DARUNAVIR JUNO darunavir 400 mg film coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

darunavir, Quantity: 400 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium chloride; hyprolose; macrogol 4000; titanium dioxide; crospovidone; polacrilin potassium; iron oxide red; colloidal anhydrous silica; iron oxide yellow; purified talc; silicified microcrystalline cellulose; polyvinyl alcohol; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adult patients,DARUNAVIR JUNO (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients.,Paediatric patients,DARUNAVIR JUNO (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

Product summary:

Visual Identification: DARUNAVIR JUNO 400 mg film-coated tablets are beige-coloured, oval shaped, biconvex, debossed with D on one side and 400 on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-04-22

Patient Information leaflet

1
DARUNAVIR JUNO
_Darunavir (da-ROO-nuh-veer) _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Darunavir Juno tablets.
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 being given
Darunavir Juno against the
benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING DARUNAVIR JUNO.
You may need to read it again.
WHAT DARUNAVIR JUNO
IS USED
FOR
Darunavir Juno is an antiretroviral
medicine. It belongs to a group of
medicines called protease (PRO-
tee-ase) inhibitors. Darunavir
Juno works by reducing the
amount of HIV in your body.
Reducing the amount of HIV in
your blood improves your
immune system and reduces the
risk of developing illnesses as a
result of HIV infection.
Darunavir Juno is used to treat
adults, and children 6 years of age
or above weighing more than
20 kg, who are infected by HIV
(Human Immunodeficiency
Virus).
In adults, Darunavir Juno must be
taken in combination with
cobicistat or with a low dose of
ritonavir, and with other anti-HIV
medicines.
In children, Darunavir Juno must
be taken in combination with a
low dose of ritonavir, and with
other anti-HIV medicines.
Your doctor will discuss with you
which combination of medicines
will work best with Darunavir
Juno.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DARUNAVIR
JUNO HAS BEEN PRESCRIBED FOR
YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE DARUNAVIR
JUNO
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE DARUNAVIR JUNO:
•
if you are allergic
(hypersensitive) to darunavir,
other ingredients of
DARUNAVIR JUNO or to
ritonavir or to cobicistat.
Symptoms of an allergic
reaction may include rash,
itching or hives on the skin,
shortness of breath, wheezing
or difficulty breathing,
swell

Summary of Product characteristics

DARUNAVIR JUNO PI Ver 6.0
1
AUSTRALIAN PRODUCT INFORMATION – DARUNAVIR JUNO (DARUNAVIR)
1.
NAME OF THE MEDICINE
Darunavir
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg, 600 mg or 800 mg of
darunavir.
For a full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
DARUNAVIR JUNO 400 mg film-coated tablets are beige-coloured, oval
shaped, biconvex,
film coated tablets, debossed with “D” on one side and “400”
on the other side.
DARUNAVIR JUNO 600 mg film-coated tablets are beige-coloured, oval
shaped, biconvex,
film coated tablets, debossed with “D” on one side and “600”
on the other side.
DARUNAVIR JUNO 800 mg film-coated tablets are brown colored, oval
shaped, biconvex,
film-coated tablets, debossed with “D” on one side and “800”
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULT PATIENTS
DARUNAVIR JUNO (with low dose ritonavir as a pharmacokinetic enhancer)
is indicated in
combination with other antiretroviral agents for the treatment of
human immunodeficiency
virus-1 (HIV-1) infection in adult patients.
PAEDIATRIC PATIENTS
DARUNAVIR JUNO (with low dose ritonavir as a pharmacokinetic enhancer)
is indicated in
combination with other antiretroviral agents for the treatment of
human immunodeficiency
virus (HIV) infection in treatment-experienced paediatric patients
aged 6 years and older,
weighing at least 20 kg.
4.2 DOSE AND METHOD OF ADMINISTRATION
_DARUNAVIR Juno is unavailable in tablet strengths below 600 mg. For
paediatric patients _
_requiring treatment with lower strengths of darunavir, other brands
are available. _
DOSAGE (DOSE AND INTERVAL)
_Adults: _
For antiretroviral treatment-experienced patients, HIV-1 genotype
testing is recommended.
_Once Daily Dose _
The recommended dose of DARUNAVIR JUNO is 800 mg once daily with
ritonavir 100 mg
once daily taken with food. The once daily dose regimen is recommended
for the following
patients:
DARUNAVIR JUNO PI Ver 6.0
2
• Antiretroviral treatment