qanastek/EMEA-V3 huggingface dataset:
The MAH shall propose a detailed methodology for the Health Care Professionals and Patient survey.
Il- MAH għandu jipproponi metodoloġija dettaljata għall- istħarriġ tal- Professjonisti tal- Kura tas- Saħħa u l- Pazjent.
In addition to the assessment of the satisfaction of eculizumab information provided, the proposed questionnaire will investigate other methods for assessing the effectiveness of the risk minimisation program (e.g. surveys to follow compliance to vaccination).
Minbarra l- evalwazzjoni tas- sodisfazzjon bl- informazzjoni pprovduta dwar eculizumab, il- kwestjonarju propost se jinvestiga metodi oħra sabiex tiġi evalwata l - effikaċja tal- programm għat- tnaqqis tar- riskju (p. e. stħarriġ sabiex isegwi l- osservanza tat - tilqim).
The evaluation of the goals for distribution of educational materials should also be considered.
L- evalwazzjoni tal- miri għat- tqassim ta ’ materjali edukattivi għandha tiġi wkoll ikkunsidrata.
The Marketing Authorisation Holder must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq irid jiżgura li s- sistema ta ’ farmakoviġilanza tkun fis- seħħ u tiffunzjona qabel ma l- prodott jitqiegħed fis- suq u għaż- żmien kollu li l- prodott fis- suq jibqa ’ jintuża.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Il- MAH jintrabat li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza dettaljati fil- Pjan ta ’ Farmakoviġilanza.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Pjan Aġġornat għall- Ġestjoni tar- Riskju għandu jiġi pprovdut skond il- Linja Gwida tal- CHMP dwar Sistemi ta ’ Ġestjoni tar- Riskju għal prodotti mediċinali li jintużaw mill - bniedem.
15 A.LABELLING
15 ANNESS III
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING Carton Label
16 A. TIKKETTA
NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion Eculizumab
Soliris 300mg konċentrat għal soluzzjoni għall- infużjoni Eculizumab
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 30 ml contains 300 mg of eculizumab (10mg/ml)
Kull kunjett ta ’ 30 ml fih 300 mg ta ’ eculizumab (10mg/ ml)
Eculizumab is a humanised monoclonal IgG2/4 k antibody produced in NS0 cell line by recombinant DNA technology.
Eculizumab huwa antikorp IgG2/ 4κ monoklonali umanizzat prodott f' linja ta ’ ċelloli NS0 b' teknoloġija tad- DNA rikombinanti.
After dilution, the final concentration of the solution to be infused is 5 mg/ml.
Wara d- dilwizzjoni, il- konċentrazzjoni finali tas- soluzzjoni li trid tiġi hija 5 mg/ ml.
LIST OF EXCIPIENTS Sodium as chloride, phosphate dibasic, phosphate monobasic, polysorbate 80 and water for injections.
Sodium bħala chloride, phosphate dibasic, phosphate monobasic, polysorbate 80 u ilma għall - injezzjonijiet.
See package leaflet for further information
Ara l- fuljett ta 'tagħrif għal aktar informazzjoni
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 x 30 ml (10 mg/ml)
Konċentrat għal soluzzjoni għall- infużjoni 1 x 30ml (10mg/ ml)
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
MOD TA ’ KIF U MNEJN JINGĦATA
Must be diluted before use.
Għal użu għal ġol- vini.
Read the package leaflet before use.
Għandu jiġi dilwit qabel jintuża.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children.
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
EXPIRY DATE EXP:
DATA TA ’ META JISKADI
After dilution, the medicinal product should be used immediately within 24 hours.
Wara d- dilwizzjoni, il- prodott mediċinali għandu jintuża immedjatament fi żmien 24 siegħa.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ (2°C – 8°C).
Do not Freeze.
Tagħmlux fil- friża.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Marketing Authorisation Holder:
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Alexion Europe SAS 54-56 Avenue Hoche 75008 PARIS France
Alexion Europe SAS 54- 56 Avenue Hoche 75008 PARIS Franza
MARKETING AUTHORISATION NUMBER(S) EU/1/07/393/001
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
BATCH NUMBER LOT:
NUMRU TAL- LOTT
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Prodott mediċinali li jingħata bir- riċetta tat- tabib.
Single use Type I glass vial
Kunjett tal- ħġieġ ta ’ Tip I għal użu ta ’ darba
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Soliris 300 mg concentrate for solution for infusion Eculizumab For intravenous use
Soliris 300mg konċentrat għal soluzzjoni għall- infużjoni Eculizumab Għal użu għal ġol- vini
METHOD OF ADMINISTRATION To be diluted before use.
Għandu jiġi dilwit qabel jintuża.
EXPIRY DATE EXP:
DATA META JISKADI
BATCH NUMBER LOT
NUMRU TAL- LOTT
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 ml (10 mg/ml)
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI
OTHER
30ml (10mg/ ml)
PACKAGE LEAFLET
OĦRAJN
INFORMATION FOR THE USER
21 FULJETT TA 'TAGĦRIF:
Soliris 300 mg, concentrate for solution for infusion Eculizumab
Soliris 300mg, konċentrat għal soluzzjoni għall- infużjoni Eculizumab
- If you have any further questions, ask your doctor or pharmacist
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex
tell your doctor or pharmacist.
imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Soliris is and what it is used for 2.
X' inhu Soliris u għalxiex jintuża 2.
Before you use Soliris 3.
Qabel ma tuża Soliris 3.
How to use Soliris 4.
Kif għandek tuża Soliris 4.
How to store Soliris 6.
Kif taħżen Soliris 6.
WHAT SOLIRIS IS AND WHAT IT IS USED FOR
X' INHU SOLIRIS U GĦALXIEX JINTUŻA
The active substance of Soliris is eculizumab and it belongs to a class of medicines called monoclonal antibodies.
Is- sustanza attiva ta ’ Soliris hi eculizumab u tappartjeni għal klassi ta ’ mediċini msejħa antikorpi monoklonali.
Eculizumab binds to and inhibits a specific protein in the body that causes inflammation.
Eculizumab jeħel ma ’ u jimpedixxi proteina speċifika fil- ġisem li tikkawża l - infjammazzjoni.
Soliris is used for the treatment of patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Soliris jintuża għall- kura ta ’ pazjenti b’ ċertu tip ta ’ marda li taffettwa s- sistema tad- demm imsejħa emoglobinurja notturna parossimali (PNH).
In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots.
F’ pazjenti b’ PNH, iċ- ċelloli ħomor tad- demm tagħhom jistgħu jinqerdu li jista ’ jwassal għal livelli baxxi tad- demm (anemija), għeja, diffikultà biex tiffunzjona, uġigħ, awrina skura, qtugħ ta ’ nifs, u emboli.
Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells.
Ezulizumab jista ’ jimblokka r- rispons infjammatorju tal- ġisem, u l- ħila tiegħu li jattakka u jeqred iċ- ċelloli tad- demm PNH vulnerabbli tiegħu stess.
There is only experience in the treatment of patients with previous history of transfusions.
Hemm esperjenza biss fil- kura ta ’ pazjenti bi storja preċedenti ta ’ trasfużjonijiet.
BEFORE YOU USE SOLIRIS
QABEL MA TUŻA SOLIRIS
Do not use Soliris
Tużax Soliris
- if you are allergic (hypersensitive) to eculizumab, proteins derived from mouse products, have
- jekk int allerġiku/ a (sensittiv/ a żżejjed) għal eculizumab, proteini derivati minn prodotti tal -
(See Section 6, What Soliris contains).
ġrieden, kellek reazzjoni allerġika għal antikorpi monoklonali oħra, jew għal xi sustanzi oħra ta ’ Soliris (Ara Sezzjoni 6, X’ fih Soliris).
- If you have not been vaccinated against meningitis infection.
- Jekk ma ġejtx imlaqqam kontra infezzjoni tal- meninġite.
- If you have a meningitis infection.
- Jekk għandek infezzjoni tal- meninġite.
- If you have a disease that alters your immune system.
- Jekk għandek marda li taffettwa s- sistema immuni tiegħek.
Take special care with Soliris
Oqgħod attent ħafna b' Soliris
Meningitis alert:
Twissija ta 'meninġite:
Soliris treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningitis.
Il- kura b' Soliris tista 'tnaqqas ir- reżistenza naturali tiegħek kontra l- infezzjonijiet, speċjalment kontra ċerti organiżmi li jikkawżaw il- meninġite.
Consult your doctor before you take Soliris to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningitis, at least 2 weeks before beginning therapy, or that your current meningitis vaccination is up to date.
Ikkonsulta mat- tabib tiegħek qabel tieħu Soliris biex tkun żgur li tirċievi tilqima kontra Neisseria meningitidis, organiżmu li jikkawża l- meninġite, talanqas ġimagħtejn qabel ma tibda t- terapija, jew li t- tilqima attwali tiegħek kontra l- meninġite hija aġġornata.
You should also be aware that vaccination may not
Għandek tkun taf ukoll li t- tilqim jista 'ma
21 prevent this type of infection.
22 jevitax din it- tip ta 'infezzjoni.
In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
Konformi ma ’ rakkomandazzjonijiet nazzjonali, it- tabib tiegħek jista ’ jikkunsidra li teħtieġ miżuri supplimentari biex tevita infezzjoni.
Meningitis symptoms Because of the importance of rapidly identifying and treating certain types of infection in patients who receive Soliris, you will be provided a card to carry with you, listing specific trigger symptoms.
Sintomi tal- meninġite Minħabba l- importanza li jiġu identifikati u kkurati malajr ċerti tipi ta 'infezzjonijiet f' pazjenti li jirċievu Soliris, inti se tingħata kard biex iġġorrha miegħek, li telenka sintomi speċifiċi ta' allarm.
This card is named: “Patient Safety Card”..
Din il- kard jisimha: “ Kard għas- Sigurtà tal- Pazjent ”.
If you experience any of the following symptoms, you should immediately inform your doctor:
Jekk tħoss xi wieħed minn dawn is- sintomi, inti għandek iċċempel minnufih lit- tabib tiegħek:
- bothersome headache with nausea or vomiting
- uġigħ ta 'ras fastidjuż b' nawsja jew rimettar;
- bothersome headache with a stiff neck or back
- uġigħ ta 'ras fastidjuż b' għonq iebes jew dahar iebes;
- fever
- deni;
- fever and a rash
- deni u raxx;
- confusion
- konfużjoni;
- severe muscle aches combined with flu-like symptoms
- uġigħ sever fil- muskoli flimkien ma 'sintomi bħal ta' l- influwenza;
- sensitivity to light
- sensittività għad- dawl.
Treatment for meningitis while travelling If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you.
Kura għall- meninġite waqt l- ivvjaġġar Jekk tkun qiegħed tivvjaġġa f' reġjun remot fejn ma tkunx tista 'tikkuntattja lit- tabib tiegħek jew fejn issib ruħek għal xi żmien li ma tistax tirċievi kura medika, it- tabib tiegħek jista' jagħmel arranġamenti sabiex tinħareġ, bħala miżura preventiva, riċetta għal antibijotiku kontra Neisseria meningitidis li inti żżomm miegħek.
If you experience any of the symptoms amongst those cited above, you should take a tablet of antibiotic.
Jekk tħoss xi sintomi fost dawk imsemmija fuq, inti għandek tieħu pillola ta ’ antibijotiku.
You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotic tablets.
Ftakar li għandek tara tabib mill- aktar fis, anki jekk tħossok aħjar wara li tkun ħadt il - pilloli antibijotiċi.
Infections Inform your doctor before you take Soliris if you have any infections.
Infezzjonijiet Avża lit- tabib tiegħek qabel tieħu SOLIRIS jekk ikollok xi infezzjonijiet.
Allergic reactions Soliris contains a protein and proteins can cause allergic reactions in some people.
Reazzjonijiet allerġiċi Soliris fih proteina, u l- proteini jistgħu jikkawżaw reazzjonijiet allerġiċi f’ ċerti nies.
Using Soliris with other medicines:
Meta tuża Soliris ma 'mediċini oħra:
Using Soliris with food and drink:
Meta tuża Soliris ma ’ l- ikel u max- xorb:
Interactions between your treatment with Soliris and food or drink are unlikely.
Mhumiex probabbli interazzjonijiet bejn il- kura tiegħek b’ Soliris u l- ikel u x- xorb.
Woman of childbearing potential:
Nisa li jistgħu jinqabdu tqal:
Women who are able to get pregnant should use adequate contraception methods during treatment and up to 5 months after treatment.
Nisa li jistgħu jinqabdu tqal għandhom jużaw metodi ta ’ kontraċezzjoni adegwati matul il- kura u sa 5 xhur wara l- kura.
Ask your doctor or pharmacist for advice before using any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tuża xi mediċina.
Pregnancy Tell your doctor before starting treatment with Soliris if you are pregnant or plan to become pregnant..
Tqala Avża lit- tabib tiegħek qabel tibda l- kura b’ Soliris jekk inti tqila jew qed tippjana biex tinqabad tqila.
Soliris is not recommended during pregnancy.
Soliris mhux rakkomandat waqt it- tqala.
Breast-feeding Soliris may pass through your breast milk to your baby.
Treddigħ Soliris jista ’ jgħaddi mill- ħalib tas- sider tiegħek għat- tarbija.
Therefore, you should not breast-feed while using Soliris.
Għalhekk, inti m’ għandekx tredda ’ waqt li tkun qed tuża Soliris.
22 The effects on the ability to drive and to use machines have not been studied.
L- effetti fuq il- ħila biex issuq u tħaddem magni ma ġewx studjati.
As with all medicines, you should ask for advice from your doctor.
Bħal kull mediċina oħra, inti għandek titlob il- parir tat- tabib tiegħek.
Elderly people There is no evidence to suggest that any special precautions are needed when older people (65 years and over) are treated – although experience is still limited.
23 Persuni anzjani M’ hemmx evidenza li tissuġġerixxi li jeħtieġu xi prekawzjonijiet speċjali meta jiġu kkurati persuni anzjani (65 sena u aktar) – għalkemm l- esperjenza għadha limitata.
Children and adolescents Soliris has not been administered to patients less than 18 years of age.
Tfal u adoloxxenti Soliris ma ġiex mogħti lil pazjenti ta ’ anqas minn 18- il sena.
Important information about some of the ingredients of Soliris This medicinal product contains 5.00 mmol sodium per dose (1 vial).
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Soliris Dan il- prodott mediċinali fih 5. 00 mmol sodju kull doża (kunjett).
HOW TO USE SOLIRIS
KIF GĦANDEK TUŻA SOLIRIS
Prior to beginning treatment, your doctor will discuss with you the importance of:
Qabel ma tibda l- kura, it- tabib tiegħek għandu jiddiskuti miegħek l- importanza li:
- Receiving a vaccine against meningitis,
- Tieħu tilqima kontra l- meninġite,
- Becoming knowledgeable about symptoms associated with infections, and
- Issir taf dwar is- sintomi assoċjati ma 'l- infezzjonijiet, u
- Being carefully monitored by your doctor following any discontinuation of Soliris treatment.
- Tkun immonitorjat b' attenzjoni mit- tabib tiegħek wara kwalunkwe twaqqif ta 'kura b' Soliris.
At least 14 days before you start treatment with Soliris, your doctor will administer a vaccine against meningitis if it was not previously administered or if your vaccination is outdated.
Mill- anqas 14- il jum qabel ma tibda l- kura b' Soliris, it- tabib tiegħek jagħtik tilqima kontra l- meninġite jekk din ma tkunx ingħatat qabel jew jekk it- tilqima ma tkunx għadha tgħodd.
Instructions for proper use The treatment will be given by your doctor or other health care provider by infusing a dilution of the Soliris vial from a drip bag through a tube directly into one of your veins.
Struzzjonijiet għal użu korrett Il- kura għandha tingħata mit- tabib tiegħek jew fornitur ieħor tal- kura tas- saħħa bl- infużjoni ta 'dilwizzjoni tal- kunjett ta' Soliris minn borża tad- dripp għal ġo tubu direttament f' waħda mill- vini tiegħek.
It is recommended that the beginning of your treatments, called the initial phase, will extend over 5 weeks, followed by a maintenance phase:
Huwa rakkomandat li l- bidu tal- kura tiegħek, imsejjaħ il- fażi inizjali, jestendi fuq 5 ġimgħat, segwiti minn fażi ta 'manteniment:
Initial Phase: • Every week for the first four weeks, your doctor will administer an intravenous infusion of diluted Soliris.
Fażi Inizjali: • Kull ġimgħa għall- ewwel erba 'ġimgħat, it- tabib tiegħek jagħtik infużjoni fil- vini ta' Soliris dilwit.
Each infusion will consist of a dose of 600 mg (2 vials of 30 ml) and will take approximately 30 minutes. • In the fifth week your doctor will administer an intravenous infusion of diluted Soliris at a dose of 900 mg (3 vials of 30 ml) over a 30 minute period.
Kull infużjoni tkun tikkonsisti minn doża ta '600mg (2 kunjetti ta' 30ml) u tieħu madwar 30 minuta. • Fil- ħames ġimgħa t- tabib tiegħek għandu jagħtik infużjoni fil- vini ta 'Soliris dilwit f' doża ta' 900mg (3 kunjetti ta '30ml) fuq perjodu ta' 30 minuta.
Maintenance Phase: • After the fifth week, your doctor will administer 900 mg of diluted Soliris every two weeks as a long-term treatment.
Fażi ta 'Manteniment: • Wara l- ħames ġimgħa, it- tabib tiegħek għandu jagħtik 900mg ta' Soliris dilwit kull ġimgaħtejn bħala kura fuq perjodu fit- tul.
Following each infusion, you will be monitored for about one hour.
Wara kull infużjoni, inti se tkun immonitorjat għal madwar siegħa.
Your doctor’s instructions should be carefully observed.
L- istruzzjonijiet tat- tabib tiegħek għandhom jiġu osservati bir- reqqa.
If you receive more Soliris than you should If you suspect that you have been accidentally administered a higher dose of Soliris than prescribed, please contact your doctor for advice.
Jekk tingħata Soliris aktar milli suppost Jekk tissuspetta li bi żball ingħatajt doża akbar ta 'Soliris milli ordnat, jekk jogħġbok ikkuntattja lit - tabib tiegħek għal parir.
If you forget an appointment to receive Soliris If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Soliris”
Jekk tinsa appuntament biex tingħata Soliris Jekk tinsa appuntament, jekk jogħġbok ikkuntattja lit- tabib tiegħek minnufih għal parir u ara s - sezzjoni ta 'hawn taħt “ Jekk ma tkomplix tuża Soliris ”
If you stop using Soliris Interrupting or ending treatment with Soliris may cause your PNH symptoms to come back more severely soon after stopping Soliris treatment.
Jekk ma tkomplix tuża Soliris L- interruzzjoni jew twaqqif tal- kura b’ Soliris jistgħu jikkawżaw lis- sintomi tal- PNH tiegħek biex jerġgħu jitfaċċaw b’ mod sever immedjatament wara li twaqqaf il- kura b’ Soliris.
If you stop treatment with Soliris, your doctor will
Jekk twaqqaf il- kura b' Soliris, it- tabib tiegħek se jiddiskuti miegħek l- effetti sekondarji possibbli u jispjega r- riskji.
23 discuss the possible side effects with you and explain the risks.
It- tabib tiegħek ikun irid ikompli jimmonitorjak mill- viċin.
The risks of stopping Soliris include an increase in the destruction of your red blood cells, which may cause:
24 Ir- riskji jekk twaqqaf Soliris jinkludu żieda fil- qerda taċ- ċelloli ħomor tad- demm tiegħek, li tista 'tikkawża:
- A significant fall in your red blood cell counts (anaemia),
- Tnaqqis sinifikanti fl- għadd taċ- ċelloli ħomor tad- demm tiegħek (anemija),
- You to be confused or unalert,
- Inti tkun konfuż u mhux attent,
- Chest pain, or angina,
- Uġigħ fis- sider, jew anġina,
- An increase in your serum creatine level (problems with your kidneys), or
- Żieda fil- livell ta 'kreatina fis- serum tiegħek (problemi bil- kliewi), jew
- Thrombosis (blood clotting).
- Trombożi (tagħqid tad- demm).
If you have any of these symptoms, contact your doctor.
Jekk ikollok xi wieħed minn dawn is- sintomi, ikkuntattja lit- tabib tiegħek.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta 'dan il- prodott, staqsi lit- tabib jew lill- spiżjar tiegħek.
Like all medicines, Soliris can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Soliris jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects caused by Soliris are usually mild or moderate.
L - effetti sekondarji kkawżati minn Soliris normalment huma ħfief jew moderati.
Your doctor will discuss the possible side effects with you and explain the risks and benefits of Soliris with you prior to treatment.
It- tabib tiegħek se jiddiskuti miegħek l- effetti sekondarji possibbli u jiddiskuti miegħek ir- riskji u l- benefiċċji ta ’ Soliris qabel il- kura.
If you are not sure what the side effects below are, ask your doctor to explain them to you.
Jekk m' intix ċert x' inhuma l- effetti sekondarji ta 'hawn isfel, staqsi lit- tabib tiegħek biex jispjegahomlok.
Very common side effects (occurring in at least 1 in 10 patients) include: runny nose or sore throat, urinary infection (bladder infection), headaches, dizziness, nausea, diarrhoea, back pain, pain in joints, fever, and bruise.
Effetti sekondarji komuni ħafna (iseħħu f’ mill- anqas 1 minn kull 10 pazjenti) jinkludu: imnieħer inixxi jew mard tal- gerżuma, infezzjoni ta ’ l- apparat urinarju (infezzjoni tal- bużżieqa ta ’ l- awrina), uġigħ ta ’ ras, sturdament, dardir, dijarea, uġigħ fid- dahar, uġigħ fil- ġogi, deni, u tbenġil.
Common side effects (occurring in 5 or more out of 100 patients and less than 10 in 100 patients) include: herpes simplex (cold sores), sinus infection (sinusitis), viral infection, stomach flu (gastroenteritis), lung infection, insomnia, cough, sore throat, bloody nose, abdominal pain, constipation, vomiting, upper abdominal pain, itchy skin, rash, muscle aches, pain in the limbs (arms and legs), muscle cramp, fatigue, and influenza-like illness.
Effetti sekondarji komuni (iseħħu f’ 5 pazjenti jew aktar minn kull 100 u f’ anqas minn 10 minn kull 100 pazjent) jinkludu: herpes simplex (cold sores), infezzjoni tas- sinus (sinożite), infezzjoni virali, riħ fl- istonku (gastro- enterite), infezzjoni fil- pulmun, nuqqas ta ’ rqad, sogħla, uġigħ fil- griżmejn, fsada mill- imnieħer, uġigħ addominali, stitikezza, rimettar, uġigħ fin- naħa ta ’ fuq ta ’ l- addome, ġilda li ġġiegħlek tħokk, raxx, uġigħ fil- muskoli, uġigħ fid - dirgħajn u r- riġlejn, bugħawwieġ, għeja, u mard jixbah lill- influwenza.
If any of these 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 minn dawn l- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji mhux elenkati f' dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE SOLIRIS
KIF TAĦŻEN SOLIRIS
Keep out of the reach of children.
Żommu fejn ma jintlaħaqx mit- tfal.
Store in a refrigerator (2°C – 8°C) Do not freeze.
Aħżen fi friġġ (2°C - 8°C) Tagħmlux fil- friża.
Do not use Soliris after the expiry date which is stated on the label after “EXP”.
Tużax Soliris wara d- data ta ’ skadenza li tidher fuq it- tikketta wara "JIS".
After dilution, the product should be used immediately within 24 hours.
Wara d- dilwizzjoni, il- prodott għandu jintuża immedjatament fi żmien 24 siegħa.
What Soliris contains
X' fih Soliris
The active substance is eculizumab (300 mg/30 ml in a vial corresponding to 10 mg/ml).
Is- sustanza attiva hija eculizumab (300 mg/ 30 ml f’ kunjett li jikkorrispondu għal 10 mg/ ml).
- sodium phosphate monobasic
- sodium phosphate monobasic
- sodium phosphate dibasic
- sodium phosphate dibasic
- sodium chloride
- sodium chloride
- polysorbate 80 (vegetable origin)
- polysorbate 80 (oriġini veġetali)
What Soliris looks like and contents of the pack Soliris is presented as a concentrate for solution for infusion (30 ml in a vial – pack size of 1).
Id- Dehra ta 'Soliris u l- kontenut tal- pakkett Soliris huwa ppreżentat bħala konċentrat għal soluzzjoni għall- infużjoni (30 ml f’ kunjett – pakkett ta ’ 1).
Soliris is a clear and colorless solution.
Soliris hija soluzzjoni ċara u bla kulur.
Marketing Authorisation Holder and Manufacturer:
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur:
Marketing Authorisation Holder:
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Alexion Europe SAS 54-56 Avenue Hoche 75008 Paris Tel: +33 (0) 1 56 60 52 18 France
Alexion Europe SAS 54- 56 Avenue Hoche 75008 Paris Franza
Almac Pharma Service Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom
Almac Pharma Service Seagoe Industrial Estate Craigavon BT63 5QD Renju Unit
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq.
Tel: +33 (0) 1 56 60 52 18 alexion.france@alxn.com
26 Tel: +33 (0) 1 56 60 52 18 alexion. france@ alxn. com
This leaflet was last approved in June 2007.
28 Dan il- fuljett kien approvat l- aħħar f 'ġunju 2007.
There are also links to other websites about rare diseases and treatments.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu / Hemm ukoll links għal websites oħra dwar mard rari u kura.
27 --------------------------------------------------------------------------------------------------------------------------- -------
29 --------------------------------------------------------------------------------------------------------------------------- ---
Instructions for Use for Healthcare Professionals Handling Soliris
Struzzjonijiet dwar l- Użu għall- Professjonisti tal- Kura tas- Saħħa Maniġġar ta 'Soliris
The following information is intended for medical or healthcare professionals only:
It- tagħrif li ġej qed jingħata biss għall- professjonisti fil- qasam mediku u tal- kura tas- saħħa:
1- How is Soliris supplied?
1 - Kif inhu fornut Soliris?
Each vial of Soliris contains 300 mg of active ingredient in 30 ml of product solution.
Kull kunjett ta ’ Soliris fih 300 mg ta ’ sustanza attiva fi 30 ml ta ’ soluzzjoni tal- prodott.
2- Before Administration Reconstitution and dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
2 - Qabel ma Jingħata Ir- rikostituzzjoni u d- dilwizzjoni għandhom jitwettqu skond regoli ta ’ prattika tajba, b’ mod partikolari fir- rigward asettiku.
Soliris should be prepared for administration by a qualified healthcare professional using aseptic technique. • Inspect visually Soliris solution for particulate matter and discolouration • Withdraw the required amount of Soliris from the vial(s) using a sterile syringe. • Transfer the recommended dose to an infusion bag. • Dilute Soliris to a final concentration of 5 mg/ml (initial concentration divided by 2) by adding the appropriate amount of diluent to the infusion bag.
Soliris għandu jiġi ppreparat biex jingħata minn professjonist tal- kura tas- saħħa kkwalifikat billi tintuża teknika asettika. • Eżamina viżwalment is- soluzzjoni ta ’ Soliris għal frak u bdil fil- kulur. • Iġbed l- ammont meħtieġ mill- kunjett( i) billi tuża siringa sterilizzata. • Ittrasferixxi d- doża rakkomandata għal borża ta 'l- infużjoni magħmula mill- kloridu tal- vinil. • Iddilwa Soliris għal konċentrazzjoni finali ta' 5mg/ ml (il- konċentrazzjoni inizjali diviża bin- nofs) billi żżid l- ammont korrett ta 'dilwent mal- borża ta' l- infużjoni.
For 600mg doses, use 60 ml of Soliris (10mg/ml) and add the same volume of diluent.
Għal dożi ta '600mg, uża 60ml ta' Soliris (10mg/ ml) u żid l- istess volum ta 'dilwent.
For 900 mg use 90 ml of Soliris and add 90 ml of diluent.
Għal 900mg uża 90ml ta 'Soliris u żid 90ml ta' dilwent.
The final volume of a 5 mg/ml diluted Soliris solution is 120 ml for 600 mg doses or 180 ml for 900 mg doses.
Il- volum finali ta '5mg/ ml soluzzjoni dilwita ta' Soliris huwa 120ml għal dożi ta '600mg jew 180ml għal dożi ta' 900mg.
Diluents are 0.9% Sodium chloride, 0.45% Sodium chloride or 5% Dextrose in Water • Gently agitate the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the medicinal product and diluent. • The diluted solution should be allowed to warm to room temperature [18°-25° C] prior to administration by exposure to ambient air. • Discard any unused portion left in a vial as the medicinal product contains no preservatives. • Diluted solutions of Soliris may be stored at 2°C -8° C for up to 24 hours prior to administration.
Id- dilwenti huma 0. 9% Sodium chloride, 0. 45% Sodium chloride jew 5% Dextrose fl- Ilma. • Ħawwad b' mod ġentili l- borża ta 'l- infużjoni li fiha s- soluzzjoni dilwita ta ’ Soliris biex tiżgura taħlita sewwa tal- prodott mediċinali u d- dilwent. • Qabel ma tingħata, is- soluzzjoni dilwita għandha titħalla tisħon għat- temperatura tal- kamra billi tkun esposta għall- arja ta' l- ambjent. • Armi kwalunkwe porzjon mhux użat li jifdal f' kunjett billi l- prodott mediċinali ma fih ebda preservattivi. • Soluzzjonijiet dilwiti ta ’ Soliris jistgħu jinħażnu f' temperatura ta '2°C- 8°C sa 24 siegħa qabel ma jingħataw.
3- Administration • Do not administer Soliris as an intravenous Push or Bolus Injection • Soliris should only be administered via intravenous infusion and must be diluted to a final concentration of 5 mg/ml prior to administration..
3 - Kif jingħata • Tagħtix Soliris bħala intravenous Push jew Injezzjoni Bolus. • Soliris għandu jingħata biss permezz ta 'infużjoni fil- vini u jrid jiġi dilwit għal konċentrazzjoni finali ta' 5mg/ ml qabel ma jingħata.
Diluted solutions of Soliris are stable for 24 hours at 2°C-8°C.
Is- soluzzjonijiet dilwiti ta ’ Soliris huma stabbli għal 24 siegħa f’ temperatura ta ’ 2°C- 8°C.
Prior to administration, the diluted solution should be allowed to warm to room temperature by exposure to ambient air.
Qabel ma tingħata, is- soluzzjoni dilwita għandha titħalla tisħon għat - temperatura tal- kamra billi tkun esposta għall- arja ta 'l- ambjent.
The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature. • The diluted solution of Soliris should be administered by intravenous infusion over 25 to 45 minutes via gravity feed, a syringe-type pump, or an infusion pump.
Is- soluzzjoni dilwita m' għandhiex tiġi msaħħna f' majkrowejv jew b' xi sors ta 'sħana għajr it- temperatura attwali tal- kamra. • Is- soluzzjoni dilwita ta ’ Soliris għandha tingħata b' infużjoni fil- vini fuq 25 sa 45 minuta permezz ta' gravity feed, pompa t- tip ta 'siringa, jew pompa ta' l- infużjoni.
It is not necessary to protect the diluted solution of Soliris from light during administration to the patient.
Mhux meħtieġ li s- soluzzjoni dilwita ta ’ Soliris tiġi protetta mid- dawl waqt li tkun qiegħda tingħata lill- pazjent.
The patient should be monitored for one hour following infusion.
Il- pazjent għandu jiġi mmonitorjat għal siegħa wara l- infużjoni.
4- Special Handling and Storage Soliris vials must be stored in the original carton until time of use under refrigerated conditions at 2- 8ºC and protected from light.
4 - Immaniġġar Speċjali u Ħażna Il- kunjetti ta ’ Soliris iridu jinħażnu fi friġġ f’ temperatura ta ’ 2- 8ºC, fil- kartuna oriġinali u protetti mid - dawl sakemm jiġu biex jintużaw.
Do not use beyond the expiration date stamped on the carton.
Tużax wara d- data ta 'skadenza stampata fuq il- kartuna
What is SOMAVERT?
X’ inhu SOMAVERT?
SOMAVERT is a powder and solvent that are mixed together to make up a solution for injection.
SOMAVERT huwa trab u solvent li jitħalltu flimkien biex jiffurmaw taħlita għall- injezzjoni.
It contains the active substance pegvisomant (10, 15 or 20 mg/ ml).
Huwa fih is- sustanza attiva pegvisomant (10, 15 jew 20 mg/ ml).
What is SOMAVERT used for?
Għal x' hiex jintuża SOMAVERT?
SOMAVERT is used to treat patients with acromegaly (a rare hormonal disorder that usually occurs in middle-aged adults, which is caused by the pituitary gland producing excess growth hormone).
SOMAVERT huwa użat għall- kura ta ’ pazjenti li jbatu minn acromegaly (marda ormonali rari li s - soltu jomordu biha adulti ta ’ mezza età, li hija ikkawżata minħabba li l- glandola pituwitarja tipproduċi l- ormon tat- tkabbir b’ mod eċċessiv).
SOMAVERT is used in patients who did not respond well to surgery or radiation therapy, or to treatment with somatostatin analogues (another type of medicine used in acromegaly).
SOMAVERT huwa użat f’ pazjenti li ma rrispondewx tajjeb għall- kirurġija u t- terapija bir- radjazzjoni, jew għall- kura bl- analogi somatostatin (tip ieħor ta ’ mediċina użata f’ acromegaly).
Because the number of patients with acromegaly is low, the disease is considered ‘ rare’, and SOMAVERT was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 14 February 2001.
Billi l- għadd ta 'pazjenti li jbatu minn acromegaly huwa wieħed baxx, il- marda hija meqjusa' rari ', u SOMAVERT ġie ikkategorizzat bħala' mediċina orfni '(mediċina użata fil- mardiet rari) fl- 14 ta' Frar 2001.
How is SOMAVERT used?
Kif jintuża SOMAVERT?
SOMAVERT treatment should be initiated by a doctor who has experience in the treatment of acromegaly.
Il- kura b’ SOMAVERT għandha tinbeda minn tabib li jkollu esperjenza fil- kura ta ’ acromegaly.
SOMAVERT is given by subcutaneous injection (under the skin).
SOMAVERT jingħata b' injezzjoni taħt il- ġilda (subcutaneous).
The patient first receives a loading dose of 80 mg under medical supervision.
Il- pazjent l- ewwel jirċievi doża ta ’ tagħbija ta ’ 80mg taħt sorveljanza medika.
Following this, SOMAVERT is given as a subcutaneous injection of 10 mg once a day.
Umbagħad, SOMAVERT jiġi mogħti bħala injezzjoni taħt il- ġilda ta ’ 10mg darba kuljum.
The patient or caregiver can inject SOMAVERT, after training by a doctor or a nurse.
Il- pazjent jew min jieħu ħsiebu jistgħu jinjettaw SOMAVERT, wara taħriġ minn tabib jew infermiera.
The doctor should check the response every four to six weeks and adjust the dose if needed.
It- tabib għandu jiċċekkja r- reazzjoni kull erba ’ sa sitt ġimgħat u jaġġusta d- doża kif meħtieġ.
The maximum dose is 30 mg per day.
Id- doża massima hija ta ’ 30 mg kull jum.
How does SOMAVERT work?
Kif jaħdem SOMAVERT?
Acromegaly happens because the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour.
Acromelagy timmanifesta ruħha minħabba li l- glandola pituwitarja li tinstab fil- parti inferjuri tal - moħħ tipproduċi l- ormon tat- tkabbir b’ mod eċċessiv, ġeneralment minħabba tumur beninn (mhux kanċeruż).
Growth hormone promotes growth during childhood and adolescence.
L- ormon tat- tkabbir jippromwovi l- kobor matul l- infanzja u l- adoloxxenza.
In acromegaly, this overproduction causes overgrowth of bone, swelling of soft tissue (such as the hands and feet), heart disease and other disorders.
F ’ acromegaly, din il- produzzjoni eċċessiva tikkawża kobor żejjed ta ’ l- għadam, nefħa fit- tessut artab (bħal- idejn u bħas- saqajn), mard tal- qalb u mard ieħor.
The active substance in SOMAVERT, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally fixes itself.
Is- sustanza attiva f’ SOMAVERT, pegvisomant, hija simili ħafna għall- ormon tat- tkabbir uman, imma ġiet iddisinjata ħalli timblokka r- riċetturi ma ’ liema l - ormon tat- tkabbir normalment jeħel.
By blocking the receptors, it prevents growth hormone from having an effect.
Billi timblokka r- riċetturi, hija tipprevjeni l- ormon tat- tkabbir milli jkollu effett.
This helps SOMAVERT prevent the unwanted growth and other disorders seen in acromegaly.
Dan jgħin lill- SOMAVERT jipprevjeni t- tkabbir mhux mixtieq u mard ieħor ikkawżat minn acromegaly.
Pegvisomant is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA) that makes it able to produce the substance.
Pegvisomant huwa prodott b’ metodu magħruf bħala ‘ teknoloġija
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 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 SOMAVERT been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 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 rikombinanti tad- DNA ’: huwa magħmul minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi jipproduċi s- sustanza.
SOMAVERT has been studied in 112 patients with acromegaly in a 12-week study.
SOMAVERT ġie studjat f’ 112 – il pazjent b’ acromegaly fi studju ta ’ 12 – il ġimgħa.
Three different doses of the medicine (10, 15 or 20 mg/ day) were compared with placebo (a dummy treatment).
Tlett dożi different ital- mediċina (10, 15 jew 20mg/ ġurnata) ġew imqabbla ma ’ plaċebo (kura finta).
The effectiveness was measured by comparing the levels of insulin-like growth factor-I (IGF-I) before and at the end of the study.
L- effikaċja ġiet imkejjla billi tqabblu l- livelli tal- fattur- I tat- tkabbir li jixbaħ lill- insulina (IGF- I) qabel u fl- aħħar ta ’ l- istudju.
IGF-I is regulated by human growth hormone and causes growth in the body.
IGF- I huwa regolat mill- ormon tat- tkabbir uman u jġiegħel lil ġisem jikber.
What benefit has SOMAVERT shown during the studies?
Liema benefiċċju wera SOMAVERT waqt l- istudji li ġew mwettqa?
SOMAVERT lowered IGF-I levels at all of the doses tested.
SOMAVERT naqqas il- livelli IGF- I fid- dożi kollha ittestjati.
IGF-I was normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/ day SOMAVERT, respectively, compared with 9.7% of the patients treated with placebo.
IGF- I kien normali fl- aħħar ta ’ l- istudju (ġimgħa 12) fi 38. 5%, 75% jew 82% tal- pazjenti kkurati bi 10, 15 jew 20 mg/ ġurnata ta ’ SOMAVERT, rispettivament, meta mqabbel ma 9. 7% tal- pazjenti ikkurati bi plaċebo.
What is the risk associated with SOMAVERT?
X’ inhu r- riskju assoċjat ma ’ SOMAVERT?
The most common side effects of SOMAVERT during the clinical study were injection site reactions (seen in 11% of the patients), sweating (7%), headache (6%) and asthenia (loss of strength and energy, 6%).
L- iktar effetti komuni sekondarji b’ SOMAVERT matul l- istudju kliniku kienu reazzjonijiet fuq is- sît ta ’ l- injezzjoni (li deheru f’ 11% tal- pazjenti), ħruġ ta ’ għaraq (7%), uġigħ ta ’ ras (6%) u astenja (telfa ta ’ saħħa u enerġija, 6%).
Some patients who received SOMAVERT developed anti-growth hormone antibodies (proteins that are produced in response to SOMAVERT).
Uħud mill- pazjenti li ħadu SOMAVERT żviluppaw antikorpi kontra l - ormon tat- tkabbir (proteini illi huma prodotti b’ reazzjoni għall- SOMAVERT).
For the full list of all side effects reported with SOMAVERT, see the Package Leaflet.
Għal- lista sħiħa ta 'l - effetti sekondarji kollha rrapportati b' SOMAVERT, ara l- Fuljett ta' Tagħrif.
SOMAVERT should not be used in people who may be hypersensitive (allergic) to pegvisomant or any of the other ingredients.
SOMAVERT m’ għandux jintuża f’ nies li jista ’ jkollhom sensittività żejda (allerġiċi) għall - pegvisomant jew għal xi ingredjenti oħra.
Diabetic patients using the medicine have a risk of hypoglycaemia (low blood sugar), and their antidiabetes treatment may need to be adjusted.
Pazjenti dijabetiċi li jużaw il- mediżina għandhom riskju ta ’ ipogliċimija (livell baxx taz- zokkor), u l- kura anti dijabetika tagħhom għandu mnejn ikollha bżonn tiġi aġġustata.
Why has SOMAVERT been approved?
Għaliex ġie approvat SOMAVERT?
The Committee for Medicinal products for Human Use (CHMP) decided that SOMAVERT’ S benefits are greater than its risks for the treatment of patients with acromegaly who have had an inadequate response to surgery and/ or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-I concentrations or was not tolerated.
Il- Kumitat Għal Prodotti Mediċinali għall- Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ SOMAVERT huma akbar mir- riskji tiegħu għall- kura ta ’ pazjenti li kellhom reazzjoni inadegwata għall- kirurġija u/ jew għat- terapija tar- radjazzjoni u li kura xierqa medika bl- analogi somatostatin ma nnormalizzatx il- konċentrazzjonijiet ta ’ l- IGF- I fihom jew ma ġiet ittollerata.
The Committee recommended that SOMAVERT be given marketing authorisation.
Il- Kumitat irrakkomanda li SOMAVERT jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Somavert:
Informazzjoni oħra dwar SOMAVERT:
The European Commission granted a marketing authorisation valid throughout the European Union for SOMAVERT to Pfizer Limited on 13 November 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal SOMAVERT lill- Pfizer Limited fit- 13 ta ’ Novembru 2002.
The marketing authorisation was renewed on 13 November 2007.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fit- 13 ta ’ Novembru 2007.
The full EPAR for SOMAVERT is available here.
http: // ec. europa. eu/ enterprise/ pharmaceuticals/ register/ o023. htmIr- rekord tan- nominazzjoni ta ’ SOMAVERT bħala mediċina orfni huwa disponibbli minn hawnhekk. http: // www. emea. europa. eu/ humandocs/ Humans/ EPAR/ somavert/ somavert. htmL- EPAR sħiħ dwar SOMAVERT jinstab hawnhekk.
This summary was last updated in 11-2007.
Dan is- sommarju ġie aġġornat l- aħħar fil- 11- 2007.
Strength
Mnejn jing ata
Route of Administration
Qawwa G amla farma ewtika
EU/ 1/ 02/ 240/ 001
EU/ 1/ 02/ 240/ 001 Somavert
Powder and solvent for solution for injection
Trab u solvent g al soluzzjoni g all- injezzjoni
Powder: vial (glass) Solvent: vial (glass)
Trab: kunjett (ie Solvent: kunjett (
10 mg; Solvent:
10mg Solvent:
8 ml
8ml
30 vials + 30 vials
30 kunjett + 30 kunjett
EU/ 1/ 02/ 240/ 002
EU/ 1/ 02/ 240/ 002 Somavert
15 mg; Solvent:
15mg Solvent:
EU/ 1/ 02/ 240/ 003
EU/ 1/ 02/ 240/ 003 Somavert
20 mg; Solvent:
20mg Solvent:
EU/ 1/ 02/ 240/ 004
EU/ 1/ 02/ 240/ 004 Somavert
Powder: vial (glass); Solvent: vial (glass)
Trab: kunjett (ie Solvent: kunjett (
SOMAVERT 10 mg powder and solvent for solution for injection.
SOMAVERT 10 mg trab u solvent għal soluzzjoni għal injezzjoni.
Each vial contains 10 mg of pegvisomant.
Kull kunjett fih 10 mg ta ’ pegvisomant.
After reconstitution, 1 ml of solution contains 10 mg pegvisomant.
Wara rikostituzzjoni, 1 ml ta ’ soluzzjoni jkollu 10 mg pegvisomant.
Pegvisomant is produced in E. Coli by recombinant DNA technology.
Coli b’ teknologija rikombinanti tad- DNA.
The powder is white to slightly off-white.
It- trab huwa ta ’ lewn abjad għal daqsxejn offwajt.
Treatment of patients with acromegaly who have had an inadequate response to surgery and/ or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated.
Trattament ta ’ pazjenti b’ akromegalija li kellhom reazzjoni mhux tajba biżżejjed (inadegwata) għall - kirurġija u/ jew għat- terapija ta ’ radjazzjoni, fejn trattament mediku xieraq bi prodotti analogi ta ’ somatostatin ma nnormalizzawx il- konċentrazzjonijiet ta ’ IGF- I jew ma ġiex ittollerat.
Treatment should be initiated under the supervision of a physician experienced in the treatment of acromegaly.
It- trattament għandu jinbeda taħt is- superviżjoni ta ’ tabib li għandu esperjenza fil- kura ta ’ l - akromegalija.
For the different dosage regimens the following strengths are available:
Għall- amministrazzjoni ta ’ dożaġġi differenti, huma disponibbli l- qawwiet segwenti:
SOMAVERT 10 mg, SOMAVERT 15 mg and SOMAVERT 20 mg.
SOMAVERT 10 mg, SOMAVERT 15 mg u SOMAVERT 20 mg.
For instructions on preparation, see section 6.6.
Għal struzzjonijiet dwar il- preparazzjoni, ara sezzjoni 6. 6.
A loading dose of 80 mg pegvisomant should be administered subcutaneously under medical supervision.
Loading dose ta ’ 80 mg pegvisomant għandha tiġi mogħtija taħt il- ġilda taħt sorveljanza medika.
Following this, SOMAVERT 10 mg reconstituted in 1 ml of solvent should be administered once daily as a subcutaneous injection.
In segwitu, SOMAVERT 10 mg rikostitwit f’ 1 ml ta ’ solvent għandu jingħata darba kuljum bħala injezzjoni taħt il- ġilda.
The site of injection should be rotated daily to help prevent lipohypertrophy.
Is- sit ta ’ l- injezzjoni għandha tkun mibdula kuljum sabiex tgħin tevita il- lipoipertrofija.
Dose adjustments should be based on serum IGF-I levels.
L- aġġustamenti fid- doża għandhom ikunu bbażati fuq il- livelli ta ’ IGF- I fis- serum.
Serum IGF-I concentrations should be measured every four to six weeks and appropriate dose adjustments made in increments of 5 mg/ day in order to maintain the serum IGF-I concentration within the age-adjusted normal range and to maintain an optimal therapeutic response.
Il - konċentrazzjonijiet ta ’ IGF- I fis- serum għandhom jiġu mkejla kull erba ’ sa sitt ġimgħat u jsiru l - aġġustamenti xierqa fid- doża b’ żidiet ta ’ 5 mg kuljum sabiex il- konċentrazzjoni ta ’ IGF- I fis- serum tinżamm fil- medda normali aġġustata bl- età u sabiex jinżamm rispons terapewtiku ottimali.
The maximum dose should not exceed 30 mg/ day.
Id- doża massima ma għandhiex taqbeż 30 mg kuljum.
2 Paediatric patients
2 Pazjenti anzjani
Patients with impaired hepatic or renal function
Pazjenti b’ indeboliment fil- funzjoni tal- fwied jew tal- kliewi
The safety and effectiveness of SOMAVERT in patients with renal or hepatic insufficiency has not been established.
Is- sigurtà u l- effikaċja ta ’ SOMAVERT f’ pazjenti b’ insuffiċjenza tal- fwied u tal- kliewi ma ġietx stabbilita.
Growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (for example, visual field defects).
F’ xi każi, tumuri pitwitarji li jsaffu ormoni tat- tkabbir, jistgħu jikbru bir- riżultat li jikkawżaw kumplikazzjonijiet serji (eż. difetti fil- vista in ġenerali).
Treatment by SOMAVERT does not reduce tumour size.
Il- kura b’ SOMAVERT ma tnaqqasx il- kobor tat- tumur.
All patients with these tumours should be carefully monitored in order to avoid any eventual progression in tumour size under treatment.
Kull pazjent b’ tumuri simili għandu jiġi sorveljat b’ attenzjoni partikolari, sabiex jiġi evitat kull tkabbir eventwali fit- tumur li jkun qed jiġi ttrattat.
SOMAVERT is a potent antagonist of growth hormone action.
SOMAVERT hu antagonist qawwi kontra l- azzjoni ta ’ l- ormoni tat- tkabbir.
A growth hormone deficient state may result from SOMAVERT administration, despite the presence of elevated serum growth hormone levels.
Minkejja l- preżenza f’ livell għoli ta ’ ormoni tat- tkabbir fis- serum, jista ’ jirriżulta stat ta ’ defiċjenza ta ’ ormoni tat- tkabbir, mill- għoti ta ’ SOMAVERT.
Serum IGF-I concentrations should be monitored and maintained within the age-adjusted normal range by adjustment of SOMAVERT dosing.
Il- konċentrazzjonijiet ta ’ IGF- I fis- serum għandhom jiġu sorveljati u miżmuma fil- medda normali determinata bl- età, b’ aġġustament fid- doża ta ’ SOMAVERT.