Tasigna 150mg capsules

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Nilotinib hydrochloride monohydrate

Доступно од:

Novartis Pharmaceuticals UK Ltd

АТЦ код:

L01XE08

INN (Међународно име):

Nilotinib hydrochloride monohydrate

Дозирање:

150mg

Фармацеутски облик:

Capsule

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: ; GTIN: 5010678920079

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
TASIGNA
® 150 MG HARD CAPSULES
nilotinib
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tasigna is and what it is used for
2.
What you need to know before you take Tasigna
3.
How to take Tasigna
4.
Possible side effects
5.
How to store Tasigna
6.
Contents of the pack and other information
1.
WHAT TASIGNA IS AND WHAT IT IS USED FOR
WHAT TASIGNA IS
Tasigna is a medicine containing an active substance called nilotinib.
WHAT TASIGNA IS USED FOR
Tasigna is used to treat a type of leukaemia called Philadelphia
chromosome positive chronic myeloid
leukaemia (Ph-positive CML). CML is a cancer of the blood which makes
the body produce too many
abnormal white blood cells.
Tasigna is used in adult and paediatric patients with newly diagnosed
CML. It is also used in paediatric
patients with CML who are no longer benefiting from previous treatment
including imatinib or who
experienced serious side effects with previous treatment and are not
able to continue taking it.
HOW TASIGNA WORKS
In patients with CML, a change in DNA (genetic material) triggers a
signal that tells the body to produce
abnormal white blood cells. Tasigna blocks this signal, and thus stops
the production of these cells.
MONITORING DURING TASIGNA TREATMENT
Regular tests, including blood tests, will be performed during
treatment. These tests will monitor:
-
the amount of blood cells (white blood cells, red blood cells and
platelets) in the body to see how
Tasigna is tolerated.
-
pancreas and liver

Карактеристике производа

OBJECT 1
TASIGNA 150MG HARD CAPSULES
Summary of Product Characteristics Updated 20-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Tasigna
®
150 mg hard capsules
2. Qualitative and quantitative composition
One hard capsule contains 150 mg nilotinib (as hydrochloride
monohydrate).
Excipient with known effect
One hard capsule contains 117.08 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
White to yellowish powder in red opaque hard gelatin capsules, size 1
with black axial imprint
“NVR/BCR”.
4. Clinical particulars
4.1 Therapeutic indications
Tasigna is indicated for the treatment of:
- adult and paediatric patients with newly diagnosed Philadelphia
chromosome positive chronic
myelogenous leukaemia (CML) in the chronic phase,
- paediatric patients with Philadelphia chromosome positive CML in
chronic phase with resistance or
intolerance to prior therapy including imatinib.
4.2 Posology and method of administration
Therapy should be initiated by a physician experienced in the
diagnosis and the treatment of patients with
CML.
Posology
Treatment should be continued as long as clinical benefit is observed
or until unacceptable toxicity
occurs.
If a dose is missed the patient should not take an additional dose,
but take the usual prescribed next dose.
_Posology for Philadelphia chromosome positive CML adult patients_
The recommended dose is 300 mg twice daily.
For a dose of 400 mg once daily (see dose adjustments below), 200 mg
hard capsules are available.
_Posology for Philadelphia chromosome positive CML paediatric
patients_
Dosing in paediatric patients is individualised and is based on body
surface area (mg/m
2
). The
recommended dose of nilotinib is 230 mg/m
2
twice daily, rounded to the nearest 50 mg dose (to a
maximum single dose of 400 mg) (see Table 1). Different strengths of
Tasigna hard capsules can be
combined to attain the desired dose.
There is no experience with treatment of paediatric patients below 2
years of