debossed
with “Cipla” on one
side and plain on other side.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
DALIDUO is indicated for the treatment of immunodeficiency
virus-1(HIV-1) infection in adults
who are virologically suppressed (HIV-1 RNA ˂ 50 copies/ml), for at
least 6 months on a stable
PI, NI or NNRTI plus NRTI based regimens, without known or suspected
resistance to either
S4
Cipla Medpro (Pty) Ltd
DALIDUO
1.3.1.1
(film-coated tablets)
09 November 2021
Version 3
Page 2 of 48
antiretroviral component. Co - administration with any other NNRTI
medicines is not
recommended (SEE SECTION 4.5)
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
DALIDUO should be initiated by a medical practitioner experienced in
the management of HIV
infection.
Adults
The recommended dose is one DALIDUO tablet once a day.
SPECIAL POPULATIONS
_Elderly patients: _
There is limited data available for the use of dolutegravir, an active
component in DALIDUO in
patients aged 65 years and over. There is therefore no dose
adjustments required for DALIDUO
in elderly patients.
_Children and adolescents (< 18 years old): _
The safety and efficacy of rilpivirine, an active component in DALIDUO
has not been proven in
adolescents and children. Treatment with rilpivirine, an active
component in DALIDUO is not
recommended for use in children and adolescents ≤ 18 years.
_Renal impair