Cytarabine 20mg/ml Injection Solution for Injection 100mg/5ml (25mL)

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

CYTARABINE

Dostępny od:

Hospira UK Limited

Kod ATC:

L01BC01

INN (International Nazwa):

CYTARABINE

Forma farmaceutyczna:

SOLUTION FOR INJECTION

Skład:

CYTARABINE 100 mg/5ml

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Status autoryzacji:

Authorised

Data autoryzacji:

2007-05-07

Ulotka dla pacjenta

PAGE 1 OF 7 2016-0017891 & 2016-0017897
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE 20 MG/ML INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor.
IN THIS LEAFLET:
1. What Cytarabine Injection is and what it is used for
2. What you need to know before you use Cytarabine Injection
3. How to use Cytarabine Injection
4. Possible side effects
5. How to store Cytarabine Injection
6. Contents of the pack and other information
1. WHAT CYTARABINE INJECTION IS AND WHAT IT IS USED FOR
Cytarabine Injection is an anti-cancer medicine. Treatment with an
anti-cancer medicine is sometimes
called cancer chemotherapy.
Cytarabine Injection is used to treat some types of leukaemia (cancer
affecting the blood) and
lymphomas (cancer of the lymph glands). It may be used in combination
with other anti-cancer
medicines.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE INJECTION
DO NOT USE CYTARABINE INJECTION
• if you have shown signs of hypersensitivity (severe allergy) to
cytarabine in the past, or any of the
other ingredients of this medicine (listed in section 6)
• if your blood cell count (number of cells in your blood) is very
low due to some cause other than
cancer (unless your doctor decides the benefits of treatment outweigh
the risks)
• if you are feeling increasing difficulties in body coordination
after radiation treatment or treatment
with another anticancer medicine such as methotrexate
• if you are pregnant
Tell your doctor if you think any of the above applies to you before
this medicine is used.
TAKE SPECIAL CARE WITH CYTARABINE INJECTION
•
if your blood cell count is low
•
if you have any problems with your liver including jaundice (causes
yellowing of the skin)
•
if you have recently received cancer medicine treatment or
radiot

Charakterystyka produktu

Cytarabine 20mg/ml – Jul 2017 PAGE 1 OF 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cytarabine 20 mg/ml Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 20 mg of cytarabine.
Presentations
100 mg/5 ml
500 mg/25 ml
1 g/50 ml
Amount cytarabine
present
100 mg
500 mg
1 g
For excipients see 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cytarabine may be used alone or in combination with other
antineoplastic agents. It is
indicated alone or in combination for induction of remission and/or
maintainance in
patients with acute myeloid leukaemia, acute non-lymphoblastic
leukaemias, acute
lymphoblastic leukaemias, acute lymphocytic leukaemia,
erythroleukaemia, blast crises
of chronic myeloid leukaemia, diffuse histiocytic lymphomas
(non-hodgkin's lymphomas
of high malignancy), meningeal leukaemia and meningeal neoplasms.
Clinicians should
refer to the current literature on combination therapy before
initiating treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cytarabine 20 mg/ml Injection is a ready to use solution and is
suitable for intravenous,
subcutaneous and intrathecal use.
Cytarabine 20 mg/ml Injection can be diluted with Sterilised Water for
Injections BP,
Glucose
Intravenous
Infusion
BP
or
Sodium
Chloride
Intravenous
Infusion
BP.
Prepared
infusions,
in
the
recommended
diluents
should
be
used
immediately.
Alternatively, the diluted infusion fluids may be stored at 2-8°C,
protected from light, but
portions remaining unused after 24 hours must be discarded.
REMISSION INDUCTION: ADULTS
Cytarabine 20mg/ml – Jul 2017 PAGE 2 OF 12
CONTINUOUS DOSING: The usual dose in leukaemia, is 2 mg/kg by rapid
intravenous
injection daily for ten days. If after ten days neither therapeutic
response not toxicity has
been observed, the dose may be increased to 4 mg/kg until a
therapeutic response or
toxicity is evident. Daily blood counts should be taken. Almost all
patients can be
carried to to