Cytarabin Actavis 100 mg/ml Injektions-/infusionsvätska, lösning

Country: Svíþjóð

Tungumál: sænska

Heimild: Läkemedelsverket (Medical Products Agency)

Virkt innihaldsefni:

cytarabin

Fáanlegur frá:

Actavis Group PTC ehf.

ATC númer:

L01BC01

INN (Alþjóðlegt nafn):

cytarabine

Skammtar:

100 mg/ml

Lyfjaform:

Injektions-/infusionsvätska, lösning

Samsetning:

cytarabin 100 mg Aktiv substans

Gerð lyfseðils:

Receptbelagt

Vörulýsing:

Förpacknings: Injektionsflaska, 1 ml; Injektionsflaska, 5 ml; Injektionsflaska, 10 ml; Injektionsflaska, 20 ml

Leyfisstaða:

Avregistrerad

Leyfisdagur:

2016-12-08

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER 100 MG/ML SOLUTION FOR INJECTION/INFUSION
cytarabine
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cytarabin Actavis is and what it is used for
2.
What you need to know before you are given Cytarabin Actavis
3.
How to use Cytarabin Actavis
4.
Possible side effects
5.
How to store Cytarabin Actavis
6.
Contents of the pack and other information
1.
WHAT CYTARABIN ACTAVIS IS AND WHAT IT IS USED FOR
Cytarabin Actavis is used in adults and children. The active
ingredient is cytarabine.
Cytarabine is one of a group of medicines known as cytotoxics; these
medicines are used in the
treatment of acute leukaemias (cancer of blood where you have too many
white blood cells).
Cytarabine interferes with the growth of cancer cells, which are
eventually destroyed.
Remission induction is an intensive treatment to force leukaemia into
retreat. When it works, the
balance of cells in your blood becomes more normal and your health
improves. This relatively healthy
spell is called a remission.
Maintenance therapy is a milder treatment to make your remission last
as long as possible. Quite low
doses of Cytarabin Actavis are used to keep the leukaemia under
control and stop it flaring up again.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CYTARABIN ACTAVIS
DO NOT USE CYTARABIN ACTAVIS:
-
If you are allergic to cytarabine, or any of the other ingredients of
this medicine (listed in
section 6).
-
If the cell count in your blood report is very low due to some cause
other than cancer, or as
decided by your doctor.
-
If you are feeling increasing difficulties in body coordination after
radiation treatment with
ano

Vara einkenni

1
1.
NAME OF THE MEDICINAL PRODUCTI
Cytarabin Actavis 100 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 100 mg cytarabine.
Each 1 ml vial contains 100 mg cytarabine.
Each 5 ml vial contains 500 mg cytarabine.
Each 10 ml vial contains 1000 mg cytarabine.
Each 20 ml vial contains 2000 mg cytarabine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
The product is a clear, colourless to pale yellow solution.
pH: 7.0 – 9.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For induction of remission in acute myeloid leukaemia in adults and
for other acute leukaemias of
adults and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment with cytarabine should be initiated by, or be in
consultation with, a doctor with extensive
experience in treatment with cytostatics. Only general recommendations
can be given, as acute
leukaemia is almost exclusively treated with combinations of
cytostatics.
Dosage recommendations may be made according to body weight (mg/kg) or
according to BSA
(mg/m
2
). Dosage recommendations may be converted from those in terms of
bodyweight to those
related to surface area by means of nomograms.
_1. Remission induction_
Induction therapy dosage and schedule vary depending on the regimen
used.
a) Continuous treatment
The following dose regimens have been used for continuous treatment in
remission induction.
i) Rapid injection - 2 mg/kg/day is a judicious starting dose.
Administer for 10 days. Obtain daily
blood counts. If no antileukaemic effect is noted and there is no
apparent toxicity, increase to
4 mg/kg/day and maintain until therapeutic response or toxicity is
evident. Almost all patients can be
carried to toxicity with these doses.
2
ii) 0.5 - 1.0 mg/kg/day may be given in an infusion of up to 24 hours
duration. Results from one hour
infusions have been satisfactory in the majority of patients. After 10
days this initial daily dose may
be increased to 2 mg/kg/d