Arseentrioxide Sandoz 2 mg/ml, concentraat voor oplossing voor infusie

Nazione: Paesi Bassi

Lingua: olandese

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

Principio attivo:

ARSEENTRIOXIDE

INN (Nome Internazionale):

ARSEENTRIOXIDE

Forma farmaceutica:

Concentraat voor oplossing voor infusie

Composizione:

NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507)

Via di somministrazione:

Intraveneus gebruik

Data dell'autorizzazione:

2022-08-02

Foglio illustrativo

Sandoz B.V.
Page 1/7
Arseentrioxide Sandoz 2 mg/ml, concentraat voor oplossing
voor infusie
RVG 127559
1313-v1
1.3.1.3 Leaflet
Juli 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARSEENTRIOXIDE SANDOZ 2 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
arsenic trioxide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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<,> your
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you are given [Nationally completed name]
3.
How [Nationally completed name] is given
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] is used in adult patients with newly
diagnosed low-to-intermediate
risk acute promyelocytic leukaemia (APL), and in adult patients, whose
disease has not responded
to other therapies. APL is a unique type of myeloid leukaemia, a
disease in which abnormal white
blood cells and abnormal bleeding and bruising occur.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN [NATIONALLY COMPLETED NAME]
[Nationally completed name] must be given under the supervision of a
physician experienced in
the treatment of acute leukaemias.
YOU MUST NOT RECEIVE
[NATIONALLY COMPLETED NAME]
if you are allergic to arsenic trioxide or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before you are given
[NATIONALLY COMPLETED NAME]
, if
-
you have impaired kidney function.
-
you have any liver problems.
Your doctor will take the following precautions:
-
Tests will be performed to chec

Scheda tecnica

Sandoz B.V.
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Arseentrioxide Sandoz 2 mg/ml, concentraat voor oplossing
voor infusie
RVG 127559
1311-v1
1.3.1.1 Summary of Product Characteristics
Juli 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Arseentrioxide Sandoz 2 mg/ml, concentraat voor oplossing voor
infusie.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of [Nationally completed name] contains 2 mg of arsenic
trioxide.
Each vial of 6 ml contains 12 mg of arsenic trioxide.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Sterile, clear, colorless solution, free of particles.
pH: 7.5-8.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for induction of remission,
and consolidation in adult
patients with:
•
Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia
(APL) (white
blood cell count, ≤ 10 x 10
3
/µl) in combination with all-trans-retinoic acid (ATRA)
•
Relapsed/refractory acute promyelocytic leukaemia (APL) (previous
treatment should have
included a retinoid and chemotherapy) characterised by the presence of
the t(15;17)
translocation and/or the presence of the pro-myelocytic
leukaemia/retinoic-acid-receptor-
alpha (PML/RAR-alpha) gene.
The response rate of other acute myelogenous leukaemia subtypes to
arsenic trioxide has not been
examined.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
[Nationally completed name] must be administered under the supervision
of a physician who is
experienced in the
management of acute leukaemias, and the special monitoring procedures
described in section 4.4 must
be followed.
Posology
The same dose is recommended for adults and elderly.
Sandoz B.V.
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Arseentrioxide Sandoz 2 mg/ml, concentraat voor oplossing
voor infusie
RVG 127559
1311-v1
1.3.1.1 Summary of Product Characteristics
Juli 2022
_Newly diagnosed low-to-intermediate risk acute promyelocytic
leukaemia (APL) _
_ _
_Induction treatment schedule _
[Nationally completed name] must be adminis