Spectrila
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
20-11-2023
Valmisteyhteenveto
(SPC)
20-11-2023
Julkisesta arviointikertomuksesta
(PAR)
28-01-2016
Aktiivinen ainesosa:
asparaginase
Saatavilla:
Medac Gesellschaft fuer klinische Spezialpraeparate mbH
ATC-koodi:
L01XX02
INN (Kansainvälinen yleisnimi):
asparaginase
Terapeuttinen ryhmä:
Antineoplastic agents
Terapeuttinen alue:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Käyttöaiheet:
Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
Tuoteyhteenveto:
Revision: 6
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2016-01-14
Pakkausseloste
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SPECTRILA 10,000 U POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
asparaginase
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 or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Spectrila is and what it is used for
2.
What you need to know before you are given Spectrila
3.
How to use Spectrila
4.
Possible side effects
5.
How to store Spectrila
6.
Contents of the pack and other information
1.
WHAT SPECTRILA IS AND WHAT IT IS USED FOR
Spectrila contains asparaginase, which is an enzyme that interferes
with natural substances necessary
for cancer cell growth. All cells need an amino acid called asparagine
to stay alive. Normal cells can
make asparagine for themselves, while some cancer cells cannot.
Asparaginase lowers asparagine
level in blood cancer cells and stops the cancer growing.
Spectrila is used to treat adults and children with acute
lymphoblastic leukaemia (ALL) which is a
form of blood cancer. Spectrila is used as part of a combination
therapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SPECTRILA
SPECTRILA MUST NOT BE USED
•
if you are allergic to asparaginase or to the other ingredient of this
medicine (listed in section 6),
•
if you have or previously had inflammation of the pancreas
(pancreatitis),
•
if you have severe liver function problems,
•
if you have a blood clotting disorder (such as haemophilia),
•
if you had severe bleeding (haemorrhage) or severe blood clotting
(thrombosis) under previous
asparaginase treatment.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given Spectrila.
The following life-threatening situations could arise during treatment
with Spectrila:
•
severe inflamm
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Spectrila 10,000 U powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 10,000 units of asparaginase*.
After reconstitution, each ml of solution contains 2,500 units of
asparaginase.
One unit (U) is defined as the quantity of enzyme required to liberate
one µmol ammonia per minute at
pH 7.3 and 37 °C.
*Produced in
_Escherichia coli _
cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Spectrila is indicated as a component of antineoplastic combination
therapy for the treatment of acute
lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18
years and adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Spectrila should be prescribed and administered by physicians and
healthcare personnel experienced in
the use of antineoplastic products. It should only be given in a
hospital setting where appropriate
resuscitation equipment is available.
Posology
Spectrila is usually employed as part of combination chemotherapy
protocols with other antineoplastic
agents (see also section 4.5).
_Adults and children older than 1 year _
The recommended intravenous dose of asparaginase is 5,000 units per
square metre (U/m²) body
surface area (BSA) given every third day.
Treatment may be monitored based on the trough serum asparaginase
activity measured three days
after administration of Spectrila. If asparaginase activity values
fail to reach target levels, a switch to a
different asparaginase preparation could be considered (see section
4.4).
_Children 0 – 12 months old _
Based on limited data, the recommended dose in infants is as follows:
-
age less than 6 months:
6,700 U/m² BSA,
-
age 6 – 12 months:
7,500 U/m² BSA.
3
Data on efficacy and safety of Spectrila in adults are limited.
Data on effic
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