Atriance 250mg50ml solution for infusion vials

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Nelarabine

Доступна з:

Novartis Pharmaceuticals UK Ltd

Код атс:

L01BB07

ІПН (Міжнародна Ім'я):

Nelarabine

Дозування:

5mg/1ml

Фармацевтична форма:

Solution for infusion

Адміністрація маршрут:

Intravenous

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 08010300; GTIN: 5000123112524

інформаційний буклет

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATRIANCE
® 5 MG/ML SOLUTION FOR INFUSION
nelarabine
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Atriance is and what it is used for
2.
What you need to know before you are given Atriance
3.
How Atriance is given
4.
Possible side effects
5.
How to store Atriance
6.
Contents of the pack and other information
1.
WHAT ATRIANCE IS AND WHAT IT IS USED FOR
Atriance contains nelarabine which belongs to a group of medicines
known as
_antineoplastic agents,_
used in chemotherapy to kill some types of cancer cells.
ATRIANCE IS USED TO TREAT PATIENTS WITH:

a type of leukaemia, called T-cell acute lymphoblastic leukaemia.
Leukaemia causes an
abnormal increase in the number of white blood cells. The abnormal
high number of white
blood cells can appear in the blood and other parts of the body. The
type of leukaemia relates to
the type of white blood cell mainly involved. In this case, its cells
are called lymphoblasts.

a type of lymphoma, called T-cell lymphoblastic lymphoma. This
lymphoma is caused by a
mass of lymphoblasts, a type of white blood cell.
If you have any questions about your illness, talk to your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ATRIANCE
YOU (OR YOUR CHILD, IF HE/SHE IS BEING TREATED) MUST N

Характеристики продукта

OBJECT 1
ATRIANCE 5 MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 21-May-2018 | Novartis
Pharmaceuticals UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Atriance
®
5 mg/ml solution for infusion
2. Qualitative and quantitative composition
Each ml of solution contains 5 mg of nelarabine.
Each vial contains 250 mg of nelarabine.
Excipient with known effect
Each ml of solution contains 1.725 mg (75 micromols) of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Nelarabine is indicated for the treatment of patients with T-cell
acute lymphoblastic leukaemia (T-ALL)
and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not
responded to or has relapsed
following treatment with at least two chemotherapy regimens.
Due to the small patient populations in these disease settings, the
information to support these indications
is based on limited data.
4.2 Posology and method of administration
Nelarabine must only be administered under the supervision of a
physician experienced in the use of
cytotoxic agents.
Posology
Complete blood counts including platelets must be monitored regularly
(see sections 4.4 and 4.8).
_Adults and adolescents (aged 16 years and older) _
The recommended dose of nelarabine for adults and adolescents aged 16
years and older is 1,500 mg/m
2
administered intravenously over two hours on days 1, 3 and 5 and
repeated every 21 days.
_Children and adolescents (aged 21 years and younger) _
The recommended dose of nelarabine for children and adolescents (aged
21 years and younger) is 650
mg/m
2
administered intravenously over one hour daily for 5 consecutive days,
repeated every 21 days.
In clinical studies