Imbruvica

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Ibrutinib 140mg;  ;  

Disponibil de la:

Janssen-Cilag (New Zealand) Ltd

INN (nume internaţional):

Ibrutinib 140 mg

Dozare:

140 mg

Forma farmaceutică:

Capsule

Compoziție:

Active: Ibrutinib 140mg     Excipient: Croscarmellose sodium Gelatin Magnesium stearate Microcrystalline cellulose Opacode black S-1-17822 Opacode black S-1-17823 Sodium laurilsulfate Titanium dioxide

Tip de prescriptie medicala:

Prescription

Produs de:

Lonza Guangzhou Ltd

Indicații terapeutice:

IMBRUVICA is indicated for the treatment of · patients with MCL who have received at least one prior therapy

Rezumat produs:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with child-resistant polypropylene closure - 90 capsules - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with child-resistant polypropylene closure - 120 capsules - 36 months from date of manufacture stored at or below 30°C

Data de autorizare:

2014-11-03

Prospect

IMBRUVICA
®
(221005) NZ DCMI
1
IMBRUVICA
® CAPSULES
AND TABLETS
_ibrutinib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about IMBRUVICA
capsules and tablets. 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 being given
IMBRUVICA against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY QUESTIONS OR
CONCERNS ABOUT TAKING
IMBRUVICA ASK YOUR DOCTOR OR
HEALTHCARE PROFESSIONAL.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING IMBRUVICA.
You may need to read it again.
WHAT IMBRUVICA IS
USED FOR
IMBRUVICA is an anticancer
medicine that contains the active
substance ibrutinib.
IMBRUVICA is used to treat the
following blood cancers in adults:
•
Mantle Cell Lymphoma (MCL), a
type of cancer affecting the
lymph nodes;
•
Chronic Lymphocytic Leukaemia
(CLL), including Small
Lymphocytic Lymphoma (SLL),
a type of cancer affecting a type
of white blood cell called
lymphocytes that also involve the
lymph nodes.
•
Waldenström's
macroglobulinemia (WM), a very
rare cancer affecting the
lymphocytes
IMBRUVICA works by blocking a
protein in the body that helps cancer
cells live and grow. This protein is
called Bruton's tyrosine kinase. By
blocking this protein, IMBRUVICA
may help kill and reduce the number
of cancer cells and may also slow the
spread of the cancer.
ASK YOUR DOCTOR OR HEALTHCARE
PROFESSIONAL IF YOU HAVE ANY
QUESTIONS ABOUT WHY IMBRUVICA
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE
IMBRUVICA
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE IMBRUVICA:
•
if you are allergic
(hypersensitive) to ibrutinib, or
other ingredients of
IMBRUVICA. See Product
Description at the end of this
leaflet for a list of ingredients.
DO NOT TAKE IMBRUVICA:
•
if the packaging is torn or shows
signs of tampering.
•
if the expiry date (month and
year) printed on the

Caracteristicilor produsului

35.220512
1
IMBRUVICA (230419) ADS
IMBRUVICA
®
IBRUTINIB
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
IMBRUVICA
®
140 mg capsules
IMBRUVICA
®
140 mg, 280 mg, 420 mg, 560 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPSULES
_140 MG CAPSULES _
IMBRUVICA capsules contain 140 mg of ibrutinib as the active
ingredient.
FILM-COATED TABLETS
_140 MG TABLETS _
IMBRUVICA tablets contain 140 mg of ibrutinib as the active
ingredient.
_280 MG TABLETS _
IMBRUVICA tablets contain 280 mg of ibrutinib as the active
ingredient.
_420 MG TABLETS _
IMBRUVICA tablets contain 420 mg of ibrutinib as the active
ingredient.
_560 MG TABLETS _
IMBRUVICA tablets contain 560 mg of ibrutinib as the active
ingredient.
Excipients with known effect: sugars as lactose
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
CAPSULES
White opaque, size 0, hard gelatin capsule marked with “ibr 140
mg” in black ink.
FILM-COATED TABLETS
_140 MG TABLETS _
Yellow-green to green round film-coated tablet debossed with “ibr”
on one side and “140” on the
other.
_280 MG TABLETS _
Purple oblong film-coated tablet debossed with “ibr” on one side
and “280” on the other.
_420 MG TABLETS _
Yellow-green to green oblong film-coated tablet debossed with
“ibr” on one side and “420” on the
other._ _
_560 MG TABLETS _
Yellow to orange oblong film-coated tablet debossed with “ibr” on
one side and “560” on the other
35.220512
2
IMBRUVICA (230419) ADS
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IMBRUVICA is indicated for the treatment of
•
patients with MCL who have received at least one prior therapy
•
patients with CLL/SLL
•
patients with CLL with deletion 17p
•
patients with Waldenström’s macroglobulinemia (WM)
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
IMBRUVICA should be administered orally once daily with a glass of
water at approximately the
same time each day. The capsules or tablets should be swallowed whole
with water. Do not
open, break, or chew the capsules. Do not brea