qanastek/EMEA-V3 huggingface dataset:
The dosing schedule can be more flexible, please speak to your doctor for more information.
Jekk jogħġbok tkellem mat- tabib tiegħek għal aktar informazzjoni.
The person to be vaccinated should complete the three-dose vaccination course; otherwise the person to be vaccinated may not be fully protected.
Il- persuna li tkun ser titlaqqam għandha ttemm kors ta ’ tilqim ta ’ tliet dożi; inkella, il- persuna li tkun ser titlaqqam tista ’ ma tkunx protetta b' mod komplet.
Gardasil will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Gardasil ser jingħata bħala injezzjoni minn ġol- ġilda fil- muskolu (preferibbilment il- muskolu tan- naħa ta ’ fuq tad- driegħ jew fil- koxxa).
The vaccine should not be mixed in the same syringe with any other vaccines and solutions.
Il- vaċċin m’ għandux jitħallat fl- istess siringa ma ’ vaċċini u soluzzjonijiet oħrajn.
If you forget to take Gardasil:
Jekk tinsa tieħu Gardasil:
If you miss a scheduled injection, your doctor will decide when to give the missed dose.
Jekk ma tieħux injezzjoni skedata, it- tabib tiegħek se jiddeċiedi meta tieħu d- doża li tkun qbiżt.
It is important that you follow the instructions of your doctor or nurse regarding return visits for the follow-up doses.
Huwa importanti li ssegwi l- istruzzjonijiet tat- tabib jew tan- ners tiegħek dwar iż- żjarat li jsiru wara għad- dożi tal- follow- up.
If you forget or are not able to go back to your doctor at the scheduled time, ask your doctor for advice.
Jekk tinsa jew jekk ma tkunx tista 'tmur lura għand it- tabib tiegħek fiż- żmien skedat, staqsi lit- tabib tiegħek għal parir.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta 'dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all vaccines and medicines, Gardasil can cause side effects, although not everybody gets them.
Bħal mediċini u l- vaċċini l- oħrajn kollha, Gardasil jista ’ jikkawża effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects can be seen after the use of Gardasil:
L- effetti sekondarji li ġejjin jistgħu jidhru wara l- użu ta ’ Gardasil:
Very commonly (more than 1 in 10 patients), side effects found at the injection site include: pain, swelling and redness.
(iktar minn pazjent wieħed minn kull 10 pazjenti), effetti sekondarji li nstabu fis- sit ta ’ l- injezzjoni jinkludu: uġigħ, nefħa, u ħmura.
Fever was also seen.
Id- deni kien osservat ukoll.
Commonly (more than 1 in 100 patients), side effects found at the injection site include: bruising, itching.
(iktar minn pazjent wieħed minn kull 100 pazjent), effetti sekondarji li nstabu fis- sit ta ’ l - injezzjoni jinkludu: tbenġil, ħakk.
Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.
Rari ħafna (inqas minn pazjent wieħed minn kull 10, 000 pazjent) diffikultà biex tieħu n- nifs (bronkospażmu) kienet irrappurtata.
Rarely (less than 1 in 1000 patients), hives (urticaria).
Rari (inqas minn pazjent wieħed minn kull 1000 pazjent), urtikarja.
Side effects that have been reported during marketed use include:
Effetti sekondarji li ġew irrapportati matul l- użu waqt li l- prodott ikun fis- suq jinkludu:
Fainting, sometimes accompanied by shaking or stiffening, has been reported.
Ġie rrapportat ħass ħażin xi kultant akkompanjat b’ rogħda jew b’ ebusija.
Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Għalkemm episodji ta ’ ħassħażin m’ humiex komuni, il- pazjenti għandhom jiġu osservati għal 15- il minuta wara li huma jirċievu tilqima tal- HPV.
Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives and rash have been reported.
Ġew irrapportati reazzjonijiet allerġiċi li jistgħu jinkludu diffikultà fit- teħid tan- nifs, tħarħir (spażmi fil- bronki), urtikarja u raxx.
Some of these reactions have been severe.
Uħud minn dawn ir- reazzjonijiet kienu severi.
As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin), Guillain-Barré Syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body), dizziness and headache, nausea and vomiting, joint pain, aching muscles, unusual tiredness or weakness, and generally feeling unwell.
51 Bħal b’ vaċċini oħra, l- effetti sekondarji li ġew irrapportati matul l- użu ġenerali jinkludu: glandoli minfuħin (għonq, l- abt, jew l- irqiq tal- koxxa), is- sindromu ta ’ Guillain- Barré (dgħjufija tal- muskolu, sensazzjonijiet anormali, tagħrix fl- idejn, saqajn u fil- parti ta ’ fuq tal- ġisem), stordamenti u uġigħ ta ’ ras, tqalligħ, uġigħ fil- ġogi, uġigħ fil- muskoli, għeja mhux tas- soltu jew dgħufija u ġeneralment tħossok ma tiflaħx.
51 If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE GARDASIL
KIF TAĦŻEN GARDASIL
Keep this vaccine out of the reach and sight of children.
Żomm dan il- vaċċin fejn ma jintlaħaqx u ma jidhirx mit- tfal.
The vaccine should not be used after the expiry date which is stated on the vial label and the outer carton (after EXP).
Il- vaċċin m’ għandux jintuża wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kunjett u fuq il - kartuna ta ’ barra (wara JIS).
The expiry date refers to the last day of that month.
Id- data ta 'meta jiskadi tirreferi għall- aħħar jum ta' dak ix- xahar.
Store in a refrigerator (2ºC - 8ºC).
Aħżen fil- friġġ f’ temperatura ta ’ (2ºC - 8ºC).
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m' għandhomx jintremew fis- sink jew ma 'l- iskart tad- dar.
These measures will help to protect the environment.
Dawn il- miżuri ser jgħinu biex jiġi protett l- ambjent.
If you have any further questions on Gardasil after reading this leaflet, please ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet dwar Gardasil wara li taqra dan il- fuljett, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Gardasil contains
X’ fih Gardasil
The active substances are: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16, and 18).
Proteina mhux infettiva ippurifikata b' mod qawwi għal kull wieħed mit- tipi ta 'Papillomavirus Uman (6, 11, 16, u 18).
20 micrograms 40 micrograms 40 micrograms 20 micrograms
Papillomavirus Uman1 Proteina tip 6 L12, 3 20 mikrogramma Papillomavirus Uman1 Proteina tip 11 L12, 3 40 mikrogramma Papillomavirus Uman1 Proteina tip 16 L12, 3 40 mikrogramma Papillomavirus Uman1 Proteina tip 18 L12, 3 20 mikrogramma 1 Papillomavirus Uman = HPV.
CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
2 L1 proteina fis- sura ta 'partikuli qishom virus prodotti fiċ- ċelluli tal- moffa (Saccharomyces cerevisiae CANADE 3C- 5 (Speċi 1895)) minn teknoloġija DNA rikombinanti.
The other ingredients in the vaccine suspension are:
Is- sustanzi l- oħrajn fis- sospensjoni tal- vaċċin huma:
Sodium chloride, L-histidine, polysorbate 80, sodium borate and water for injections.
Sodium chloride, L- histidine, polysorbate 80, sodium borate, u ilma għall- injezzjoni.
What Gardasil looks like and contents of the pack
Id- dehra ta 'Gardasil u d- daqs tal- pakkett
1 dose of Gardasil suspension for injection contains 0.5 ml.
Doża waħda ta 'Gardasil sospensjoni għall- injezzjoni fiha 0. 5 ml.
Gardasil is available in packs of 1, 10 or 20 vials.
52 Gardasil hu disponibbli f' pakketti ta '1, 10 jew 20 kunjett.
Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Nederland Sanofi Pasteur MSD, Tel: +31.23.567.96.00
Nederland Danmark Sanofi Pasteur MSD, Sanofi Pasteur MSD Tel: +31. 23. 567. 9600 Tlf: +45. 23 32 69 29
This leaflet was last approved in: ------------------------------------------------------------------------------------------------------------------------ The following information is intended for medical or healthcare professionals only:
------------------------------------------------------------------------------------------------------------------------ It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
53 Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Prodotti mediċinali parenterali għandhom ikunu eżaminati viżwalment għal materjal f’ sura ta ’ partikuli jew tibdil fil- kulur qabel ma jingħataw.
54 B1 PACKAGE LEAFLET (PREFILLED SYRINGE WITH SAFETY DEVICE)
54 B1 FULJETT TA ’ TAGĦRIF (SIRINGA MIMLIJA GĦAL- LEST B’ APPARAT TAS- SIGURTA)
55 PACKAGE LEAFLET:
55 FULJETT TA ’ TAGĦRIF:
Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Gardasil, sospensjoni għall- injezzjoni f’ siringa mimlija lesta Vaċċin għall- Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit)
56  suffers from an illness with high fever.
56 • issofri minn mard b’ deni qawwi.
Gardasil may not have an optimal effect if:
Gardasil jista ’ ma jkollux l- aħjar effett jekk:
 used with medicines that suppress the immune system.
• jintuża ma ’ mediċini li jrażżnu s- sistema immuni.
57 Gardasil is given as an injection by your doctor.
Gardasil jingħata bħala injezzjoni mit- tabib tiegħek.
As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin), Guillain-Barré Syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body), dizziness and headache, nausea and vomiting, joint pain, aching muscles, unusual tiredness or weakness, and generally feeling unwell.
58 Bħal b’ vaċċini oħra, l- effetti sekondarji li ġew irrapportati matul l- użu ġenerali jinkludu: glandoli minfuħin (għonq, l- abt, jew l- irqiq tal- koxxa), is- sindromu ta ’ Guillain- Barré (dgħjufija tal- muskolu, sensazzjonijiet anormali, tagħrix fl- idejn, saqajn u fil- parti ta ’ fuq tal- ġisem) sturdament u uġigħ ta ’ ras, tqalligħ u remettar, uġigħ fil- ġogi, uġigħ fil- muskoli, għeja mhux tas- soltu jew dgħufija, ġeneralment tħossok ma tiflaħx.
58 If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
The vaccine should not be used after the expiry date which is stated on the syringe label and the outer carton (after EXP).
Il- vaċċin m’ għandux jintuża wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kunjett u fuq il - kartuna ta ’ barra (wara JIS).
These measures will help to protect the environment.
Dawn il- miżuri ser għinu biex jiġi protett l- ambjent.
Gardasil is available in packs of 1, 10, or 20 pre-filled syringes with a needle guard (safety) device.
59 Gardasil hu disponibbli f' pakketti ta '1, 10, jew 20 siringi mimlijin lesti b’ apparat tal- protezzjoni tal - labra (sigurtà).
 Gardasil is available in a pre-filled syringe, with needle guard (safety device) ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.  If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’s size and weight.  Parenteral drug products should be inspected visually for particulate matter and discolouration 60 prior to administration.
• Gardasil jiġi f’ siringa mimlija għal- lest bi protezzjoni tal- labra (apparat ta ’ sigurtà) biex tintuża għal injezzjoni ġol- muskoli (IM), preferibbilment fiż- żona tad- deltojd tan- naħa ta ’ fuq tad - driegħ. • Jekk fil- pakkett ikun hemm 2 labriet ta ’ tulijiet differenti, agħżel il- labra adattata sabiex tiżgura amministrazzjoni IM skond id- daqs u l- piż tal- pazjent tiegħek. • Il- prodotti ta ’ mediċini parenterali għandhom jiġu eżaminati viżwalment għal frak u tidnis tal - kulur qabel ma jingħataw.
Discard the product if particulates are present or if it appears discoloured.
Armi l- prodott jekk ikun hemm preżenti frak jew jidher imdennes.
The needle guard (safety) device consists of a plastic cylinder (needle guard) that, before the dose is given, covers the syringe barrel.
L- apparat ta ’ protezzjoni (sigurtà) tal- labrahuwa magħmul minn ċilindru tal- plastik (protezzjoni tal - labra) li, qabel ma tingħata d- doża, jgħatti l- bettija tas- siringa.
Prior to completion of the injection, avoid contact with the activation clips (as indicated by asterisks * in the first illustration) on the device to keep from prematurely covering the needle with the needle guard.
Qabel ma tkun lesta l- injezzjoni, evita kuntatt mal- klips ta ’ l- attivazzjoni (kif indikat bl - asterisks * fl- ewwel stampa) fuq l- apparat biex tevita li l- labra tiġi mgħottija kmieni wisq bl- apparat ta ’ protezzjoni tal- labra.
Remove the syringe tip cap and the needle cap.
Neħħi l- għatu tal- ponta tas- siringa u l- għatu tal - labra.
Screw the needle onto the syringe barrel in a clockwise direction while pressing in the 2 plastic beads to lock the needle securely onto the syringe.
Invita l- labra mal- bettija tas- siringa fid - direzzjoni tal- ħin waqt li tagħfas fuq iż- żewġ żibġiet tal- plastik biex tillokkja l- labra sewwa għal fuq is- siringa.
Release the plunger slowly.
61 Itlaq il- planġer bil- mod.
61 To remove the detachable labels, rotate the plunger until the coloured tab becomes visible.
Biex tneħħi t- tikketti li jinqalgħu, dawwar il- planġer sakemm it- tab bil- kulur jiġi jidher.
62 B2 PACKAGE LEAFLET (PREFILLED SYRINGE WITHOUT SAFETY DEVICE)
62 B2 FULJETT TA ’ TAGĦRIF (SIRINGA MIMLIJA GĦAL- LEST MINGĦAJR APPARAT TA ’ SIGURTÀ)
BEFORE YOU USE GARDASIL
QABEL MA TUŻA GARDASIL 2.
64  suffers from an illness with high fever.
64 • issofri minn mard b’ deni qawwi.
You should tell your doctor if the person to be vaccinated:
Għandek tgħid lit- tabib tiegħek jekk il- persuna li ser titlaqqam:
 has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia  has a weakened immune system, for example due to a genetic defect or HIV infection
• għandha mard ta 'ħruġ ta' demm (marda li ġġiegħelek titlef aktar demm mis- soltu), pereżempju l- emofilja • għandha sistema immuni batuta, pereżempju minħabba difett ġenetiku jew infezzjoni bl- HIV.
65 Gardasil is given as an injection by your doctor.
Gardasil jingħata bħala injezzjoni mit- tabib tiegħek.
As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin), Guillain-Barré Syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body), dizziness and headache, nausea and vomiting, joint pain, aching muscles, unusual tiredness or weakness, and generally feeling unwell.
66 Bħal b’ vaċċini oħra, l- effetti sekondarji li ġew irrapportati matul l- użu ġenerali jinkludu: glandoli minfuħin (għonq, l- abt, jew l- irqiq tal- koxxa), is- sindromu ta ’ Guillain- Barré (dgħjufija tal- muskolu, sensazzjonijiet anormali, tagħrix fl- idejn, saqajn u fil- parti ta ’ fuq tal- ġisem) u sturdament u uġigħ ta ’ ras, tqalligħ u remettar, uġigħ fl- għadam u uġigħ fil- muskoli, għeja mhux tas- soltu jew dgħufija, u ġeneralment tħossok ma tiflaħx.
66 If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Gardasil is available in packs of 1, 10 or 20 pre-filled syringes.
67 Gardasil jiġi f' pakketti ta '1, 10 jew 20 siringa waħda mimlija għal- lest.
 Gardasil is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.  If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’s size and weight.  Parenteral drug products should be inspected visually for particulate matter and discolouration 68 prior to administration.
• Gardasil jiġi f’ siringa mimlija għal- lest biex tintuża għal injezzjoni ġol- muskoli (IM), preferibbilment fiż- żona tad- deltojd tan- naħa ta ’ fuq tad- driegħ. • Jekk fil- pakkett ikun hemm 2 labriet ta ’ tulijiet differenti, agħżel il- labra adattata sabiex tiżgura amministrazzjoni IM skond id- daqs u l- piż tal- pazjent tiegħek. • Il- prodotti ta ’ mediċini parenterali għandhom jiġu eżaminati viżwalment għal frak u tidnis tal - kulur qabel ma jingħataw.
Shake well before use.
Ħawwad sew qabel l- użu.
Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Waħħal il- labra billi ddawwar f’ direzzjoni favur l- arloġġ sakemm il- labra teħel sewwa mas- siringa.
Administer the entire dose as per standard protocol.
Agħti d- doża kollha skond il- protokoll standard.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri jridu jiżguraw li l- kundizzjonijiet jew restrizzjonijiet kollha fir- rigward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali deskritti hawn taħt huma implimentati:
Gliolan should be used only by neurosurgeons who have attended a training course in accordance with the standards detailed below:
Gliolan għandu jintuża biss minn newrokirurgi li jkunu attendew għal kors ta ’ taħriġ skond l- istandards deskritti fid- dettall hawn taħt:
The Member States shall agree with the Marketing Authorisation Holder, prior to launch, measures for the implementation of the following:
L- Istati Membri għandhom jaqblu mad- Detentur ta ’ l- Awtorizzazzjoni Għat- Tqegħid fis- Suq, qabel it - tnedija, fuq miżuri għall- implimentazzjoni ta ’ dawn li ġejjin: − Kors ta ’ taħriġ għal newrokirurgi li huwa mmirat għall- minimizzazzjoni tar- riskji u biex jiġi appoġġjat l- użu sikur u effettiv għall- prodott.
The training course will take place at qualified training centres using qualified trainers.
Il- kors ta ’ taħriġ se jseħħ f’ ċentri ta ’ taħriġ awtorizzati li jużaw ħarrieġa kwalifikati.
This course shall consist of measures aiming to minimise adverse events associated with the Gliolan-fluorescence-guided surgery (in particular neurological serious adverse events) through adequate education about:
Dan il- kors għandu jkun magħmul minn miżuri li jimmiraw li jnaqqsu l- avvenimenti avversi assoċjati mal- kirurġija ggwidata bil- fluworexxenza ta ’ Gliolan (b’ mod partikolari avvenimenti avversi newroloġiċi serji) permezz ta ’ edukazzjoni adegwata dwar:
Minimum requirements for a qualified trainer are:
Rekwiżiti minimi għal ħarrieġ kwalifikat huma:
- Board-certification as neurosurgeon according to local, national requirements;
- Ċertifikazzjoni mill- bord bħala newrokirurgu skond ir- rekwiżiti lokali, nazzjonali;
- Previous successful participation at a training course, or equivalent course during the phase
- Parteċipazzjoni preċedenti b’ suċċess f’ kors ta ’ taħriġ, jew kors ekwivalenti matul il- prova ta ’
III trial;
fażi III;
- Experience with Gliolan-fluorescence-guided surgery in at least 20 cases.
- Esperjenza b’ kirurġija ggwidata bil- fluworexxenza ta ’ Gliolan f’ għallinqas 20 każ.
Minimum requirements for a qualified training centre are:
Rekwiżiti minimi għal ċentru ta ’ taħriġ awtorizzat huma:
- Microscope modified for fluorescence-guided resection;
- Mikroskopju modifikat għal risezzjoni ggwidata bil- fluworexxenza;
What is Gliolan?
X’ inhu Gliolan?
Gliolan is a powder to be made up into a solution to be taken by mouth.
Gliolan huwa trab magħmul f’ soluzzjoni sabiex tittieħed mill- ħalq.
It contains the active substance 5-aminolevulinic acid hydrochloride (30 mg/ ml).
Fih is- sustanza attiva 5- aminolevulinic acid hydrochloride (30 mg/ ml).
What is Gliolan used for?
Għal x’ hiex jintuża Gliolan?
Gliolan is used in adult patients with malignant glioma (a type of brain tumour).
Gliolan jintuża f’ pazjenti adulti bi glijoma (tip ta ’ tumur tal- moħħ) malinna.
Gliolan helps surgeons to see the tumour more clearly during an operation to remove it from the brain.
Gliolan jgħin lill- kirurgi jaraw it- tumur b’ mod aktar ċar matul operazzjoni biex ineħħuħ mill- moħħ.
Because the number of patients with malignant glioma is low, the disease is considered ‘ rare’, and Gliolan was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 13 November 2002.
Minħabba li n- numru ta ’ pazjenti bi glijoma malinna huwa wieħed baxx, il- marda hija meqjusa ‘ rari ’, u Gliolan ġie kklassifikat bħala ‘ mediċina orfni ’ (mediċina wżata f’ mard rari) fit- 13 ta ’ Novembru 2002.
How is Gliolan used?
Kif jintuża Gliolan?
Gliolan should only be used by experienced brain surgeons who are familiar with surgery of malignant glioma, who have an in-depth knowledge of the anatomy of the brain, and who have completed a training course in surgery guided by fluorescence.
Gliolan għandu jintuża biss minn kirurgi tal- moħħ b’ esperjenza li huma familjari wkoll mal- kirurġija ta ’ glijoma malinna, li għandhom għarfien tajjeb ħafna ta ’ l- anatomija tal- moħħ, u li temmew kors ta ’ studju f’ kirurġija ggwidata bil- fluworexxenza.
The recommended dose of Gliolan is 20 mg per kilogram body weight, taken two to four hours before the patient is anaesthetised.
Id- doża rakkomandata ta ’ Gliolan hija 20 mg għal kull kilogramm tal- piż tal- ġisem, meħuda bejn sagħtejn jew erba ’ sigħat qabel ma ’ l- pazjent jingħata anesteżija.
Gliolan powder should be dissolved in 50 ml tap water by a nurse or pharmacist before the patient drinks the solution.
It- trab ta ’ Gliolan għandu jiddewweb f’ 50 ml ilma tal- vit mill- infermiera jew spiżjar qabel ma ’ l- pazjent jixrob is- soluzzjoni.
Gliolan should be used with caution in patients who have problems with their liver or kidneys.
Gliolan għandu jintuża b’ attenzjoni f’ pazjenti li għandhom problemi fil- fwied jew fil- kliewi tagħhom.
How does Gliolan work?
Kif jaħdem Gliolan?
The active substance in Gliolan, 5-aminolevulinic acid, is a ‘ sensitiser used in photodynamic therapy’.
Is- sustanza attiva fi Gliolan, 5- aminolevulinic acid, hija ‘ sensitizzatur użat f’ terapija fotodinamika ’.
It is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX).
Hija assorbita miċ- ċelloli fil- ġisem, fejn din tiġi maqluba minn enzimi f’ sostanzi kimiċi fluworexxenti, b’ mod partikolari protoporphyrin IX (PPIX).
Since glioma cells take up more of the active substance and convert it more rapidly into PPIX, higher levels of PPIX accumulate in the cancer cells than in normal tissue.
Minħabba li ċ- ċelloli tal- glijoma jassorbu aktar mis - sustanza attiva u jaqilbuha aktar malajr f’ PPIX, fiċ- ċelloli tal- kanċer jakkumulaw livelli ogħla ta ’ PPIX milli fit- tessut normali.
When illuminated under blue light of a specific wavelength, the PPIX in the tumour glows an intense red, while the normal brain tissue appears blue.
Meta illuminat taħt dawl blu ta ’ wavelength speċifiku, il- PPIX fit- tumur jiddi b’ kulur aħmar qawwi, filwaqt li t- tessut tal- moħħ normali jidher blu.
This enables the surgeon to see the tumour more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue.
Dan jippermetti lill- kirurgu jara t- tumur b’ mod aktar ċar matul kirurġija tal- moħħ u li jneħħiħ b’ mod aktar preċiż, b’ hekk it- tessut tal- moħħ b’ saħħtu ma jintmessx kemm jista ’ jkun.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Gliolan been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Gliolan?
The effects of Gliolan were first tested in experimental models before being studied in humans.
Għall- ewwel, l- effetti ta ’ Gliolan ġew ittestjati f’ mudelli esperimentali qabel ma ġew studjati fuq il - bniedem.
However, because 5-aminolevulinic acid is a naturally occurring substance which is already used in some other conditions, the company also presented data from the published literature.
Madankollu, minħabba li 5- aminolevulinic acid huwa sustanza naturali li diġà tintuża f’ xi kundizzjonijiet oħra il- kumpanija ippreżentat ukoll informazzjoni mil- letteratura ippubblikata.
Gliolan has been studied in one main study involving 415 patients with malignant glioma who were about to undergo brain surgery to remove the tumour.
Gliolan ġie studjat fi studju wieħed ewlieni li involva 415- il pazjent bi glijoma malinna li kienu ser jagħmlu operazzjoni fuq il- moħħ biex jitneħħielhom it- tumur.
The outcome of the operation was compared between patients taking Gliolan (operated under blue light) and that of patients who did not take any medicines to improve the visibility of the tumour (operated under normal white light).
Ir- riżultat ta ’ l- operazzjoni ġie mqabbel bejn pazjenti li kienu qed jieħdu Gliolan (operati taħt dawl blu) u dawk il- pazjenti li ma ħadu l- ebda mediċina biex tittejjeb il- visibilità tat- tumur (operati taħt dawl abjad normali).
The main measures of effectiveness were the proportion of patients who had no visible tumour on a brain scan taken 72 hours after the operation, and the proportion who survived six months without the brain tumour coming back or getting bigger (‘ progressing’).
Il- miżuri prinċipali ta ’ l- effikaċja kienu l- proporzjon ta ’ pazjenti li ma kellhom l- ebda tumur viżibbli meta ġew skenjati 72 siegħa wara l- operazzjoni, u l- proporzjon li salvaw għal 6 xhur mingħajr ma reġa ’ feġġ it- tumur fil - moħħ jew mingħajr ma dan kiber (iprogressa).
The brain scans were analysed by an expert who did not know whether the patients had received Gliolan or not.
L- iskens tal- moħħ ġew analizzati minn espert li ma kienx jaf jekk il- pazjent ingħatax Gliolan jew le.
What benefit has Gliolan shown during the studies?
X' benefiċċji ta 'Gliolan intwerew f' dawn l- istudji?
Removal of the brain tumour during surgery was more complete when Gliolan was used.
It- tneħħija tat- tumur tal- moħħ waqt il- kirurġija kienet iktar kompleta meta ntuża Gliolan.
At 72 hours after the operation, 63.6% of the patients given Gliolan had no visible tumour on a brain scan, compared with 37.6% of those who did not receive Gliolan.
72 siegħa wara l- operazzjoni, 63. 6% tal- pazjenti li ngħataw Gliolan ma kellhomx tumur viżibbli fuq l- immaġini skennjata tal- moħħ meta mqabbla ma ’ 37. 6% ta ’ dawk li ma rċevewx Gliolan.
After six months, 20.5% of the patients given Gliolan were still alive without progression, compared with 11.0% of those who did not receive the medicine.
Wara 6 xhur, 20. 5% tal- pazjenti li ngħataw Gliolan kienu għadhom ħajjin mingħajr progress, meta mqabbla ma ’ 11. 0% ta ’ dawk li ma rċevewx il- mediċina.
What is the risk associated with Gliolan?
X’ inhuma r- riskji assoċjati ma ’ Gliolan?
The most common side effects seen with Gliolan are due to a combination of the medicine itself, as well as anaesthesia and the removal of the tumour.
L- iktar effetti sekondarji komuni li jidhru bi Gliolan huma dovuti għall- kombinazzjoni tal- mediċina infisha, għall- anasteżija u għat- tneħħija tat- tumur.
The side effects seen most commonly (in more than 1 patient in 10) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leukocytosis (high levels of leukocytes, a type of white blood cell) and increased levels of liver enzymes in the blood (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and amylase).
L- effetti negattivi li huma l- iktar komuni (f’ iktar minn pazjent 1 kull 10) huma l- anemija (livell baxx ta ’ ċelloli ħomor), tromboċitopenja (livell baxx ta ’ pjastrini), lukoċitożi (livell għoli ta ’ lukoċiti, tip ta ’ ċelloli bojod) u livelli għoljin ta ’ enzimi tal- fwied fid- demm (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase u amylase).
For the full list of all side effects reported with Gliolan, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti mhux mixtieqa li ġew rapportati bi Gliolan, ara l- Fuljett ta ’ Tagħrif.
Gliolan should not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid hydrochloride or porphyrins.
Gliolan m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal 5- aminolevulinic acid jew għal hydrochloride jew porphyrins.
It should also not be used by patients who have porphyria (an inability to break down porphyrins) or during pregnancy.
M’ għandux jintuża wkoll minn pazjenti li għandhom porphyria (ma jistgħux ikissru l- porphyrins) jew waqt it- tqala.
Why has Gliolan been approved?
Għaliex ġie approvat Gliolan?
The Committee for Medicinal Products for Human Use (CHMP) noted that surgical treatment for malignant glioma should aim to remove as much of the tumour as possible while sparing healthy brain tissue.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) innota li trattament kiruġiku għall- glijomi malinni għandu jimmira li jneħħi kemm jista ’ jkun possibbli mit- tumur waqt li jevita tneħħija ta ’ tessut tajjeb tal- moħħ.
It concluded that Gliolan increases the ability of the tumour to be distinguished from healthy brain tissue during surgery, and that it increases the proportion of patients whose tumours are completely removed and extends the time that patients survive without progression.
Il- kumitat ikkonkluda li Gliolan iżid l- abbiltà li ssir distinzjoni bejn it- tumur u t- tessut it- tajjeb tal- moħħ waqt il- kirurġija, u li jżid il- proporzjon ta ’ pazjenti li jkollhom tneħħija kompleta tat- tumur u jtawwal iż- żmien ta ’ għajxien tal- pazjenti mingħajr progressjoni.
The Committee decided that Gliolan’ s benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma.
Il- kumitat iddeċieda li l- benefiċċji ta ’ Gliolan jisbqu r- riskji tiegħu għall- viżwalizzazzjoni ta ’ tessut malinn waqt il- kirurġija ta ’ glijoma malinna.
It recommended that Gliolan be given marketing authorisation.
Huwa rakkomanda li Gliolan jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Gliolan?
Liema miżuri qegħdin jittieħdu biex jiġi żgurat l- użu sikur ta ’ Gliolan?
Before the medicine is launched, the company that makes Gliolan will set up training courses in all Member States for brain surgeons to inform them about how to use the medicine safely and effectively during surgery.
Qabel ma tniedi l- mediċina, il- kumpanija li tagħmel Gliolan sejra tistabbilixxi korsijiet ta ’ taħriġ fl - Istati Membri kollha għall- kirurgi tal- moħħ sabiex tinformahom dwar kif jużaw il- mediċina b’ mod sikur u effettiv matul il- kirurġija.
Other information about Gliolan:
Informazzjoni oħra dwar Gliolan:
The European Commission granted a marketing authorisation valid throughout the European Union for Gliolan to m e d a c Gesellschaft für klinische Spezialpräparate mbH on 7 September 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Gliolan lil m e d a c Gesellschaft für klinische Spezialpräparate mbH fis- 7 ta ’ Settembru 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Gliolan is available here.
Is- sommarju ta ’ l- opinjoni tal- Kumitat għal Prodotti Mediċinali Orfni għal Gliolan huwa disponibbli minn hawnhekk.
The full EPAR for Gliolan can be found here.
L- EPAR sħiħ għal Gliolan huwa disponibbli minn hawnhekk.
This summary was last updated in 07-2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ 07- 2007.
Package size
Użu orali
Powder for oral solution Powder for oral solution Powder for oral solution
Trab għal soluzzjoni orali
Oral use Oral use Oral use
Trab għal soluzzjoni orali
Vial (glass) Vial (glass) Vial (glass)
Kunjett (ħġieġ)
1 vial 2 vials 10 vials
10 kunjetti
Gliolan 30 mg/ ml powder for oral solution.
Gliolan 30 mg/ ml trab għal soluzzjoni orali.
One vial contains 1.17 g of 5-aminolevulinic acid, corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Kunjett wieħed fih 1. 17 g ta ’ 5- aminolevulinic acid, li jikkorrispondi għal 1. 5 g ta ’ 5- aminolevulinic acid hydrochloride (5- ALA HCl).
One ml of reconstituted solution contains 23.4 mg of 5-aminolevulinic acid, corresponding to 30 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).
1 ml ta ’ soluzzjoni rikostitwita fih 23. 4 mg ta ’ 5- aminolevulinic acid, li jikkorrispondu għal 30 mg ta ’ 5- aminolevulinic acid hydrochloride (5- ALA HCl).
Powder for oral solution.
Trab għal soluzzjoni orali.
The powder is a white to off-white cake.
It- trab huwa kejk abjad għal offwajt.
Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).
Gliolan huwa indikat f’ pazjenti adulti għall- wiri ta ’ tessut malinn waqt operazzjoni għal glijoma malinna (WHO grad III u IV).
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.
Dan il- prodott mediċinali għandu jintuża biss minn newrokirurgi ta ’ esperjenza familjari mal- kirurġija ta ’ glijomi malinni u għarfien profond ta ’ l- anatomija funzjonali tal- moħħ li jkunu temmew b’ suċċess kors fil- kirurġija iggwidata bil- fluworexxenza.
The recommended dosage is 20 mg 5-aminolevulinic acid hydrochloride per kilogram body weight.
Id- doża rakkomandata hija 20 mg ta ’ 5- aminolevulinic acid hydrochloride għal kull kilogramm ta ’ piż tal- ġisem.
The solution should be administered orally three hours (range 2-4 hours) before induction of anaesthesia.
Is- soluzzjoni għandha tingħata b’ mod orali tliet sigħat (medda 2- 4 sigħat) qabel l- induzzjoni ta ’ l- anestesija.
Use of 5-ALA under conditions other than the ones used in the clinical trials entail an undetermined risk.
L- użu ta ’ 5- ALA taħt kundizzjonijiet differenti minn dawk użati fil- provi kliniċi jinvolvi riskju mhux determinat.
Patients with renal or hepatic impairment No studies have been performed in patients with clinically relevant hepatic or renal impairment.
Pazjenti b’ indeboliment tal- kliewi jew tal- fwied Ma sarux studji fuq pazjenti b’ indeboliment klinikament rilevanti tal- fwied jew tal- kliewi.
Therefore, this medicinal product should be used with caution in such patients.
Għalhekk, dan il- prodott mediċinali għandu jintuża b’ kawtela f’ tali pazjenti.
Paediatric population There is no experience in children.
Popolazzjoni pedjatrika M’ hemm l- ebda esperjenza fuq it- tfal.
Elderly patients There are no special instructions for use in elderly patients with regular organ function.
Pazjenti anzjani M’ hemm l- ebda struzzjonijiet speċjali għall- użu f’ pazjenti anzjani b’ funzjoni ta ’ l- organi regolari.
• Hypersensitivity to 5-aminolevulinic acid hydrochloride or porphyrins. • Acute or chronic types of porphyria. • Pregnancy (see sections 4.6 and 5.3)
Sensittività eċċessiva għall- 5- aminolevulinic acid hydrochloride jew poryphyrins. • Tipi akuti jew kroniċi ta ’ poryphyria. • Tqala (ara sezzjoni 4. 6 u 5. 3). •
5-ALA-induced fluorescence of brain tissue does not provide information about the tissue’ s underlying neurological function.
Il- fluworexxenza tat- tessut tal- moħħ indotta mill- 5- ALA ma tipprovdix informazzjoni dwar il- funzjoni newroloġika preżenti tal- moħħ.
Therefore, resection of fluorescing tissue should be weighed up carefully against the neurological function of fluorescing tissue.
Għalhekk, ir- risezzjoni ta ’ tessut fluworexxenti għandha tiġi evalwata bir- reqqa kontra l- funzjoni newroloġika tat- tessut fluworexxenti.
Special care must be taken in patients with a tumour in the immediate vicinity of an important neurological function and pre-existing focal deficits (e. g. aphasia, vision disturbances, paresis etc.) that do not improve on corticosteroid treatment.
Għandha tingħata attenzjoni speċjali f’ pazjenti b’ tumur fil- viċinanza immedjata ta ’ funzjoni newroloġika importanti u nuqqasijiet fokali diġà eżistenti (eż. afasja, disturbi tal- vista, paresi eċċ) li ma jmorrux għall- aħjar b’ kura bil- kortikosterojdi.
Fluorescence-guided resection in these patients has been found to impose a higher risk of critical neurological deficits.
Ir- risezzjoni ggwidata bil- fluworexxenza f’ dawn il - pazjenti nstab li timponi riskju akbar ta ’ nuqqasijiet newroloġiċi kritiċi.
A safe distance to eloquent cortical areas and subcortical structures of at least 1 cm should be maintained independent of the degree of fluorescence.
Għandha tinżamm distanza ta ’ sigurtà ta ’ mill- anqas 1 ċm minn żoni kortikali elokwenti jew strutturi subkortikali indipendentement mil- livell ta ’ fluworexxenza.
In all patients with a tumour in the vicinity of an important neurological function, either pre- or intraoperative measures should be used to localise that function relative to the tumour in order to maintain safety distances.
Fil- pazjenti kollha b’ tumur fil- viċinanza ta ’ funzjoni newroloġika importanti, għandhom jintużaw miżuri qabel jew waqt l- operazzjoni sabiex tiġi lokalizzata dik il- funzjoni relattiva għat- tumur biex jinżammu d- distanzi ta ’ sigurtà.
After administration of this medicinal product, exposure of eyes and skin to strong light sources (e. g. operating illumination, direct sunlight or brightly focused indoor light) should be avoided for 24 hours.
Wara l- għoti ta ’ dan il- prodott mediċinali, l- esponiment ta ’ l- għajnejn u tal- ġilda għal sorsi tad- dawl qawwija (eż. mixegħla ta ’ waqt l- operazzjonijiet, dawl tax- xemx dirett jew dawl ta ’ ġewwa ffukat b’ mod qawwi) għandu jiġi evitat għal 24 siegħa.
Co-administration with other potentially phototoxic substances (e. g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) should be avoided (see also section 5.3).
L- għoti ma ’ sustanzi oħra potenzjalment fototossiċi (eż. tetracyclines, sulfonamides, fluoroquinolones, estratti ta ’ hypericin) għandu jiġi evitat (ara wkoll sezzjoni 5. 3).
Within 24 hours after administration, other potentially hepatotoxic medicinal products should be avoided.
Sa 24 siegħa wara li jingħata, prodotti mediċinali oħra li jistgħu jagħmlu ħsara lill- fwied għandhom jiġu evitati.
In patients with pre-existing cardiovascular disease, this medicinal product should be used with caution since literature reports have shown decreased systolic and diastolic blood pressures, pulmonary artery systolic and diastolic pressures as well as pulmonary vascular resistance.
F’ pazjenti b’ mard kardjovaskulari diġà eżistenti, dan il- prodott mediċinali għandu jintuża b’ kawtela billi r- rapporti fil- letteratura wrew tnaqqis fil- pressjoni sistolika u l- pressjoni dijastolika tad- demm, fil - pressjoni sistolika u l- pressjoni dijastolika ta ’ l- arterja pulmonari kif ukoll reżistenza vaskulari pulmonarja.
One case of an increased phototoxic reaction (severe sunburn lasting for 5 days) has been reported in a patient after co-administration of 5-aminolevulinic acid and a hypericin extract (a known phototoxic agent).
Ġie rrappurtat każ wieħed ta ’ reazzjoni fototossika akbar (ħarqa tax- xemx severa li damet għal 5 ijiem) f’ pazjent wara l- għoti ta ’ 5- aminolevulinic acid ma ’ estratt tal- hypericin (aġent fototossiku magħruf).
Patients should not be exposed to any photosensitizing agent up to 2 weeks after administration of Gliolan.
Il- pazjenti m’ għandhomx ikunu esposti għal xi sostanza ta ’ fotosensitizzar sa ġimagħtejn wara l- għoti ta ’ Gliolan.
Use in pregnancy There are no adequate data from the use of this medicinal product in pregnant woman.
L- użu fit- tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ dan il- prodott mediċinali waqt it- tqala.
Some limited animal studies suggest an embryotoxic acitivity of 5-ALA plus light exposure (see section 5.3).
Xi studji limitati fuq bhejjem jissuġġerixxu attività tossika ta ’ 5- ALA flimkien ma ’ esponiment għad- dawl (ara sezzjoni 5. 3).
Therefore, this medicinal product should not be used during pregnancy.
Għalhekk, dan il- prodott mediċinali m’ għandux jintuża waqt it- tqala.
Use in lactation It is unknown whether 5-ALA or its metabolite PPIX are excreted in human breast milk.
L- użu waqt it- treddigħ Mhux magħruf jekk 5- ALA jew il- metabolit tiegħu PPIX jitneħħewx fil- ħalib tas- sider uman.
The excretion of 5-ALA or PPIX in milk has not been studied in animals.
Ir - risezzjoni ta ’ 5- ALA jew ta ’ PPIX fil- ħalib ma ġietx studjata fil- bhejjem.
Breast-feeding should be interrupted for 24 hours after treatment with this medicinal product.
It- treddigħ għandu jiġi interrott għal 24 siegħa wara t- trattament b’ dan il- prodott mediċinali.
Gliolan has no influence on the ability to drive and use machines.
Gliolan m’ għandu l- ebda effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
3
3 4. 8 Effetti mhux mixtieqa
- immediate reactions occurring after oral administration of the medicinal product before induction
Ir- reazzjonijiet avversi li kienu osservati wara l- użu ta ’ dan il- prodott mediċinali għar- risezzjoni ta ’ glijoma ggwidata bil- fluworexxenza huma mqassmin fiż- żewġ kategoriji li ġejjin:
of anaesthesia (= active substance-specific side effects)
ta ’ l- anestesija (= effetti sekondarji speċifiċi għas- sustanza attiva)
- combined effects of 5-ALA, anaesthesia, and tumour resection (= procedure-specific side effects).
- effetti kombinati tal- 5- ALA, l- anestesija, u r- risezzjoni tat- tumur (= effetti sekondarji speċifiċi
Very common (≥ 1/ 10) Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1,000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1,000) Very rare (≤ 1/ 10,000), not known (cannot be estimated from the available data).
Komuni ħafna (≥ 1/ 10) Komuni (≥ 1/ 100, < 1/ 10) Mhux komuni (≥ 1/ 1, 000, < 1/ 100) Rari (≥ 1/ 10, 000, < 1/ 1, 000) Rari ħafna (≤ 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mad- data disponibbli).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
Substance-specific side effects:
Effetti sekondarji speċifiċi għas- sustanza:
Cardiac disorders Gastrointestinal disorders Skin and subcutaneous tissue disorders
Disturbi fil- qalb Disturbi gastro- intestinali Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Hypotension Uncommon:
Pressjoni baxxa Mhux komuni:
Nausea Uncommon:
Dardir Mhux komuni:
Photosensitivity reaction, photodermatosis
Reazzjoni ta ’ fotosensittività, fotodermatożi
The extent and frequency of procedure-related neurological side effects depend on the localisation of the brain tumour and the degree of resection of tumour tissue lying in eloquent brain areas (see section 4.4).
Effetti sekondarji relatati mal- proċedura Il- firxa u frekwenza ta ’ l- effetti sekondarji newroloġiċi relatati mal- proċedura jiddependu fuq il - lokalizzazzjoni tat- tumur tal- moħħ u l- grad tar- risezzjoni tat- tessut ta ’ tumur li jkun qiegħed f’ żoni elokwenti tal- moħħ (ara sezzjoni 4. 4).
Blood and lymphatic system disorders
Anemija, tromboċitopenija, lewkoċitożi limfatika Disturbi fis- sistema nervuża
Anaemia, thrombocytopenia, leukocytosis
Disturbi newroloġiċi (eż. emiparesi, afasja, konvulżjonijiet, emianopsija)
Nervous system disorders
Rari ħafna:
Hypesthesia
Ipoestesija
Cardiac disorders Vascular disorders Gastrointestinal disorders
Disturbi fil- qalb Disturbi vaskulari Disturbi gastro- intestinali
Hypotension Common:
Pressjoni baxxa Komuni:
Thromboembolism Common:
Tromboemboliżmu Komuni:
Vomiting, nausea Very rare:
Rimettar, dardir Rari ħafna:
Blood bilirubin increased, Alanine aminotransferase increased, Aspartate aminotransferase increased, Gamma glutamyltransferase increased, Blood amylase increased
Żieda fil- bilirubin fid- demm, żieda fl- alanine aminotransferase, żieda fl- aspartate aminotransferase, żieda fil- gamma glutamyltransferase, żieda fl- amylase fid- demm
In a single-arm study including 21 healthy male volunteers, erythema of the skin could be provoked by direct exposure to UVA light up to 24 hours after oral application of 20 mg/ kg body weight 5-ALA HCl.
Fi studju single- arm li kien jinkludi 21 voluntier raġel b’ saħħtu, eritema tal- ġilda setgħet tiġi pprovokata b’ esponiment dirett għad- dawl UVA sa 24 siegħa wara l- applikazzjoni orali ta ’ 20 mg ta ’ piż tal- ġisem ta ’ 5- ALA HCl għal kull kilogramm.
Possibly drug-related mild nausea was reported in 1out of 21 volunteers.
Dardir ħafif possibbilment relatat mal- mediċina ġie rrappurtat f’ 1 mill- 21 voluntier.
In another single-centre study, 21 patients with malignant glioma received 0.2, 2, or 20 mg/ kg body weight 5-ALA HCl followed by fluorescence-guided tumour resection.
Fi studju ieħor ta ’ ċentru wieħed (single- centre study), 21 pazjent bi glijoma malinna rċevew 0. 2, 2, jew 20 mg/ kg ta ’ piż tal- ġisem ta ’ 5- ALA HCl segwit mir- risezzjoni tat- tumur iggwidata bil - fluworexxenza.
The only adverse reaction reported in this trial was one case of mild sunburn occurring in a patient treated with the highest dose.
L- unika reazzjoni avversa rrappurtata f’ din il- prova kien każ wieħed ta ’ ħarqa ħafifa bix- xemx li seħħet f’ pazjent ittrattat bl- ogħla doża.
In a single-arm study including 36 patients with malignant glioma, drug-related adverse events were reported in 4 patients (one patient: mild diarrhoea, one patient: moderate hypesthesia, one patient: moderate chills, and one patient: arterial hypotension 30 minutes after application of 5-ALA HCl).
4 Fi studju single- arm li kien jinkludi 36 pazjent bi glijoma malinnja, ġew irrappurtati episodji avversi relatati mal- mediċina f’ erba ’ pazjenti (pazjent minnhom: dijarea ħafifa, pazjent ieħor: ipoestesija moderata, pazjent ieħor: kesħa moderata, u pazjent ieħor: pressjoni baxxa arterjali 30 minuta wara l- għoti ta ’ 5- ALA HCl).
All patients received the medicinal product in a dose of 20 mg/ kg body weight and underwent fluorescence-guided resection.
Il- pazjenti kollha rċevew il- prodott mediċinali f’ doża ta ’ 20 mg/ kg ta ’ piż tal - ġisem u kienu sottoposti għal tneħħija ggwidata bil- fluworexxenza.
Follow-up time was 28 days.
Iż- żmien ta ’ wara l- kura kien ta ’ 28 ġurnata.
4 In a comparative, unblinded phase-III trial (MC-ALS.3/ GLI), 201 patients with malignant gliomas received 5-ALA HCl in a dose of 20 mg/ kg body weight and 176 of these patients underwent fluorescence-guided resection with subsequent radiotherapy.
Fi studju komparattiv ta ’ Fażi III, tat- tip unblinded (MC- ALS. 3/ GLI), 201 pazjent bi glijomi malinni rċevew 5- ALA HCl f’ doża ta ’ 20 mg/ kilogramm ta ’ piż tal- ġisem u 176 minn dawn il- pazjenti kienu sottoposti għal tneħħija ggwidata bil- fluworexxenza b’ radjuterapija sussegwenti.
173 patients received standard resection without administration of the medicinal product and subsequent radiotherapy.
173 pazjent irċevew tneħħija standard mingħajr ma ngħataw il- prodott mediċinali u r- radjuterapija sussegwenti.
Follow-up time comprised at least 180 days after administration.
Iż- żmien ta ’ wara l- kura kien jinkludi mill- anqas 180 jum wara l- għoti.
At least possibly related adverse reactions were reported in 2/ 201 (1.0%) patients: mild vomiting 48 hours after surgery, and mild photosensitivity 48 hours after study surgery.
Reazzjonijiet avversi possibbilment relatati kienu rrapportati talanqas fi 2/ 201 (1. 0%) pazjent: rimettar ħafif 48 siegħa wara l- kirurġija, u fotosensittività ħafifa 48 siegħa wara l- kirurġija ta ’ l- istudju.