qanastek/EMEA-V3 huggingface dataset:
In the event of a medical emergency, you should tell any health care professional treating your condition that you have taken VIAGRA and when you did.
F’ każ ta ’ emerġenza medika, inti għandek tgħid lill- professjonist tal- kura tas- saħħa li qed jikkurak, li inti ħadt VIAGRA, u meta.
Do not take VIAGRA with other medicines unless your doctor tells you that you can.
Tieħux VIAGRA ma ’ mediċini oħra sakemm it- tabib tiegħek ma jgħidlekx li inti tista ’ tagħmel dan.
You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these products may cause a potentially dangerous decrease in your blood pressure.
Ma għandekx tieħu VIAGRA jekk qed tieħu mediċini msejjħa nitrati, minħabba li flimkien dawn il - prodotti jistgħu jikkawżaw pressjoni baxxa li tista ’ tkun ta ’ ħsara.
Always tell your doctor or pharmacist if you are taking any of these medicines that are often used for the relief of angina pectoris (or “ chest pain”).
Dejjem għandek tgħid lit- tabib jew l- ispiżjar tiegħek jekk qed tieħu minn dawn l- mediċini li jintużaw sikwit għal kura ta ’ anġina pectoris.
You should not take Viagra if you are using any of the drugs known as nitric oxide donors such as amyl nitrite (“ poppers”) as the combination may also lead to a potentially dangerous decrease in your blood pressure.
Ma għandekx tieħu Viagra jekk qed tieħu mediċini li huma magħrufa bħala donaturi ta ’ nitric oxide bħal amyl nitrite (“ poppers ”), dawn ukoll jistgħu jikkawżaw pressjoni baxxa potenzjalment ta ’ ħsara jekk jittieħdu mal- Viagra
If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of VIAGRA.
Jekk inti qed tieħu mediċini magħrufa bħala inibituri ta ’ protease, bħal dawk għall- kura tal- HIV, it - tabib tiegħek jista ’ jibda jtik l- anqas doża (25 mg) ta ’ VIAGRA.
This is most likely to occur within 4 hours after taking VIAGRA.
Pazjenti fuq kura ta ’ alpha blockers għal pressjoni għolja jew nefħa tal- prostata jistgħu iħossu sturdament qawwi jew sturdament ħafif li jista jkun ikkawżat minn pressjoni baxxa posturali, jiġifieri l- pressjoni titbaxxa meta toqgħod bil- qiegħda jew meta tqum bil- wieqfa bil- għaġġla.
In order to reduce the likelihood that these symptoms occur, you should be on a regular
Xi pazjenti
52 daily dose of your alpha-blocker before you start VIAGRA.
52 ħassew dawn is- sintomi meta kienu qed jieħdu VIAGRA ma ’ alpha blockers.
Your doctor may start you on a lower dose (25 mg) of VIAGRA.
It- tabib tiegħek jista ’ jibdik b’ doża baxxa ta ’ 25mg ta ’ VIAGRA.
Taking VIAGRA with food and drink VIAGRA can be taken with or without food.
Meta tieħu VIAGRA ma ’ l- ikel u max- xorb VIAGRA tista ’ tittieħed ma ’ jew mingħajr l- ikel.
However, you may find that VIAGRA takes longer to start working if you take it with a heavy meal.
Jista jkun li ddum ftit iktar biex tagħmel effett, jekk tittieħed ma ’ ikla sostanzjali.
Drinking alcohol can temporarily impair your ability to get an erection.
Ix- xorb alkoħoliku jista ’ temporanjament ifixkel l- abilità li jkollok erezzjoni.
To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking VIAGRA.
Biex tieħu l- aħjar benefiċċju mill- mediċina tiegħek, huwa rrakkomandat li inti ma tixrobx ammont kbir ta ’ alkoħol qabel ma tieħu VIAGRA.
Pregnancy and Breast feeding VIAGRA is not indicated for use by women.
Tqala u Treddigħ VIAGRA mhux magħmula biex tintuża min- nisa.
Driving and using machines VIAGRA can cause dizziness and can affect vision.
Sewqan u tħaddim ta ’ magni VIAGRA tista ’ tikkawża stordament u taffettwa l- vista.
You should be aware of how you react to VIAGRA before you drive or use machinery.
Qabel ma ssuq jew tuża makkinarju, għandek tkun taf sew l- effett li għandha fuqek VIAGRA.
Important information about some of the ingredients of VIAGRA If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking VIAGRA.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ VIAGRA Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, bħal lactose, għandek tavża lit- tabib tiegħek qabel tieħu VIAGRA.
HOW TO TAKE VIAGRA
KIF GĦANDEK TIEĦU VIAGRA
Always take VIAGRA exactly as your doctor has told you.
Dejjem għandek tieħu VIAGRA eżattament skond il- parir tat- tabib.
The usual starting dose is 50 mg.
Id- doża tal- bidu li ssoltu tingħata hija 50 mg.
You should not take VIAGRA more than once a day.
M’ għandekx tuża VIAGRA iżjed minn darba kuljum.
You should take VIAGRA about one hour before you plan to have sex Swallow the tablet whole with a glass of water.
Inti għandek tieħu VIAGRA madwar siegħa qabel ma tippjana li jkollok x’ taqsam sesswalment mal - partner.
If you have the impression that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.
Jekk inti jkollok l- impressjoni li l- effett ta ’ VIAGRA huwa wisq qawwi jew dgħajjef wisq, kellem lit - tabib jew lill- ispiżjar tiegħek.
VIAGRA will only help you to get an erection if you are sexually stimulated.
VIAGRA tgħinek biss biex ikollok erezzjoni jekk inti tkun stimulat sesswalment.
The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour.
Il- ħin li tieħu VIAGRA biex taħdem ivarja minn persuna għal oħra, iżda normalment tieħu bejn nofs siegħa u siegħa.
You may find that VIAGRA takes longer to work if you take it with a heavy meal.
Inti tista ’ ssib li VIAGRA ddum iżjed biex taħdem jekk inti teħodha ma ’ ikla kbira.
If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.
Jekk VIAGRA ma tgħinekx biex jkollok erezzjoni, jew jekk l- erezzjoni ma ddumx biżżejjed biex inti jkollok rapport sesswali sħiħ, inti għandek tgħid lit- tabib tiegħek.
If you take more VIAGRA than you should:
Jekk tieħu VIAGRA aktar milli suppost:
You may experience an increase in side effects and their severity.
Tista tesperjenza żieda fl- effetti sekondarji u fis- severita ’ tagħhom.
Doses above 100 mg do not increase the efficacy.
Dożi ta ’ aktar minn 100 mg ma jżidux l- effiċjenza..
You should not take more tablets than your doctor tells you to.
M’ għandekx tieħu aktar pilloli milli suppost.
Contact your doctor if you take more tablets than you should.
Jekk tieħu aktar pilloli milli suppost, ikkuntattja lit- tabib tiegħek.
Like all medicines, VIAGRA can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, VIAGRA jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects reported in association with the use of Viagra are usually mild to moderate and of a short duration.
Dawn l- effetti sekondarji rrappurtati ma ’ l- użu tal- Viagra huma ġeneralment ħfief għal moderati u għal żmien qasir.
If you have chest pains during or after intercourse:
Jekk għandek uġigħ tas- sider waqt jew wara r- rapport sesswali:
- Get in a semi-sitting position and try to relax.
- Oqgħod bilqiegħda u pprova rrilassa
- Do not use nitrates to treat your chest pain.
- Tużax nitrates sabiex tfejjaq l- uġiegħ
- Contact your doctor immediately.
- Ikkuntattja lit- tabib tiegħek immedjatament
All medicines including VIAGRA can cause allergic reactions.
Il- mediċini kollha, inkluża il- VIAGRA jistgħu jikkawżaw reazzjonijiet allerġiċi.
You should contact your doctor immediately if you experience any of the following symptoms after taking VIAGRA: sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
Għandek tikkuntattja lit- tabib tiegħek immedjatament jekk tesperjenza xi effetti minn dawn li ġejjin wara li tkun ħadt VIAGRA: tħarħir fin- nifs f’ daqqa, diffikulta ’ biex tieħu n- nifs u sturdament, nefħa fil- kapell ta ’ l - għajn, fil- wiċċ u fil- griżmejn.
Prolonged and sometimes painful erections have been reported after taking VIAGRA.
Erezzjonijiet prolongati u xi mndaqqiet bl- uġieħ, ġew irrappurtati wara li tittieħed il- VIAGRA.
If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.
Jekk għandek erezzjoni li ddum iktar minn 4 sigħat, għandek tikkuntattja lit- tabib tiegħek immedjatament.
If you experience a sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.
Jekk tesperjenza tnaqqis jew telf fil- vista f’ daqqa, waqqaf il- VIAGRA u kkuntattja immedjatament lit - tabib tiegħek.
A very common side effect (likely to occur in more than 1 in 10 patients) is headache.
Effett sekondarju komuni ħafna (jiġri f’ pazjent minn kull 10) huwa l- uġiegħ ta ’ ras.
Common side effects (likely to occur in 1 to 10 patients in 100) include: facial flushing, indigestion, effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and dizziness.
Effetti sekondarji komuni (jiġru f’ minn 1 sa 10 pazjenti minn kull 100), jinkludu: ħmura fil- wiċċ, indiġestjoni, effetti fuq il- vista (fosthom vista mżewwqa (b’ xi kulur), sensittivita ’ għad- dawl, vista mċajpra jew nuqqas ta ’ vista ċara), imnifsejn miżduda, u sturdament.
Uncommon side effects (likely to occur in 1 to 10 patients in 1000) include: vomiting,, skin rash, bleeding at the back of the eye, eye irritation, bloodshot eyes / red eyes, eye pain, double vision, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain and feeling tired.
Effetti sekondarji mhux komuni (jiġru f’ minn 1 sa 10 pazjenti minn kull 1, 000) jinkludu: rimettar, raxx, emoraġija fuq wara ta ’ l- għajn, irritazzjoni fl- għajnejn, għajnejn ħomor, uġiegħ fl- għajn, tara kollox doppju, sensazzjoni mhux normali fil- għajn, taħbit tal- qalb irregolari jew mgħaġġel, uġiegħ fil - muskoli, ngħas tqil, tnaqqis fis- sens tal- mess, vertigo, tisfir fil- widnejn, dardir, ħalq xott, uġiegħ fis - sider u għeja.
Rare side effects (likely to occur in 1 to 10 patients in 10000) include: high blood pressure, low blood pressure, fainting, stroke, nosebleed and sudden decrease or loss of hearing.
Effetti sekondarji rari (jiġru f’ minn 1 sa 10 pazjenti minn kull 10, 000) jinkludu: pressjoni għolja, pressjoni baxxa, ħass ħażin, puplesija, tinfaġar, u tnaqqis jew telf f’ daqqa tas- smigħ.
Additional side effects reported from post-marketing experience include: pounding heartbeat, chest pain, sudden death, heart attack or temporary decreased blood flow to parts of the brain.
Effetti sekondarji oħra li kienu rrappurtati minn meta l- prodott ġie introdott fis- suq jinkludu: taħbit irregolari tal- qalb, uġigħ fis- sider, mewt għall- għarrieda, attakk tal- qalb u tnaqqis temporanju fiċ - ċirkolazzjoni tad- demm f’ xi partijiet tal- moħħ.
Most, but not all, of these men had heart problems before taking this medicine.
Il- biċċa l- kbira ta ’ dawn l- irġiel, iżda mhux kollha, kellhom problemi tal- qalb qabel ma ħadu din il- mediċina.
It is not possible to determine whether these events were directly related to VIAGRA.
Mhux possibbli li wieħed jistabbilixxi jekk dawn il- każijiet kinux relatati direttament ma ’ VIAGRA.
Cases of convulsions or seizures have also been reported.
Każi ta ’ attakki ta ’ konvulżjonijiet jew aċċessjonijiet kienu wkoll irrappurtati.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE VIAGRA
KIF TAĦŻEN VIAGRA
Keep out of the reach and sight of children Do not store above 30oC.
Taħżinhiex f’ temperatura ’ l fuq minn 30°C.
Do not use VIAGRA after the expiry date which is stated on the carton.
Tużax VIAGRA wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Medicines should not be disposed of via wastewater or household waste.
54 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What VIAGRA contains
X’ fiha Viagra
− The active substance is sildenafil.
Is- sustanza attiva hi s- sildenafil.
Each tablet contains 25 mg of sildenafil (as the citrate salt). − The other ingredients are:
Kull pillola fiha 25mg ta ’ sildenafil (bħala citrate). − Is- sustanzi l- oħra huma: −
− Tablet core:
− Qalba tal- pillola:
microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate,
microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate,
− Film coat:
− Rita tal- kisja:
hypromellose, titanium dioxide (E171), lactose, triacetin, indigo carmine aluminium lake (E132)
hypromellose, titanium dioxide (E171), lactose, triacetin, indigo carmine aluminium lake (E132)
What VIAGRA looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett
VIAGRA film-coated tablets are blue, with a rounded-diamond shape.
Il- pilloli miksijin b’ rita ta ’ VIAGRA huma blu, b’ forma ta ’ djament ġej għat- tond.
They are marked “ PFIZER ” on one side and “ VGR 25” on the other side.
Huma mmarkati bil- kelma “ PFIZER ” fuq naħa waħda u b ’ “ VGR 25 ” fuq in- naħa l- oħra.
The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets.
Il- pilloli jiġu fi strixxi tal- fojl li fihom 2, 4, 8 jew 12- il pillola.
Some pack sizes may not be marketed in your country.
Jista ’ jkun li mhux id- daqsijiet kollha jkun għal skop kummerċjali fil - pajjiż tiegħek.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni Għat- Tqegħid fis- suq u l- Manifattur
The marketing authorisation holder of VIAGRA is Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq ta ’ VIAGRA huwa Pfizer Limited, Sandwich, Kent, CT13 9NJ, Ir- Renju Unit
The manufacturer of VIAGRA is Pfizer PGM, Zone Industrielle, 29 route des Industries, 37530 Pocé- sur-Cisse, France.
Il- manifattur ta ’ VIAGRA huwa Pfizer PGM, Zone Industrielle, 29 route des Industries, 37530 Pocé - sur- Cisse, Franza.
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 għamel kuntatt mar- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Detailed information on VIAGRA is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- mediċini (EMEA): http: // www. emea. europa. eu
VIAGRA 50 mg film-coated tablets Sildenafil citrate
VIAGRA 50 mg pilloli miksijin b’ rita Sildenafil (bħala citrate)
VIAGRA belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
VIAGRA tagħmel ma ’ grupp ta ’ mediċinali msejjħa inibituri ta ’ phosphodiesterase type 5( PDE5).
It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited.
Hija taħdem billi tgħin tirrilassa l- blood vessels li jġorru d- demm għal pene u tippermetti d- demm biex jidħol fil- pene meta tkun eċitat sesswalment.
− If you are using any of the drugs known as nitric oxide donors such as amyl nitrite (“ poppers”), as the combination may also lead to a potentially dangerous decrease in your blood pressure.
Jekk inti qed tieħu mediċini li huma magħrufin li jiġġeneraw nitric oxide bħal amyl nitrite − (“ poppers ”), dawn ukoll jistgħu jikkawżaw pressjoni baxxa potenzjalment ta ’ ħsara jekk jittieħdu mal- Viagra.
− If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
57 Jekk inti għandek ċertu mard rari ereditarju tal- għajnejn (bħal retinitis pigmentosa). −
57 − If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).
Jekk qatt tlift il- vista minħabba newropatija anterjuri iskimika, mhux arteritika tal- għajn − (NAION)
− If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.
- jekk fil- preżent inti għandek ulċera fl- istonku, jew problema ta ’ tnixxija tad- demm (bħal
Special considerations for children and adolescents VIAGRA should not be given to individuals under the age of 18.
Inti m’ għandekx tuża VIAGRA ma ’ xi kura oħra, kemm mill- ħalq u kemm lokalizzarta, għal problema ta ’ l- erezzjoni tal- pene.
In the event of a medical emergency, you should tell any health care professional treating your condition that you have taken VIAGRA and when you did.
F’ każ ta ’ emerġenza medika, inti għandek tgħid lill- professjonista tal- kura tas- saħħa li qed jikkurak li inti ħadt VIAGRA u meta.
If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of VIAGRA.
Jekk inti qed tieħu mediċini magħrufin bħala inibituri ta ’ protease, bħal dawk għall- kura tal- HIV, it - tabib tiegħek jista ’ jibda jtik l- anqas doża (25 mg) ta ’ VIAGRA.
This is most likely to occur within 4 hours after taking VIAGRA.
Pazjenti fuq kura ta ’ alpha blockers għal pressjoni għolja jew nefħa tal- prostata jistgħu iħossu sturdament qawwi jew sturdament ħafif li jista jkunu kkawżat minn pressjoni baxxa posturali jiġifieri l- pressjoni titbaxxa meta toqgħod bil- qiegħda jew meta tqum bil- wieqfa bil- għaġġla.
58 daily dose of your alpha-blocker before you start VIAGRA.
58 ħassew dawn is- sintomi meta kienu qed jieħdu VIAGRA ma ’ alpha blockers.
Taking VIAGRA with food and drink VIAGRA can be taken with or without food.
Meta tieħu VIAGRA ma ’ l- ikel u max- xorb VIAGRA tista tittieħed ma ’ jew mingħajr l- ikel.
You may experience an increase in side effects and their severity.
Tista tesperjenza żieda ta ’ l- effetti sekondarji u s- severità tagħhom. Dożi ta ’ aktar minn 100 mg ma jżidux l- effiċjenza.
Doses above 100 mg do not increase the efficacy.
M’ għandekx tieħu aktar pilloli milli suppost.
You should not take more tablets than your doctor tells you to.
Jekk tieħu aktar pilloli milli suppost, ikkuntattja lit- tabib tiegħek.
Contact your doctor if you take more tablets than you should.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ din il- mediċiina, tiegħek.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
staqsi lit- tabib jew lill- ispiżjar
59 Like all medicines, VIAGRA can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, VIAGRA jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you have chest pains during or after intercourse:
Jekk għandek uġiegħ tas- sider waqt jew wara r- rapport sesswali:
If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.
Jekk għandek erezzjoni li ddum iktar minn 4 sigħat, għandek tikkuntattja immedjatament lit- tabib tiegħek immedjatament.
Common side effects (likely to occur in 1 to 10 patients in 100) include: facial flushing, indigestion, effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and dizziness.
Effetti sekondarji komuni (jiġru f’ minn 1 sa 10 pazjenti minn kull 100), jinkludu: ħmura fil- wiċċ, indiġestjoni, effetti fuq il- vista (fosthom vista mżewwqa (b’ xi kulur), sensittivita ’ għad- dawl, vista mċajpra jew nuqqas ta ’ vista ċara), imnifsejn miżduda u sturdament.
Uncommon side effects (likely to occur in 1 to 10 patients in 1000) include: vomiting,, skin rash, bleeding at the back of the eye, eye irritation, bloodshot eyes / red eyes, eye pain, double vision, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain and feeling tired.
Effetti sekondarji mhux komuni (jiġru f’ minn 1 sa 10 pazjenti minn kull 1, 000) jinkludu: rimettar, raxx, emoraġija fuq wara ta ’ l- għajn, irritazzjoni fl- għajnejn, għajnejn ħomor, uġiegħ fl- għajn, tara kollox doppju, sensazzjoni mhux normali fil- għajn, taħbit tal- qalb irregolari jew mgħaġġel, uġiegħ fil - muskoli, ngħas tqil, tnaqqis fis- sens tal- mess, vertigo, tisfir fil- widnejn, dardirm ħalq xott, uġiegħ fis - sider u għejja.
Rare side effects (likely to occur in 1 to 10 patients in 10000) include: high blood pressure, low blood pressure, fainting, stroke, nosebleed and sudden decrease or loss of hearing.
Effetti sekondarji rari (jiġru f’ minn 1 sa 10 pazjenti minn kull 10000) jinkludu: pressjoni għolja, pressjoni baxxa, ħass ħażin, puplesija, tinfaġar u tnaqqis jew telf f’ daqqa tas- smigħ.
Medicines should not be disposed of via wastewater or household waste.
60 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Each tablet contains 50 mg of sildenafil (as the citrate salt). − The other ingredients are:
Kull pillola fiha 25mg ta ’ sildenafil (bħala citrate). − Is- sustanzi l- oħra huma: −
They are marked “ PFIZER” on one side and “ VGR 50” on the other side.
Huma mmarkati bil- kelma “ PFIZER ” fuq naħa waħda u b ’ “ VGR 50 ” fuq in- naħa l- oħra.
The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets in a carton or card packaging.
Il- pilloli jiġu fi strixxi tal- fojl li fihom 2, 4, 8 jew 12- il pillola f’ pakkett jew ipakkettar tal- kartun.
Some pack sizes may not be marketed in your country.
Jista ’ jkun li mhux id- daqsijiet kollha jkun għal skop kummerċjali fil- pajjiż tiegħek.
Deutschland Pfizer Pharma GmbH Tel: +49 (0)30 550055 51000
61 Deutschland Pfizer Pharma GmbH Tel: +49 (0) 30 550055 51000
Detailed information on VIAGRA is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - mediċini (EMEA): http: // www. emea. europa. eu
VIAGRA 100 mg film-coated tablets Sildenafil citrate
VIAGRA 100 mg pilloli miksijin b’ rita Sildenafil (bħala citrate)
− If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
63 Jekk inti għandek ċertu mard rari ereditarju tal- għajnejn (bħal retinitis pigmentosa). −
63 − If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).
Jekk qatt tlift il- vista minħabba newropatija anterjuri iskimika, mhux arteritika tal- għajn − (NAION)
Special considerations for children and adolescents VIAGRA should not be given to individuals under the age of 18.
Inti m’ għandekx tuża VIAGRA ma ’ xi kura oħra kemm mill- ħalq u kemm lokalizzata għal problema ta ’ l- erezzjoni tal- pene.
In the event of a medical emergency, you should tell any health care professional treating your condition that you have taken VIAGRA and when you did.
F’ każ ta ’ emerġenza medika, inti għandek tgħid lill- professjonist tal- kura tas- saħħa li qed jikkurak li inti ħadt VIAGRA u meta.
This is most likely to occur within 4 hours after taking VIAGRA.
Pazjenti fuq kura ta ’ alpha blockers għal pressjoni għolja jew nefħa tal- prostata jistgħu iħossu sturdament qawwi jew sturdament ħafif li jista jkunu kkawżati minn pressjoni baxxa posturali jiġifieri l- pressjoni titbaxxa meta toqgħod bil- qiegħda jew meta tqum bil- wieqfa bil- għaġġla.
64 daily dose of your alpha-blocker before you start VIAGRA.
64 ħassew dawn is- sintomi meta kienu qed jieħdu VIAGRA ma ’ alpha blockers.
Drinking alcohol can temporarily impair the ability to get an erection.
Ix- xorb alkoħoliku jista ’ temporanjament jfixkel l- abilità li jkollok erezzjoni.
To get the maximum benefit from your medicine, you are advised not to drink large amounts of alcohol before taking VIAGRA.
Biex tieħu l- aħjar benefiċċju mill- mediċina tiegħek, huwa rakkomandat li inti ma tixrobx ammont kbir ta ’ alkoħol qabel ma tieħu VIAGRA.
You may experience an increase in side effects and their severity.
Tista tesperjenza żieda ta ’ l- effetti mhux mixtieqa u s- severità tagħhom.
Doses above 100 mg do not increase the efficacy.
Dożi ta ’ aktar minn 100 mg ma jżidux l- effiċjenza.
You should not take more tablets than your doctor tells you to.
65 M’ għandekx tieħu aktar pilloli milli suppost.
If you have any further questions on the use of thismedicine, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ din il- mediċina, staqsi lit- tabib jew lill- ispiżjar tiegħek.
A very common side effect (likely to occur in more than 1 in 10 patients)is headache.
Effett sekondarju komuni ħafna (jiġri f’ pazjent minn kull 10) huwa l- uġiegħ ta ’ ras.
Each tablet contains 100 mg of sildenafil (as the citrate salt). − The other ingredients are:
Kull pillola fiha 25mg ta ’ sildenafil (bħala citrate). − Is- sustanzi l- oħra huma: −
They are marked “ PFIZER” on one side and “ VGR 100” on the other side.
Huma mmarkati bil- kelma “ PFIZER ” fuq naħa waħda u b ’ “ VGR 100 ” fuq in- naħa l- oħra.
Danmark Pfizer ApS Tlf: +45 44 20 11 00
67 Danmark Pfizer ApS Tlf: +45 44 20 11 00
What is Vidaza?
X’ inhu Vidaza?
Vidaza is a powder to be made up into a suspension for injection.
Vidaza huwa trab li jinħall f’ sospensjoni għall- injezzjoni.
It contains the active substance azacitidine.
Fih is- sustanza attiva azacitidine.
What is Vidaza used for?
Għal xiex jintuża Vidaza?
Vidaza is used for the treatment of adults with the following diseases, if they cannot have a bone marrow transplant:  myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Vidaza jintuża għat- trattament ta ’ adulti b’ dawn il- mardiet, jekk ma jkunx jista ’ jkollhom trapjant tal - mudullun:  sindromi mijodisplastiċi, grupp ta ’ kundizzjonijiet fejn ikun hemm ftit wisq ċelloli tad- demm prodotti mill- mudullun.
In some cases, myelodysplastic syndromes can lead to the development of acute myeloid leukaemia (AML, a type of cancer affecting white blood cells called myeloid cells).
F’ xi każijiet, is- sindromi mjelodisplastiċi jistgħu jwasslu għall- iżvilupp ta ’ lewċemija mjelojde akuta (AML, tip ta ’ kanċer li jolqot iċ- ċelloli bojod tad- demm magħrufa bħala ċelloli mjelojdi).
Vidaza is used in patients with an intermediate to high risk of progressing to AML or death;  chronic myelomonocytic leukaemia (CMML, a type of cancer affecting white blood cells called monocytes).
Vidaza jintuża f’ pazjenti b’ riskju bejn intermedjarju u għoli li jwassal għal AML jew għall- mewt;  lewċemija mjelomonoċitika kronika (CMML, tip ta ’ kanċer li jolqot iċ- ċelloli tad- demm bojod magħrufa bħala monoċiti).
Vidaza is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;  AML that has developed from a myelodysplastic syndrome.
Vidaza jintuża meta l- mudullun ikun fih bejn 10 u 29% ta ’ ċelloli anomali u l- mudullun ma jkunx qed jipproduċi ammonti kbar ta ’ ċelloli tad- demm bojod;  AML li jiżviluppa minn sindromu mjelodisplastiku.
Vidaza is only used when the bone marrow consists of 20 to 30% abnormal cells.
Vidaza jintuża biss meta l- mudullun ikun jikkonsisti minn bejn 20 u 30% ċelloli anomali.
Because the number of patients with these diseases is low, the diseases are considered ‘ rare’, and Vidaza was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 6 February 2002 for myelodysplastic syndromes and on 29 November 2007 for AML.
Minħabba li l- għadd ta ’ pazjenti b’ dawn il- mardiet huwa wieħed baxx, il- mardiet huma meqjusin ‘ rari ’, u fis- 6 ta ’ Frar 2002, Vidaza ġie denominat bħala ‘ mediċina orfni ’ (mediċina li tintuża għal mardiet rari) għas- sindromi mjelodisplażiċi u fid- 29 ta ’ Novembru 2007 għall- AML.
At the time of orphan medicine designation, CMML was classified as a type of myelodysplastic syndrome.
Fi żmien tad - denominazzjoni bħala orfni, CMML ġie kklassifikat bħala tip ta ’ sindromu mjelodisplastiku.
How is Vidaza used?
Kif jintuża Vidaza?
Vidaza treatment should be started and monitored under the supervision of a doctor who has experience in the use of chemotherapy.
It- trattament b’ Vidaza għandu jinbeda u jiġi sorveljat taħt is- superviżjoni ta ’ tabib b’ esperjenza fl- użu tal- kemjoterapija.
Patients should receive medicines to prevent nausea (feeling sick) and vomiting before Vidaza treatment.
Il- pazjenti għandhom jirċievu mediċini għall- prevenzjoni ta ’ nawżea (dardir) u r - remettar qabel it- trattament b’ Vidaza.
The recommended starting dose of Vidaza is 75 mg per square metre body surface area (calculated using the patient ’ s height and weight).
Id- doża inizjali rakkomandata ta ’ Vidaza hija ta ’ 75 mg għal kull metru kwadru ta ’ superfiċje (ikkalkolata mit- tul u mill- piż tal- pazjent).
This four- week period is one ‘ cycle’.
Jingħata bħala injezzjoni taħt il- ġilda fil- part ta ’ fuq tad - driegħ, fil- koxxa jew fl- addome (fiż- żaqq) għal ġimgħa waħda, segwita minn tliet ġimgħat mingħajr trattament.
Treatment continues for at least six cycles and then for as long as it benefits the patient.
Dan il- perjodu ta ’ erba ’ ġimgħat jikkonsisti f ’ ‘ ċiklu ’ wieħed.
The liver, kidneys and blood should be checked before each cycle.
It- trattament jibqa ’ sejjer għal mill- inqas sitt ċikli u mbagħad sakemm jibqa ’ jkun ta ’ ġid għall- pazjent.
If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed or a lower dose should be used.
Il- fwied, il- kliewi u d- demm għandhom jiġu kkontrollati qabel kull ċiklu.
Patients who have severe liver problems should be carefully monitored for side effects, but Vidaza must not be used in patients with advanced liver cancer.
Jekk l- għadd ta ’ ċelloli fid- demm jitbaxxa wisq jew il - pazjent jiżviluppa problemi fil- kliewi, iċ- ċiklu ta ’ trattament li jkun imiss għandu jiġi ttardjat jew inkella għandha tintuża doża iktar baxxa.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Pazjenti li jkollhom problemi gravi fil- fwied għadhom jiġu 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. sorveljati bir- reqqa għall- effetti sekondarji, iżda Vidaza m’ għandux jintuża f’ pazjenti b’ kanċer tal - fwied f’ fażi avvanzata.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Ara s- Sommarju tal- Karatteristiċi tal- Prodott (li wkoll huwa parti mill- EPAR) għad- dettalji kollha.
How does Vidaza work?
Kif jaħdem Vidaza?
The active substance in Vidaza, azacitidine, is a medicine belongs to the group ‘ anti-metabolites’.
Is- sustanza attiva f’ Vidaza, azacitidine, hija mediċina li tagħmel parti mill- grupp ta ’ ‘ antimetaboliti ’.
Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA).
Azacitidine huwa analogu taċ- ċitadina (cytidine), li jfisser li huwa inkorporat fil- materjal ġenetiku taċ - ċelloli (RNA u DNA).
It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA.
Huwa maħsub li jaħdem billi jibdel il- mod kif iċ- ċellola tattiva u tiddiżattiva l - ġeni u wkoll billi jinterferixxi mal- produzzjoni ta ’ RNA u DNA ġdid.
These actions are thought to correct the problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Dawn l- azzjonijiet huma maħsuba li jikkoreġu l- problemi bil- maturazzjoni u t- tkabbir taċ- ċelloli tad- demm ġodda fil- mudullun li jikkawżaw diżordnijiet mjelodisplażiċi, u li joqtlu ċ- ċelloli kanċerużi fil- lewċemija.
How has Vidaza been studied?
Kif ġie studjat Vidaza?
The effects of Vidaza were first tested in experimental models before being studied in humans.
L- effetti ta ’ Vidaza għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil - bnedmin.
Vidaza has been studied in one main study involving 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML, who were unlikely to go on to have a bone marrow transplant.
Vidaza ġie studjat fi studju wieħed ewlieni li fih ħadu sehem 358 adult b’ riskju bejn intermedjarju u għoli għas- sindromi mjelodisplażiċi, CMML jew AML, li ma kinux mistennija li jkollhom trapjant tal - mudullun.
The patients ’ bone marrow contained 10 to 29% abnormal cells and their white blood cell counts were not too high.
Il- mudullun tal- pazjenti kien jikkonsisti minn bejn 10 u 29% ta ’ ċelloli anomali u l- għadd ta ’ ċelloli bojod fid- demm ma kienx għoli ħafna.
The study compared Vidaza with conventional care (treatment chosen for each patient based on local practice and the patient’ s condition).
L- istudju qabbel Vidaza mal- kura konvenzjonali (trattament magħżul għal kull pazjent skont il- prassi lokali u l- kundizzjoni tal- pazjent).
All of the patients also received ‘ best supportive care’ (any medicines or techniques to help patients, such as antibiotics, painkillers and transfusions), with some patients also receiving other anticancer medicines such as cytarabine with or without an anthracycline.
Il- pazjenti kollha ngħataw ‘ l- aqwa kura ta ’ appoġġ ’ (kull mediċina jew teknika li tgħin il- pazjenti, bħall - antibijotiċi, mediċini għal kontra l- uġigħ u trasfużjonijiet), b’ xi pazjenti jingħataw ukoll mediċini oħra għal kontra l- kanċer bħal ċitarabina (cytarabine) bi jew mingħajr antraċiklina (anthracycline).
The main measure of effectiveness was how long the patients survived.
Il- mezz ewlieni għall- kejl tal- effikaċja kien kemm dam jgħix iktar il- pazjent.
The study lasted 44 months.
L- istudju dam 44 xahar.
What benefit has Vidaza shown during the studies?
X’ benefiċċji wera Vidaza f’ dawn l- istudji mwettqa?
Vidaza was more effective than conventional care in extending survival.
Vidaza kien iktar effikaċi mill- kura konvenzjonali biex itawwal is- sopravivenza.
Patients receiving Vidaza survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care.
Il- pazjenti li kienu qed jingħataw Vidaza damu jgħixu medja ta ’ 24. 5 xhur, meta mqabbla ma ’ 15- il xahar f’ pazjenti li ngħataw kura konvenzjnali.
The effect of Vidaza was similar in all three diseases.
L- effett ta ’ Vidaza kien simili fit- tliet mardiet.
What is the risk associated with Vidaza?
X’ inhu r- riskju assoċjat ma ’ Vidaza?
The most common side effects with Vidaza (seen in more than 60% of patients) are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions.
L- effetti sekondarji l- aktar komuni b’ Vidaza (li dehru f’ iktar minn 60% tal- pazjenti) huma r - reazzjonijiet tad- demm inkluża t- tromboċitopenija (għadd baxx ta ’ platelets), newtropenija (ammonti baxxi ta ’ newtrofili, tip ta ’ ċellolli tad- demm bojod) u lewkopenija (għadd baxx ta ’ ċelloli tad- demm bojod), effetti sekondarji li jolqtu l- iskonku u l- imsaren inklużi n- nawżea u r- rimettar, u reazzjonjiet fis- sit tal- injezzjoni.
For the full list of all side effects reported with Vidaza, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarja kollha rrappurtati b’ Vidaza, ara l- Fuljett ta ’ Tagħrif.
Vidaza should not be used in people who may be hypersensitive (allergic) to azacitidine or any of the other ingredients.
Vidaza m’ għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għal azacitidine jew għal xi sustanza oħra tiegħu.
It must not be used in patients with advanced liver cancer or in women who are breast-feeding.
M’ għandux jintuża f’ pazjenti b’ kanċer f’ fażi avvanzata tal- fwied jew f’ nisa li jkunu qed ireddgħu.
Why has Vidaza been approved?
Għaliex ġie approvat Vidaza?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vidaza’ s benefits are greater than its risks for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with intermediate-2 and high-risk myelodysplastic syndromes, CMML with 10-29% abnormal blasts without myeloproliferative disorder or AML with 20-30% blasts and multilineage dysplasia.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Vidaza huma ikbar mir- riskji tiegħu għat- trattament ta ’ pazjenti adulti li mhumiex eliġibbli għat - trapjant ta ’ ċelloli staminali ematopojetiċi b’ sindromi mjelodisplażiċi b’ riskju bejn intermedjarju- 2 u għoli, CMML bi blasts anomali ta ’ 10- 29% mingħajr disturbi mjeloproliferattivi jew AML u displażija multilineari.
The Committee recommended that Vidaza be given marketing authorisation.
Il- Kumitat irrakkomanda li Vidaza jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Vidaza:
Tagħrif ieħor dwar Vidaza:
The European Commission granted a marketing authorisation valid throughout the European Union for Vidaza to Celgene Europe Ltd on 17 December 2008.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Vidaza valida fl- Unjoni Ewropea kollha lil Celgene Europe Ltd fi 17 ta ’ Diċembru 2008.
The records of Vidaza’ s designations as an orphan medicine are available here (myelodysplastic syndromes) and here (AML).
Id- dokumenti tad- denominazzjoni ta ’ Vidaza bħala mediċina orfni huma disponibbli minn hawn (għas- sindromi mijelodisplażiċi) u minn hawn (għall- AML).
The full EPAR for Vidaza can be found here.
L- EPAR sħiħ għal Vidaza jista ’ jiġi kkonsultat hawn.
EU number
l- EU
powder for suspension for injection
Trab għal suspensjoni għall- injezzjoni
subcutaneous use
Użu għal taħt il- ġilda
Vidaza 25 mg/ ml powder for suspension for injection
Vidaza 25 mg/ ml trab għal suspensjoni għall- injezzjoni
Each vial contains 100 mg azacitidine.
Kull kunjett fih 100 mg azacitidine.
After reconstitution, each ml suspension contains 25 mg azacitidine.
Wara r- rikostituzzjoni, kull ml ta ’ suspensjoni jkun fih 25 mg azacitidine.
Powder for suspension for injection.
Trab għal suspensjoni għall- injezzjoni.
Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, • acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification.
Vidaza hu indikat għall- kura ta ’ pazjenti adulti li mhumiex eliġibbli għal trapjant b’ ċelluli staminali ematopojetiċi li għandhom: • sindromi majelodisplastiċi (MDS) intermedji- 2 u ta ’ riskju għoli skond l- International Prognostic Scoring System (IPSS), • lewkimja majelomonoċitika kronika (CMML) b’ 10- 29% ta ’ blasts tal- mudullun mingħajr disturb majeloproliferattiv, • lewkimja majelojde akuta (AML) b’ 20- 30% blasts u displasja multi- lineage, skond il - klassifikazzjoni tal- Organizzazzjoni Dinjija tas- Saħħa (WHO).
Vidaza treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents.
Il- kura b’ Vidaza għandha tinbeda u tkun immonitorjata taħt is- superviżjoni ta ’ tabib b’ esperjenza fl - użu ta ’ mediċini kemoterapewtiċi.
Patients should be premedicated with anti-emetics for nausea and vomiting.
Il- pazjenti għandhom jingħataw mediċina minn qabel kontra r - rimettar għan- nawsja u r- rimettar.
Posology The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/ m2 of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle).
Pożoloġija Id- doża tal- bidu rakkomandata għall- ewwel ċiklu ta ’ kura, għall- pazjenti kollha mingħajr ma jingħata kas tal- valuri ematoloġiċi tal- laboratorju fil- linja bażi, hi ta ’ 75 mg/ m2 ta ’ erja tas- superfiċje tal- ġisem, injettata taħt il- ġilda, kuljum għal 7 ijiem, segwit minn perjodu ta ’ serħan ta ’ 21 jum (ċiklu tal- kura ta ’ 28 jum).
It is recommended that patients be treated for a minimum of 6 cycles.
Hu rakkomandat li l- pazjenti jkunu kkurati għal minimu ta ’ 6 ċikli.
Treatment should be continued as long as the patient continues to benefit or until disease progression.
Il- kura għandha titkompla sakemm il- pazjent ikompli jibbenefika minnha jew sal- progressjoni tal- marda.
Patients should be monitored for haematologic response/ toxicity and renal toxicities (see section 4.4); a delay in starting the next cycle or a dose reduction as described below may be necessary.
Il- pazjenti għandhom ikunu mmonitorjati għar- rispons/ tossiċità ematoloġika u għat- tossiċitajiet renali (ara sezzjoni 4. 4); l- ittardjar tal- bidu taċ- ċiklu li jmiss jew it- tnaqqis tad- doża kif deskritt hawn taħt jista ’ jkun meħtieġ.
Dose adjustment due to haematological toxicity Haematological toxicity is defined as the lowest count reached in a given cycle (nadir) if platelets fall below 50.0 x 109/ l and/ or absolute neutrophil count (ANC) below 1 x 109/ l.
Aġġustament fid- doża minħabba tossiċità ematoloġika It- tossiċità ematoloġika hi definita bħala l- inqas għadd li jintlaħaq f’ ċiklu partikulari (nadir) jekk il - plejtlits jaqgħu taħt 50. 0 x 109/ l u/ jew l- għadd assolut tan- newtrofili (Absolute Neutrophil Count, ANC) jaqa ’ taħt 1 x 109/ l.
2 Recovery is defined as an increase of cell line(s) where haematological toxicity was observed of at least half of the difference of nadir and the baseline count plus the nadir count (i. e. blood count at recovery ≥ Nadir Count + (0.5 x [Baseline count – Nadir count]).
2 L- irkuprar hu definit bħala żieda ta ’ linja( i) taċ- ċelluli fejn it- tossiċità ematoloġika tkun ġiet osservata f’ mill- inqas nofs id- differenza tan- nadir u l- għadd fil- linja bażi flimkien mal- għadd tan- nadir (i. e. għadd taċ- ċelluli tad- demm fl- irkuprar ≥ Għadd tan- nadir + (0. 5 x [Għadd fil- linja bażi – Għadd tan - nadir]).
Patients without reduced baseline blood counts (i. e.
Pazjenti mingħajr għadd taċ- ċelluli tad- demm fil- linja bażi mnaqqas (i. e.
White Blood Cells (WBC) > 3.0 x 109/ l and ANC > 1.5 x 109/ l, and platelets > 75.0 x 109/ l) prior to the first treatment If haematological toxicity is observed following Vidaza treatment, the next cycle of Vidaza therapy should be delayed until the platelet count and the ANC have recovered.
Ċelluli Bojod tad- Demm (WBC) > 3. 0 x 109/ l u ANC > 1. 5 x 109/ l, u plejtlits > 75. 0 x 109/ l) qabel l- ewwel kura Jekk it- tossiċità ematoloġika tkun osservata wara l- kura b’ Vidaza, iċ- ċiklu li jmiss tat- terapija b’ Vidaza għandu jiġi ttardjat sakemm l- għadd tal- plejtlits u l- ANC jkunu rkupraw.
If recovery is achieved within 14 days, no dose adjustment is necessary.
Jekk l- irkuprar jintlaħaq fi żmien 14- il jum, l- ebda aġġustament fid- doża mhu meħtieġ.
However, if recovery has not been achieved within 14 days, the dose should be reduced according to the following table.
Madankollu, jekk l- irkuprar ma jkunx intlaħaq fi żmien 14- il jum, id- doża għandha titnaqqas skond it- tabella li ġejja.
Following dose modifications, the cycle duration should return to 28 days.
Wara t- tibdil fid- doża, it- tul taċ- ċiklu għandu jerġa ’ lura għal 28 jum.
Nadir counts 9 9
Għadd tan- nadir
% Dose in the next cycle, if recovery* is not
% Tad- doża fiċ- ċiklu li jmiss, jekk l- irkuprar * ma
Platelets (x 10 / l)
Plejtlits (x 109/ l)
achieved within 14 days
jintlaħaqx fi żmien 14- il jum
≤ 1.0 > 1.0
≤ 1. 0 > 1. 0
≤ 50.0 > 50.0
≤ 50. 0 > 50. 0
*Recovery = counts ≥ Nadir count + (0.5 x [Baseline count – Nadir count])
* Irkuprar = għadd ≥ Għadd tan- nadir + (0. 5 x [Għadd fil- linja bażi – Għadd tan- nadir])
Patients with reduced baseline blood counts (i. e.
Pazjenti b’ għadd taċ- ċelluli tad- demm fil- linja bażi mnaqqsa (i. e.
WBC < 3.0 x 109/ l or ANC < 1.5 x 109/ l or platelets < 75.0 x 109/ l) prior to the first treatment Following Vidaza treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is less than 50%, or greater than 50% but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
WBC < 3. 0 x 109/ l jew ANC < 1. 5 x 109/ l jew plejtlits < 75. 0 x 109/ l) qabel l- ewwel kura Wara l- kura b’ Vidaza, jekk it- tnaqqis fl- għadd tal- WBC jew tal- ANC jew tal- plejtlits minn dak ta ’ qabel il- kura ikun inqas minn 50%, jew iktar minn 50% iżda b’ titjib fi kwalunkwe differenzazzjoni ta ’ razez ta ’ ċelluli, iċ- ċiklu li jmiss m’ għandux jittardja u m’ għandu jsir l- ebda aġġustament fid- doża.
If the decrease in WBC or ANC or platelets is greater than 50% from that prior to treatment, with no improvement in cell line differentiation, the next cycle of Vidaza therapy should be delayed until the platelet count and the ANC have recovered.
Jekk it- tnaqqis fl- għadd tal- WBC jew tal- ANC jew tal- plejtlits ikun iktar minn 50% minn dak ta ’ qabel il- kura, bla ebda titjib fid- differenzazzjoni ta ’ razez ta ’ ċelluli, iċ- ċiklu li jmiss tal- kura b’ Vidaza għandu jkun ittardjat sakemm l- għadd tal- plejtlets u l- ANC ikunu rkupraw.
If recovery is achieved within 14 days, no dose adjustment is necessary.
Jekk l- irkuprar jintaħaq fi żmien 14- il jum, l- ebda aġġustament fid- doża mhu meħtieġ.
However, if recovery has not been achieved within 14 days, bone marrow cellularity should be determined.
Madankollu, jekk l- irkuprar ma jkunx intlaħaq fi żmien 14- il jum, iċ- ċellularità tal- mudullun trid tkun stabbilita.
If the bone marrow cellularity is > 50%, no dose adjustments should be made.
Jekk iċ- ċellularità tal - mudullun tkun ta ’ > 50%, m’ għandhom isiru l- ebda aġġustamenti fid- doża.
If bone marrow cellularity is ≤ 50%, treatment should be delayed and the dose reduced according to the following table:
Jekk iċ- ċellularità tal - mudullun tkun ta ’ ≤ 50%, il- kura għandha tiġi ttardjata u d- doża titnaqqas skond it- tabella li ġejja:
Bone marrow cellularity
Irkuprar * ≤ 21 jum
% Dose in the next cycle if recovery is not achieved within 14 days Recovery* ≤ 21 days Recovery* > 21 days
Irkuprar * > 21 jum
Special populations Renal impairment:
Popolazzjonijiet speċjali Indeboliment renali:
No formal studies have been conducted in patients with decreased renal function.
Ma saru l- ebda studji formali fuq pazjenti bi tnaqqis fil- funzjoni renali.
Patients with severe organ impairment should be carefully monitored for adverse events.
Pazjenti b’ indeboliment sever ta ’ l- organi għandhom ikunu mmonitorjati bl- attenzjoni għal avvenimenti avversi.
No specific modification to the starting dose is recommended in patients with renal impairment (e. g. baseline serum creatinine or blood urea nitrogen [BUN] ≥ 2-fold above upper limit of normal [ULN] or serum bicarbonate less than 20 mmol/ l) prior to starting treatment; subsequent dose modifications should be based on haematology and renal laboratory values.
L- ebda tibdil speċifiku fid- doża tal- bidu mhu rakkomandat f’ pazjenti b’ indeboliment renali (eż. krejatinina fis- serum fil- linja bażi jew in- nitrogen ta ’ l- urea fid- demm [BUN] ikun ≥ darbtejn iżjed mil- limitu ta ’ fuq tan- normal [ULN] jew il- bicarbonate fis- serum ikun inqas minn 20 mmol/ l) qabel il - bidu tal- kura; tibdil sussegwenti fid- doża għandu jkun ibbażat fuq l- ematoloġija u fuq il- valuri renali tal- laboratorju.
If unexplained reductions in serum bicarbonate levels to less than 20 mmol/ l occur, the dose should be reduced by 50% on the next cycle.
Jekk iseħħ tnaqqis inspjegabbli fil- livelli tal- bicarbonate fis- serum għal inqas minn 20 mmol/ l, id- doża għandha titnaqqas b’ 50% fiċ- ċiklu ta ’ wara.
If unexplained elevations in serum creatinine or BUN to ≥ 2-fold above baseline values and above ULN occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50% on the next treatment cycle (see section 4.4).
Jekk iseħħu żidiet inspjegabbli fil - krejatinina fis- serum jew BUN għal ≥ darbtejn iżjed mill- valuri tal- linja bażi u mill- ULN, iċ- ċiklu li
No formal studies have been conducted in patients with hepatic impairment (see section 4.4).
Ma saru l- ebda studji formali fuq pazjenti b’ indeboliment epatiku (ara sezzjoni 4. 4).