Gliolan
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
28-04-2023
Produktets egenskaber
(SPC)
28-04-2023
Offentlige vurderingsrapport
(PAR)
24-09-2007
Aktiv bestanddel:
5-aminolevulinic acid hydrochloride
Tilgængelig fra:
Photonamic GmbH & Co. KG
ATC-kode:
L01XD04
INN (International Name):
5-aminolevulinic acid hydrochloride
Terapeutisk gruppe:
Antineoplastic agents
Terapeutisk område:
Glioma
Terapeutiske indikationer:
Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (World Health Organization grade III and IV).
Produkt oversigt:
Revision: 8
Autorisation status:
Authorised
Autorisation dato:
2007-09-07
Indlægsseddel
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIOLAN 30 MG/ML POWDER FOR ORAL SOLUTION
5-aminolevulinic acid hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Gliolan is and what it is used for
2.
What you need to know before you take Gliolan
3.
How to take Gliolan
4.
Possible side effects
5.
How to store Gliolan
6.
Contents of the pack and other information
1.
WHAT GLIOLAN IS AND WHAT IT IS USED FOR
Gliolan is used for the visualisation of certain brain tumours (called
malignant glioma) during tumour
surgery.
Gliolan contains a substance called aminolevulinic acid (5-ALA). 5-ALA
accumulates preferably in
tumour cells where it is transformed into another similar substance.
If the tumour is then exposed to
blue light, this new substance emits a red-violet light which helps to
better see what is normal tissue
and what is tumour tissue. This helps the surgeon to remove the tumour
while sparing healthy tissue.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIOLAN
DO NOT TAKE GLIOLAN
•
if you are allergic to 5-ALA or porphyrins.
•
in case of known or suspected acute or chronic types of porphyria
(i.e. inherited or acquired
disorders of certain enzymes in the synthesis pathway of red blood
pigment).
•
in case of known or suspected pregnancy.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Gliolan.
•
For 24 hours after administration of this medicine,
PROTECT YOUR EYES AND SKIN FROM STRONG
LIGHT
(for example direct sunlight or brightly focused indoor light).
•
If you have a
HEART DISEASE
or had heart disease in the past, you should tell your doctor. In this
case, this medicine shou
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Gliolan 30 mg/ml powder for oral solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA),
corresponding to 1.5 g 5-aminolevulinic
acid hydrochloride (5-ALA HCl).
One ml of reconstituted solution contains 23.4 mg of 5-ALA,
corresponding to 30 mg 5-ALA HCl.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
The powder is a white to off-white cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gliolan is indicated in adults for visualisation of malignant tissue
during surgery for malignant glioma
(WHO grade III and IV).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should only be used by experienced
neurosurgeons conversant with surgery of
malignant gliomas and in-depth knowledge of functional brain anatomy
who have completed a
training course in fluorescence-guided surgery.
Posology
The recommended dose is 20 mg 5-ALA HCl per kilogram body weight.
The total number of bottles needed to achieve the intended dose for
the individual patient can be
determined according to the equation below (rounded up to the nearest
whole bottle):
_ _
_Patient body weight (kg) _
_Number of bottles = _
_——————————————_
_ _
_ _
_75 kg/bottle _
The administration volume needed to achieve the intended dose for the
individual patient can be
calculated according to the equation below:
_ _
_Patient body weight (kg) x 20 mg/kg _
_Administration volume (ml) = _
_———————————————————_
_ _
_ _
_30 mg/ml _
_Renal or hepatic impairment _
No trials have been performed in patients with clinically relevant
hepatic or renal impairment.
Therefore, this medicinal product should be used with caution in such
patients.
_ _
_Elderly_
There are no special instructions for use in elderly patients with
regular organ function.
3
_Paediatric population _
The safety and efficacy of Gliolan in children and adolescents aged 0
to 18 years ha
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