ATRIANCE 5 mg /Ml Roztwór Do Infuzji

Treść ulotki

1. Atriance 5 mg/ml solution for infusion
   1. What is Atriance and what is it used for
   2. What you need to know before using Atriance
   3. How to use Atriance
   4. Possible side effects
   5. How to store Atriance
   6. Package contents and other information

Atriance 5 mg/ml solution for infusion

nelarabine

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Atriance is and what it is used for
• 2. What you need to know before you use Atriance
• 3. How to use Atriance
• 4. Possible side effects
• 5. How to store Atriance
• 6. Contents of the pack and other information

1. What is Atriance and what is it used for

Atriance contains nelarabine which belongs to a group of medicines known as agents

antineoplastic, used in chemotherapy to kill some types of cancer cells.

Atriance is used for the treatment of patients with:
a type of leukemia, called T-cell acute lymphoblastic leukemia. Leukemia causes an
abnormal increase in the number of white blood cells (blood cells). Excessively high numbers of white blood cells can appear in the blood and other parts of the body. The type
of leukemia is related to the type of white blood cells primarily involved. In this case, they 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 cells.
For any questions regarding your condition, please consult your doctor.

2. What you need to know before using Atriance

You (or your child if being treated) must not receive Atriance
if you (or your child if being treated) are allergic to nelarabine or to any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions
Serious effects on the nervous system have been reported with the use of Atriance. Symptoms may be
mental (e.g. fatigue), or physical (e.g. convulsions, sensation of numbness or tingling,
weakness and paralysis). The doctor will regularly check for the occurrence of
these symptoms during treatment (see also section 4, “Possible side effects”).
The doctor must also know the following before administering this medicine to you:

if you (or your child if being treated) have any problems with your kidneys or liver. It may
be necessary to adjust your dose of Atriance

if you (or your child if being treated) have recently been vaccinated, or plan to be vaccinated,
with a live vaccine (e.g. for poliomyelitis, chickenpox, typhoid).

if you (or your child if being treated) have any blood problems(e.g. anemia).

Blood tests during treatment
The doctor may ask you to have blood tests regularly during treatment to
check for problems that may be associated with the use of Atriance.

Elderly
If you are an elderly person, you may be more sensitive to side effects on the nervous system
(see the list under “Warnings and precautions”). The doctor will check you for these symptoms
regularly during treatment.

Tell your doctor if any of these situations apply to you.
Other medicines and Atriance
Tell your doctor or pharmacist if you are taking,have recently taken, or might
take any other medicines. This includes any herbal products or medicines
bought without a prescription.
Remember to tell your doctor if you start taking any other medicines while you are being treated
with Atriance.

Pregnancy, breastfeeding and fertility
Atriance is not recommended in pregnant women. It may harm a baby conceived
before, during or immediately after treatment. It is recommended to discuss with your doctor the
assessment of an appropriate method of contraception. Do not try to become pregnant/become a father until the doctor tells you it is safe.
Male patients who may wish to father a child should ask their doctor for
advice or treatment regarding family planning. If pregnancy occurs during
treatment with Atriance, you should tell your doctor immediately.
It is not known whether Atriance is excreted in breast milk. Breastfeeding must be
stopped while you are being treated with Atriance. Ask your doctor for advice before taking
any medicine.

Driving and operating machinery
Atriance may cause a feeling of drowsiness or sleepiness, both during treatment and for some
days after treatment. If you feel tired or weak, do not drive and do not use any
tools or machinery.

Atriance contains sodium
This medicine contains 88.51 mg (3.85 mmol) of sodium (the main component of table salt)
per vial (50 ml). This is equivalent to 4.4% of the maximum recommended daily intake with
the diet of an adult.

3. How to use Atriance

The dose of Atriance that you will receive will be based on:

your/your child's body surface area (if being treated)(this will be calculated by the
doctor based on height and weight).

the results of the blood testperformed before treatment

Adults and adolescents (aged 16 years or older)
The usual doseis 1,500 mg/m of body surface area per day.

A doctor or nursewill administer the appropriate dose of Atriance with a drip
infusion (intravenous infusion). Generally, the infusion is administered in the arm for approximately
2 hours.

You will be given an infusion (intravenous infusion) once a day on treatment days 1,
3 and 5. This treatment schedule will normally be repeated every three weeks. This treatment may
vary, depending on the results of blood tests performed at regular intervals. The doctor
will decide how many treatment cycles are required.

Children and adolescents (aged 21 years or younger)
The recommended dose is 650 mg/m of body surface area per day.

A doctor or nursewill administer to you/your child (if being treated) an appropriate
dose of Atriance with an infusion (intravenous infusion). Generally, the infusion is administered
in the arm for approximately 1 hour.

You/your child (if being treated) will be given an infusion (intravenous infusion) once
a day for 5 days. This treatment schedule will normally be repeated every three weeks.
This treatment may vary, depending on the results of blood tests performed at regular
intervals. The doctor will decide how many treatment cycles are required.

If you stop taking Atriance
The doctor will decide when to stop treatment.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The majority of side effects reported with Atriance have been observed in adults, children and
adolescents. Some side effects have been reported more frequently in adult patients. The reason for
this is unknown.
If you have any doubts, talk to your doctor.

More serious side effects
These can occur in more than 1 in 10 peopletreated with Atriance.

Signs of infection. Atriance can reduce the number of white blood cells in the blood and reduce
resistance to infections (including pneumonia). This can also be life-threatening. The
signs of infection include:
fever
serious worsening of general condition
local symptoms such as sore throat, mouth sores or urinary problems (for example, a
burning sensation when urinating, which may be caused by a urinary infection)
If you experience any of these signs, tell your doctor immediately. A blood test will be performed
to check for a possible reduction in white blood cells in the blood.

Other very common side effects
These can occur in more than 1 in 10 peopletreated with Atriance.
Changes in the perception of sensations in the hands and feet, muscle weakness that
manifests as difficulty getting up from a chair, or difficulty walking (peripheral neuropathy); reduced
sensitivity to light touch, or pain; abnormal sensations such as a burning sensation, tingling, a
feeling of something crawling on the skin.
General feeling of weakness and fatigue (temporary anemia). In some cases you may
need a blood transfusion.
Unusual bruising or bleeding, caused by a decrease in the number of cells
responsible for blood clotting. This can lead to serious bleeding following
relatively minor injuries, such as small cuts. Rarely, it can lead to even more serious bleeding
(hemorrhages). Talk to your doctor for advice on how to minimize the risk of bleeding.
Feeling of numbness and drowsiness; headache; dizziness.
Shortness of breath, difficulty and fatigue in breathing; cough.
Feeling of stomach upset (nausea); unwell/vomiting; diarrhea; constipation
Muscle pain.
Swelling of body parts caused by the accumulation of abnormal amounts of fluid (edema).
High body temperature (fever); fatigue; feeling of weakness/loss of strength.
If any of these effects cause you problems, talk to your doctor.

Common side effects
These can occur in up to 1 in 10 peopletreated with Atriance.
Violent, uncontrollable muscle contractions, often accompanied by loss of consciousness,
which may be due to an epileptic seizure (convulsions).
Clumsiness and lack of coordination, which affects balance, walking, the
movements of the limbs or eyes, or speech.
Rhythmic, involuntary tremors of one or more limbs (tremors).
Muscle weakness (possibly associated with peripheral neuropathy- see above), joint pain, back pain; pain
in the hands and feet including tingling and
numbness.
Low blood pressure.
Weight loss and loss of appetite (anorexia); stomach pains; mouth pain, ulcers
or inflammation in the mouth.
Problems with memory, feeling disoriented; blurred vision; altered or
loss of taste (dysgeusia).
Fluid build-up around the lungs causing chest pain and difficulty breathing
(pleural effusion); wheezing
Increased levels of bilirubin in the blood, which can cause a yellowing of the skin and
drowsiness (feeling sleepy).
Increased levels of liver enzymes (liver) in the blood.
Increased levels of creatinine in the blood (a sign of kidney problems, which can lead to
urinating less frequently).
The release of the contents of cancer cells (tumor lysis syndrome), which can cause
further stress on your body. Initial symptoms include nausea and vomiting, shortness of breath,
irregular heartbeat, cloudy urine, drowsiness and/or joint pain. If this occurs, it is more likely to
occur with the first dose. The doctor will take appropriate precautions to minimize the risk of this
happening.
Reduction in the levels of certain substances in the blood:
low levels of calcium, which can cause muscle cramps, abdominal cramps or spasms
low levels of magnesium, which can cause muscle weakness, confusion,
"jerky" movements, high blood pressure, irregular heartbeat and slowing
of reflexes at significantly low magnesium levels.
low levels of potassium which can cause a feeling of weakness
low levels of glucose, which can cause nausea, sweating, weakness, fainting,
confusion or hallucinations
If any of these effects cause you problems, talk to your doctor.

Rare side effects
These can occur in up to 1 in 1,000 peopletreated with Atriance.
A serious condition that destroys skeletal muscle characterized by the presence of myoglobin in the
urine (a product of muscle cell destruction) (rhabdomyolysis),
increased levels of creatine phosphokinase in the blood.
If any of these effects cause you problems, talk to your doctor.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
reported in Annex V. By reporting side effects, you can help provide more information on the safety
of this medicine.

5. How to store Atriance

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the vial.
This medicine does not require any special storage conditions.
Atriance after opening the vial is stable for up to 8 hours, up to 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Atriance contains
The active ingredient is nelarabine. Each ml of Atriance solution for infusion contains 5 mg of
nelarabine. Each vial contains 250 mg of nelarabine.
The other ingredients are sodium chloride, water for injections, hydrochloric acid,
sodium hydroxide (see section 2 “Atriance contains sodium”).

Description of the appearance of Atriance and contents of the pack
Atriance solution for infusion is a clear, colorless solution. It is available in glass
vials with a rubber stopper and sealed with an aluminum crimp.
Each vial contains 50 ml.
Atriance is available in packs of 1 vial or 6 vials.

Marketing Authorization Holder
Sandoz Pharmaceuticals d.d.
Verovškova ulica 57
1000 Ljubljana
Slovenia

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestrasse 11
4866 Unterach am Attersee
Austria
FAREVA Unterach GmbH
Mondseestraße 11
Unterach am Attersee, 4866,
Austria
For further information on this medicine, contact the local representative of the marketing authorization holder

België/Belgique/Belgien
Sandoz N.V.
Telecom Gardens
Medialaan 40
B-1800 Vilvoorde
Tél/Tel: +32 (0)2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d
Branch Office Lithuania
Seimyniskiu 3A
LT – 09312 Vilnius
Tel: +370 5 2636 037

България
КЧТ Сандоз България
Teл.: +359 2 970 47 47

Luxembourg/Luxemburg
Sandoz N.V.
Telecom Gardens
Medialaan 40
B-1800 Vilvoorde
Tél/Tel: +32 (0)2 722 97 97

Česká republika
Sandoz s.r.o.
Na Pankráci 1724/129
CZ-140 00, Praha 4
Tel: +420 225 775 111
office.cz@ sandoz.com

Magyarország
Sandoz Hungária Kft.
Bartók Béla út 43-47
H-1114 Budapest
Tel: +36 1 430 2890
[email protected]

Danmark
Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 København S
Tlf: +45 6395 1000
[email protected]

Malta
Sandoz Pharmaceuticals d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Tel: +356 21222872

Deutschland
Hexal AG
Industriestr. 25
D-83607 Holzkirchen
Tel: +49 8024 908-0
[email protected]

Nederland
Sandoz B.V.
Hospitaaldreef 29,
NL-1315 RC Almere
Tel: +31 (0)36 5241600
[email protected]

Eesti
Sandoz d.d. Eesti filiaal
Pärnu mnt 105
EE – 11312 Tallinn
Tel: +372 6652405

Norge
Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 København S
Danmark
Tlf: +45 6395 1000
[email protected]

Ελλάδα
SANDOZ HELLAS
ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Österreich
Sandoz GmbH
Biochemiestr. 10
A-6250 Kundl
Tel: +43(0)1 86659-0

España
Bexal Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Tel: +34 900 456 856

Polska
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02 672 Warszawa
Tel.: +48 22 209 7000
[email protected]

France
Sandoz SAS
49, avenue Georges Pompidou
F-92300 Levallois-Perret
Tél: +33 1 49 64 48 00

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 211 964 000

Hrvatska
Sandoz d.o.o.
Maksimirska 120
10 000 Zagreb
Tel : +385 1 235 3111
[email protected]

România
Sandoz S.R.L.
Strada Livezeni Nr. 7a
540472 Târgu Mureș
Tel: +40 21 407 51 60

Ireland
Sandoz Pharmaceuticals d.d.
Verovškova ulica 57
1000 Ljubljana
Slovenia

Slovenija
Lek farmacevtska družba d.d.
Verovškova 57
SI-1526 Ljubljana
Tel: +386 1 580 21 11
[email protected]

Ísland
Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Kaupmaannahöfn S
Danmörk
Tlf: +45 6395 1000
[email protected]

Slovenská republika
Sandoz d.d. - organizačná zložka
Žižkova 22B
811 02 Bratislava
Tel: +421 2 48 200 600
[email protected]

Suomi/Finland
Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Kööpenhamina S
Tanska
Puh: + 358 010 6133 400
[email protected]

Κύπρος
Sandoz Pharmaceuticals d.d.
Verovskova 57
SI-1000 Ljubljana
Σλοβενία
Τηλ: +357 22 69 0690

Italia
Sandoz S.p.A.
Largo Umberto Boccioni, 1
I-21040 Origgio / VA
Tel: +39 02 96 54 1
[email protected]

Sverige
Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Köpenhamn S
Danmark
Tel: +45 6395 1000
[email protected]

Latvija
Sandoz d.d. Latvia filiāle
K.Valdemāra 33 – 29
LV-1010 Rīga
Tel: +371 67892006
This medicine has received an authorisation under “exceptional circumstances”.
This means that, because the disease is rare, information on this medicine is limited.
The European Medicines Agency will annually review any new information on this
More detailed information on this medicine is available on the European Medicines Agency website,
http://www.ema.europa.eu. Links to other websites on rare diseases and related therapeutic treatments are also provided.
The following information is intended for healthcare professionals only:

INSTRUCTIONS ON HOW TO STORE AND DISPOSE OF ATRIANCE
Storage of Atriance solution for infusion
This medicine does not require any special storage conditions.
Atriance is stable for up to 8 hours after opening the vial, at up to 30°C.

Instructions for handling and disposal of Atriance
Normal procedures must be followed for the correct handling and disposal of
antineoplastic medicines, i.e.:
Personnel must be trained on how to handle and transport the medicine.
Pregnant personnel must be excluded from activities related to the use of this
medicine.
Personnel handling this medicine during handling/transport must wear
protective clothing, including mask, goggles and gloves.
All items used for administration or cleaning, including gloves, must be
placed in high-risk waste bags for incineration at high
temperature. Any liquid waste from the preparation of nelarabine infusion solution can be
disposed of with large amounts of water.
Accidental contact with skin or eyes should be treated immediately with large
amounts of water.