Viekira Pak

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

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

제공처:

AbbVie Limited

INN (International Name):

Ombitasvir 12.5 mg

약제 형태:

Film coated tablet

구성:

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

처방전 유형:

Prescription

Manufactured by:

AbbVie Ireland NL B.V.

치료 징후:

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.

제품 요약:

Package - Contents - Shelf Life: 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, PVC/PE/PTCFE/Alu blister pack. 28 daily packs in a monthly carton. - 112 tablets - 36 months from date of manufacture stored at or below 30°C

승인 날짜:

2014-07-15

환자 정보 전단

VIEKIRA PAK CMI
Version 10
August 2018
Page
1
_ _
VIEKIRA PAK
_A COMBINATION THERAPY CONTAINING OMBITASVIR, PARITAPREVIR, RITONAVIR
AND _
_DASABUVIR _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VIEKIRA PAK.
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 IS
USED FOR
VIEKIRA PAK 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 two
different types of tablets for patients
with hepatitis C.
These must be taken according to the
instructions given by your doctor.
VIEKIRA PAK includes medicines
called direct-acting antiviral agents.
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
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VIEKIRA PAK IF YOU
HAVE AN ALLERGY TO:

ANY MEDICINE CONTAINING
OMBITASVIR, PARITAPREVIR,
RITONAVIR OR DASABUVIR

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 or a tight
feeling in your chest

swelling of the face, lips or
tongue, which may cause
difficulty in swallowin

제품 특성 요약

VIEKIRA PAK
Version 14
16 August 2018
1 of 55
NEW ZEALAND DATA SHEET
1.
VIEKIRA PAK COMBINATION THERAPY PACK
VIEKIRA PAK contains ombitasvir/paritaprevir/ritonavir 12.5/75/50 mg
tablets copackaged
with dasabuvir 250 mg tablets.
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.
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VIEKIRA PAK is indicated for the treatment of genotype 1 chronic
hepatitis C infection,
including
patients
with
compensated
cirrhosis,
HIV-1
co-infection,
and
liver
transplant
recipients. Duration of therapy and addition of ribavirin are
dependent on patient population
(see sections 4.2 Dose and method of administration, section 4.4
Special warnings and
precautions for use, and section 5.1 Pharmacodynamic properties).
VIEKIRA PAK
Version 14
16 August 2018
2 of 55
4.2
DOSE AND METHOD OF ADMINISTRATION
VIEKIRA
PAK
is
fixed-dose
combination
tablets
of
ombitasvir/paritaprevir/ritonavir,
copackaged with dasabuvir tablets.
Ombitasvir/paritaprevir/ritonavir tablets must be administered with
dasabuvir tablets.
RECOMMENDED DOSE IN ADULTS
The
recommended
oral
dose
of
VIEKIRA
PAK
is
two
ombitasvir/paritaprevir/ritonavir
12.5/75/50 mg tablets once daily (in the morning) and one dasabuvir
250 mg tablet twice
daily (morning and evening).
VIEKIRA PAK is used in combination with ribavirin in certain patient
po