qanastek/EMEA-V3 huggingface dataset:
At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’ s skeleton healthy.
Fil - menopawsa, l- ovarji jieqfu jipproduċu l- ormon tan- nisa, l- estroġen, li jgħin iżomm l- iskeletru tan- nisu
As a result, bone loss occurs and bones become weaker.
Bħala riżultat, ikun hemm telf ta 'l- għadam u l- għadam jiddgħajfu.
The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Aktar kemm mara tilħaq il- menopawsa kmieni, akbar ikun ir- riskju għal menopawsa.
38 Early on, osteoporosis usually has no symptoms.
Fl- istadju bikri, l- osteoporożi ġeneralment ma jkollhiex sintomi.
If left untreated, however, it can result in broken bones.
Madankollu, jekk ma tiġiex trattata, tista 'tirriżulta f' għadam imkisser.
Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss.
Għalkemm ġeneralment jikkawża l- uġigħ, ksur fl- għadam tas- sinsla jista 'ma jiġix innotat sakemm jikkaġuna telf fit- tul.
Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone.
L- għadam jista 'jitkisser waqt attività normali ta' kuljum bħall- irfigħ, jew minn ferriment minuri li ġeneralment ma jiksirx l- għadam normali.
Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘ dowager’ s hump’) and loss of mobility.
L- għadam ġeneralment jitkisser fil- ġenbejn, fis- sinsla, jew fil- polz u jista 'jikkaġuna mhux biss uġigħ imma problemi konsiderevoli bħal qagħda baxxuta (il- ħotba ta' dowager) u nuqqas ta 'mobilità.
How can osteoporosis be treated?
Kif tista 'tiġi trattata l- osteoporożi?
Osteoporosis can be treated and it is never too late to begin treatment.
L- osteoporożi tista 'tiġi trattata u qatt mhu tard wisq biex jinbeda t- trattament.
FOSAVANCE not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.
FOSAVANCE mhux biss jimpedixxi t- telf ta 'għadam imma fil- fatt jgħin biex l- għadam li int stajt tlift jerġa' jinbena mill - ġdid u jnaqqas ir- riskju li l- għadam tas- sinsla u tal- ġenbejn jinkisser.
As well as your treatment with FOSAVANCE, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Barra mit- trattament b' FOSAVANCE, it- tabib tiegħek għandu mnejn jissuġerixxilek tagħmel xi tibdiliet f' ħajtek sabiex jgħin il- kondizzjoni tiegħek, bħal:
Stopping smoking
Tieqaf tpejjep
Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.
It- tipjip jidher li jżid ir- rata li minħabba fih jintilef l- għadam u, għalhekk, jista 'jżid ir- riskju għal għadam miksur.
Exercise
Eżerċizzju
Like muscles, bones need exercise to stay strong and healthy.
Bħal muskoli, l- għadam jinħtieġ l- eżerċizzju biex jibqa 'tajjeb u b' saħħtu.
Consult your doctor before you begin any exercise programme.
Ikkonsulta t- tabib tiegħek qabel ma tibda xi programm ta 'eżerċizzji.
Eating a balanced diet Your doctor can advise you about your diet or whether you should take any dietary supplements.
Tiekol dieta bilanċjata It- tabib tiegħek jista 'jagħtik parir dwar id- dieta tiegħek jew jekk għandekx tieħu xi supplimentari dietetiċi.
BEFORE YOU TAKE FOSAVANCE
QABEL MA TIEĦU FOSAVANCE
Do not take FOSAVANCE (1) if you are allergic (hypersensitive) to alendronate sodium trihydrate, colecalciferol or any of the other ingredients, (2) if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing, (3) if you cannot stand or sit upright for at least 30 minutes, (4) if your doctor has told you that you have low blood calcium.
Tiħux FOSAVANCE (1) jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal alendronate sodium trihydrate, colecalciferol jew xi wieħed mis- sustanzi l- oħra, (2) jekk għandek ċertu problemi f' gerżumtek (esofagu - it- tubu li jgħaqqad 'il ħalqek ma l- istonku) bħal tidjiq jew diffikultajiet biex tibla', (3) jekk ma tistax toqgħod fuq saqajk jew toqgħod bilqieghda dritt għal talanqas 30 minuta, (4) jekk it- tabib tiegħek qallek li għandek kalċju baxx fid- demm tiegħek.
If you think any of these apply to you, do not take the tablets.
Jekk taħseb li xi wieħed minn dawn japplika għalik, m' għandekx tieħu l- pilloli.
Talk to your doctor first and follow the advice given.
Kellem lit- tabib tiegħek u segwi l- istruzzjonijiet li jagħtik.
Take special care with FOSAVANCE It is important to tell your doctor before taking FOSAVANCE • if you suffer from kidney problems, • if you have any allergies, • if you have any swallowing or digestive problems, • if you have low blood calcium levels, • if you have cancer, • if you are undergoing chemotherapy or radiotherapy, • if you are taking steroids, • if you don’ t receive routine dental care.
Oqgħod attent ħafna b' FOSAVANCE Huwa importanti li tgħid lit- tabib tiegħek qabel ma tibda tieħu FOSAVANCE • jekk tbati minn problemi fil- kliewi. • jekk għandek xi allerġiji. • jekk għandek xi problemi meta tibla 'jew problemi diġestivi. • jekk għandek livelli baxxi ta' kalċju fid- demm. • jekk għandek kanċer. • jekk qed ikollok kemoterapija jew radjuterapija. • jekk qed tieħu sterojdi. • jekk ma tirċiviex kura dentali ta 'spiss.
Irritation, inflammation or ulceration of the gullet (oesophagus – the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/ or if they lie down less than 30 minutes after taking FOSAVANCE.
Irritazzjoni, infjammazzjoni jew ulċerazzjoni tal- ġriżmejn (esofagu – it- tubu li jgħaqqad 'il ħalqek ma' l- istonku tiegħek) kultant b' sintomi ta 'uġigħ fis- sider, qrusa fl- istonku, jew jista' jkun hemm diffikultà jew uġigħ meta tibla ', speċjalment jekk pazjenti ma jibilgħux tazza mimlija bl- ilma u/ jew jekk jimteddu anqas minn 30 minuta wara li jieħdu FOSAVANCE.
These side effects may worsen if patients continue to take FOSAVANCE after developing these symptoms.
Dawn l- effetti sekondarji jistgħu jiggravaw jekk il- pazjenti jkomplu jieħdu FOSAVANCE wara li jiżviluppaw dawn is- sintomi.
39 Children and adolescents FOSAVANCE should not be given to children and adolescents.
40 Tfal u adoloxxenti FOSAVANCE ma għandux jingħata lil tfal u adoloxxenti.
Taking other medicines It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of FOSAVANCE if taken at the same time.
Meta tieħu mediċini oħra Jista 'jkun li supplimenti tal- kalċju, antaċidi u xi mediċini orali ser jinterferixxu ma' l- assorbiment ta 'FOSAVANCE jekk jittieħdu fl- istess ħin.
Therefore, it is important that you follow the advice given in section 3.
Għalhekk, huwa importanti ssegwi l- parir mogħti f' sezzjoni 3.
HOW TO TAKE FOSAVANCE.
KIF GĦANDEK TIEĦU FOSAVANCE
It is likely that certain medicines or food additives may prevent the vitamin D in FOSAVANCE from getting into your body, including artificial fat substitutes, mineral oils, orlistat and the cholesterol- lowering medicines, cholestyramine and colestipol.
Jista 'jkun li ċertu mediċini jew addittivi ta' l- ikel jimpedixxu l- vitamina D f' FOSAVANCE milli tidħol f' ġismek, u dawn jinkludu sostituti artifiċjali tax- xaħam, żjut minerali, orlistat u l- mediċini li jnaqqsu l - kolesterol, cholestyramine u colestipol.
Medicines for fits (seizures) may decrease the effectiveness of vitamin D.
Mediċini għall- aċċessjonijiet (attakki ta 'puplesija) jistgħu jnaqqsu l- effettività ta' vitamina D.
Taking FOSAVANCE with food and drink It is likely that food and beverages (including mineral water) will make FOSAVANCE less effective if taken at the same time.
Meta tieħu FOSAVANCE ma 'l- ikel u max- xorb Jista' jkun li l- ikel u x- xorb (li jinkludi l- ilma minerali) jistgħu jagħmlu 'l FOSAVANCE anqas effettiv jekk jittieħed fl- istess ħin.
Therefore, it is important that you follow the advice given in section 3.
Għalhekk, huwa importanti li ssegwi l- parir mogħti f' sezzjoni 3.
Pregnancy and breast-feeding FOSAVANCE is only intended for use in postmenopausal women.
Tqala u Treddigħ FOSAVANCE huwa maħsub biex jintuża f' nisa wara l- menopawsa.
You should not take FOSAVANCE if you are or think you may be pregnant, or if you are breast-feeding.
M' għandekx tieħu FOSAVANCE jekk inti, jew taħseb li inti tqila jew jekk qed tredda '.
Driving and using machines FOSAVANCE should not affect your ability to drive or operate machines.
Sewqan u tħaddim ta 'magni FOSAVANCE m' għandux jaffettwa l- ħila tiegħek biex issuq jew tħaddem magni.
Important information about some of the ingredients of FOSAVANCE FOSAVANCE contains lactose and sucrose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'FOSAVANCE FOSAVANCE fih il- lactose u s- sucrose.
HOW TO TAKE FOSAVANCE
KIF GĦANDEK TIEĦU FOSAVANCE
Take one FOSAVANCE tablet once a week.
Ħu pillola waħda ta 'FOSAVANCE darba fil- ġimgħa.
Follow these instructions carefully to make sure you will benefit from FOSAVANCE.
Segwi dawn l- istruzzjonijiet b' attenzjoni sabiex tagħmel żgur li int ser tibbenefika minn FOSAVANCE.
1) Choose the day of the week that best fits your schedule.
1) Agħżel il- jum tal- ġimgħa li joqgħod l- aħjar fl- iskeda tiegħek.
Every week, take one FOSAVANCE tablet on your chosen day.
Kull ġimgħa, ħu pillola waħda ta 'FOSAVANCE fil- jum magħżul tiegħek.
It is very important to follow instructions 2), 3), 4) and 5) to help the FOSAVANCE tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Huwa importanti ħafna li ssegwi l- istruzzjonijiet 2), 3), 4) u 5) sabiex tgħin il- pillola ta 'FOSAVANCE tilħaq' l- istonku tiegħek malajr u sabiex jitnaqqas iċ- ċans li jiġu irritati l- griżmejn (esofagu - it- tubu li jgħaqqad 'il ħalqek ma l- istonku).
2) After getting up for the day and before taking any food, drink, or other medicine, swallow your FOSAVANCE tablet with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.). • Do not take with mineral water (still or sparkling). • Do not take with coffee or tea. • Do not take with juice or milk.
2) Wara li tqum għall- jum u qabel ma tieħu xi ikel, xorb, jew mediċina oħra, ibla 'il- pillola ta' FOSAVANCE tiegħek b' tazza mimlija ilma (mhux ilma minerali) (mhux inqas minn 200 ml jew 7 fl. oz.). • Tiħdux ma 'l- ilma minerali (still jew li jfexfex). • Tiħdux mal- kafe jew it- te. • Tiħdux mal- meraq jew il- ħalib.
Do not chew the tablet or allow it to dissolve in your mouth.
M’ għandekx tomgħod il- pillola jew tħalliha tinħall f' ħalqek.
40 3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet.
41 3) M' għandekx timtedd — żomm ruħek wieqaf (bilqieghda, bilwieqfa jew imxi) — għal ta 'lanqas 30 minuta wara li tibla' il- pillola.
4) Do not take FOSAVANCE at bedtime or before getting up for the day.
4) M' għandekx tieħu FOSAVANCE fil- ħin ta 'qabel l- irqadt jew qabel ma tqum għall- jum.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.
5) Jekk tiżviluppa diffikutà jew uġigħ meta tibla ', uġigħ f' sidrek, jew qrusa fl- istonku ġdida jew li taġġrava, tibqax tieħu FOSAVANCE u kkuntattja lit- tabib tiegħek.
6) After swallowing your FOSAVANCE tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
6) Wara li tibla 'l- pillola ta' FOSAVANCE tiegħek, stenna għal ta 'lanqas 30 minuta qabel ma tieħu l- ewwel ikla, xarba jew mediċina tiegħek tal- jum, li jistgħu jinkludu antaċidi, supplimenti tal- kalċju u vitamini.
FOSAVANCE is effective only if taken when your stomach is empty.
FOSAVANCE hu effettiv biss meta l- istonku tiegħek ikun vojt.
If you take more FOSAVANCE than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Jekk tieħu FOSAVANCE aktar milli suppost Jekk tieħu ħafna pilloli bi żball, ixrob tazza mimlija ħalib u kkuntattja lit- tabib tiegħek minnufih.
Do not make yourself vomit, and do not lie down.
Tipprovax iġġiegħel lilek nnifsek tirremetti, u timtedtx.
If you forget to take FOSAVANCE If you miss a dose, just take one tablet on the morning after you remember.
Jekk tinsa tieħu FOSAVANCE Jekk tinsa tieħu xi doża, hu pillola waħda ta 'FOSAVANCE fl- għodwa ta' wara li tiftakar.
If you stop taking FOSAVANCE It is important that you continue taking FOSAVANCE for as long as your doctor prescribes the medicine.
Jekk tieqaf tieħu FOSAVANCE Huwa importanti li tkompli tieħu FOSAVANCE għal kemm idum jippreskrivih it- tabib tiegħek.
FOSAVANCE can treat your osteoporosis only if you continue to take the tablets.
FOSAVANCE jista 'biss jittratta l- osteoporożi tiegħek jekk tibqa' tieħu l- pilloli.
Like all medicines, FOSAVANCE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, FOSAVANCE jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common (occurring in at least 1 of 100 patients and less than 1 of 10 patients treated).
It- termini li ġejjin jiġu użati biex jiddeskrivu kemm ta 'spiss huma rapportati l- effetti sekondarji.
Very rare (occurring in less than 1 of 10,000 patients treated).
Komuni (li jseħħu ta 'lanqas f' pazjent 1 minn 100 u inqas minn pazjent 1 minn 10 trattati) Mhux komuni (li jseħħu ta' lanqas f' pazjent 1 minn 1000 u inqas minn pazjent 1 minn 100) Rari (li jseħħu ta 'lanqas f' pazjent 1 minn 10, 000 u inqas minn pazjent 1 minn 1000 trattat) Rari ħafna (li jseħħu f' pazjent 1 minn 10, 000 pazjent trattat)
Common: • heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing, • bone, muscle and/ or joint pain, • abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence, • headache.
Komuni: • ħruq ta ’ stonku; diffikultà biex tibla; uġigħ malli tibla; ulċerazzjoni fil- griżmejn (esofagu - it - tubu li jgħaqqad lil ħalqek ma ’ l- istonku) li tista 'twassal għal uġigħ fis- sider, ħruq ta ’ stonku jew diffikultà jew uġigħ malli tibla', • uġigħ fl- għadam, fil- muskoli jew fil- ġogi, • uġigħ addominali; sensazzjoni ta 'skonfort fl- istonku jew tifwiq wara l- ikel; stitikezza; sensazzjoni ta' stonku mimli jew minfuħ; dijarrea; gass, • uġigħ ta ’ ras.
Uncommon: • nausea; vomiting, • irritation or inflammation of the gullet (oesophagus – the tube that connects your mouth with your stomach) or stomach, • black or tar-like stools, • rash; itching; redness of the skin.
Mhux komuni: • dardir; rimettar, • irritazzjoni jew infjammazzjoni tal- griżmejn (esofagu – it- tubu li jgħaqqad lil ħalqek ma 'l - istonku) jew l- istonku; • ippurgar iswed jew qisu - qatran, • raxx; ħakk; ħmura tal- ġilda.
41 • symptoms of low blood calcium levels including muscle cramps or spasms and/ or tingling sensation in the fingers or around the mouth, • stomach or peptic ulcers (sometimes severe or with bleeding), • narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach), • blurred vision, pain or redness in the eye, • rash made worse by sunlight, • severe bone, muscle and/ or joint pain, • mouth ulcers when the tablets have been chewed or sucked, • transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment.
42 Rari: • reazzjonijiet allerġiċi bħal ħorriqija, nefħa tal- wiċċ, xofftejn, ilsien u/ jew gerżuma, li jistgħu jikkawżaw diffikultà fit- teħid tan- nifs jew biex tibla ’, • sintomi ta ’ livelli baxxi ta ’ kalċju fid- demm li jinkludu bugħawwiġijiet fil- muskoli u/ jew sensazzjoni ta ’ tnemnim fis- swaba ’ u madwar il- ħalq, • ulċeri fl- istonku jew peptiċi (xi kultant serji jew bil- fsada), • tidjiq tal- griżmejn (esofagu – it- tubu li jgħaqqad lil ħalqek ma 'l- istonku), • vista mċajpra, uġigħ jew ħmura fl- għajnejn, • raxx li jiggrava bid- dawl tax- xemx, • uġigħ sever fl- għadam, fil- muskoli u/ jew fil- ġogi, • ulċeri fil- ħalq wara li l- pilloli jingidmu jew jiġu msoffija, • sintomi temporanji bħal ta ’ l- influwenza, bħal uġigħ fil- muskoli, ġeneralment tħossok mhux f' siktek u kultant bid- deni normalment fil- bidu tat- trattament.
Very rare: • severe skin reactions.
Rari ħafna: • reazzjonijiet serji fuq il- ġilda.
During post-marketing experience the following side effects have been reported (frequency not known): • dizziness, • joint swelling, • tiredness, • hair loss, • jaw problems associated with delayed healing and infection, often following tooth extraction, • swelling in the hands or legs.
Matul l- esperjenza ta 'wara t- tqegħid fis- suq, ġew irraportati l- effetti sekondarji li ġejjin (frekwenza mhux magħrufa): • sturdamenti, • nefħa fil- ġogi, • għejja, • telf ta ’ xagħar, • problemi fix- xedaq assoċjati ma' fejqan ittardjat u infezzjoni, ta 'spiss wara t- tneħħija ta ’ snien, • nefħa fl- idejn u fir- riglejn.
Tell your doctor or pharmacist promptly about these or any other unusual symptoms.
Għid lit- tabib tiegħek minnufih dwar dawn jew xi sintomi mhux komuni oħrajn.
It will help if you make a note of what you experienced, when it started and how long it lasted.
Jgħin jekk tieħu nota ta 'dak li ħassejt, meta ħassejtu u għal kemm dam sejjer.
HOW TO STORE FOSAVANCE
KIF TAĦŻEN FOSAVANCE
Do not use FOSAVANCE after the expiry date which is stated on the carton and the wallet after EXP.
Tużax FOSAVANCE wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- kartiera wara JIS.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m' għandekx bżonn.
What FOSAVANCE contains
X' fih FOSAVANCE
The active substances are alendronate sodium trihydrate and colecalciferol (vitamin D3).
Is- sustanzi attivi huma alendronate sodium trihydrate u colecalciferol (vitamin D3).
Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Kull pillola fiha 70 mg alendronic acid bħala alendronate sodium trihydrate u 70 mikrogramma (2800 IU) colecalciferol (vitamina D3).
The other ingredients are microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate (E572) butyl hydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).
43 Is- sustanzi l- oħra huma microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate (E572), butyl hydroxytoluene (E321), modified starch (maize), u sodium aluminium silicate (E554).
42 What FOSAVANCE looks like and contents of the pack
Id- dehra ta 'FOSAVANCE u l- kontenuti tal- pakkett
FOSAVANCE 70 mg/ 2800 IU tablets are available as capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘ 710’ on the other.
FOSAVANCE pilloli tas 70mg/ 2800 IU jiġu bħala pilloli f' għamla ta 'kapsuli, ta' lewn bajdani jew bojod jagħtu fil- griż immarkati b 'kontorn ta' immaġni ta 'għadma fuq naħa u' 710 'fuq in- naħa l- oħra.
The tablets are supplied in wallets with sealed aluminium blisters in cartons in the following pack sizes
Il- pilloli huma fornuti f' kartieri f' folji ta 'l- aluminju ssiġillati f' kartun fid- daqsijiet tal- pakketti li ġejjin
• 2 tablets (1 wallet containing 2 tablets in aluminium blisters) • 4 tablets (1 wallet containing 4 tablets in aluminium blisters) • 6 tablets (3 wallets each containing 2 tablets in aluminium blisters). • 12 tablets (3 wallets each containing 4 tablets in aluminium blisters). • 40 tablets (10 wallets each containing 4 tablets in aluminium blisters).
• 2 pilloli (kartiera 1 li fiha 2 pilloli f' folji ta 'l- aluminju) • 4 pilloli (kartiera waħda fiha 4 pilloli f' folji ta' l- aluminju) • 6 pilloli (3 kartieri kull wieħed minnhom fih 2 pilloli f' folji ta 'l- aluminju). • 12- il pillola (3 kartieri kull waħda minnhom fiha 4 pilloli f' folji ta' l- aluminju). • 40 pillola (10 kartieri kull waħda minnhom fiha 4 pilloli f’ folji ta 'l- aluminju).
Marketing Authorisation Holder Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN 11 9BU Ir- Renju Unit
Manufacturer FROSST IBERICA, S. A.
Manufattur FROSST IBERICA, S. A.
Via Complutense, 140 E-28805 Alcalá de Henares Madrid Spain
Via Complutense, 140 E- 28805 Alcalá de Henares Madrid Spanja
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.: +36 1 888 53 00 hungary_msd@merck. com
Tel.: + 36 1 888 53 00 hungary_ msd@ merck. com
Tel.: +420 233 010 111 msd_cr@merck. com
Tel.: + 420 233 010 111 msd_ cr@ merck. com
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@merck. com
44 Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@ merck. com
43 Deutschland MSD SHARP & DOHME GMBH Tel: +49 (0) 89 4561 2612 Infocenter@msd. de
Deutschland MERCK SHARP & DOHME GMBH Tel: +49 (0) 89 4561 2612 Infocenter@ msd. de
Polska MSD Polska Sp. z o. o.
Polska MSD Polska Sp. z. o. o.
Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 (0) 8 626 14 00 medicinskinfo@merck. com
Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 (0) 8 626 1400 medicinskinfo@ merck. com
Latvija SIA “ Merck Sharp & Dohme Latvija” Tel: +371 67364 224 msd_lv@merck. com
Latvija SIA "Merck Sharp & Dohme Latvija" Tel: +371. 67364. 224 msd_ lv@ merck. com
44 Lietuva UAB “ Merck Sharp & Dohme” Tel.: +370 5 278 02 47 msd_lietuva@merck. com
45 Lietuva UAB "Merck Sharp & Dohme" Tel: +370 5 278 02 47 msd_ lietuva@ merck. com
INFORMATION FOR THE USER
46 FULJETT TA ’ TAGĦRIF:
46 Early on, osteoporosis usually has no symptoms.
Fl- istadju bikri, l- osteoporożi ġeneralment ma jkollhiex sintomi.
Do not take FOSAVANCE (1) if you are allergic (hypersensitive) to alendronate sodium trihydrate, colecalciferol or any of the other ingredients, (2) if you have certain problems with your gullet (oesophagus - the tube that connects your mouth, with your stomach) such as narrowing or difficulty swallowing, (3) if you cannot stand or sit upright for at least 30 minutes, (4) if your doctor has told you that you have low blood calcium.
Tiħux FOSAVANCE (1) jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal alendronate sodium trihydrate, colecalciferol jew xi wieħed mis- sustanzi l- oħra, (2) jekk għandek ċertu problemi f' gerżumtek (esofagu - it- tubu li jgħaqqad 'il ħalqek ma ’ l- istonku) bħal tidjiq jew diffikultajiet biex tibla', (3) jekk ma tistax toqgħod fuq saqajk jew toqgħod bilqieghda dritt għal talanqas 30 minuta, (4) jekk it- tabib tiegħek qallek li għandek kalċju baxx fid- demm tiegħek.
Take special care with FOSAVANCE It is important to tell your doctor before taking FOSAVANCE • if you suffer from kidney problems, • if you have any allergies, • if you have any swallowing or digestive problems, • if you have low blood calcium levels, • if you have cancer, • if you are undergoing chemotherapy or radiotherapy, • if you are taking steroids, • if you don’ t receive routine dental care.
Oqgħod attent ħafna b' FOSAVANCE Huwa importanti li tgħid lit- tabib tiegħek qabel ma tibda tieħu FOSAVANCE • jekk tbati minn problemi fil- kliewi. • jekk għandek xi allerġiji. • jekk għandek xi problemi meta tibla 'jew problemi diġestivi. • jekk għandek livelli baxxi ta' kalċju fid- demm • jekk għandek kanċer. • jekk qed ikollok kemoterapija jew radjuterapija. • jekk qed tieħu sterojdi. • jekk ma tirċiviex kura dentali ta 'spiss.
47 Children and adolescents FOSAVANCE should not be given to children and adolescents.
48 Tfal u adoloxxenti FOSAVANCE ma għandux jingħata lil tfal u adoloxxenti.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including vitamin D or medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, inkluż vitamina D jew mediċini mingħajr riċetta.
2) Choose the day of the week that best fits your schedule.
1) Agħżel il- jum tal- ġimgħa li joqgħod l- aħjar fl- iskeda tiegħek.
3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet.
49 3) M' għandekx timtedd — żomm ruħek wieqaf (bilqieghda, bilwieqfa jew imxi) — għal ta 'lanqas 30 minuta wara li tibla' il- pillola.
48 4) Do not take FOSAVANCE at bedtime or before getting up for the day.
4) M' għandekx tieħu FOSAVANCE fil- ħin ta 'qabel l- irqadt jew qabel ma' tqum għall- jum.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.
5) Jekk tiżviluppa diffikultà jew uġigħ meta tibla ', uġigħ f' sidrek, jew qrusa fl- istonku ġdida jew li taġġrava, tibqax tieħu FOSAVANCE u ikkuntattja lit- tabib tiegħek.
6) After swallowing your FOSAVANCE tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
6) Wara li tibla 'l- pillola ta' FOSAVANCE tiegħek, stenna għal ta 'lanqas 30 minuta qabel ma tieħu l- ewwel ikla, xarba jew mediċina tiegħek tal- jum, li jistgħu jinkludu antaċidi, supplimenti tal - kalċju u vitamini.
If you take more FOSAVANCE than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Jekk tieħu FOSAVANCE aktar milli suppost Jekk tieħu ħafna pilloli bi żball, ixrob tazza mimlija ħalib u ikkuntattja lit- tabib tiegħek minnufih.
Uncommon: • nausea; vomiting, • irritation or inflammation of the gullet (oesophagus – the tube that connects your mouth with your stomach) or stomach, • black or tar-like stools, • rash; itching; redness of the skin.
Mhux komuni: • dardir; rimettar, • irritazzjoni jew infjammazzjoni tal- griżmejn (esofagu – it- tubu li jgħaqqad lil ħalqek ma 'l - istonku) jew l- istonku; • ippurgar iswed jew qisu qatran, • raxx; ħakk; ħmura tal- ġilda.
49 • narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach), • blurred vision, pain or redness in the eye, • rash made worse by sunlight, • severe bone, muscle and/ or joint pain, • mouth ulcers when the tablets have been chewed or sucked, • transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment.
50 Rari: • reazzjonijiet allerġiċi bħal ħorriqija, nefħa tal- wiċċ, xofftejn, ilsien u/ jew gerżuma, li jistgħu jikkawżaw diffikultà fit- teħid tan- nifs jew biex tibla ’, • sintomi ta ’ livelli baxxi ta ’ kalċju fid- demm li jinkludu bugħawwiġijiet fil- muskoli u/ jew sensazzjoni ta ’ tnemnim fis- swaba ’ u madwar il- ħalq, • ulċeri fl- istonku jew peptiċi (xi kultant serji jew bil- fsada), • tidjiq tal- griżmejn (esofagu – it- tubu li jgħaqqad lil ħalqek ma 'l- istonku), • vista mċajpra, uġigħ jew ħmura fl- għajnejn, • raxx li jiggrava bid- dawl tax- xemx, • uġigħ sever fl- għadam, fil- muskoli u/ jew fil- ġogi, • ulċeri fil- ħalq wara li l- pilloli jingidmu jew jiġu msoffija, • sintomi temporanji bħal ta ’ l- influwenza, bħal uġigħ fil- muskoli, ġeneralment tħossok mhux f' siktek u kultant bid- deni normalment fil- bidu tat- trattament.
During post-marketing experience the following side effects have been reported (frequency not known): • dizziness, • joint swelling, • tiredness, • hair loss, • jaw problems associated with delayed healing and infection, often following tooth extraction, • swelling in the hands or legs.
Matul l- esperjenza ta 'wara t- tqegħid fis- suq, ġew irraportati l- effetti sekondarji li ġejjin (frekwenza mhux magħrufa): • sturdamenti, • nefħa fil- ġogi, • għejja, • telf ta ’ xagħar • problemi fix- xedaq assoċjati ma' fejqan ittardjat u infezzjoni, ta 'spiss wara t- tneħħija ta ’ snien, • nefħa fl- idejn u fir- riglejn.
The other ingredients are microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate (E572) butylated hydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).
51 Is- sustanzi l- oħra huma microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate (E572), butyl hydroxytoluene (E321), modified starch (maize), u sodium aluminium silicate (E554).
50 What FOSAVANCE looks like and contents of the pack
Id- dehra ta 'FOSAVANCE u l- kontenuti tal- pakkett
FOSAVANCE 70 mg/ 5600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘ 270’ on the other.
FOSAVANCE pilloli tas- 70 mg/ 5600 IU jiġu bħala pilloli f' għamla ta 'kapsuli rettangolari modifikati, ta' lewn bajdani jew bojod jagħtu fil- griż immarkati b 'kontorn ta' immaġni ta 'għadma fuq naħa u' 270 'fuq in- naħa l- oħra.
The tablets are supplied in wallets with sealed aluminium blisters in cartons in the following pack sizes
Il- pilloli jiġu f' kartieri f' folji ta 'l- aluminju ssiġillati f' kartun fid- daqsijiet tal- pakketti li ġejjin
• 2 tablets (1 wallet containing 2 tablets in aluminium blisters) • 4 tablets (1 wallet containing 4 tablets in aluminium blisters) • 12 tablets (3 wallets each containing 4 tablets in aluminium blisters). • 40 tablets (10 wallets each containing 4 tablets in aluminium blisters).
• 2 pilloli (kartiera 1 li fiha 2 pilloli f' folji ta 'l- aluminju) • 4 pilloli (kartiera waħda fiha 4 pilloli f' folji ta' l- aluminju) • 12- il pillola (3 kartieri kull waħda minnhom fiha 4 pilloli f' folji ta 'l- aluminju) • 40 pillola (10 kartieri kull waħda minnhom fiha 4 pilloli f’ folji ta' l- aluminju).
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@merck. com
52 Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@ merck. com
52 Lietuva UAB “ Merck Sharp & Dohme” Tel.: +370 5 278 02 47 msd_lietuva@merck. com
53 Lietuva UAB “ Merck Sharp & Dohme ” Tel.: +370 5 278 02 47 msd_ lietuva@ merck. com
What is Foscan?
X' inhu Foscan?
Foscan is a solution for injection containing the active substance temoporfin (1 or 4 mg/ ml).
Foscan huwa soluzzjoni għall- injezzjoni li fiha s- sustanza attiva temoporfina (1 jew 4 mg/ ml).
What is Foscan used for?
Għal xiex jintuża Foscan?
Foscan is used to relieve the symptoms of advanced head and neck squamous cell carcinoma (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Foscan jintuża biex itaffi s- sintomi ta 'karċinoma b' ċelluli squamous tar- ras u ta' l- għonq (tip ta 'kanċer li jibda miċ- ċelluli li jiksu l- ħalq, l- imnieħer, il- gerżuma jew il- widna).
It is used in patients in whom other treatments have stopped working, and who are not suitable for radiotherapy (treatment with radiation), surgery or systemic chemotherapy (medicines used to treat cancer; ‘ systemic ’ means that they are given as treatments throughout the body).
Jintuża fil- pazjenti li għalihom trattamenti oħra ma baqgħux jaħdmu u li mhumiex adatti għal trattament ta 'radjoterapija (trattament bir- radjazzjoni), kirurġija jew kemjoterapija sistemika (mediċini użati fit- trattament tal- kanċer;' sistemika 'tfisser li jingħataw bħala trattamenti fil- ġisem kollu).
How is Foscan used?
Kif jintuża Foscan?
Foscan must only be given in a specialist cancer centre where a team can assess the patient’ s treatment under the supervision of a doctor who has experience in photodynamic therapy (treatment that uses light).
Foscan għandu jintuża esklussivament f' ċentru speċjalizzat fil- kura tal- kanċer li fih ikun hemm tim li jivvaluta t- trattament tal- pazjent taħt is- superviżjoni ta 'tabib b' esperjenza fit- terapija fotodinamika (trattament li juża l- azzjoni tad- dawl).
Treatment with Foscan is a two-step process: the medicine is given first, before it is activated using a laser.
It- trattament b' Foscan hu proċess f’ żewġ fażijiet: tingħata l - ewwel il- mediċina, imbagħad tiġi attivata bl- użu ta 'lejżer.
The medicine is given by an indwelling intravenous cannula (a thin tube permanently inserted into a vein) as a single slow injection over at least six minutes.
Il- mediċina tingħata permezz ta 'kannula intravenuża permanenti (tubu rqiq mdaħħal permanentement f' vina) b' injezzjoni waħda mogħtija bil - mod fuq tul ta' żmien ta 'mhux inqas minn sitt minuti.
The dose is 0.15 mg per kilogram body weight.
Id- doża hija 0. 5 mg għal kull kilo tal- piż tal - ġisem.
Four days later, the entire surface of the tumour and the surrounding 0.5-cm margin is illuminated with light from a laser at a specific wavelength, using a fibre-optic cable, for around three minutes and 20 seconds.
Wara erbat ijiem, iż- żona kollha fejn hemm it- tumur hija mdawla sa 0. 5 ċm lil hinn mill - marġni tal- madwar, b' dawl iġġenerat minn lejżer b' wavelength speċifiku għal madwar 3 minuti u 20 sekonda bl- użu ta 'kejbil tal- fibra ottika.
Each area of the tumour should be illuminated only once during each treatment.
Kull żona tat- tumur għandha tkun imdawla ta 'l- anqas darba waqt kull trattament.
During treatment, other areas of the body should be shielded from the light so that the activation of the medicine is limited to the tumour.
Waqt it- trattament, iż- żoni l- oħra tal- ġisem għandhom ikunu mgħottija mid- dawl sabiex il- mediċina tiġi attivata mit- tumur biss.
If a second treatment is necessary, this should take place at least four weeks later.
Jekk jeħtieġ ċiklu ieħor tat- trattament, dan għandu jsir ta 'l- anqas erba' ġimgħat wara.
How does Foscan work?
Kif jaħdem Foscan?
The active substance in Foscan, temoporfin, is a photosensitising agent (a substance that changes when exposed to light).
Is- sustanza attiva f' Foscan, temoporfina, hija aġent fotosensitizzanti (sustanza li tinbidel meta esposta għad- dawl).
When Foscan is injected, temoporfin is distributed within the body, including within the tumour.
Wara l- injezzjoni ta 'Foscan, it- temoporfina tinxtered mal- ġisem, inkluż fit- tumur.
When it is illuminated with laser light of a specific wavelength, temoporfin is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen.
Meta tiddawwal bid- dawl tal- lejżer b' wavelength speċifiku, it- temoporfina tiġi attivata u tirreaġixxi ma 'l - ossiġenu preżenti fiċ- ċelluli, b' hekk jinħoloq tip ta' ossiġenu reattiv u tossiku ħafna.
This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Peress li t- tidwil
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. ikun limitat għat- tumur, issir ħsara liċ- ċelluli tumurali biss, mingħajr ma jintlaqtu partijiet oħra tal - ġisem.
How has Foscan been studied?
Kif ġie studjat Foscan?
Foscan has been studied in four main studies involving a total of 409 patients with head or neck cancer.
Foscan ġie studjat f' erba 'studji ewlenin imwettqa fuq total ta' 409 pazjenti li jbatu minn kanċer tar- ras jew ta 'l- għonq.
The first three studies looked at whether the tumour was eradicated after up to three treatments with Foscan in a total of 189 patients.
L- ewwel tliet studji eżaminaw jekk it- tumur ġiex eliminat wara massimu ta 'tliet ċikli ta' trattament b' Foscan fuq total ta '189 pazjent.
The fourth study looked at the reduction of symptoms in 220 patients with advanced head or neck cancer who could not receive surgery or radiotherapy.
Ir- raba 'studju eżamina t- tnaqqis tas- sintomi f' 220 pazjent b' kanċer tar- ras jew ta' l- għonq fi stadju avvanzat, li ma setgħux jiġu sottoposti għal kirurġija jew radjoterapija.
In all studies, the response was assessed between 12 and 16 weeks after the final treatment with Foscan, but Foscan was not compared with any other treatment.
Fl- istudji kollha, ir- rispons ġie vvalutat bejn il- ġimgħa 12 u 16 wara l- aħħar trattament b' Foscan, madankollu Foscan ma tqabbilx ma 'trattamenti oħra.
What benefit has Foscan shown during the studies?
X' benefiċċju wera Foscan waqt l- istudji mwettqa?
The results of the first three studies were insufficient to support the use of Foscan in the eradication of head and neck cancer tumours.
Ir- riżultati ta 'l- ewwel tliet studji dehru insuffiċjenti biex isostnu l- użu ta' Foscan fl- eliminazzjoni tat - tumuri tar- ras u ta 'l- għonq.
However, in the study looking at improving symptoms of advanced head and neck cancer, 28 (22%) of the 128 patients assessed had a significant improvement in their most troubling symptom.
Madankollu, fl- istudju li analizza t- titjib tas- sintomi fil- pazjenti b' kanċer tar- ras u ta 'l- għonq fi stadju avvanzat, 28 pazjent (22%) fuq total ta' 128 li ġew osservati, urew titjib sinifikanti tas- sintomi l- aktar fastidjużi.
Around a quarter of the patients in this study also had a reduction in tumour size.
F' madwar kwart tal- pazjenti involuti f' dan l- istudju ġie osservat tnaqqis fid- daqs tat- tumur ukoll.
What is the risk associated with Foscan?
X' inhu r- riskju assoċjat b' Foscan?
The most common side effects with Foscan (seen in more than 1 patient in 10) are pain at the injection site, at the site of the tumour or in the face, haemorrhage (bleeding), scarring, mouth necrosis (death of cells or tissue in the mouth), dysphagia (difficulty swallowing), face oedema (swelling) and constipation.
L- effetti sekondarji l- aktar komuni b' Foscan (li dehru f' aktar minn pazjent 1 minn 10) huma wġigħ fil - punt ta 'l- injezzjoni, fiż- żona tumurali jew fil- wiċċ, emorraġija (fsada), mirek, nekrożi tal- ħalq (mewt taċ- ċelluli jew tat- tessut tal- ħalq), disfaġija (diffikultà biex tibla'), edema fil- wiċċ (nefħa) u stitikezza.
For the full list of all side effects reported with Foscan, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' Foscan, ara l- Fuljett ta' Tagħrif.
Foscan should not be used in people who may be hypersensitive (allergic) to temoporfin or any of the other ingredients.
Foscan ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għat- temoporfina jew għal xi sustanza oħra tiegħu.
Foscan must not be used in patients with porphyria (an inability to break down porphyrins), other diseases made worse by light, allergy to porphyrins, or tumours that are spreading into a blood vessel or that are next to where the laser is to be shone.
Foscan ma għandux jintuża f' pazjenti li jbatu minn porfirija (inkapaċità li jimmetabolizzaw il- porfirini), minn mard ieħor li jaggravaw minħabba d- dawl, minn allerġija għall - porfirini jew minn tumuri li qegħdin jinxterdu f' arterja jew f' vina jew li jinsabu qrib fejn ikun qiegħed jipponta l- lejżer.
Foscan must also not be used in patients who have an operation planned in the next 30 days, who have an eye disease that is likely to need examination using a ‘ slit lamp’ (an instrument used by eye specialists to look into the eye) in the next 30 days, or who are already being treated with another medicine that increases sensitivity to light.
Foscan ma għandux ukoll jingħata f' pazjenti li se jsirilhom intervent kirurġiku fit- 30 ġurnata sussegwenti, f' pazjenti li jbatu minn marda ta 'l- għajnejn li aktarx teħtieġ vista bl- islit lamp (strument użat mill- okulisti biex jittawlu ġewwa l- għajn) fit- 30 ġurnata sussegwenti jew f' pazjenti li diġà jinsabu fi trattament b' mediċina oħra li żżid is- sensittività għad- dawl.
Patients receiving Foscan should take care to avoid exposure to bright light for up to six months after injection to avoid skin burns.
Sa sitt xhur wara l- injezzjoni ta 'Foscan, il- pazjenti għandhom jevitaw l- esponiment għad- dawl qawwi biex jevitaw ir- riskju li tinħarqilhom il- ġilda.
See the Package Leaflet for full details.
Ara l- Fuljett ta 'Tagħrif għad- dettalji kollha.
Why has Foscan been approved?
Għaliex ġie approvat Foscan?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Foscan’ s effects on relieving the symptoms associated with advanced head and neck cancer were of interest.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l- effetti ta 'Foscan fit- taffija tas- sintomi assoċjati mal- kanċer tar- ras u ta' l- għonq fi stadju avvanzat kien jistħoqqilhom jiġu nnutati.
Therefore, the Committee decided that Foscan’ s benefits are greater than its risks for the palliative treatment of patients with advanced head and neck squamous cell carcinoma who have failed other treatments and are not suitable for radiotherapy, surgery or systemic chemotherapy.
Għaldaqstant, il- Kumitat iddeċieda li l- benefiċċji ta 'Foscan huma ogħla mir- riskji tiegħu għat- trattament palljattiv ta' pazjenti b' karċinoma b' ċelluli squamous tar- ras u ta 'l - għonq fi stadju avvanzat b' falliment tat- trattamenti preċedenti u li mhumiex adatti għal trattament ta' radjoterapija, kirurġija jew kemjoterapija sistemika.
The Committee recommended that Foscan be given marketing authorisation.
Il- Kumitat irrakkomanda li Foscan jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Foscan was originally authorised under ‘ Exceptional Circumstances’, because, as the disease is rare and for scientific reasons, limited information was available at the time of approval.
Foscan kien oriġinarjament awtorizzat f '"Ċirkostanzi Eċċezzjonali", għax, minħabba li l- marda hija rari u għal raġunijiet xjentifiċi, kien hemm disponibbli biss tagħrif limitat fi żmien l- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 21 May 2008.
Billi l- kumpanija pprovdiet it- tagħrif addizzjonali mitlub, iċ - "Ċirkostanzi Eċċezzjonali" intemmu fil - 21 ta 'Mejju 2008.
Other information about Foscan:
Aktar tagħrif dwar Foscan:
The European Commission granted a marketing authorisation valid throughout the European Union for Foscan on 24 October 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha għal Foscan fl- 24 ta 'Ottubru 2001.
The marketing authorisation was renewed on 24 October 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet mġedda fl- 24 ta 'Ottubru 2006.
The marketing authorisation holder is Biolitec Pharma Ltd.
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq huwa Biolitec Pharma Ltd.
The full EPAR for Foscan can be found here.
L- EPAR sħiħ għal Foscan jista 'jiġi kkonsultat hawn.
Pharmaceutical form Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection
Foscan
Route of administration Intravenous use Intravenous use Intravenous use Intravenous use Intravenous use
Soluzzjoni għall- injezzjoni
Packaging Vial (amber glass) Vial (amber glass) Vial (amber glass) Vial (amber glass) Vial (amber glass)
Fjala (ħġieġ ta ’ l- ambra)
Package size 1 vial 1 vial 1 vial 1 vial 1 vial
Fjala (ħġieġ ta ’ l- ambra)
SUMMARY OF PRODUCT CHARACTERISTICS
1 ISEM TAL- PRODOTT MEDIĊINALI 1.
NAME OF THE MEDICINAL PRODUCT
Foscan 1 mg/ ml soluzzjoni għall- injezzjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA 2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kull ml fih 1 mg ta ’ temoporfin.
Each ml contains 1 mg of temoporfin.
Sustanzi mhux attivi:
Each ml contains 376 mg of ethanol anhydrous and 560 mg of propylene glycol
Kull ml fih 376 mg ta ’ ethanol anidru u 560 mg ta ’ propylene glycol.
PHARMACEUTICAL FORM
GĦAMLA FARMAĊEWTIKA 3.
Dark purple solution.
Soluzzjoni vjola skura.
CLINICAL PARTICULARS
TAGĦRIF KLINIKU 4.
Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.
Foscan hu intiż biex itejjeb il- kondizzjoni ta ’ pazjenti b’ karċinoma avvanzata taċ- ċelluli skwamużi fir- ras u fl- għonq wara l- falliment ta ’ terapiji preċedenti u meta radjoterapija, kirurġija jew kemjoterapija sistematika ma jkunux adattati għalihom.
Foscan photodynamic therapy must only be administered in specialist oncology centres in which a multidisciplinary team assesses patient treatment and under the supervision of physicians experienced in photodynamic therapy.
It- terapija fotodinamika permezz ta ’ Foscan għandha tingħata biss f’ ċentri speċjalizzati ta 'l- onkoloġija fejn skwadra multidixxiplinarja tanalizza l- kura tal- pazjent li jkun taħt is- superviżjoni ta ’ tobba b’ esperjenza fit- terapija fotodinamika.
Foscan is administered via an in-dwelling intravenous cannula in a large proximal limb vein, preferably in the antecubital fossa, as a single slow intravenous injection over not less than 6 minutes.
Foscan jingħata permezz ta ’ kannula li titpoġġa f’ vina qrib tar- riġel/ driegħ, preferibbilment fil- fossa antekubitali, bħala injezzjoni waħda, bil- mod, ġol- vina, f’ mhux anqas minn 6 minuti.
The patency of the in-dwelling cannula should be tested before injection and every precaution taken against extravasation (see section 4.4).
Il- kondizzjoni tal- kannula sitwata għandha tkun eżaminata qabel kull injezzjoni u għandha tittieħed kull prekawzjoni kontra l- estravażjoni (ara sezzjoni 4. 4).
The dark purple colour of the solution, together with the amber vials makes a visual check for particulates impossible.
Il- kulur vjola skur tas- soluzzjoni, flimkien mal- kunjetti ta ’ kulur ambra, ma jippermettux kontroll viżwali għal preżenza ta 'frak.
Thus, an in-line filter must be used as a precautionary measure and is provided in the package.
Għalhekk, għandu jintuża filtru lineari bħala miżura ta ’ prekawzjoni u dan jiġi provdut fil- pakkett.
Do not flush with sodium chloride or any other aqueous solution.
Tħalltux ma ’ sodium chloride jew ma ’ xi soluzzjoni akweja oħra.
The dose is 0.15mg/ kg body weight.
Id- doża hi ta ’ 0. 15 mg/ kg piż tal- ġisem.
Do not dilute Foscan.
Foscan m’ għandux jiġi dilwit.
96 hours after the administration of Foscan, the treatment site is to be illuminated with light at 652 nm from an approved laser source.
Agħti d- doża meħtieġa ta ’ Foscan b’ injezzjoni ġol vina, f’ mhux inqas minn 6 minuti 96 siegħa wara li jingħata Foscan, is- sit li jkun qed jiġi kkurat għandu jkun illuminat b 'dawl ta’ 652 nm minn sors ta ’ laser approvat.
Light must be delivered to the entire surface of the tumour using an approved microlens fibre-optic.
Id- dawl għandu jitwassal fuq il- wiċċ kollu tat- tumur permezz ta ’ mikrolens tal- fibra ottika.
Wherever possible, the illuminated area must extend beyond the tumour margin by a distance of 0.5cm.
Kull meta hu possibli, il- parti mixgħula għandha tkun estiża mill- marġini tat- tumur b’ distanza ta ’ 0. 5 ċm.
Light must be administered not less than 90 hours and not more than 110 hours after Foscan injection.
Id- dawl għandu jingħata għal mhux anqas minn 90 siegħa u mhux aktar minn 110 sigħat wara li tingħata l- injezzjoni ta ’ Foscan.
The incident light dose is 20J/ cm2, delivered at an irradiance of 100mW/ cm2 to the tumour surface, implying an illumination time of approximately 200 seconds.
Id- doża ta ’ dawl mitfugħ hi ta ’ 20 J/ ċm2, imwassla b’ irridazzjoni ta ’ 100 mW/ ċm2 fil- wiċċ tat- tumur, li jimplika ħin ta ’ illuminazzjoni ta ’ madwar 200 sekonda.
2 Each field is to be illuminated once only at each treatment.
2 Kull parti għandha tiġi lluminata darba biss matul kull trattament.
Multiple non-overlapping fields may be illuminated.
Jistgħu jiġu mixgħula aktar minn parti waħda li ma jmissux ma ’ xulxin.
Care must be taken to ensure that no area of tissue receives more than the specified light dose.
Għandha tingħata attenzjoni biex jiġi assigurat li l- ebda parti mit- tessut ma ’ tirċievi aktar mid- doża ta ’ dawl speċifikat.
Tissue outside the target area must be shielded completely to avoid photoactivation by scattered or reflected light.
It- tessut li ma jridx jintlaqat għandu jitgħatta kompletament sabiex jiġi evitat il- fotoattivazzjoni mit- tifrix jew riflessjoni tad- dawl.