Viekira Pak-RBV

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ombitasvir 12.5mg; Paritaprevir 75mg; Ritonavir 50mg; Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250 mg;  ; Ribavirin 400mg;  ; Ribavirin 600mg

Available from:

AbbVie Limited

INN (International Name):

Ombitasvir 12.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Ombitasvir 12.5mg Paritaprevir 75mg Ritonavir 50mg Excipient: Colloidal silicon dioxide Copovidone Opadry pink 85F140088 Propylene glycol monolaurate Sodium stearyl fumarate Sorbitan laurate Tocofersolan Active: Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250 mg   Excipient: Colloidal silicon dioxide Copovidone Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry beige 85F97497 Active: Ribavirin 400mg   Excipient: Carnauba wax Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry blue 85F90553 Povidone Active: Ribavirin 600mg Excipient: Carnauba wax Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry blue 85F90623 Povidone

Prescription type:

Prescription

Manufactured by:

AbbVie Ireland NL B.V.

Therapeutic indications:

Indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis, HIV-1 coinfection, and liver transplant recipients. Duration of therapy and addition of ribavirin are dependent on patient population.

Product summary:

Package - Contents - Shelf Life: Blister pack, Ribavirin tablet 600 mg. PVC/PCTFE blister with aluminium foil lidding - 28 tablets -   - Blister pack, Ribavirin tablet 400 mg. PVC/PCTFE blister with aluminium foil lidding - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Dasabuvir tablet. PVC/PE/PTCFE blister with an aluminium foil lidding. - 56 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Ombitasvir/Paritaprevir/Ritonavir tablet PVC/PE/PTCFE blister with an aluminium foil lidding. - 56 tablets - 36 months from date of manufacture stored at or below 30°C - Combination pack, 28 daily Viekira Pak blister packs and 4 weekly Ribavirin blisters in a monthly carton - 168 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2014-07-15

Patient Information leaflet

VIEKIRA PAK-RBV CMI
Version 10
August 2018
Page 1
_ _
VIEKIRA PAK-RBV
_A COMBINATION THERAPY CONTAINING OMBITASVIR, PARITAPREVIR, RITONAVIR,
_
_DASABUVIR AND RIBAVIRIN _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VIEKIRA PAK-
RBV.
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 this medicine
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 VIEKIRA PAK-
RBV IS USED FOR
VIEKIRA PAK-RBV is used to treat
some types of chronic (long-lasting)
hepatitis C in adults, including those
with cirrhosis (scarring of the liver).
Hepatitis C is a liver disease caused
by a virus, which infects and
damages liver cells.
This treatment consists of three
different types of tablets for patients
with hepatitis C.
These must be taken according to the
instructions given by your doctor.
VIEKIRA PAK-RBV includes
medicines called direct-acting
antiviral agents, and also includes
ribavirin to treat your HCV infection.
It works by by lowering the amount
of hepatitis C virus in your body. It
removes the virus from your blood
over a period of time.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is only available with
a doctor’s prescription.
BEFORE YOU TAKE
VIEKIRA PAK-RBV
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VIEKIRA PAK-RBV
IF YOU HAVE AN ALLERGY TO:

ANY MEDICINE CONTAINING
OMBITASVIR, PARITAPREVIR,
RITONAVIR, DASABUVIR OR
RIBAVIRIN

ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
Some symptoms of an allergic
reaction include

hives, skin rash or itching of the
skin

shortness of breath, wheezing,
difficulty breathing

Summary of Product characteristics

VIEKIRA PAK-RBV
Version 14
16 August 2018
1 of 65
NEW ZEALAND DATA SHEET
1.
VIEKIRA PAK-RBV (RIBAVIRIN 200 MG)
VIEKIRA PAK-RBV (RIBAVIRIN 400 MG)*
VIEKIRA PAK-RBV (RIBAVIRIN 1000 MG)*
VIEKIRA PAK-RBV (RIBAVIRIN 1200 MG)*
VIEKIRA
PAK-RBV
is
a
composite
pack
containing
ombitasvir/paritaprevir/ritonavir
12.5/75/50 mg tablets copackaged with dasabuvir 250 mg tablets, and
200 mg, 400 mg* or
600 mg* ribavirin tablets.
* Presentation not currently available in New Zealand.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each co-formulated ombitasvir/paritaprevir/ritonavir film-coated
tablet contains 12.5 mg of
ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
For the full list of excipients, see section 6.1.
Each dasabuvir film-coated tablet contains 250 mg of dasabuvir (as
sodium monohydrate).
Excipient with known effect:
Each film-coated tablet contains 44.94 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Each ribavirin film-coated tablet contains 200 mg, 400 mg* or 600 mg*
of ribavirin.
* Presentation not currently available in New Zealand.
Excipient with known effect:
Each 200 mg film-coated tablet contains 15 mg lactose (as
monohydrate).
Each 400 mg film-coated tablet contains 30 mg lactose (as
monohydrate).
Each 600 mg film-coated tablet contains 45 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
VIEKIRA PAK-RBV
Version 14
16 August 2018
2 of 65
3.
PHARMACEUTICAL FORM
Ombitasvir/paritaprevir/ritonavir 12.5/75/50 mg tablets are
pink-coloured, film-coated, oblong
biconvex shaped, debossed with “AV1” on one side.
Dasabuvir 250 mg tablets are beige-coloured, film-coated, oval-shaped,
debossed with
“AV2” on one side.
Ribavirin 200 mg tablets are light-blue, film-coated, oblong-shaped
and debossed with “200”
on one side and “3RP” on the other side.
Ribavirin 400 mg tablets are blue, film-coated, oblong-shaped and
debossed with “400” on
one side and “3RP” on the other side*.
Ribavirin 600 mg tablets are deep-blue, film-coated, oblo