Rebetol 40mgml oral solution

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Ribavirin

Beszerezhető a:

Merck Sharp & Dohme Ltd

ATC-kód:

J05AP01

INN (nemzetközi neve):

Ribavirin

Adagolás:

40mg/1ml

Gyógyszerészeti forma:

Oral solution

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: ; GTIN: 5012376031491

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
REBETOL® 40 MG/ML ORAL SOLUTION
ribavirin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rebetol is and what it is used for
2.
What you need to know before you use Rebetol
3.
How to use Rebetol
4.
Possible side effects
5.
How to store Rebetol
6.
Contents of the pack and other information
This Package Leaflet contains information for the paediatric patient
(child or adolescent, 3 through
17 years of age), or for his or her parent or caregiver.
1.
WHAT REBETOL IS AND WHAT IT IS USED FOR
Rebetol contains the active substance ribavirin. This medicine stops
the multiplication of hepatitis C
virus. Rebetol must not be used alone.
The combination of Rebetol and other medicines is used to treat
patients who have chronic hepatitis C
(HCV).
Rebetol may be used in paediatric patients (children 3 years of age
and older and adolescents), who are
not previously treated and without severe liver disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE REBETOL
DO NOT TAKE REBETOL
Do not take Rebetol if any of the following apply to you or the child
you are caring for.
If you are not sure, TALK TO YOUR DOCTOR
or
PHARMACIST
before taking Rebetol.

are
ALLERGIC
to ribavirin or any of the other ingredients of this medicine (listed
in section 6).

are
PREGNANT OR PLANNING TO BECOME PREGNANT
(see section “Pregnancy and breast-feeding”).

are
BREAST-FEEDING
.

had a serious
HEART
problem during the past 6 months.

have any
BLOOD DISORDER
s, such as ana

Termékjellemzők

OBJECT 1
REBETOL ORAL SOLUTION
Summary of Product Characteristics Updated 10-Nov-2015 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Rebetol 40 mg/mL oral solution
2. Qualitative and quantitative composition
Each mL of oral solution contains 40 mg of ribavirin.
Excipients with known effect
Rebetol contains 142 mg of sorbitol and 300 mg of sucrose per mL.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
Clear, colourless to pale or light yellow oral solution
4. Clinical particulars
4.1 Therapeutic indications
Rebetol is indicated in combination with other medicinal products for
the treatment of chronic hepatitis C
(CHC) for paediatric patients (children 3 years of age and older and
adolescents) not previously treated
and without liver decompensation (see sections 4.2, 4.4, and 5.1).
4.2 Posology and method of administration
Treatment should be initiated, and monitored, by a physician
experienced in the management of chronic
hepatitis C.
Posology
Rebetol must be used in combination therapy as described in section
4.1.
Please refer to the corresponding Summary of Product Characteristics
(SmPC) of medicinal products used
in combination with Rebetol for additional prescribing information
particular to that product and for
further dosage recommendations on co-administration with Rebetol.
Rebetol oral solution is supplied in a concentration of 40 mg/mL.
Rebetol oral solution is administered orally in two divided doses
(morning and evening) with food.
_Paediatric population_
No data are available in children below 3 years of age.
Dosing of Rebetol for children and adolescent patients is determined
by the patient body weight. For
example, the body weight dosing used in conjunction with interferon
alfa-2b or peginterferon alfa-2b is
shown in TABLE 1. Please refer to the corresponding SmPC of medicinal
products used in combination
with Rebetol as some combination regimens do not adhere to the Rebetol
dosing guidance provided in
TABLE 1.
In clinical studies performed in t