Clofarabine Sandoz 1 mg/ml, concentraat voor oplossing voor infusie

País: Holanda

Língua: holandês

Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes ativos:

CLOFARABINE

Disponível em:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Código ATC:

L01BB06

DCI (Denominação Comum Internacional):

CLOFARABINE

Forma farmacêutica:

Concentraat voor oplossing voor infusie

Composição:

NATRIUMCHLORIDE ; WATER VOOR INJECTIE,

Via de administração:

Intraveneus gebruik

Área terapêutica:

Clofarabine

Resumo do produto:

Hulpstoffen: NATRIUMCHLORIDE; WATER VOOR INJECTIE;

Data de autorização:

2018-01-08

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOFARABINE SANDOZ 1 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
CLOFARABINE
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.
•
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What {[nationally completed name]} is and what it is used for
2.
What you need to know before you use {[nationally completed name]}
3.
How to use {[nationally completed name]}
4.
Possible side effects
5.
How to store {[nationally completed name]}
6.
Contents of the pack and other information
1.
WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR
{[Nationally completed name]} contains the active substance
clofarabine. Clofarabine is one of a
family of medicines called anticancer medicines. It works by hindering
the growth of abnormal white
blood cells, and eventually kills them. It works best against cells
which are multiplying quickly – such
as cancer cells.
{[Nationally completed name]} is used to treat children (≥ 1 year
old), teenagers and young adults up
to 21 years old with acute lymphoblastic leukaemia (ALL) when previous
treatments have not worked
or have stopped working. Acute lymphoblastic leukaemia is caused by
abnormal growth of some types
of white blood cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE {[NATIONALLY COMPLETED NAME]}
DO NOT USE {[NATIONALLY COMPLETED NAME]}:
-
IF YOU ARE ALLERGIC to clofarabine or any of the other ingredients of
this medicine (listed in
section 6);
-
IF YOU ARE BREAST-FEEDING (please read the section “Pregnancy and
breast-feeding” below);
-
IF YOU HAVE SEVERE KIDNEY OR LIVER PROBLEMS.
TELL YOUR DOCTOR IF ANY OF THESE CONDITIONS APPLY TO YOU. If you are
the parent of a child who is
being treated with {[nationally completed name]}, TELL THE DOCTOR

Características técnicas

Sandoz B.V.
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Clofarabine Sandoz 1 mg/ml, concentraat voor oplossing voor infusie
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1.3.1.1 Summary of Product Characteristics
Juni 2018
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clofarabine Sandoz 1 mg/ml, concentraat voor oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 1 mg of clofarabine.
Each 20 ml vial contains 20 mg of clofarabine.
Excipient with known effect
Each 20 ml vial contains 180 mg of sodium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear colourless solution with a pH of 4.5 to 7.5 and osmolarity of
270 to 310 mOsm/L.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric
patients who have relapsed or are
refractory after receiving at least two prior regimens and where there
is no other treatment option
anticipated to result in a durable response. Safety and efficacy have
been assessed in studies of
patients ≤ 21 years old at initial diagnosis (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult population (including elderly) _
There are currently insufficient data to establish the safety and
efficacy of clofarabine in adult
patients (see section 5.2)._ _
_ _
_Paediatric population _
_Children and adolescents (≥ 1 year old) _
Sandoz B.V.
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Clofarabine Sandoz 1 mg/ml, concentraat voor oplossing voor infusie
RVG 119525
V02
1.3.1.1 Summary of Product Characteristics
Juni 2018
The recommended dose in monotherapy is 52 mg/m
2
of body surface area administered by
intravenous infusion over 2 hours daily for 5 consecutive days. Body
surface area must be calculated
using the actual height and weight of the patient before the start of
each cycle. Treatment cycles
should be repeated every 2 to 6 weeks (from the starting day of the
previous cycle) following recovery
of normal haematopoiesis (i.e. ANC ≥ 0.75 × 10
9
/l) and return to baseli