Daklinza 60 mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Daclatasvir dihydrochloride

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

Daclatasvir dihydrochloride

Unit dalam pakej:

28tablet Tablets

Dikeluarkan oleh:

AstraZeneca Pharmaceuticals LP

Risalah maklumat

DAKLINZA
TM FILM-COATED TABLETS
Daclatasvir (30mg and 60mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What DAKLINZA™ is used for
2.
How DAKLINZA™ works
3.
Before you use DAKLINZA™
4.
How to use DAKLINZA™
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DAKLINZA™
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DAKLINZA™ IS USED FOR
Daklinza™ contains the active ingredient
daclatasvir. It is used to treat adults with
hepatitis C, an infectious disease that
affects the liver, caused by the hepatitis
C virus.
HOW DAKLINZA™ WORKS
Daklinza™ works by stopping the
hepatitis C virus from multiplying and
infecting new cells. This lowers the
amount of hepatitis C virus in your body
and removes the virus from your blood
over a period of time.
BEFORE YOU USE DAKLINZA™
-
When you must not use it
Do not take Daklinza™

if you are allergic to daclatasvir or
any of the other ingredients of this
medicine (listed in section
“Ingredients” of this leaflet)

if you are taking (by mouth or other
ways that affect the whole body) any
of the following medicines
-
phenytoin, carbamazepine,
oxcarbazepine or phenobarbital,
used to treat epileptic seizures
-
rifampicin, rifabutin or rifapentine,
antibiotics used to treat tuberculosis
-
dexamethasone, a steroid used to
treat allergic and inflammatory
diseases
-
medicines containing St. John’s
wort (_Hypericum perforatum_, a
herbal preparation).
These medicines lower the effect of
Daklinza™ and may result in your
treatment not working. If you take any of
these medicines, tell your doctor
immediately.
Since Daklinza™ must always be used in
combination with other medicines
against hepatitis C infection, please make
sure that you read the "Do not take"
section of the package leaflets for these
medicines. If you are unsure of any
information in the package leaflets,
please contact your doctor or pharmacist.
_Pregnancy and contraception _
Tell your doctor if

Ciri produk

1
1. NAME OF THE MEDIC INAL PRODUCT
Daklinza 30mg and 60 mg film -coated tablets
2. QUALITATIVE AND Q UANTITATIVE COMPOSIT ION
Each film -coated tablet contains daclatasvir dihydrochloride equivalent to 30mg or 60 mg daclatasvir .
Excipient(s) with known effect:
Each 30 -mg film -coated tablet contains 58 mg of lactose (as anhydrous).
Each 60-mg film -coated tablet contains 116 mg of lactose (as anhydrous).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FO RM
Film -coated tablet (tablet ).
30mg tablet : Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed tablet with
"BMS" on one side and "213" on the other side.
60 mg tablet : Light green biconvex pentagonalof dimensions 9.1 mm x 8.9 mm, debossed tablet with
“BMS” on one side and “215” on the other side.
4. CLINICAL PARTICUL ARS
4.1 Therapeutic indications
Daklinza is indicated in combination with other medicinal products for the treatment of chronic
hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
For HCV genotype specific activity, see sections 4.4 and 5.1.
4.2 Posology and method of administration
Treatment with Daklinza should be initiated and monitored by a physician experienced in the
management of chronic hepatitis C.
Posology
The r ecommended dose of Daklinza is 60 mg once daily, to be taken orally with or without meals.
Daklinza must be administered in combination with other medicinal products. The Product
Information for the other medicinal products in the regimen should also be c onsulted before initiation
of therapy with Daklinza.
Table 1 provides the recommended Daklinza -containing treatment regimens and duration based on
HCV genotype and patient population. For specific dosage recommendations for sofosbuvir, refer to
the prescr ibing information. The optimal duration of D aklinza and sofosbuvir with or without ribavirin
has not been established for HCV genotype 3 patients with cirrhosis or for HCV genotype 1 patients
with Child -Pugh C cirrhosis (see sections 5.1) .