Erwinase 10,000 Units. Powder for solution for injection

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Cristanspase

Dostopno od:

Jazz Pharmaceuticals France SAS

Koda artikla:

L01XX; L01XX02

INN (mednarodno ime):

Cristanspase

Odmerek:

10000  international unit(s)

Farmacevtska oblika:

Powder for solution for injection

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Other antineoplastic agents; asparaginase

Status dovoljenje:

Marketed

Datum dovoljenje:

1998-09-18

Navodilo za uporabo

Ireland August 2016 page 20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERWINASE
®
10.000 Units, Powder for solution for injection
Crisantaspase (Asparaginase from _Erwinia chrysanthemi_; _Erwinia_
L-asparaginase)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Erwinase is and what it is used for.
2. What you need to know before you take Erwinase.
3.
How to take Erwinase.
4.
Possible side effects.
5.
How to store Erwinase.
6.
Contents of the pack and other information.
1.
WHAT ERWINASE IS AND WHAT IT IS USED FOR
Erwinase contains asparaginase from _Erwinia chrysanthemi_.
Erwinase is an anti-blood-cell-cancer medicine.
It is used in combination with other anticancerous agents to treat
Acute Lymphoblastic Leukaemia,
a type of blood-cell-cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ERWINASE
DO NOT USE ERWINASE:
-
If you are allergic (hypersensitive) to crisantaspase (_Erwinia_
L-asparaginase) or any of the other
ingredients of this medicine (listed in section 6).
-
If you have a history of pancreas problems (acute pancreatitis).
-
If you are having a baby, trying to have a baby or if you are
breast-feeding.
WARNINGS AND PRECAUTIONS
-
Crisantaspase (Erwinia L-asparaginase) is a substance which your body
may become sensitive to
after repeated treatments.
-
Treatment with Erwinase can sometimes affect the results of certain
blood or urine tests. Your
doctor will be aware of this and may carry out routine blood tests
before and during your treatment
to check for any changes.
-
Treatment with Erwinase may make you more susceptible to infection.
-
Posterior reversible encephalopathy syndrome (characterised by
headache, confusion, seizures
Ireland August 2016 pag

Lastnosti izdelka

Health Products Regulatory Authority
03 March 2020
CRN008VDT
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Erwinase 10,000 Units. Powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Crisantaspase (Asparaginase from _Erwinia chrysanthemi_; _Erwinia_
L-asparaginase), 10,000 Units/vial.
Excipients with known effect:
Glucose monohydrate: 5 mg / vial
Sodium chloride: 0.5 mg / vial
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for solution for injection.
White solid in a vial.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Erwinase is used in combination with other antineoplastic agents to
treat acute lymphoblastic leukaemia.
Patients receiving treatment with L-asparaginase from _Escherichia
coli_ and who develop hypersensitivity to that enzyme may be
able to continue treatment with Erwinase as the enzymes are
immunologically distinct.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Erwinase should be prescribed and administered by physicians and/or
health care personnel experienced in the use of
antineoplastic products. It should only be given in a hospital setting
where appropriate resuscitation equipment is available.
Patients should be closely monitored and carefully observed for any
adverse reactions throughout the administration period
(see section 4.4).
Posology
Reference to current recognised acute lymphoblastic leukaemia
protocols should be made for information on dose, route and
frequency of treatment.
Method of administration
Erwinase solution can be given by intravenous infusion or
intramuscular injection.
For IV infusion, it is recommended that the reconstituted Erwinase
solution be further diluted in 100 mL of normal saline and
administered over 1 to 2 hours.
For instructions on reconstitution of the medicinal product before
administration, see section 6.6.
4.3 CONTRAINDICATIONS

History of severe hypersensitivity reaction to crisantaspase or to any
of the excipients listed in section 6.1

Current or past severe p