Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - gliolan

Document Subject

Generated Narrative: MedicinalProductDefinition mp28443e1a5133f6583423ca208758fe45

identifier: http://ema.europa.eu/identifier/EU/1/07/413/001-003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Gliolan 30 mg/ml powder for oral solution.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-28443e1a5133f6583423ca208758fe45

identifier: http://ema.europa.eu/identifier/EU/1/07/413/001-003

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - gliolan

Attesters

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

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.

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 should be used with caution because your blood pressure may be decreased.

Renal or hepatic impairment No trials have been performed in patients with poor liver or kidney function. Therefore, this medicine should be used with caution in such patients.

Elderly There are no special instructions for use in elderly patients with normal organ function.

Children and adolescents (< 18 years) There is no experience with Gliolan in children and adolescents. Therefore this medicine is not recommended in this age group.

Other medicines and Gliolan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly medicines that may cause skin problems when the skin comes under strong light (for example some types of medicines called antibiotics), but also medicines obtained without prescription (for example hypericin or Saint John s wort extracts).

One case of severe sunburn lasting for 5 days has been reported in a patient after having taken this medicine and a hypericin extract. You should not take any such products up to 2 weeks after you have taken Gliolan.

Within 24 hours after having taken Gliolan, avoid any other medicines that may harm the liver.

Gliolan with food and drink This medicine is generally used once only, namely 2-4 hours before anaesthesia for surgery for certain brain tumours called glioma. You should not drink or eat for at least 6 hours before anaesthesia.

Pregnancy and breast-feeding Pregnancy It is not known whether Gliolan will harm an unborn baby. Do not use this medicine if you are pregnant.

Breast-feeding It is not known whether this medicine enters breast milk. Breast-feeding mothers should not breast-feed for 24 hours after treatment with this medicine.

Driving and using machines This medicine itself has no influence on the ability to drive and use machines.

This medicine is a powder that must be first mixed with drinking water before use. This is always done by a pharmacist or a nurse and not by yourself. The usual dose is 20 mg 5-ALA HCl per kilogram body weight. The pharmacist or nurse will calculate the exact dose you need and the amount of the solution (in ml) you have to drink. You have to drink the prepared solution 2-4 hours before anaesthesia.

If the surgery is postponed by more than 12 hours, surgery should be re-scheduled for the next day or later. Another dose of this medicine can be taken 2 4 hours before anaesthesia.

If you take more Gliolan than you should If you have taken more Gliolan than you should, your doctor will decide on any necessary measures to avoid any problems, including sufficient protection from strong light (for example direct sunlight).

If you forget to take Gliolan This medicine is given once only at the day of surgery, 2 4 hours before start of anaesthesia. If you have forgotten to take this medicine during this time period, it is not advisable to take it just before start of anaesthesia. In this case, anaesthesia and surgery must be postponed for at least 2 hours, if possible.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most serious side effects include mild alterations of blood cell counts (red and white cells, platelets), disorders that affect the nervous system (neurological disorders) like partial paralysis of one side of the body (hemiparesis) and blood clots that may obstruct blood vessels (thromboembolism). Further frequently observed side effects are being sick (vomiting), feeling sick (nausea) and slight increase of some enzymes (transaminases, -GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.

Tell your doctor immediately if you experience any complaints.

Side effects are divided into the following two categories:

• immediate side effects after having taken Gliolan and before anaesthesia
• combined side effects of Gliolan, anaesthesia, and tumour resection.

After having taken Gliolan and before start of anaesthesia, the following side effects may occur:

Uncommon side effects (may affect up to 1 in 100 people): Feeling sick (nausea), decrease of blood pressure (hypotension), skin reactions (for example rash, looking like sunburn).

In combination with anaesthesia and tumour resection further side effects may occur:
Very common side effects (may affect more than 1 in 10 people): Mild alterations of blood cell counts (red and white cells, platelets), and slight increase of some enzymes (transaminases, -GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood. These changes peak between 7 and 14 days after surgery. The changes will completely resolve within a few weeks. Usually you will not experience any symptoms when these changes occur.

Common side effects (may affect up to 1 in 10 people): Feeling sick (nausea), being sick (vomiting), disorders that affect the nervous system (neurological disorders) like partial paralysis of one side of the body (hemiparesis), total or partial loss of ability to use or understand language (aphasia), seizures (convulsions) and blindness for half the field of vision in one or both eyes (hemianopsia), and blood clots that may obstruct blood vessels (thromboembolism).

Uncommon side effects (may affect up to 1 in 100 people): Decrease of blood pressure (hypotension), brain swelling (brain oedema).

Very rare side effects (may affect up to 1 in 10 000 people) or not known (frequency cannot be estimated from the available data): Decrease of your sense of touch (hypaesthesia), and loose or watery stools (diarrhoea).

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light.

The reconstituted solution is physically-chemically stable for 24 hours at 25 C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Gliolan contains The active substance is 5-aminolevulinic acid hydrochloride (5-ALA HCl). One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-ALA HCl. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.

What Gliolan looks like and contents of the pack This medicine is a powder for oral solution. The powder is a white to off-white cake. The reconstituted solution is a clear and colourless to slightly yellowish fluid.
Gliolan is provided in a glass bottle and presented in packs of 1, 2 and 10 bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder photonamic GmbH & Co. KG Eggerstedter Weg 25421 Pinneberg Germany

Manufacturer Lyocontract GmbH Pulverwiese 1 38871 Ilsenburg Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien, Nederland Pharmanovia Benelux B.V. Burgemeester Gulj laan 2
NL-4837 CZ Breda Nederland/Pays-Bas/Niederlande Tel/T l: + 31 (0)76 5600info.benelux@pharmanovia.com

Italia medac pharma s.r.l. a socio unico Via Viggiano I-00178 Roma Tel: + 39 06 51 59 info@medacpharma.it

, Deutschland, Eesti, , Hrvatska, sland, , Latvija, Lietuva, Luxembourg/Luxemburg, Magyarorsz g, Malta, sterreich, Rom nia, Slovenija/ United Kingdom (Northern Ireland) medac GmbH Theaterstra e 6
D-22880 Wedel /Deutschland/Saksamaa/ / Njema ka/ skaland/V cija/Vokietija/ Allemagne/N metorsz g/Il- ermanja/Germania/ Nem ija/Germany Te ./Tel/S mi/ /T l: + 49 (0)4103 8006-0 gliolan@medac.de

Norge medac Gesellschaft f r klinische Spezialpr parate G.m.b.H, Tyskland, filial Postboks N-1312 Slependen Tlf: +47 90 63 81 Polska medac GmbH Sp. z o.o. Oddzia w Polsce ul Post pu 21 B PL-02-676 Warszawa Tel.: + 48 22 430 00 kontakt@medac.pl

esk republika medac GmbH organiza n slo ka Horn CZ 639 00 Brno Tel: + 420 543 233 info@medac.eu

Portugal medac GmbH sucursal em Portugal Alameda Ant nio S rgio n 22 6 C P-1495-132 Alg s Tel: + 351 21 410 75 83/4 geral@medac.de

Danmark medac Gesellschaft f r klinische Spezialpr parate G.m.b.H, Tyskland, filial Bagerstr de 28, 1. DK-4640 Faxe Tlf: +46 (0)44 7850 Slovensk republika medac GmbH organiza n zlo ka Slovensko Staromestsk 3 SK-811 03 Bratislava Tel: + 420 543 233 info@medac.eu

Espa a Laboratorios Gebro Pharma, S.A. Tel: + 34 93 205 86 Suomi/Finland medac Gesellschaft f r klinische Spezialpr parate G.m.b.H, Tyskland, filial Spektri Business Park Mets nneidonkuja 4 FIN-02130 Espoo Puh/Tel: + 358 (0)10 420 4France medac SAS 1 rue Croix Barret F-69007 Lyon T l: + 33 (0)4 37 66 14 infomed@medac.fr

Sverige medac Gesellschaft f r klinische Spezialpr parate G.m.b.H, Tyskland, filial Hyllie Boulevard S-215 32 Malm
Tel: +46 (0)44 7850 Ireland Fannin Ltd Fannin House South County Business Park Leopardstown IRL - Dublin Tel: + 353 (0)1 290 7medical@dccvital.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: