DALIVINE TABLET

Country: দক্ষিণ আফ্রিকা

ভাষা: ইংরেজি

সূত্র: South African Health Products Regulatory Authority (SAHPRA)

থেকে পাওয়া:

Cipla Medpro Manufacturing (Pty) Ltd

ডোজ:

See ingredients

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

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

অনুমোদন অবস্থা:

Registered

তথ্য লিফলেট

Cipla Medpro (Pty) Ltd
DALIVINE
1.3.2
Film-coated tablets
09 November 2021 Version 3
Page 1 of 11
PATIENT INFORMATION LEAFLET FOR DALIVINE
SCHEDULING STATUS:
DALIVINE (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.
• DALIVINE 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 DALIVINE and what is used for:
2.
What you need to know before you take DALIVINE.
3.
How to take DALIVINE.
4.
Possible side effects
5.
How to store DALIVINE
6.
Contents of the pack and other information.
S4
Cipla Medpro (Pty) Ltd
DALIVINE
1.3.2
Film-coated tablets
09 November 2021 Version 3
Page 2 of 11
1.WHAT IS DALIVINE AND WHAT IS USED FOR
DALIVINE 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 DALIVINE.
DO NOT TAKE DALIVINE:
•
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 (PP

পণ্য বৈশিষ্ট্য

Cipla Medpro (Pty) Ltd
DALIVINE
1.3.1.1
(film-coated tablets)
09 November 2021
Version 3
Page 1 of 48
PROFESSIONAL INFORMATION FOR:
DALIVINE
SCHEDULING STATUS
1. NAME OF THE MEDICINE
DALIVINE 50/ 25 film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DALIVINE (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
DALIVINE 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
DALIVINE
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:
DALIVINE should be initiated by a medical practitioner experienced in
the management of HIV
infection.
Adults
The recommended dose is one DALIVINE tablet once a day.
SPECIAL POPULATIONS
_Elderly patients: _
There is limited data available for the use of dolutegravir, an active
component in DALIVINE in
patients aged 65 years and over. There is therefore no dose
adjustments required for DALIVINE
in elderly patients.
_Children and adolescents (< 18 years old): _
The safety and efficacy of rilpivirine, an active component in
DALIVINE has not been proven in
adolescents and children. Treatment with rilpivirine, an active
component in DALIVINE is not
recommended for use in children and adolescents ≤ 18 years.
_