qanastek/EMEA-V3 huggingface dataset:
One pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer).
Siringa mimlija għal- lest (ħġieġ tat- tip I) b’ tapp planġer (bromobutyl miksi b’ polimeru tal - fluworokarbonju).
3 ml of solution filled in a 3 ml syringe.
3 ml ta ’ soluzzjoni mimlija f’ siringa ta ’ 3ml.
A hypodermic needle (25 G; 16 mm) is included in the package.
Labra ipodermika (25 G; 16 mm) hija inkluża fil- pakkett.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintuża għal meta jintrema
The solution should be clear and colourless and free from visible particles.
Is- soluzzjoni għandha tkun ċara u bla kulur u ħielsa minn frak li jidher.
130 D-10115 Berlin
130 D- 10115 Berlin Il- Ġermanja
9 DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
9 DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- FABRIKAZZJONI RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- fabbrikant responsabbli mill- ħruġ tal- lott
RENTSCHLER Biotechnologie GmbH Erwin-Rentschler-Strasse 21 D-88471 Laupheim Germany
RENTSCHLER Biotechnologie GmbH Erwin- Rentschler- Strasse 21 D- 88471 Laupheim Il- Ġermanja
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ SID L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata b’ riċetta tat- tabib
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET U RESTRIZZJONIJIET FUQ IS- SIGURTA ’ U L- UŻU EFFIKAĊI TAL- PRODOTT MEDIĊINALI
Pharmacovigilance system
Sistema tal- farmakoviġilanza
The MAH must ensure that the system of pharmacovigilance, as described in version 5.0 dated 11 April 2008 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sid l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jassigura li s- sistema tal- farmakoviġilanza, hekk kif deskritta fil- verżjoni 5. 0 tal- 11 ta ’ April 2008 ippreżentata fil- Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun imwaqqfa u tkun qed tiffunzjona qabel u waqt li l - prodott ikun fis- suq.
Risk Management Plan
Pjan ta ’ Ġestjoni tar- Riskji
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 dated 15 April 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Sid l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu sabiex iwettaq l- istudji u l- attivitajiet addizzjonali tal- farmakoviġilanza dettaljati fil- Pjan tal- Farmakoviġilanza, kif maqbul fil- verżjoni 1. 2 tal- 15 ta ’ April 2008 tal- Pjan ta ’ Ġestjoni tar- Riskji (RMP) ippreżentat fil- Modulu 1. 8. 2 ta ’ l - Applikazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ l- RMP kif ġie maqbul mis - CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji gwida tas- CHMP dwar is- Sistema ta ’ Ġestjoni tar- Riskji għall- prodotti mediċinali għall- użu mill- bniedem, l- RMP għandu jingħata fl- istess ħin tar- Rapport Perjodiku ta ’ Aġġornament tas- Sigurtà (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jitressaq ukoll RMP aġġornat. • Meta tidħol informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà, il- Pjan tal- Farmakovġilanza jew l- attivitajiet ta ’ minimizzazzjoni tar- riskji li jkunu attwali. • Fi żmien 60 jum ta ’ meta għandu jintlaħaq objettiv importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji). • Fuq talba ta ’ l- EMEA
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Kartuna
Firazyr 30 mg solution for injection pre-filled syringe Icatibant
Firazyr 30 mg soluzzjoni għal injezzjoni f’ siringa mimlija għal- lest Icatibant
Each 3 ml pre-filled syringe contains icatibant acetate equivalent to 30 mg icatibant.
Kull siringa ta ’ 3 ml mimlija għal- lest fiha aċetat ta ’ icatibant ekwivalenti għal 30 mg icatibant.
Each ml of the solution contains 10mg of icatibant.
Kull 1 ml tas- soluzzjoni fih 10 mg icatibant.
Contains: acetic acid glacial, sodium hydroxide, sodium chloride, water for injections.
Fih: acetic acid glacial, sodium hydroxide, sodium chloride, ilma għall- injezzjonijiet.
Solution for injection 1 pre-filled syringe.
Soluzzjoni għal injezzjoni 1 siringa mimlija għal- lest.
25G needle
Labra 25G
Subcutaneous use Read the package leaflet before use For single use only
Użu għal taħt il- ġilda Aqra l- fuljett ta ’ tagħrif qabel l- użu Għal użu singolu biss
Do not store above 25ºC.
Taħżinx f’ temperatura ’ l fuq minn 25ºC.
Marketing Authorisation Holder Jerini AG Invalidenstrasse.
Marketing Authorisation Holder Jerini AG Invalidenstrasse.
130 D-10115 Berlin Germany
130 D- 10115 Berlin Il- Ġermanja
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA 14.
15 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW FUQ L- ISTRIXXI
{Blister tray lid}
{Għatu tat- trej bil- blisters}
EXPIRY DATE
DATA TA ’ SKADENZA
EXP
JISKADI
BATCH NUMBER Lot
NUMRU TAL- LOTT
OTHER Subcutanous use
Użu għal taħt il- ġilda
{Syringe label}
{Tikketta tas- siringa}
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, IL- VOLUM JEW L- UNITÀ
INFORMATION FOR THE USER
INFORMAZZJONI GĦALL- UTENT
What Firazyr is and what it is used for 2.
X’ inhu Firazyr u għalxiex jintuża 2.
Before you use Firazyr 3.
Qabel ma tuża Firazyr 3.
How to use Firazyr 4.
Kif għandek tuża Firazyr 4.
How to store Firazyr 6.
Kif taħżen Firazyr 6.
WHAT FIRAZYR IS AND WHAT IT IS USED FOR
X’ INHU FIRAZYR U GĦALXIEX JINTUŻA
Firazyr is used for treating the symptoms of hereditary angioedema (HAE) in adult patients.
Firazyr jintuża biex jiġu trattati s- sintomi ta ’ anġjoedema ereditarja (HAE) f’ pazjenti adulti.
In HAE levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea.
F’ HAE, il- livelli ta ’ sustanza fid- demm tiegħek imsejħa bradykinin jiżdiedu u dan iwassal għal sintomi bħal nefħa, uġigħ, nawżea u dijarrea.
Firazyr blocks the activity of bradykinin and therefore ends the further progression of the symptoms of an HAE attack.
Firazyr jimblokka l- attività ta ’ bradykinin u għalhekk iwaqqaf il- progressjoni supplementari tas - sintomi ta ’ attakk ta ’ HAE.
BEFORE YOU USE FIRAZYR
QABEL MA TUŻA FIRAZYR
Do not use Firazyr
Tużax Firazyr
- If you know that you are allergic (hypersensitive) to icatibant, or any of the other ingredients of
- Jekk taf li int allerġiku/ a (tbati minn ipersensittività) għal icatibant, jew sustanzi oħra ta ’
Take special care with Firazyr
Oqgħod attent ħafna b’ Firazyr
Some of the side effects connected with Firazyr are similar to the symptoms of your disease.
Xi effetti sekondarji konnessi ma ’ Firazyr huma simili għas- sintomi tal- marda tiegħek.
Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received Firazyr.
Informa mill- ewwel lit- tabib tiegħek jekk tinnota li s- sintomi tiegħek ta ’ l- attakk jiġu agħar wara li tkun ħadt Firazyr.
If you are suffering from angina (reduced blood flow to the heart muscle), please consult your doctor before using Firazyr.
Jekk tbati minn anġina (fluss tad- demm imnaqqas lejn il- muskolu tal- qalb), jekk jogħġbok ikkonsulta lit- tabib tiegħek qabel tuża Firazyr.
If you have recently suffered a stroke, please consult your doctor before using Firazyr.
Jekk dan l- aħħar tatek puplesija, jekk jogħġbok ikkonsulta lit- tabib tiegħek qabel tuża Firazyr.
Firazyr is not known to interact with other medicines, but please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed by a doctor.
Firazyr mhux magħruf li jinteraġixxi ma ’ mediċini oħra, iżda jekk jogħġbok għid lit- tabib jew lill - ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta tat- tabib.
If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for
Jekk qed tieħu mediċina magħrufa bħala inibitur ta ’ l- Angiotensin Converting Enzyme (ACE)
19 example: captopril, enalapril, ramipril, quinapril, lisinopril) which is used to lower your blood pressure or for any other reason, you should inform your doctor before receiving Firazyr.
19 (per eżempju: captopril, enalapril, ramipril, quinapril, lisinopril) li tintuża biex tbaxxi l- pressjoni tad - demm tiegħek jew għal xi raġuni oħra, inti għandek tinforma lit- tabib tiegħek qabel tirċievi Firazyr.
Taking Firazyr with food and drink
Meta tieħu Firazyr ma ’ l- ikel u max- xorb
Food and drink have no effect on the action of Firazyr.
L- ikel u x- xorb ma għandhomx effett fuq l- azzjoni ta ’ Firazyr.
If you are pregnant or plan becoming pregnant, discuss this with your doctor before starting to use Firazyr.
Jekk inti tqila jew qed tippjana biex tinqabad tqila, iddiskuti dan mat- tabib tiegħek qabel tibda tuża Firazyr.
If you are breast-feeding you should not breast-feed for 12 hours after you have received Firazyr.
Jekk qiegħda tredda ’, inti m’ għandekx tredda ’ għal 12- il siegħa wara li tkun ħadt Firazyr.
Do not drive or use machinery if you feel tired or dizzy as a result of your HAE attack or after using Firazyr.
Issuqx jew tħaddem magni jekk tħossok għajjien/ a jew stordut/ a b’ riżultat ta ’ l- attakk ta ’ l- HAE tiegħek jew wara li tuża Firazyr.
Important information about some of the ingredients of Firazyr
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Firazyr
The injection solution contains less than 1 mmol (23 milligrams) of sodium, so it is essentially ‘ sodium-free’.
Is- soluzzjoni għal injezzjoni fiha anqas minn 1 mmol (23 milligramma) sodju, għalhekk hija prattikament ‘ mingħajr sodju ’.
HOW TO USE FIRAZYR
KIF GĦANDEK TUŻA FIRAZYR
Firazyr will always be injected by your doctor or nurse.
Firazyr dejjem għandu jiġi injettat mit- tabib jew mill- infermier tiegħek.
Your doctor will tell you when it is safe for you to go home.
It- tabib tiegħek jgħidlek meta tista ’ tmur id- dar mingħajr periklu.
When and how often should you use Firazyr?
Meta u kull kemm għandek tuża Firazyr?
Your doctor has determined the exact dose of Firazyr and will tell you how often it should be used.
It- tabib tiegħek stabbilixxa d- doża eżatta ta ’ Firazyr u se jgħidlek kull kemm għandu jintuża.
The recommended dose of Firazyr is one injection (3 ml, 30 mg) applied subcutaneously (under the skin) as soon as you notice the attack of hereditary angioedema becoming moderately or severely worse (for example increased skin swelling, particularly affecting the face and neck, or increasing tummy pain).
Id- doża rakkomandata ta ’ Firazyr hija injezzjoni waħda (3 ml, 30 mg) mogħtija miinn taħt il- ġilda malli tinnota li l- attakk ta ’ anġjoedema ereditarja qiegħed isir moderatament jew severament agħar (per eżempju nefħa akbar fil- ġilda, li taffettwa b’ mod partikolari l- wiċċ u l- għonq, jew uġigħ ta ’ żaqq li jiżdied).
If you experience no relief of symptoms after 6 hours, an additional injection of Firazyr (3 ml) can be given.
Jekk ma tħoss ebda solljiev tas- sintomi wara 6 sigħat, tista ’ tingħata injezzjoni oħra ta ’ Firazyr (3 ml).
If after a further 6 hours you still experience no relief you might have a third injection Firazyr (3 ml).
Jekk wara 6 sigħat oħra xorta ma tħoss ebda solljiev, inti tista ’ tieħu t- tielet injezzjoni ta ’ Firazyr (3 ml).
You should not have more than 3 injections in a 24 hour period and no more than 8 injections of Firazyr in total per month.
M’ għandekx tieħu aktar minn 3 injezzjonijiet f’ perjodu ta ’ 24 siegħa u mhux aktar minn 8 injezzjonijiet b’ kollox fix- xahar.
How should Firazyr be administered?
Kif għandu jingħata Firazyr?
Firazyr is intended for subcutaneous injection (under the skin).
Firazyr huwa maħsub għal injezzjoni minn taħt il- ġilda.
Each syringe should only be used once.
Kull siringa għandha tintuża darba biss.
Firazyr is injected with a short needle into the fatty tissue under the skin in the abdomen (tummy).
Firazyr jiġi injettat b’ labra qasira fit- tessut xaħmi taħt il- ġilda fl- addome (żaqq).
Like all medicines, Firazyr can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Firazyr jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Almost all patients receiving Firazyr will experience a reaction at the site of the injection.
Kważi l- pazjenti kollha li jirċievu Firazyr jesperjenzaw reazzjoni fejn tingħata l- injezzjoni.
The reaction may include burning sensations, reddening of the skin (erythema), pain, swelling, feeling of warmth and itching (pruritus).
Ir - reazzjoni tista ’ tinkludi sensazzjonijiet ta ’ ħruq, ħmura tal- ġilda (eritema), uġigħ, nefħa, sensazzjoni ta ’ sħana u tekil tal- ġilda (ħakk).
These effects are usually mild and clear up by themselves without the need for any additional treatment.
Dawn l- effetti ġeneralment ikunu ħfief u jmorru waħedhom mingħajr il- ħtieġa ta ’ xi trattament addizzjonali.
20 The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10), common (affects 1 to 10 users in 100), uncommon (affects 1 to 10 users in 1,000), rare (affects 1 to 10 users in 10,000), very rare (affects less than 1 user in 10,000), not known (frequency cannot be estimated from the available data).
20 Il- frekwenza ta ’ l- effetti sekondarji possibli mniżżla hawn taħt huma definiti kif imiss: komuni ħafna (jaffetwaw iktar minn pazjent wieħed minn kull 10), komuni (jaffetwaw minn pazjent wieħed sa 10 minn kull 100), rari (jaffetwaw pazjent wieħed minn kull 10 minn f’ kull 10, 000), rari ħafna (jaffetwaw inqas minn pazjent wieħed minn kull 10, 000), mhux magħruf (il- frekwenza ma tistax tiġi stmata mid- dejta disponibbli).
Injection site reactions (burning sensations, reddening of the skin, pain, swelling, feeling of warmth, itching.) Common:
Reazzjonijiet fil- punt ta ’ l- injezzjoni (sensazzjonijiet ta ’ ħruq, ħmura tal- ġilda, uġigħ, nefħa, sensazzjoni ta ’ sħana, ħakk).
Asthma Bruising Cough Fever Hot flushes Increased amount of uric acid in the blood (indicator of gout) Itching Sore throat Positive test for protein in your urine Vomiting Tiredness Weight gain
Riżultati anomali minn xi testijiet tad- demm Imnieħer miżdud Uġigħ ta ’ ras Sturdament Dgħjufija fil- muskolari Nawżea Uġigħ fl- addome (żaqq) Raxx, ħmura fil- ġilda Mhux komuni) Ażżma Tbenġil Sogħla Deni Fwawar tal- menopawsa Żieda fl- ammont ta ’ aċidu uriku fid- demm (indikatur ta ’ gotta) Ħakk Uġigħ fil- griżmejn Test pożittiv għall- proteina fl- awrina tiegħek Rimettar Għeja Żieda fil- piż
Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received Firazyr.
Għid lit- tabib tiegħek immedjatament jekk tinnota li s- sintomi tiegħek ta ’ l- attakk marru għall- agħar wara li ħadt Firazyr.
HOW TO STORE FIRAZYR
KIF TAĦŻEN FIRAZYR
Do not use Firazyr after the expiry date stated on the label.
Tużax Firazyr wara d- data ta ’ skadenza li tidher fuq it- tikketta.
The expiry date refers to the last day of the month stated on the label.
Id- data ta ’ skadenza tirreferi għall - aħħar ġurnata ta ’ dak ix- xahar.
Firazyr should not be used if the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed.
Firazyr m’ għandux jintuża jekk il- pakkett tas- siringa jew tal- labra tkun saritlu l- ħsara jew jekk ikun hemm sinjali viżibbli ta ’ deterjorament, per eżempju jek is- soluzzjoni tkun imdaħħna, jekk ikollha frak fil- wiċċ, jew jekk il- kulur tas- soluzzjoni jkun inbidel.
Medicines should not be disposed of via waste water or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- drenaġġ jew ma ’ l- iskart domestiku.
What Firazyr contains
X’ fih Firazyr
- The active substance is icatibant 30 milligrams (as acetate) in 3 ml solution for injection in each
- Is- sustanza attiva hi icatibant 30 milligramma (bħala aċetat) fi 3 ml soluzzjoni għal injezzjoni
pre-filled syringe.
f’ siringa mimlija għal- lest.
- The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for
- Is- sustanzi l- oħra huma sodium chloride, acetic acid glacial, sodium hydroxide u ilma għall -
injection.
injezzjoni.
The solution does not contain any preservative.
Is- soluzzjoni ma fihiex preservattivi.
What Firazyr looks like and contents of the pack
Id- dehra ta ’ Firazyr u l- kontenuti tal- pakkett
Firazyr is presented as a clear, colourless solution for injection in a pre-filled glass syringe (3 ml).
Firazyr jiġi bħala soluzzjoni ċara, bla kulur għal injezzjoni f’ siringa tal- ħġieġ mimlija għal- lest (3 ml).
130 10115 Berlin Germany.
Jerini AG Invalidenstrasse 130 10115 Berlin Il- Ġermanja.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATIMILL- ISTATI MEMBRI
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 għandhom jiżguraw li l- kundizzjonijiet jew restrizzjonijiet kollha fir- rigward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali deskritti hawn taħt, ikunu implimentati:
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following: • Educational material • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) għandu jiftiehem dwar id- dettalji ta ’ programm edukattiv mal- Awtoritajiet Kompetenti Nazzjonali u jrid jimplimenta dan il- programm b’ mod nazzjonali biex jiżgura li, qabel ma jagħtu r- riċetta, it- tobba kollha jiġu pprovduti b’ pakkett ta ’ tagħrif għall- professjonisti fil- qasam tal- kura tas- saħħa li jkun fih dan li ġej: • Materjal edukattiv • Sommarju tal- Karatteristiċi tal- Prodott (SPC) u Fuljett ta ’ Tagħrif u Tikketta
Key elements to be included in the educational material
Elementi ewlenin li jridu jkunu inklużi fil- materjal edukattiv
• Posology • Instructions for administration • Information on gel depot formation and possible injections site reactions • Information on the identified and potential risks.
• Pożoloġija • Struzzjonijiet għall- għoti • Informazzjoni dwar il- formazzjoni ta ’ ġell depot u reazzjonijiet possibbli fis- sit tal- injezzjonijiet • Informazzjoni dwar ir- riskji identifikati u potenzjali.
FIRMAGON
FIRMAGON Sommarju tal- EPAR għall- pubbliku
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport Pubblika Ewropew ta ’ Valutazzjoni (EPAR).
What is Firmagon?
X’ inhu Firmagon?
Firmagon is a powder and solvent that are made up into a solution for injection.
Firmagon huwa trab u solvent li meta jitħalltu jsiru soluzzjoni għall- injezzjoni.
It contains the active substance degarelix.
Fih is- sustanza attiva degarelix.
What is Firmagon used for?
Għalxiex jintuża Firmagon?
Firmagon is used to treat patients with advanced prostate cancer.
Firmagon jintuża għall- kura ta ’ pazjenti b’ kanċer tal- prostata fi stat avvanzat.
This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen. ‘ Advanced ’ means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs.
Dan huwa kanċer li jaffettwa l- glandola tal- prostata, il- glandola ta ’ taħt il- bużżieqa tal- awrina fl- irġiel li tipproduċi l - likwidu fis- semen. ‘ Avvanzat ’ tfisser li l- kanċer infirex barra l- glandola għal xi nodi limfatiċi, iżda mhux għal organi oħra.
Firmagon can be used if the cancer is ‘ hormone-dependent’, which means that it responds to treatments that reduce the levels of the hormone testosterone.
Firmagon jista ’ jintuża jekk il- kanċer huwa ‘ dipendenti fuq l- ormoni ’, li jfisser li jwieġeb għal trattamenti li jnaqqsu l- livelli tal- ormon testosteron.
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss permezz ta ’ riċetta tat- tabib.
How is Firmagon used?
Kif jintuża Firmagon?
Firmagon is injected under the skin of the abdomen.
Firmagon huwa injettat taħt il- ġilda taż- żaqq.
Treatment starts with two 120-mg injections, followed by single 80-mg injections every month.
It- trattament jibda b’ żewġ injezzjonijiet ta ’ 120 mg, segwiti minn injezzjonijiet singoli ta ’ 80 mg kull xahar.
Firmagon must not be injected into a vein or a muscle.
Firmagon m’ għandux jiġi injettat ġo vina jew muskolu.
Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of testosterone and prostate-specific antigen (PSA).
It- tobba għandhom jimmonitorjaw l- effikaċja tal- kura b’ Firmagon billi josservaw il- livelli tad- demm tat- testosteron u tal- antiġen speċifiku tal- prostata (prostate- specific antigen - PSA).
PSA is a protein that is produced by the prostate gland and is often found at high levels in men with prostate cancer.
PSA huwa proteina li tiġi prodotta mill- glandola tal- prostata u spiss tinstab f’ livelli għoljin f’ irġiel li jkollhom kanċer tal- prostata.
Firmagon should be used with caution in patients who have severe kidney or liver problems.
Firmagon għandu jintuża b’ mod kawt f’ pazjenti li għandhom problemi serji bil- kliewi jew bil- fwied.
How does Firmagon work?
Kif jaħdem Firmagon?
Testosterone can make prostate cancer cells grow.
It- testosteron jista ’ jkabbar iċ- ċelloli tal- kanċer tal- prostata.
The active substance in Firmagon, degarelix, is a gonadotrophin-releasing hormone antagonist, which means that it blocks the effects of a natural hormone called gonadotrophin-releasing hormone (GnRH).
Is- sustanza attiva f’ Firmagon, degarelix, hija antagonista tal- ormon li jirrilaxxa l- gonadotrofina, jiġifieri jimblokka l- effetti ta ’ ormon naturali msejjaħ ormon li jirrilaxxa l- gonadotrofina (gonadotrophin- releasing hormone - GnRH).
GnRH normally stimulates the pituitary gland at the base of the brain to produce two hormones which cause the testes to produce testosterone.
Il- GnRH normalment jistimola l- glandola pitwitarja fil- bażi tal- moħħ biex tipproduċi żewġ ormoni li jġiegħlu lit- testikoli jipproduċu t- testosteron.
By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows down the growth of the cancer cells.
Billi jimblokka dawn il- proċessi, Firmagon inaqqas l- ammont ta ’ testosteron fil- ġisem u jnaqqas il- veloċità tat- tkabbir taċ- ċelloli tal- kanċer.
When injected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks.
Meta jiġi injettat, Firmagon jifforma ġel taħt il- ġilda li jirrilaxxa s- sustanza attiva bil- mod fuq medda ta ’ ftit ġimgħat.
How has Firmagon been studied?
Kif ġie studjat Firmagon?
The effects of Firmagon were first tested in experimental models before being studied in humans.
L- effetti ta ’ Firmagon l- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bnedmin.
Two doses of Firmagon have been compared with leuprorelin in one main study involving 610 men with prostate cancer at all stages of the disease.
Żewġ dożi ta ’ Firmagon tqabblu ma ’ leuprorelin fi studju wieħed ewlieni li kien jinvolvi 610 irġiel bil - kanċer tal- prostata f’ kull stadju tal- marda.
The main measure of effectiveness was the number of patients whose testosterone levels were below those seen in men whose testes were producing no testosterone, over the first year of treatment.
Il- kejl ewlieni ta ’ effikaċja kien l- għadd ta ’ pazjenti li l - livelli tat- testosteron tagħhom kienu aktar baxxi minn dawk li dehru f’ irġiel li t- testikoli tagħhom ma kinux qed jipproduċu testosteron, matul l- ewwel sena ta ’ kura.
What benefit has Firmagon shown during the studies?
Liema benefiċċju wera Firmagon waqt l- istudji mwettqa?
Firmagon was as effective as leuprorelin at reducing testosterone levels.
Firmagon kien effettiv daqs leuprorelin fit- tnaqqis tal- livelli tat- testosteron.
During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level.
Matul l- ewwel sena, 97% tal- pazjenti li kienu qed jirċievu Firmagon fid- doża approvata ta ’ 80 mg darba fix- xahar kellhom livelli ta ’ testosteron inqas mil- livell meħtieġ.
This was compared with 96% of patients receiving leuprorelin.
Dan tqabbel ma ’ 96% ta ’ pazjenti li kienu qed jirċievu leuprorelin.
Similar results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month.
Riżultati simili dehru f’ pazjenti li kienu qed jirċievu Firmagon fid- doża ogħla ta ’ 160 mg darba fix- xahar.
What is the risk associated with Firmagon?
X’ inhu r- riskju assoċjat ma ’ Firmagon?
The most common side effects with Firmagon (seen in more than 1 patient in 10) are hot flushes and problems at the injection site such as pain and redness.
L- iktar effetti sekondarji komuni b’ Firmagon (li dehru f' iktar minn pazjent 1 minn kull 10) huma fwawar u problemi fil- post tal- injezzjoni bħalma huma uġigħ u ħmura.
For the full list of all side effects reported with Firmagon, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrapportati b’ Firmagon, ara l- Fuljett ta' Tagħrif.
Firmagon should not be used in people who may be hypersensitive (allergic) to degarelix or any of the other ingredients.
Firmagon m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal degarelix jew għal xi sustanza oħra tiegħu.
Why has Firmagon been approved?
Għaliex ġie approvat Firmagon?
The Committee for Medicinal Products for Human Use (CHMP) noted that Firmagon was as effective as leuprorelin in the main study.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) innota li Firmagon kien effettiv daqs leuprorelin fl- istudju ewlieni.
However, because the main study looked at the medicine ’ s effects on testosterone levels rather than the cancer or the patient’ s outcome directly, and because leuprorelin is only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon to advanced prostate cancer.
Madankollu, minħabba li l- istudju ewlieni ħares lejn l - effetti tal- mediċina fuq il- livelli tat- testosteron aktar milli fuq il- kanċer jew ir- riżultati fil- pazjent b’ mod dirett, u minħabba li leuprorelin jintuża biss għal kanċer tal- prostata fi stat avvanzat, il- Kumitat iddeċieda li jillimita l- użu ta ’ Firmagon għall- kanċer tal- prostata fi stat avvanzat.
The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘ GnRH agonists’ (other medicines for prostate cancer that stimulate the production of GnRH).
Il- Kumitat innota wkoll li t- trattament b’ Firmagon ma jagħtix bidu għal żieda f’ daqqa temporanja fil - livelli tat- testosteron li jidhru b ’ ‘ antagonisti GnRH ’ (mediċini oħrajn għall- kanċer tal- prostata li jistimulaw il- produzzjoni ta ’ GnRH).
This means that patients do not need to take other medicines to block testosterone at the start of treatment.
Dan ifisser li l- pazjenti m’ għandhomx għalfejn jieħdu mediċini oħra biex jimblukkaw it- testosteron fil- bidu tal- kura.
Therefore, the CHMP decided that Firmagon’ s benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Għaldaqstant, is- CHMP ddeċieda li l- benefiċċji ta ’ Firmagon huma akbar mir- riskji tiegħu fil- kura ta ’ pazjenti rġiel adulti b’ kanċer tal- prostata fi stat avvanzat dipendenti fuq l- ormoni.
The Committee recommended that Firmagon be given marketing authorisation
Il- Kumitat irrakkomanda li Firmagon jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Firmagon?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Firmagon?
The company that makes Firmagon will make sure that educational materials are provided to all doctors in all Member States who will prescribe the medicine.
Il- kumpanija li tipproduċi Firmagon ser tiżgura li materjal edukattiv jingħata lit- tobba kollha fl- Istati Membri kollha li ser jippreskrivu din il- mediċina.
The materials will include information on Firmagon’ s safety and remind doctors how to administer the medicine.
Il- materjal sejjer jinkludi informazzjoni dwar is - sigurtà ta ’ Firmagon u jfakkar lit- tobba kif għandhom jagħtu l- mediċina.
Other information about Firmagon:
Informazzjoni oħra dwar Firmagon:
The European Commission granted a marketing authorisation valid throughout the European Union for Firmagon to Ferring Pharmaceuticals A/ S on 17 February 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal Firmagon lil Ferring Pharmaceuticals A/ S fi 17 ta ’ Frar 2009.
The full EPAR for Firmagon can be found here.
L- EPAR sħiħ għal Firmagon jista ’ jinsab hawnhekk.
This summary was last updated in 01-2009.
Dan is- sommarju ġie aġġornat l- aħħar f’ Jannar 2009.
EMEA Number
Numru ta ’ Proċedura ta ’ l - EU
Powder: vial (glass) Solvent: vial (glass)
Trab: kunjett (ħġieġ) Solvent: kunjett (ħġieġ)
1 vial +1 vial +1 syringe +2 needles
1 kunjett + 1 kunjett + 1 siringa + 2 labar
2 vials+2 vials+ 2 syringes +4 needles
2 kunjetti + 2 kunjetti + 2 siringi + 4 labar
FIRMAGON 80 mg powder and solvent for solution for injection
FIRMAGON 80 mg trab u solvent għal soluzzjoni għall- injezzjoni
Each vial contains 80 mg degarelix (as acetate).
Kull kunjett fih 80 mg ta ’ degarelix (bħala acetate).
After reconstitution, each ml of solution contains 20 mg of degarelix.
Wara r- rikostituzzjoni, kull millilitru ta ’ soluzzjoni jkun fih 20 mg ta ’ degarelix.
Powder and solvent for solution for injection (Powder for injection and solvent)
Trab u solvent għal soluzzjoni għall- injezzjoni (Trab għall- injezzjoni u solvent)
White to off-white powder Solvent:
Trab ta ’ lewn minn abjad sa off- white Solvent:
Clear, colourless solution
Soluzzjoni ċara u mingħajr kulur
FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
FIRMAGON hu antagonist tal- ormon li jerħi gonadotrophin (GnRH) indikat għall- kura ta ’ pazjenti rġiel adulti b’ kanċer tal- prostata avvanzat dipendenti fuq l- ormoni.
Starting dose
Doża tal- bidu
Maintenance dose – monthly administration
Doża tal- manteniment – għoti ta ’ kull xahar
240 mg administered as two subcutaneous injections of 120 mg each
240 mg mogħtija bħala żewġ injezzjonijiet taħt il- ġilda ta ’ 120 mg kull waħda
80 mg administered as one subcutaneous injection
80 mg mogħtija bħala injezzjoni waħda taħt il- ġilda
The first maintenance dose should be given one month after the starting dose.
L- ewwel doża tal- manteniment għandha tingħata xahar wara d- doża tal- bidu.
The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels.
L- effett terapewtiku ta ’ degarelix għandu jiġi mmonitorjat permezz tal- parametri kliniċi u l- livelli fis - serum ta ’ antiġen speċifiku għall- prostata (PSA).
Clinical studies have shown that testosterone (T) suppression occurs immediately after administration of the starting dose with 96% of the patients having plasma testosterone levels corresponding to medical castration (T≤ 0.5 ng/ ml) after three days and 100% after one month.
Studji kliniċi wrew li t- trażżin tat- testosterone (T) iseħħ immedjatment wara l- għoti tad- doża tal- bidu b’ 96% tal- pazjenti li jkollhom livelli ta ’ testosterone fil- plażma li jikkorrispondu għall- kastrazzjoni medika (T≤0. 5 ng/ mL) wara tlett ijiem u 100% wara xahar.
Long term treatment with the maintenance dose up to 1 year shows that 97% of the patients have sustained suppressed testosterone levels (T≤ 0.5 ng/ ml).
Il- kura fit- tul bid- doża tal- manteniment sa sena turi li 97% tal- pazjenti jkollhom livelli ta ’ testosterone imrażżna sostnuti (T≤0. 5 ng/ ml).
In case the patient's clinical response appears to be sub-optimal, it should be confirmed that serum testosterone levels are remaining sufficiently suppressed.
F’ każ li r- rispons kliniku tal- pazjent jidher li ma jkunx mill- aħjar, għandu jkun ikkonfermat li l- livelli tat- testosterone fis- serum qed jibqgħu mrażżna b’ mod suffiċjenti.
Since degarelix does not induce a testosterone surge it is not necessary to add an anti-androgen as surge protection at initiation of therapy.
Minħabba li degarelix ma jikkawżax żieda f’ daqqa fit- testosterone, mhux meħtieġ li żżid antiandrogen bħala protezzjoni kontra ż- żieda f’ daqqa fil- bidu tat- terapija.
Method of administration FIRMAGON must be reconstituted prior to administration.
Kif jingħata FIRMAGON irid ikun rikostitwit qabel l- għoti.
For instructions on reconstitution and administration, please see section 6.6.
Għal struzzjonijiet dwar ir- rikostituzzjoni u l- għoti, jekk jogħġbok ara sezzjoni 6. 6.
Subcutaneous use ONLY, not to be administered intravenously.
2 Użu għal taħt il- ġilda BISS, m’ għandux jingħata ġol- vina.
2 Intramuscular administration is not recommended as it has not been studied.
L- għoti ġol- muskoli mhuwiex rakkomandat għax għadu ma kienx studjat.
FIRMAGON is administered as a subcutaneous injection in the abdominal region.
FIRMAGON jingħata bħala injezzjoni taħt il- ġilda fiż- żona addominali.
As with other medicinal products administered by subcutaneous injection, the injection site should vary periodically.
Bħal prodotti mediċinali oħrajn li jingħataw permezz ta ’ injezzjoni taħt il- ġilda, is- sit tal- injezzjoni għandu jinbidel perjodikament.
Injections should be given in areas where the patient will not be exposed to pressure e. g. not close to waistband or belt and not close to the ribs.
L- injezzjonijiet għandhom jingħataw f’ żoni fejn il- pazjent ma jkunx espost għal pressjoni, eż. mhux qrib il- qadd jew fejn jintlibes iċ- ċinturin u mhux qrib il- kustilji.
Special patient populations Elderly, hepatically or renally impaired patients:
Popolazzjonijiet ta ’ pazjenti speċjali Pazjenti anzjani, u dawk b’ indeboliment epatiku jew renali:
There is no need to adjust the dose for the elderly or in patients with mild or moderate liver or kidney function impairment (see section 5.2).
M’ hemmx bżonn li taġġusta d- doża għal pazjenti anzjani jew f’ pazjenti b’ indeboliment ħafif jew moderat fil- funzjoni tal- fwied jew tal- kliewi (ara sezzjoni 5. 2).
Patients with severe liver or kidney impairment have not been studied and caution is therefore warranted (see section 4.4).
Pazjenti li jkollhom indeboliment sever tal- fwied jew tal- kliewi ma kinux studjati u għalhekk hu rakkomandat li tintuża l- kawtela (ara sezzjoni 4. 4).
There is no relevant indication for use of FIRMAGON in women, children and adolescents.
M’ hemmx indikazzjoni rilevanti għall- użu ta ’ FIRMAGON fin- nisa, tfal u adolexxenti.
The data available on efficacy and safety experience with degarelix is limited to a one year treatment.
Id- dejta disponibbli dwar l- effikaċja u s- sigurtà b’ degarelix hi limitata għal kura li damet sena.
Effect on QT/ QTc interval Long-term androgen deprivation therapy may prolong the QT interval.
Effett fuq l- intervall QT/ QTc It- terapija fit- tul bi privazzjoni tal- androgen tista ’ ttawwal l- intervall QT.
In the confirmatory study comparing FIRMAGON to leuprorelin periodic (monthly) ECGs were performed; both therapies showed QT/ QTc intervals exceeding 450 msec in approximately 20% of the patients, and 500 msec in 1% and 2% of the degarelix and leuprorelin patients, respectively (see section 5.1).
Fl- istudju konfermatorju li qabbel FIRMAGON ma ’ leuprorelin mogħti perjodikament (kull xahar), saru ECGs; iż- żewġ terapiji wrew intervalli tal- QT/ QTcs li kienu jaqbżu 450 msek f’ madwar 20% tal- pazjenti, u 500 msek f’ 1% u 2% tal- pazjenti li kienu qed jieħdu degarelix u leuprorelin, rispettivament (ara sezzjoni 5. 1).
FIRMAGON has not been studied in patients with a history of a corrected QT interval over 450 msec, in patients with a history of or risk factors for torsades de pointes and in patients receiving concomitant medicinal products that might prolong the QT interval.
FIRMAGON ma kienx studjat f’ pazjenti bi storja medika ta ’ intervall tal- QT ikkoreġut ta ’ iktar minn 450 msek; f’ pazjenti bi storja medika ta ’, jew fatturi ta ’ riskju għal torsades de pointes u f’ pazjenti li jkunu jirċievu prodotti mediċinali fl- istess li jistgħu jtawlu l- intervall QT.
Therefore in such patients, the benefit/ risk ratio of FIRMAGON must be thoroughly appraised (see sections 4.5 and 4.8).
Għalhekk, f’ dawn il - pazjenti, il- proporzjon tal- benefiċċju/ riskju ta ’ FIRMAGON għandu jiġi evalwat bir- reqqa (ara sezzjonijiet 4. 5 u 4. 8).
Hepatic impairment Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with degarelix.
Indeboliment epatiku Pazjenti b’ disturb epatiku magħruf jew issuspettat ma kinux inklużi fi provi kliniċi fit- tul b’ degarelix.
Mild, transient increases in ALT and AST have been seen, these were not accompanied by a rise in bilirubin or clinical symptoms.
Żidiet ħfief u temporanji fl- ALT u l- AST kienu osservati, dawn ma kinux akkompanjati minn żieda fil- bilirubina jew fis- sintomi kliniċi.
Monitoring of liver function in patients with known or suspected hepatic disorder is advised during treatment.
Il- monitoraġġ tal- funzjoni tal- fwied f’ pazjenti b’ disturb epatiku magħruf jew issuspettat hu rakkomandat matul il- kura.
The pharmacokinetics of degarelix has been investigated after single intravenous administration in subjects with mild to moderate hepatic impairment (see section 5.2).
Il- farmakokinetika ta ’ degarelix kienet investigata wara l- għoti ta ’ doża waħda ġol- vini f’ individwi li kellhom indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 5. 2).
Renal impairment Degarelix has not been studied in patients with severe renal impairment and caution is therefore warranted.
Indeboliment renali Degarelix ma kienx studjat f’ pazjenti b’ indeboliment renali sever u għalhekk il- kawtela hi meħtieġa.
Hypersensitivity Degarelix has not been studied in patients with a history of severe untreated asthma, anaphylactic reactions or severe urticaria or angioedema.
Sensittività eċċessiva Degarelix ma kienx studjat f’ pazjenti bi storja medika ta ’ ażma severa mhux ikkurata, reazzjonijiet anafilattiċi jew urtikarja jew anġjoedima severi.
Changes in bone density Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with a GnRH agonist.
Tibdil fid- densità tal- għadam Tnaqqis fid- densità tal- għadam kien irrappurtat fil- letteratura medika f’ irġiel li kellhom orkijektomija jew kienu ġew ikkurati b’ agonist ta ’ GnRH.
It can be anticipated that long periods of testosterone suppression in men will have effects on bone density.
Jista ’ jkun antiċipat li perjodi twal ta ’ trażżin tat - testosterone fl- irġiel ser ikollhom effetti fuq id- densità tal- għadam.
Bone density has not been measured during treatment with degarelix.
Id- densità tal- għadam ma tkejlitx matul il- kura b’ degarelix.
3 A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist.
3 Tolleranza għaz- zokkor Tnaqqis fit- tolleranza għaz- zokkor kien osservat f’ irġiel li kellhom orkijektomija jew li kienu kkurati b’ agonist ta ’ GnRH.
Development or aggravation of diabetes may occur; therefore diabetic patients may require more frequent monitoring of blood glucose when receiving androgen deprivation therapy.
L- iżvilupp jew l- aggravament tad- dijabete jista ’ jseħħ; għalhekk pazjenti dijabetiċi jista ’ jkollhom bżonn monitoraġġ iktar frekwenti taz- zokkor fid- demm meta jkunu qed jirċievu terapija tal- privazzjoni tal- androgen.
The effect of degarelix on insulin and glucose levels has not been studied.
L- effett ta ’ degarelix fuq il- livelli tal- insulina u taz - zokkor ma kienx studjat.
No formal drug-drug interaction studies have been performed.
Ma saru l- ebda studji formali dwar l- interazzjonijiet bejn mediċina u oħra.
Since androgen deprivation treatment may prolong the QTc interval, the concomitant use of degarelix with medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes such as class IA (e. g. quinidine, disopyramide) or class III (e. g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, cisapride, moxifloxacine, antipsychotics, etc. should be carefully evaluated (see section 4.4).
Minħabba li l- kura tal- privazzjoni tal- androgen tista ’ ttawwal l- intervall QTc, l- użu fl- istess ħin ta ’ degarelix ma ’ prodotti mediċinali li huma magħrufa li jtawlu l- intervall QTc jew prodotti mediċinali li huma kapaċi jikkaġunaw torsades de pointes bħal prodotti mediċinali antiarritmiċi tal- klassi IA (eż. quinidine, disopyramide) jew tal- klassi III (eż. amiodarone, sotalol, dofetilide, ibutilide), methadone, cisapride, moxifloxacine, mediċini antipsikotiċi, eċċ. għandhom jiġu evalwati b’ attenzjoni (ara sezzjoni 4. 4).
Degarelix is not a substrate for the human CYP450 system and has not been shown to induce or inhibit CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/ 5 to any great extent in vitro.
Degarelix mhuwiex substrat għas- sistema CYP450 umana u ma ntweriex li jikkaġuna jew jinibixxi CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, jew CYP3A4/ 5 f’ xi grad partikularment kbir in vitro.
Therefore, clinically significant pharmacokinetic drug-drug interactions in metabolism related to these isoenzymes are unlikely.
Għalhekk, interazzjonijiet farmakokinetiċi klinikament sinifikanti bejn mediċina u oħra fil- metaboliżmu relatat ma ’ dawn l- isoenzimi mhumiex mistennija.
There is no relevant indication for use of FIRMAGON in women.
Mhemmx indikazzjoni rilevanti għall- użu ta ’ FIRMAGON fin- nisa.
No studies on the effects of degarelix on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti ta ’ degarelix fuq il- ħila biex issuq jew tħaddem magni.
However, fatigue and dizziness are common adverse reactions that might influence the ability to drive and use machines.
Madankollu, l - għeja kbira u l- isturdament huma reazzjonijiet avversi komuni li jistgħu jinfluwenzaw il- ħila li ssuq u tħaddem magni.
The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study (N=409) were due to the expected physiological effects of testosterone suppression, including hot flushes and weight increase (reported in 25% and 7%, respectively, of patients receiving treatment for one year), or injection site adverse events.
L- iktar reazzjonijiet avversi li kienu osservati b’ mod komuni matul it- terapija b’ degarelix fi studju konfermatorju ta ’ fażi III (N=409) kienu minħabba l- effetti fiżjoloġiċi mistennija tat- trażżin tat - testosterone, li jinkludu fwawar u żieda fil- piż (irrappurtati f’ 25% u 7%, rispettivament, tal- pazjenti li kienu qed jirċievu l- kura għal sena), jew avvenimenti avversi fil- post fejn tingħata l- injezzjoni.
Transient chills, fever or influenza like illness were reported to occur hours after dosing (in 3%, 2% and 1% of patients, respectively).
Tkexkix ta ’ bard temporanju, deni jew mard qisu influwenza kienu rrappurtati li seħħew fis- sigħat ta ’ wara d- dożaġġ (fi 3%, 2% u 1% tal- pazjenti, rispettivament).
The injection site adverse events reported were mainly pain and erythema, reported in 28% and 17% of patients, respectively, less frequently reported were swelling (6%), induration (4%) and nodule (3%).
L- avvenimenti avversi rrappurtati fis- sit tal- injezzjoni kienu primarjament uġigħ u eritema, irrappurtati fi 28% u fi 17% tal- pazjenti, rispettivament, u b’ mod inqas frekwenti kienu rrappurtati nefħa (6%), ebusija (4%) u l- formazzjoni ta ’ għoqod (3%).
These events occurred primarily with the starting dose whereas during maintenance therapy with the 80 mg dose, the incidence of these events pr 100 injections was:
Dawn l- avvenimenti seħħew primarjament bid- doża tal- bidu, filwaqt li matul it- terapija tal- manteniment bid- doża ta ’ 80 mg, l- inċidenza ta ’ dawn l - avvenimenti għal kull 100 injezzjoni kienet:
3 for pain and < 1 for erythema, swelling, nodule and induration.
3 għall- uġigħ u < 1 għall- eritema, nefħa, formazzjoni ta ’ għoqod u ebusija.
The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations (< 1%).
L- avvenimenti rrappurtati kienu fil- biċċa l- kbira tagħhom temporanji, ta ’ intensità minn ħafifa sa moderata u wasslu għal ammont żgħir ħafna ta ’ waqfien mit- terapija (< 1%).
The frequency of undesirable effects listed below is defined using the following convention:
Il- frekwenza tal- effetti mhux mixtieqa elenkati hawn taħt hi definita bl- użu tal- konvenzjoni li ġejja:
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100).
Komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100 sa < 1/ 10); mhux komuni (≥ 1/ 1, 000 sa < 1/ 100).
Frequency of adverse drug reactions reported in confirmatory phase III study (N=409).
Frekwenza ta ’ reazzjonijiet avversi tal- mediċina rrappurtati fi studju konfermatorju ta ’ fażi III (N=409).
MedDRA System Organ Class (SOC)
Sistema tal - Klassifika tal - Organi MedDRA (SOC)
Anaemia*
Anemija *
Psychiatric disorders Nervous system disorders
Disturbi psikjatriċi
Insomnia Dizziness, headache
Telf ta ’ libido *, dipressjoni, ansjetà
Loss of libido*, depression, anxiety
Disturbi fis- sistema nervuża Disturbi fil- widnejn u fis- sistema labirintika
Ear and labyrinth disorders
Sturdament, uġigħ ta ’ ras
Tinnitus
Żanżin fil- widnejn
Atrio-ventricular block 1st degree QT prolongation*(see sections 4.4 and 4.5)
Imblokk atrioventrikulari 1el grad titwil tal- QT * (ara sezzjonijiet 4. 4 u 4. 5)
Hot flush*
Fawra *
Hypertension, vasovagal syncope, varicose vein
Pressjoni għolja, sinkope vażovagali, vina varikuża
Respiratory, thorasic and mediastinal disorders
Disturbi respiratorji, toraċiċi u medjastinali
Nausea
Nawsja
Diarrhoea, vomiting, abdominal discomfort, dry mouth, constipation
Dijarea, rimettar, skonfort addominali, ħalq xott, stitikezza
Liver transaminases increased
Żieda fit - transaminases tal - fwied
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda
Hyperhidrosis (incl. night sweats)*
Iperidrosi (li tinkludi għaraq matul il- lejl) *
Urticaria, skin hyperpigmentation, allopecia, soft nails, rash, erythema
Urtikarja, iperpigmentazzjoni tal - ġilda, alopeċja, dwiefer rotob, raxx, eritema
Musculoskeletal, connective tissue and bone disorders
Disturbi muskolu - skeltrali, tal - connective tissue u tal- għadam
Musculoskeletal pain, muscular weakness
Disturbi fil- kliewi u fis- sistema urinarja