DAPIRING VAGINAL RING

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

IPM South Africa NPC

כמות:

See ingredients

טופס פרצבטיות:

VAGINAL RING

הרכב:

EACH VAGINAL RING CONTAINS DAPIVIRINE 25,0 mg

מצב אישור:

Registered

עלון מידע

LeBasi Pharmaceuticals (Pty) Ltd
DapiRing 25 mg vaginal delivery system
(Dapivirine)
Approved PIL (8/3/2022)
Page 1 of 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
DAPIRING 25 MG VAGINAL DELIVERY SYSTEM
DAPIVIRINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING DAPIRING
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
DapiRing 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 DapiRing is and what it is used for
2.
What you need to know before you take DapiRing
3.
How to take DapiRing
4.
Possible side effects
5.
How to store DapiRing
6.
Contents of the pack and other information
1.
WHAT DAPIRING IS AND WHAT IT IS USED FOR
THE DAPIRING IS USED TO REDUCE THE CHANCE OF WOMEN 18 YEARS AND OLDER
GETTING A HIV-1
INFECTION DURING VAGINAL SEX. It should always be used in combination
with safer sex practices
and should be used when oral PrEP is not/cannot be used or is not
available.
The DapiRing contains dapivirine, a medicine that can reduce the risk
to become HIV-1 infected.
The medicine is released from the ring into the vagina slowly over 28
days.
LeBasi Pharmaceuticals (Pty) Ltd
DapiRing 25 mg vaginal delivery system
(Dapivirine)
Approved PIL (8/3/2022)
Page 2 of 12
The DapiRing must be kept in the vagina all the time until it is
replaced with a new ring after 28
days.
The DapiRing is an off-white coloured ring that is easy to bend and
should only be used in the
vagina.
Ask your healthcare provider if you have any questions about how to
prevent getting HIV infected
or how to prevent spreading HIV to other people.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DAPIRING
DO NOT USE DAPIRING
•
If you are infected with HIV-1 or are unsure if you are infected with
HIV-1. You must get
tested to make sure that you do not already have HIV-1 infection. The
Dap

מאפייני מוצר

LeBasi Pharmaceuticals (Pty) Ltd
DapiRing 25 mg vaginal delivery system
(Dapivirine)
Approved PI (8/3/2022)
Page 1 of 27
PROFESSIONAL INFORMATION FOR DAPIRING
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE
DapiRing vaginal delivery system
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dapivirine vaginal ring contains 25 mg of dapivirine and releases
approximately 4 mg of
dapivirine over a period of one month.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal delivery system.
The dapivirine vaginal ring is a flexible, off-white vaginal ring with
an outer diameter of 56 mm and
a cross-sectional diameter of 7,7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reducing the risk of HIV-1 infection via vaginal intercourse in
HIV-uninfected women 18 years and
older in combination with safer sex practices when oral PrEP is
not/cannot be used or is not
available.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
One DapiRing is inserted into the vagina and kept in until replaced
every 28 days with a new ring.
To maintain efficacy, a new DapiRing should be inserted immediately
after the previous ring is
removed.
The DapiRing must be used as directed (see “Method of
administration”). If the DapiRing is
LeBasi Pharmaceuticals (Pty) Ltd
DapiRing 25 mg vaginal delivery system
(Dapivirine)
Approved PI (8/3/2022)
Page 2 of 27
accidentally expelled or removed, the woman should follow the
instructions given below under
“_Accidental expulsion or removal of the DapiRing_”.
_ _
SPECIAL POPULATIONS
_PAEDIATRIC POPULATION _
The safety and efficacy of the DapiRing in children under the age of
18 years have not been
established.
Currently available data are described in section 4.8 but no
recommendation on a posology can be
made.
_ _
METHOD OF ADMINISTRATION
Vaginal use.
_Preparation for inserting the DapiRing _
The woman should wash her hands in clean water and dry them before
removing the DapiRing
from the package.
The woman should choose a position that is comfortable for her to
insert t