Litak
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
04-04-2018
Fachinformation
(SPC)
04-04-2018
Öffentlichen Beurteilungsberichts
(PAR)
03-06-2006
Wirkstoff:
Cladribine
Verfügbar ab:
Lipomed GmbH
ATC-Code:
L01BB04
INN (Internationale Bezeichnung):
cladribine
Therapiegruppe:
Antineoplastic agents
Therapiebereich:
Leukemia, Hairy Cell
Anwendungsgebiete:
Litak is indicated for the treatment of hairy-cell leukaemia.
Produktbesonderheiten:
Revision: 7
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2004-04-14
Gebrauchsinformation
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
LITAK 2 MG/ML SOLUTION FOR INJECTION
cladribine
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 or pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What LITAK is and what it is used for
2.
What you need to know before you use LITAK
3.
How to use LITAK
4.
Possible side effects
5.
How to store LITAK
6.
Contents of the pack and other information
1.
WHAT LITAK IS AND WHAT IT IS USED FOR
LITAK contains the active substance cladribine. Cladribine is a
cytostatic agent. It affects the growth
of malignant (cancerous) white blood cells which play a role in hairy
cell leukaemia. LITAK is used to
treat this disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LITAK
DO NOT USE LITAK
-
if you are allergic to cladribine or any of the other ingredients of
LITAK (listed in section 6)
-
if you are pregnant or breast-feeding
-
if you are less than 18 years of age
-
if you have moderate to severe kidney or liver impairment
-
if you are using other medicines which affect the production of blood
cells in the bone marrow
(myelosuppression).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using LITAK.
At any time during or after your treatment,
TELL YOUR DOCTOR OR NURSE IMMEDIATELY
if you:
experience blurred, loss of or double vision, difficulty speaking,
weakness in an arm or a leg, a change
in the way you walk or problems with your balance, persistent
numbness, decreased sensation or loss
of sensation, memory loss or confusion. These may all be symptoms of a
SERIOUS AND POTENTIALLY
FATAL BRAIN CONDITION
known as progressive multifocal leukoencephalopathy
(PML)
.
If you had these symptoms prior to treatment with cladribine,
TELL YOUR DOCTOR
a
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
LITAK 2 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 2 mg of cladribine (2-CdA). Each vial
contains 10 mg of cladribine in
5 ml of solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LITAK is indicated for the treatment of hairy cell leukaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy with LITAK should be initiated by a qualified physician with
experience in cancer
chemotherapy.
Posology
The recommended posology for hairy cell leukaemia is a single course
of LITAK given by
subcutaneous bolus injection at a daily dose of 0.14 mg/kg body weight
for 5 consecutive days.
Deviations from the posology indicated above are not advised.
_Elderly _
Experience with patients older than 65 years is limited. Elderly
patients should be treated by individual
assessment and careful monitoring of the blood counts and of the renal
and hepatic function. The risk
requires assessment on a case-by-case basis (see section 4.4).
_Renal and hepatic impairment _
There are no data on the use of LITAK in patients with renal or
hepatic impairment. LITAK is
contraindicated in patients with moderate to severe renal impairment
(creatinine clearance
≤ 50 ml/min) or with moderate to severe hepatic impairment
(Child-Pugh score > 6) (see sections 4.3,
4.4 and 5.2).
_Paediatric population _
LITAK is contraindicated in patients less than 18 years of age (see
section 4.3).
Method of administration
LITAK is supplied as a ready-to-use solution for injection. The
recommended dose is directly
withdrawn by a syringe and injected as a subcutaneous bolus injection
without dilution. LITAK should
be inspected visually for particulate matter and discoloration prior
to administration. LITAK should
warm up to room temperature prior to administration.
3
_Self-administration by the patient
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