JULUCA dolutegravir (as sodium) 50 mg/ rilpivirine (as hydrochloride) 25 mg tablet bottle

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

rilpivirine hydrochloride, Quantity: 27.5 mg (Equivalent: rilpivirine, Qty 25 mg); dolutegravir, Quantity: 50 mg

Dostupné s:

ViiV Healthcare Pty Ltd

Léková forma:

Tablet, film coated

Složení:

Excipient Ingredients: macrogol 3350; silicified microcrystalline cellulose; povidone; sodium starch glycollate type A; polyvinyl alcohol; microcrystalline cellulose; magnesium stearate; lactose monohydrate; iron oxide yellow; croscarmellose sodium; iron oxide red; mannitol; purified talc; titanium dioxide; sodium stearylfumarate; polysorbate 20

Podání:

Oral

Jednotky v balení:

30

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

JULUCA (dolutegravir/rilpivirine) is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).

Přehled produktů:

Visual Identification: Pink, film-coated, oval, biconvex tablets debossed with SV J3T on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizace:

Registered

Datum autorizace:

2018-06-20

Informace pro uživatele

JULUCA
_dolutegravir / rilpivirine combination tablet_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about JULUCA. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking JULUCA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT JULUCA IS USED
FOR
JULUCA is used to treat HIV
(human immunodeficiency virus)
infection in adults.
Each JULUCA tablet contains two
active ingredients that are used to
treat HIV infection: dolutegravir and
rilpivirine. Dolutegravir belongs to a
group of anti-retroviral medicines
called integrase inhibitors (INIs)
Rilpivirine belongs to a group of
anti-retroviral medicines called non-
nucleoside analogue reverse
transcriptase inhibitors (NNRTIs).
JULUCA 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 cell
that are important in helping your
body to fight infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
JULUCA is not addictive.
JULUCA is not recommended for
children and adolescents under the
age of 18 years.
JULUCA is only available with a
doctor's prescription.
BEFORE YOU TAKE
JULUCA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE JULUCA IF:
•
You have ever had an allergic
reaction to any medicine
containing dolutegravir or
rilpivirine
•
You are allergic to any of the
ingredients listed at the end of
this leaflet. Some of the
symptoms of an allergic reaction
may include:
-
Shortness of breath
-
Wheezing or difficulty
breathing
-
Swelling of the face, lips
tongue or other parts of the
body
-
Rash, itching or hives on the
skin.
•
You are taking any of

Charakteristika produktu

1
AUSTRALIAN PRODUCT INFORMATION
JULUCA (DOLUTEGRAVIR/RILPIVIRINE FIXED-DOSE COMBINATION)
FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Dolutegravir (as dolutegravir sodium) and rilpivirine (as rilpivirine
hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
JULUCA film-coated tablets contain 50 mg of dolutegravir (as
dolutegravir sodium) and 25
mg of rilpivirine (as rilpivirine hydrochloride).
Dolutegravir sodium is a white to light yellow powder and is slightly
soluble in water. The
partition coefficient (log P) for dolutegravir sodium is 2.2 and the
pKa is 8.2.
Rilpivirine hydrochloride is a white to off-white powder. Rilpivirine
hydrochloride is practically
insoluble in water over a wide pH range, its pKa is 5.6 (pyrimidine
moiety) and log P
between 1-octanol and a phosphate solution (pH 7.0) is 4.86 (at
21°C).
JULUCA tablets also contain: mannitol and lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pink, film-coated, oval, biconvex tablets debossed with ‘SV J3T’
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
JULUCA (dolutegravir/rilpivirine) is indicated for the treatment of
human immunodeficiency
virus-1 (HIV-1) infection in adults who are virologically-suppressed
(HIV-1 RNA less than 50
copies per mL) on a stable antiretroviral regimen for at least 6
months with no history of
virological failure and no known or suspected resistance to any
non-nucleoside reverse
transcriptase inhibitor or integrase inhibitor (see section 5.1
PHARMACODYNAMIC
PROPERTIES, Clinical trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
JULUCA therapy should be initiated by a physician experienced in the
management of HIV
infection.
If the patient misses a dose of JULUCA, the patient should take it
with a meal as soon as
they remember if it is more than 12 hours until the next dose. If the
next dose is due within
12 hours, the patient should skip the missed dose and resume the usual
dosing schedule.
Separate preparations of dolutegravir and rilpiviri