Darunavir Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Darunavir 600mg; Darunavir 600mg

Available from:

Viatris Limited

INN (International Name):

Darunavir 600 mg

Dosage:

600 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Darunavir 600mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Magnesium stearate Microcrystalline cellulose Opadry Orange 85F93050 Sodium starch glycolate Active: Darunavir 600mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Magnesium stearate Microcrystalline cellulose Opadry white 85F18422 Purified water   Sodium starch glycolate

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Darunavir Mylan (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. Darunavir Mylan (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 greater than or equal to 6 years old and weighing at least 40 kg.

Product summary:

Package - Contents - Shelf Life: Bottle, HDPE 150cc, Closure: White PP screw CRC cap with induction sealing liner - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE 200cc, Closure: Blue PP screw cap with induction sealing liner - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2016-01-06

Patient Information leaflet

Page 1 of 6
NEW ZEALAND CONSUMER MEDICINE INFORMATION
DARUNAVIR VIATRIS
_DARUNAVIR FILM COATED TABLET 400 & 600 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Darunavir
Viatris.
This leaflet answers some common
questions about Darunavir Viatris.
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 Darunavir
Viatris 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 DARUNAVIR
VIATRIS IS USED FOR
Darunavir Viatris is used to treat
•
Human immunodeficiency virus-
1 (HIV-1) infection in adult
patients.
•
Human immunodeficiency virus
(HIV) infection in treatment-
experienced paediatric patients
aged ≥ 6 years old and weighing
at least 40 kg.
Darunavir Viatris must be taken in
combination with a low dose
ritonavir, and with other anti-HIV
medicines.
Darunavir Viatris contains the active
ingredient darunavir_._ It belongs to a
group of medicines called protease
inhibitors.
It 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
illness as a result of HIV infection.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
DARUNAVIR VIATRIS
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE DARUNAVIR VIATRIS IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
darunavir.
•
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 part

Summary of Product characteristics

Page 1 of 52
NEW ZEALAND DATA SHEET
DARUNAVIR VIATRIS
1. PRODUCT NAME
Darunavir Viatris, 300 mg, 400 mg & 600 mg, film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 300 mg, 400 mg or 600 mg of
darunavir.
Excipients with known effect: Sodium starch glycolate
Allergen Declaration: Contains phenylalanine
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Darunavir Viatris 300 mg – White to Off white, oval shaped, biconvex
film coated tablets debossed
with 'M' on one side of the tablet and 'DV3' on other side.
Dimensions: (16.50 x 8.20) + 0.3 mm approximately.
Darunavir Viatris 400 mg – White to Off white, oval shaped, biconvex
film coated tablets debossed
with 'M' on one side of the tablet and 'DV4' on other side.
Dimensions: (19.15 x 9.60) + 0.3 mm approximately.
Darunavir Viatris 600 mg – White to Off white, oval shaped, biconvex
film coated tablets debossed
with 'M' on one side of the tablet and 'DV5' on other side.
Dimensions: (21.20 x 10.60) + 0.3 mm approximately.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
_ADULT PATIENTS_
Darunavir Viatris (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 Viatris (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 old and
weighing at least 40 kg.
Page 2 of 52
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ANTIRETROVIRAL TREATMENT-NAÏVE PATIENTS_
The recommended dosage of darunavir is 800 mg once daily (q.d.) taken
with ritonavir 100 mg q.d.
and with food.
_ANTIRETROVIRAL TREATMENT-EXPERIENCED PATIENTS_
For antiretroviral treatment experienced patients, genotypic testing
is recommended. However, when
genotypic tes