Maviret

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Glecaprevir 100mg;  ; Pibrentasvir 40mg;  

제공처:

AbbVie Limited

약제 형태:

Film coated tablet

구성:

Active: Glecaprevir 100mg   Pibrentasvir 40mg   Excipient: Colloidal silicon dioxide Copovidone Croscarmellose sodium Hypromellose Iron oxide red Lactose monohydrate Macrogol 3350 Propylene glycol monocaprylate Sodium stearyl fumarate Titanium dioxide Tocofersolan

처방전 유형:

Prescription

치료 징후:

MAVIRET is indicated for the treatment of adults and adolescents 12 years and older with chronic hepatitis C virus (HCV)

제품 요약:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PCTFE Al Foil Blister Packs, daily dosage requirement - 3 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PCTFE Al Foil Blister Packs, 21 tablets (7x3) for weekly use - 21 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PCTFE Al Foil Blister Packs, 4x21 tablets for monthly use - 84 tablets - 60 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with CRC cap and desiccant - 84 tablets - 36 months from date of manufacture stored at or below 30°C

승인 날짜:

2017-03-07

환자 정보 전단

Maviret®
1
MAVIRET®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or
pharmacist.
1.
WHY AM I TAKING MAVIRET?
Maviret contains the active ingredients glecaprevir and pibrentasvir.
Maviret is used to treat chronic hepatitis C.
For more information, see Section 1. Why am I taking Maviret?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE MAVIRET?
Check the list of ingredients at the end of the CMI. Do not take
Maviret if you have ever had an allergic reaction to, or cannot
tolerate, any of them. Please note that Maviret tablets contain
lactose.
TALK TO YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE IF HE/SHE IS NOT
AWARE THAT YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I take
Maviret?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Maviret and affect how it works, or
Maviret may interfere with other medicines and affect
how they work.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE MAVIRET?
•
Take 3 tablets all together, once every day. Take the tablets with
food.
•
Do not break, crush or chew the tablets. Swallow them whole.
More instructions can be found in Section 4. How do I take Maviret?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING MAVIRET?
THINGS YOU
SHOULD DO
•
Call your doctor straight away if you become pregnant while taking
Maviret.
•
Keep all your doctor’s appointments so that your progress can be
checked.
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Maviret.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly or change the dose without
checking with your doctor.
DRIVING OR USING
MACHINES
•
Maviret is expected to have little to no effect on the ability to
drive or use machi

제품 특성 요약

MAVIRET Datasheet
28 September 2023
1 of 25
Version 12
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
MAVIRET 100 mg / 40 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg glecaprevir and 40 mg
pibrentasvir.
Excipient with known effect
Each film-coated tablet contains 7.48 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet. Glecaprevir and pibrentasvir are presented as a
fixed-dose combination, immediate
release bilayer tablet.
Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x
10.0 mm, debossed on one side
with ‘NXT’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MAVIRET is indicated for the treatment of adults and adolescents 12
years and older with chronic
hepatitis C virus (HCV) (see sections 4.2, 4.4 and 5.1).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The recommended dose of MAVIRET in adults and adolescents 12 years and
older is 300 mg/120 mg
(three 100 mg glecaprevir/40 mg pibrentasvir tablets), taken orally,
once daily at the same time with
food (see section 5.2). Addition of ribavirin is not required.
Tables 1 and 2 provide the recommended MAVIRET treatment duration
based on the patient
population in HCV genotype (GT) 1, 2, 3, 4, 5 or 6 patients with
compensated liver disease (with or
without cirrhosis).
_ _
MAVIRET Datasheet
28 September 2023
2 of 25
Version 12
TABLE 1: RECOMMENDED DURATION FOR TREATMENT-NAÏVE PATIENTS
PATIENT POPULATION
RECOMMENDED TREATMENT DURATION
NO CIRRHOSIS
CIRRHOSIS
GT 1-6
8 weeks
8 weeks
Includes patients co-infected with human immunodeficiency virus (HIV)
_._
TABLE 2: RECOMMENDED DURATION FOR TREATMENT-EXPERIENCED PATIENTS
PATIENT POPULATION
RECOMMENDED TREATMENT DURATION
NO CIRRHOSIS
CIRRHOSIS
NS5A inhibitor-naïve* GT 1, 2, 4, 5, 6
8 weeks
12 weeks
NS5A inhibitor-experienced GT 1, 2, 4, 5, 6
16 weeks
16 weeks
GT 3 (any experienced)
*
experienced with PR, SOF + PR, SOF + R, SMV + SOF, SMV + PR, TVR + PR
or BOC + PR.
PR =
(