IBAVYR ribavirin 200 mg film coated tablets bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

ribavirin, Quantity: 200 mg

Tilgjengelig fra:

Clinect Pty Ltd

INN (International Name):

Ribavirin

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: povidone; croscarmellose sodium; microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc

Administreringsrute:

Oral

Enheter i pakken:

28 tablets, 100 tablets (without CR cap, for dispensing only)

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

IBAVYR (ribavirin tablets) is indicated in combination with other oral agents for the treatment of chronic hepatitis C (CHC) in adults.

Produkt oppsummering:

Visual Identification: A white, capsule-shaped, coated tablet, debossed with '200' on one side and nothing on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2016-03-15

Informasjon til brukeren

IBAVYR
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING IBAVYR?
IBAVYR contains the active ingredient ribavirin. IBAVYR is used in
combination with other oral agents for the treatment of chronic
hepatitis C (CHC). CHC is a viral infection of the liver. For more
information, see Section 1. Why am I using IBAVYR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IBAVYR?
Do not use if you have ever had an allergic reaction to ribavirin or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF 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 use IBAVYR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with IBAVYR and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE IBAVYR?
•
Take IBAVYR exactly as your doctor has directed.
More instructions can be found in Section 4. How do I use IBAVYR? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IBAVYR?
THINGS YOU
SHOULD DO
•
Use IBAVYR Tablets exactly as your doctor has prescribed.
•
Use contraception in order to avoid pregnancy.
•
Stop using IBAVYR Tablets if you become pregnant and immediately tell
your doctor.
•
If you are male and your partner becomes pregnant while you are using
IBAVYR, ask your partner to tell
her doctor immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking IBAVYR or change the dose without first checking
with your doctor.
•
Do not take any other medicines whether they require a prescription or
not without first telling your doctor
or pharmacist.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how IBAVYR
affects you.
•
If you

Preparatomtale

1
AUSTRALIAN
PRODUCT
INFORMATION
–
IBAVYR® (RIBAVIRIN) TABLETS 200 MG
1.
NAME OF THE MEDICINE
Ribavirin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each IBAVYR (ribavirin) 200 mg tablet contains 200 mg ribavirin.
Ribavirin is a nucleoside analogue with antiviral activity.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablets.
IBAVYR (ribavirin) 200 mg tablet is a white, capsule-shaped, coated
tablet, debossed with “200” on one side
and nothing on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IBAVYR (ribavirin tablets) is indicated in combination with other oral
agents for the treatment of chronic
hepatitis C (CHC) in adults.
4.2 DOSE AND METHOD OF ADMINISTRATION
_DOSE _
Ribavirin monotherapy is not effective and IBAVYR must only be used in
combination with other oral agents
for the treatment of CHC.
Treatment with IBAVYR should be initiated and monitored by a physician
experienced in the management of
CHC.
The recommended dose and treatment duration should be individualised
to the patient depending on body
weight, baseline disease characteristics (e.g., genotype), response to
therapy, and underlying conditions.
The recommended dose and treatment duration for combination therapy
with sofosbuvir are shown in Table
1. When IBAVYR is used in combination treatment with any other oral
agent, refer to the appropriate Product
Information for dosage information.
TABLE 1: RECOMMENDED DOSE/TREATMENT DURATION FOR IBAVYR IN COMBINATION
THERAPY WITH
SOFOSBUVIR
HCV Genotype
Treatment
Duration
IBAVYR Dose (daily)
1
Sofosbuvir
Dose
(daily)
Patients
with
genotype 2 CHC
12 weeks
< 75 kg = 1000 mg
≥ 75 kg = 1200 mg
400 mg
Patients
with
genotype 3 CHC
16 weeks
2
2
Patients
with
CHC
awaiting
liver
transplantation
Until
liver
transplantation
3
1.
Administered orally in two divided doses with food.
2.
Consideration should be given to potentially extending the duration of
therapy beyond 16 weeks and up to 24 weeks guided by an
assessment of the potential benefit