qanastek/EMEA-V3 huggingface dataset:
At least one in ten men has trouble getting or keeping an erection at some time.
Dwar diffikultajiet erettili Fl- irġiel, ta ’ l- inqas wieħed minn kull għaxra jkollhom diffikultà biex jilħqu jew iżommu erezzjoni xi darba jew oħra tul ħajjithom.
There may be physical or psychological causes, or a mixture of both.
Dan jista ’ jiġri minħabba problemi fiżiċi jew psikoloġiċi, jew taħlita tat - tnejn.
Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.
Tkun xi tkun il- kawża, minħabba tibdiliet fil- muskoli, vini u arterji ma jkunx hemm biżżejjed demm li jibqa ’ fil- pene, u b’ hekk tkun diffiċli biex il- pene jibbies u jinżamm iebes.
Levitra will only work when you are sexually stimulated.
Kif taħdem Levitra Levitra jaħdem biss meta int tkun sesswalment stimulat.
It reduces the action of the natural chemical in your body which makes erections go away.
Huwa jnaqqas l- azzjoni tal- kimika naturali fil - ġisem tiegħek li jġiegħel l- erezzjonijiet imorru.
LEVITRA allows an erection to last long enough for you to satisfactorily complete sexual activity.
LEVITRA jħalli erezzjoni ddum biżżejjed biex int ittemm b’ mod sodisfaċenti l- attività sesswali.
BEFORE YOU TAKE LEVITRA
QABEL MA TIEĦU LEVITRA
Do not take Levitra
Tieħux Levitra
See the
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal vardenafil jew sustanzi oħra ta ’
ingredients in section 6.
Ara l- ingredjenti f’ sezzjoni 6.
Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
Sinjali ta 'allerġija jinkludu raxx, ħakk, nefħa fil- wiċċ jew xufftejn u qtugħ ta' nifs.
- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric
- Jekk qed tieħu mediċini li fihom nitrates, bħal glycerol trinitrate għall- anġina, jew donaturi ta ’
oxide donors, such as amyl nitrite.
nitric oxide, bħal amyl nitrite.
Taking these medicines with Levitra could seriously affect your blood pressure.
Jekk tieħu dawn il- mediċini flimkien ma ’ Levitra, jista ’ jkun hemm effett serju fuq il- pressjoni tiegħek.
- If you are taking ritonavir or indinavir, medicines for HIV.
- Jekk qed tieħu ritanovir jew indinavir, mediċini għall- HIV
- If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines
- Jekk għandek ’ l fuq minn 75 sena u qed tieħu ketoconazole jew itraconazole, mediċini kontra l -
- If you have a severe heart or liver problem
- Jekk għandek problemi severi fil- qalb jew fil- fwied
- If you are having kidney dialysis
- Jekk qed tagħmel dijalisi tal- kliewi
- If you have recently had a stroke or heart attack
- Jekk kellek attakk tal- qalb jew puplesija reċenti
- If you have or have had low blood pressure
- Jekk għandek jew kien ikollok pressjoni baxxa
- If your family has a history of degenerative eye diseases (such as retinitis pigmentosa)
- Jekk għandek xi ħadd fil- familja tiegħek li jsofri jew xi darba sofra minn mard deġenerattiv ta ’
52
l- għajnejn (bħal retinitis pigmentosa)
- If you have ever had a condition involving loss of vision due to damage to the optic nerve from
- Jekk qatt kellek kondizzjoni li tinvolvi t- telf tal- vista minħabba ħsara lin- nerv ottiku minħabba
insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION)
provvista tad- demm insuffiċjenti magħrufa bħala newropatija ottika iskemika mhux arterika (NAION)
Take special care with Levitra If you have heart trouble.
Oqgħod attent ħafna b’ Levitra • Jekk għandek problemi f' qalbek.
It may be risky for you to have sex If you suffer from irregular heart beat (cardiac arrythmia) or inherited heart diseases affecting your electrocardiogram If you have a physical condition affecting the shape of the penis.
F' dan il- każ, li jkollok x' taqsam sesswalment jista ’ jkun ta 'riskju għalik. • Jekk tbati minn taħbit tal- qalb irregolari (arritmija kardijaka) jew mard ieħor tal- qalb ereditarju li jaffettwa l- elektrokardjogram tiegħek. • Jekk għandek xi kundizzjoni fiżika li taffettwa l- forma tal- pene.
This includes conditions called angulation, Peyronie’ s disease and cavernosal fibrosis If you have an illness that can cause erections which won ’ t go away (priapism).
Dan jinkludi kundizzjonijiet imsejħa angulazzjoni, il- marda ta 'Peyronie u fibrożi fil- korpus cavernosum • Jekk għandek xi mard li jista ’ jikkawża erezzjoni li ma tgħaddix (prijapiżmu).
These include sickle cell disease, multiple myeloma and leukaemia If you have stomach ulcers (also called gastric or peptic ulcers) If you have a bleeding disorder (such as haemophilia) If you are using any other treatments for erection difficulties If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor immediately.
(Dawn jissejħu wkoll ulceri gastriċi jew peptiċi) • Jekk għandek xi marda ta ’ fsada (bħall- emofilja) • Jekk qed tuża xi kura oħra għal diffikultajiet fl- erezzjoni. • Jekk qatt kellek nuqqas f’ daqqa jew telf tal- vista, tibqax tieħu Levitra u kellem lit- tabib tiegħek minnufih.
Levitra is for men of 18 years and over It is not intended for use by women, children or men under 18.
Levitra hija għall- irġiel ta '18- il sena u fuqhom Levitra mhux indikata għall- użu fin- nisa, tfal jew irġiel taħt 18- il sena.
Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Levitra will usually be fine with most medicines.
Ġeneralment Levitra taqbel mal- biċċa l- kbira tal- mediċini.
Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite.
Madankollu, hemm xi wħud li jistgħu joħolqu problemi, speċjalment dawn li ġejjin: • Nitrates, mediċini għall- anġina, jew donaturi ta ’ nitric oxide bħal amyl nitrite.
Taking these medicines with Levitra could seriously affect your blood pressure.
Jekk tieħu dawn il- mediċini ma ’ Levitra, jista ’ jkun hemm effetti serji fuq il- pressjoni tiegħek.
Talk to a doctor without taking Levitra Medicine for the treatment of arrythmias, such as quinidine, procainamide, amiodarone or sotalol Ritonavir or indinavir, medicines for HIV.
Kellem tabib mingħajr ma tieħu Levitra. • Mediċina għall- kura ta ’ l- arritmija, bħal quinidine, procainamide, amiodarone jew sotalol • Ritonavir jew indinavir, mediċini għall- HIV.
Talk to a doctor without taking Levitra Ketoconazole or itraconazole, anti-fungal medicines Erythromycin, or clarithromycin, macrolide antibiotics Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia)
Kellem tabib mingħajr ma tieħu Levitra • Ketoconazole jew itraconazole, mediċini kontra l- moffa • Erythromycin jew clarithromycin, antibiotiċi macrolide • antibijotiku • Alfa- blockers, tip ta 'mediċina li tintuża biex tikkura pressjoni għolja jew tkabbir tal- prostata (bħal iperplasija beninna tal- prostata).
Don’ t drink grapefruit juice when you use Levitra.
Meta tieħu Levitra ma ’ l- ikel u max- xorb • Tista ’ tieħu ma 'l- ikel jew mingħajr ikel – iżda preferibbilment mhux wara ikla tqila jew b’ ħafna xaħmijiet għax dan jista ’ jittardja l- effett. • Tixrobx meraq tal- grejpfrut meta tieħu.
It can interfere with the usual effect of the medicine.
Dan jista ’ jtellef l- effett li jkollha s- soltu l - medicina.
Alcoholic drink can make erection difficulties worse.
Xorb alkoħoliku jista ’ jżid id- diffikultajiet fl- erezzjoni.
Pregnancy and breast-feeding Levitra is not for use by women.
Tqala u treddigħ Levitra mhux għall- użu minn nisa.
Driving and using machines Levitra might make some people feel dizzy or affect their vision.
Sewqan u tħaddim ta ’ magni Levitra jista ’ jġiegħel lil xi nies iħossuhom sturduti jew jaffettwa l- vista tagħhom.
If you feel dizzy, or if your vision is affected after taking Levitra don’ t drive or operate any tools or machines.
Jekk wara li tieħu Levitra tħossok sturdut jew il- vista tiegħek tiġi affetwata, m' għandekx issuq, tagħmel użu minn għodda jew tħaddem magni.
HOW TO TAKE LEVITRA
KIF GĦANDEK TIEĦU LEVITRA
Always take Levitra exactly as your doctor has told you.
Dejjem għandek tieħu Levitra skond il- parir tat- tabib.
The usual dose is 10 mg.
Id- doża li ssoltu tingħata hija 10 mg.
Take a Levitra tablet about 25 to 60 minutes before sexual activity.
Ħu pillola Levitra madwar 25 sa 60 minuta qabel attività sesswali.
Swallow one tablet with a glass of water
Bi stimulazzjoni sesswali jista ’ jkollok erezzjoni minn 25 minuta sa 4 jew 5 sigħat wara li tieħu l- pillola Levitra. • Ibla ’ pillola waħda ma 'tazza ilma
53 Don’ t use Levitra more than once a day.
Tieħux Levitra aktar minn darba kuljum.
Tell the doctor if you think Levitra is too strong or too weak.
Jekk tħoss li l- effett ta ’ Levitra huwa qawwi jew dgħajjef wisq, kellem lit- tabib.
He or she may suggest a different dose, depending on how well it works for you.
Dan jista ’ jissuġġerilek doża differenti, skond kemm Levitra taħdem tajjeb fuqek.
If you take more Levitra than you should Men who take too much Levitra may experience more side effects or may get severe back pain.
Jekk tieħu Levitra aktar milli suppost Irġiel li jieħdu aktar Levitra milli suppost jista ’ jkollhom aktar effetti mhux mixtieqa jew ikollhom uġigħ qawwi fid- dahar.
If you take more Levitra than you should, tell your doctor.
Jekk tieħu aktar Levitra milli suppost, għid lit- tabib tiegħek.
Like all medicines, Levitra can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra Levitra jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most of the effects are mild or moderate.
Il - maġġoranza ta 'l- effetti huma ħfief jew moderati.
The chance of having a side effect is described by the following categories:
Il- possibilità li jkollok effett sekondarju hija deskritta mill- kategoriji li ġejjin:
Very common (affects more than 1 user in 10) Headache Flushing
Komuni ħafna (jaffettwa aktar minn 1 minn kull 10)
Common (affects 1 to 10 users in 100) Indigestion Feeling sick (nausea) Dizziness Blocked or runny nose
• Indiġestjoni • Tqalligħ (nawseja) • Sturdament • Imnieħer miżdud jew inixxi.
Uncommon (affects 1 to 10 users in 1,000) Sensitivity of the skin to sunlight High or low blood pressure Back or muscle pain Effects on vision Bloodshot or watery eyes Rash Sleepiness Effect in results of blood tests to check liver function Increase in blood of a muscle enzyme (creatine phosphokinase) Breathlessness Fast heart beat or pounding heart Nose bleeds Facial swelling
• Sensittività tal- ġilda għad- dawl tax- xemx • Pressjoni għolja jew baxxa • Uġigħ fil- muskoli jew fid- dahar • Effetti fuq il- vista • Għajnejn ħomor jew idemmgħu • Raxx • Ħedla ta ’ ngħas • Effetti fuq ir- riżultati tat- testijiet tad- demm biex tara l- funżjoni tal- fwied • Żjieda fid- demm ta ’ enżima tal- muskoli (creatine phosphokinase) • Qtugħ ta ’ nifs • Taħbit tal- qalb mgħaġġel jew tħoss qalbek ħa toħroġ minn sidrek • Tinfaraġ • Nefħa fil- wiċċ
Rare (affects 1 to 10 users in 10,000) Fainting Muscle stiffness Increase pressure in the eye (glaucoma) Prolonged or painful erections Allergic reaction Effects on the heart (such as angina) Anxiety Swelling inside the throat Temporary loss of memory (such as transient global amnesia) Seizure
• Ħass ħażin • Muskoli iebsin • Tiżdied il- pressjoni ġo l- għajn (glawkoma) • Reazzjoni allerġika • Effetti fuq il- qalb (bħal anġina) • Ansjetà • Nefħa tal- parti ta ’ ġewwa tal- griżmejn • Telf temporanju tal- memorja( bħal amnesija globali temporanja) • Aċċessjoni
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients.
Kien hemm pazjenti li kellhom nuqqas jew telf parzjali, f’ daqqa, temporanju jew permanenti fil- vista f’ għajn waħda jew fiż- żewġ għajnejn.
Sudden decrease or loss of hearing has been reported.
Ġie rrappurtat tnaqqis jew telf tas- smigħ f’ daqqa waħda.
54 If any of the side effects gets 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 tiegħek.
HOW TO STORE LEVITRA
KIF TAĦŻEN LEVITRA
Do not use Levitra after the expiry date which is stated on the carton.
Tużax Levitra wara d- data ta 'skadenza li tidher fuq il- kartuna.
What Levitra contains
X’ fih Levitra
- The active substance is vardenafil.
- Is- sustanza attiva hi vardenafil.
Each tablet contains 5 mg of vardenafil (as hydrochloride
Kull pillola fiha 5 mg vardenafil (bħala hydrochloride
- The other ingredients of the tablets are:
- Is- sustanzi l- oħra tal- pilloli huma:
Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
Qalba tal- pillola: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172).
Rita tal- pillola: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide isfar (E172), ferric oxide aħmar (E172).
What Levitra looks like and contents of the pack Levitra 5 mg film-coated tablets are orange with the BAYER cross on one side and the strength (5) on the other side.
Id- Dehra ta ’ Levitra u l- kontenuti tal- pakkett Levitra 5 mg pilloli miksija b’ rita huma oranġjo immarkata b' salib tal- BAYER fuq naħa waħda u (5) fuq in- naħa l- oħra.
The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets.
Il- pilloli huma pprovduti f’ pakketti b’ folji li fihom 2, 4, 8 jew 12- il pillola.
Bayer AG, D-51368 Leverkusen, Germany.
Bayer AG, D- 51368 Leverkusen, Il- Ġermanja.
Manufacturer:
L- Manifattur:
Bayer HealthCare AG, D-51368 Leverkusen, Germany.
Bayer HealthCare AG, D- 51368 Leverkusen, Il- Ġermanja.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
56 Għall kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Detailed information on this medicine 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 Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. __
Levitra 10 mg film-coated tablets Vardenafil
Levitra 10 mg pilloli miksija b’ rita Vardenafil
How to store Levitra 6.
Kif taħżen Levitra 6.
WHAT LEVITRA IS AND WHAT IT IS USED FOR
X’ INHU U GĦALXIEX JINTUŻA
57
l- għajnejn (bħal retinitis pigmentosa)
insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION)
provvista tad- demm insuffiċjenti magħruga bħala newropatija ottika iskemika mhux arterika (NAION)
This includes conditions called angulation, Peyronie’ s disease and cavernosal fibrosis If you have an illness that can cause erections which won’ t go away (priapism).
Dan jinkludi kundizzjonijiet imsejħa angulazzjoni, il- marda ta 'Peyronie u fibrożi fil- korpus cavernosum • Jekk għandek xi mard li jista ’ jikkawża erezzjoni li ma tgħaddix (prijapiżmu).
Talk to a doctor without taking Levitra Ketoconazole or itraconazole, anti-fungal medicines Erythromycin or clarithromycin, macrolide antibiotics Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia)
Kellem tabib mingħajr ma tieħu Levitra • Ketoconazole jew itraconazole, mediċini kontra l- moffa • Erythromycin jew clarithromycin, antibiotiċi macrolide • Alfa- blockers, tip ta 'mediċina li tintuża biex tikkura pressjoni għolja jew tkabbir tal- prostata (bħal iperplasija beninna tal- prostata).
58 Don’ t use Levitra more than once a day.
Tieħux Levitra aktar minn darba kuljum.
59 If any of the side effects gets 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 tiegħek.
Each tablet contains 10 mg of vardenafil (as hydrochloride
Kull pillola fiha 10 mg vardenafil (bħala hydrochloride
What Levitra looks like and contents of the pack Levitra 10 mg film-coated tablets are orange with the BAYER cross on one side and the strength (10) on the other side.
Id- Dehra ta ’ Levitra u l- kontenuti tal- pakkett Levitra 10 mg pilloli miksija b’ rita huma oranġjo immarkata b' salib tal- BAYER fuq naħa waħda u (10) fuq in- naħa l- oħra.
The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets.
Il- pilloli huma pprovduti f’ pakketti b’ foljili fihom 2, 4, 8 jew 12- il pillola.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
62 Għall kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
61 PACKAGE LEAFLET:
64 FULJETT TA ’ TAGĦRIF:
Levitra 20 mg film-coated tablets Vardenafil
Levitra 20 mg pilloli miksija b’ rita Vardenafil
- If you are over 75 years of age and are taking ketaconazole or itraconazole, anti-fungal medicines
- Jekk għandek ’ l fuq minn 75 sena u qed tieħu ketoconazole jew itraconazole, mediċini kontra l -
62
l- għajnejn (bħal retinitis pigmentosa)
Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription Levitra will usually be fine with most medicines.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
But some may cause problems, especially these:
Ġeneralment Levitra taqbel mal- biċċa l- kbira tal- mediċini.
Pregnancy and breast-feeding
Tqala u treddigħ Levitra mhux għall- użu minn nisa.
Levitra might make some people feel dizzy or affect their vision.
Sewqan u tħaddim ta ’ magni Levitra jista ’ jġiegħel lil xi nies iħossuhom sturduti jew jaffettwa l- vista tagħhom.
63 Take a Levitra tablet about 25 to 60 minutes before sexual activity.
Ħu pillola Levitra madwar 25 sa 60 minuta qabel attività sesswali.
Don’ t use Levitra more than once a day.
Tieħux Levitra aktar minn darba kuljum.
Rare (affects 1 to 10 users in 10,000) Fainting Muscle stiffness Increase pressure in the eye (glaucoma) Prolonged or painful erections Allergic reaction Effects on the heart (such as angina) Anxiety Swelling inside the throat Temporary loss of memory (such as transient global amnesia) Seizure
• Ħass ħażin • Muskoli iebsin • Tiżdied il- pressjoni ġo l- għajn (glawkoma) • Reazzjoni allerġika • Effetti fuq il- qalb (bħal anġina) • Ansjetà • Nefħa tal- parti ta ’ ġewwa tal- griżmejn • Telf temporanju tal- memorja (bħal amnesija globali temporanja) • Aċċessjoni
64 Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients.
Kien hemm pazjenti li kellhom nuqqas jew telf parzjali, f’ daqqa, temporanju jew permanenti fil- vista f’ għajn waħda jew fiż- żewġ għajnejn.
If any of the side effects gets 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 tiegħek.
Each tablet contains 20 mg of vardenafil (as hydrochloride
Kull pillola fiha 5 mg vardenafil (bħala hydrochloride
What Levitra looks like and contents of the pack Levitra 20 mg film-coated tablets are orange with the BAYER cross on one side and the strength (20) on the other side.
Id- Dehra ta ’ Levitra u l- kontenuti tal- pakkett Levitra 5 mg pilloli miksija b’ rita huma oranġjo immarkata b' salib tal- BAYER fuq naħa waħda u (5) fuq in- naħa l- oħra.
65 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
68 Għall kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
ed ris tho r au ge lon ANNEX I
t za riz to aw x du ħa ANNESS I
SUMMARY OF PRODUCT CHARACTERISTICS t no uc rod lP nai dic Me
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT ’ g im li l na iċi ed tm ot od Pr
Levviax 400 mg film-coated tablets.
Levviax pilloli ta ’ 400 mg miksija b’ rita.
ed Each film-coated tablet contains 400 mg of telithromycin.
t Kull pillola miksija b’ rita għandha 400 mg ta ’ telithromycin.
For a full list of excipients, see section 6.1.
za Għal- lista kompleta ta ’ sustanżi mhux attivi, ara sezzjoni 6. 1
ris 3.
riz 3.
tho Film-coated tablet.
to Pillola miksija b’ rita.
Light orange, oblong, biconvex tablet, imprinted with H3647 on one side and 400 on the other.
aw “ 400 ” fuq in- naħa l- oħra.
r 4.1 Therapeutic indications
x 4. 1 Indikazzjonijiet terapewtiċi
ge When prescribing Levviax, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1). lon Levviax is indicated for the treatment of the following infections:
du Meta Levviax jinkiteb mit- tabib, wieħed irid iqis il- gwida uffiċjali fuq l- użu xieraq ta ’ l- antibijotiċi u ħa l- prevalenza lokali tar- reżistenza (ara wkoll sezzjoni 4. 4 u 5. 1).
In patients of 18 years and older: • Community-acquired pneumonia, mild or moderate (see section 4.4). no
Levviax huwa indikat għall- kura ta ’ l- infezzjonijiet imsemmija hawn taħt: ’ g F’ pazjenti ta ’ 18- il sena u akbar: im
• When treating infections caused by known or suspected beta-lactam and/ or macrolide resistant strains (according to history of patients or national and/ or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1): t uc
• Pulmonite ħafifa jew ta ’ grad moderat li tkun ittieħdet mill- komunità (ara sezzjoni 4. 4) • Meta jiġu ttrattati infezzjonijiet ikkawżati minn razez magħrufa jew suspettati reżistenti għal beta- lactam u/ jew makrolidi (skond il- passat mediku tal- pazjenti jew data ta ’ reżistenza nazzjonali li l
- -
u / jew reġjonali) li huma koperti mill- ispettru anti- batteriku ta ’ telithromycin (ara sezzjonijiet 4. 4 u 5. 1) − Aggravament akut ta ’ bronkite kronika na
Acute exacerbation of chronic bronchitis, Acute sinusitis rod
− Sinużite akuta iċi
In patients of 12 years and older: • Tonsillitis/ pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/ regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1). lP
F’ pazjenti bejn it- 12 - il sena u akbar: • Tonsillite jew farinġite ikkawżata minn Streptococcus pyogenes bħala alternattiva meta l - antibijotiċi beta- lactam ma jkunux adatti f’ pajjiżi/ reġuni bi prevalenza sinifikanti ta ’ S. pyogenes ed
4.2 Posology and method of administration na
reżistenti għall- makrolidi, meta medjati b’ ermTR jew mefA (ara sezzjonijiet 4. 4 u 5. 1). tm
The tablets may be taken with or without food.
Il- pilloli jistgħu jittieħdu fuq l - ot
disturbances and loss of consciousness (see section 4.4). dic
Jista ’ jiġi kkunsidrat li Levviax jiġi mogħti f’ ħin l- irqad, sabiex jitnaqqas l - impatt potenzjali ta ’ disturbi fil- vista u telf tas- sensi (ara sezzjoni 4. 4). od
800 mg once a day for 7 to 10 days,
800 mg darba kuljum, għall- perijodu bejn 7 u 10 Pr
- Acute exacerbation of chronic bronchitis:
ijiem. − Aggravament akut ta ’ bronkite kronika:
In the elderly:
Fl- anzjani:
2 No dosage adjustment is required in elderly patients based on age alone.
M’ hemmx bżonn tibdil fid- doża f’ pazjenti anzjani minħabba biss l- età tagħhom.
In children:
t Fit- tfal:
Levviax is not recommended for use in children below 12 years of age due to lack of data on safety and efficacy (see section 5.2).
za Levviax mhux irrakkomandat għall- użu fit- tfal ta taħt it- 12- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
ed Impaired renal function:
riz Indeboliment fil- funzjoni renali:
Levviax is not recommended as first choice in patients with severe renal impairment (creatinine clearance
to Levviax mhux irrakkomandat bħala l- ewwel għażla f’ pazjenti b’ indeboliment renali sever (meta r- rata li biha titneħħa l- krejatinina tkun < 30 ml/ min) jew pazjenti b’ indeboliment sever renali u dak epatiku
ris < 30ml/ min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
aw ko- eżistenti, għax il- forma tad- doża ottima (600 mg) mhix disponibbli.
If telithromycin treatment is deemed necessary, these patients may be treated with alternating daily doses of 800 mg and 400 mg, starting with the 800 mg
Jekk ikun meqjus li t- trattament b’ telithromycin huwa neċessarju dawn il- pazjenti jistgħu jkunu ittrattati b’ doża li talterna bejn ta ’ 800 mg kuljum u 400 mg kuljum, u li tibda b’ doża ta 800 mg.
In haemodialysed patients, the posology should be adjusted so that Levviax 800 mg is given after the dialysis session (see also section 5.2).
F’ pazjenti fuq dijaliżi tad- demm, il- pożoloġija għandha tkun aġġustata sabiex Levviax 800 mg
au Impaired hepatic function:
x jingħata wara s- sessjoni tad- dijaliżi (ara wkoll sezzjoni 5. 2).
No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, unless renal function is severely impaired, however the experience in patients with impaired hepatic
M’ hemmx bżonn ta tibdil fid- doża f’ pazjenti li għandhom indeboliment ħafif, moderat jew sever tal - ħa fwied, sakemm ma jkunx hemm indeboliment renali sever, madankollu, l- esperjenza f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied hija limitata.
Hence, Levviax should be used with caution (see also section 4.4 and 5.2).
Għalhekk, Levviax għandu jintuża b’ kawtela (ara wkoll sezzjoni 4. 4 u 5. 2). ’ g 4. 3 Kontra- indikazzjonijiet im
Levviax is contraindicated in patients with myasthenia gravis (see section 4.4).
Levviax huwa kontra- indikat f’ pazjenti b’ myasthenia gravis (ara sezzjoni 4. 4) F’ każ ta ’ allerġija għas- sustanza attiva, għal kwalunkwe antibijotiku li jappartjeni għall- klassi tal - li l
Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the excipients. no
makrolidi, jew għal xi wieħed mill- ingredjenti mhux attivi.
Levviax must not be used in patients with previous history of hepatitis and/ or jaundice associated with the use of telithromycin.
Levviax m’ għandux jintuża f’ pazjenti bi storja preċedenti ta ’ epatite u/ jew is- suffejra assoċjata ma ’ l - na
Concomitant administration of Levviax and any of the following substances is contraindicated: t uc
użu ta ’ telithromycin. iċi
cisapride, ergot alkaloid derivatives (such as ergotamine and dihydroergotamine), pimozide, astemizole and terfenadine (see section 4.5). rod
L- użu ta ’ Levviax flimkien ma ’ wieħed mis- sustanzi msemmija hawn taħt huwa kontra- indikat: cisapride, derivattivi ta ’ l- alkalojdi ta ’ l- ergot (bħall- ergotamine u dihydroergotamine), pimożide, astemizole u terfenadine (ara sezzjoni 4. 5). ed
Levviax should not be used concomitantly with simvastatin, atorvastatin and lovastastin.
Levviax m’ għandux jingħata flimkien ma ’ simvastatin, atorvastatin u lovastatin.
Treatment with these agents should be interrupted during Levviax treatment (see section 4.5).
Il- kura b’ dawn il - mediċini trid titwaqqaf waqt il- kura b’ Levviax (ara sezzjoni 4. 5). tm
Levviax is contraindicated in patients with a history of congenital or a family history of long QT lP
Levviax huwa kontra- indikat f’ pazjenti li għandhom sindromu ta ’ l- intervall QT twil, kemm jekk konġenitu, kif ukoll jekk jeżisti fil- passat mediku tal- familja (jekk mhux eskluż permezz ta ’ ECG) u ot
syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.
f’ dawk il- pazjenti li magħrufa li għandhom intervall QT twil. od
Levviax and strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole, is contraindicated. i
Pr
4.4 Special warnings and precautions for use dic
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
As with macrolides, due to a potential to increase QT interval, Levviax should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and or hypomagnesaemia, bradycardia (< 50 bpm), or during concomitant administration of Levviax Me
Minħabba li, bħall- makrolidi jista jtawwal l- intervall tal- QT, Levviax għandu jintuża bir- reqqa f’ pazjenti li jbatu b’ mard koronarju tal- qalb, li għandhom passat ta ’ taħbit irregolari tal- ventrikoli tal - qalb, livell baxx u mhux korrett tal- potassium u / jew tal- magnesium fid- demm, bradikardja
with QT interval prolonging agents or potent CYP 3A4 inhibitors such as protease inhibitors and ketoconazole.
3 (< 50 bpm), jew waqt l- użu ta ’ Levviax flimkien ma ’ sustanzi li jtawwlu l- intervall tal- QT, jew dawk l - impedituri qawwija ta ’ CYP3A4, bħall- impedituri tal- protejejż u l- ketoconazole.
As with nearly all antibacterial agents, diarrhoea, particularly if severe, persistent and / or bloody, during or after treatment with Levviax may be caused by pseudomembranous colitis.
Bħal kważi l- antibijotiċi kollha, id- dijarrea, speċjalment meta tkun qawwija, persistenti u / jew bid - demm, waqt jew wara l- kura b` Levviax, tista ’ tkun ikkawżata minn kolite psewdomembranea.
If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures and/ or specific therapy.
Jekk ikun hemm il- ħsieb li jista jkun hemm kolite psewdomembranja, il- kura trid titwaqqaf minnufih u l - pazjenti jridu jingħataw kura b’ miżuri ta support u / jew terapija speċifika.
3 Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose. Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Ir- rapporti inkludew imwiet u indeboliment akut fil- funzjoni respiratorja, li tista ’ tkun fatali,
Alterations in hepatic enzymes have been commonly observed in clinical studies with telithromycin.
to Tibdil fl- enżimi tal- fwied kienu komunement innotati fi studji kliniċi b’ telithromycin.
Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally
Epatite severa u indeboliment sever tal- fwied, inklużi każijiet fatali (li ġeneralment kienu assoċjati ma ’ mard serju li
ed been associated with serious underlying diseases or concomitant medications), have been reported (see section 4.8).
aw kien qed ibati minnu l- pazjent jew medikazzjoni konkomitanti) kienu rapportati wara li l- prodott tpoġġa fuq is suq (ara sezzjoni 4. 8).
ris Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
x Il- pazjenti għandhom ikunu mwissija biex iwaqqfu t- trattament u jkellmu lit- tabib tagħhom jekk jiżvilluppaw sintomi jew sinjali ta ’ mard tal- fwied bħal anoressja, suffejra, awrina skura, ħakk jew
tho Due to limited experience, Levviax should be used with caution in patients with liver impairment (see section 5.2).
du uġigħ addominali mat- tagħfis. ħa Minħabba esperjenza limitata, Levviax għandu jintuża b’ kawtela f’ pazjenti li għandhom indeboliment tal- fwied (ara sezzjoni 5. 2). ’ g Levviax jista ’ jikkawża disturbi fil- vista partikularment fit- tnaqqis fl- abilita ’ biex jaddatta u l- abilita ’ ta ’ ħelsien ta ’ l- addattament tal- vista.
Levviax may cause visual disturbances particularly in slowing the ability to accommodate and the
Disturbi fil- vista kienu jinkludu vista mċajpra, diffikulta biex im
au ability to release accommodation.
wieħed jiffoka u diplopja.
(see sections 4.7 and 4.8).
(ara sezzjonijiet 4. 7 u 4. 8). li l
r ge There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome (see sections 4.7 and 4.8). lon Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness.
Wara li l- prodott tpoġġa fuq is- suq, kien hemm rapporti ta ’ reazzjonijiet avversi ta ’ telf ħafif mis- sensi u kienu jinkludu xi każijiet assoċjati mas- sindromu vagal (ara sezzjonijiet 4. 7 u 4. 8). na
Concomitant treatment with no
Jista ’ jiġi kkunsidrat li Levviax jiġi mogħti f’ ħin l- irqad, sabiex jitnaqqas l- impatt potenzjali ta ’ disturbi fil- vista u telf tas- sensi. iċi
these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore encompass a risk of treatment failure (see section 4.5).
Kura konkomitanti b’ dawn il - ed
Levviax is an inhibitor of CYP3A4 and should only be used under specific circumstances during t uc
prodotti mediċinali tista ’ tirriżulta f’ livelli ta telithromycin taħt dawk terapewtiċi u għalhekk, dawn jistgħu jwasslu ghall- falliment fil- kura (ara sezzjoni 4. 5.). tm
treatment with other medicinal products that are metabolised by CYP3A4.
Levviax huwa impeditur ta ’ CYP3A4 u għandu jintuża taħt ċirkostanzi speċifiċi biss waqt il- kura bi prodotti mediċinali oħra li jkunu metabolizzati minn CYP3A4. ot
In areas with a high incidence of erythromycin A resistance, it is especially important to take into rod
F’ żoni ġeografiċi b’ inċidenza għolja ta ’ reżistenza għall- erythromycin A, huwa importanti bmod partikolari li jitqies l- isvilupp tal- mekkaniżmu ta suxxettibilità lejn telithromycin u antibijotiċi oħra. od
consideration the evolution of the pattern of susceptibility to telithromycin and other antibiotics.
Fil- pulmonite li tittieħed mill- komunità, l- effikaċja ntweriet f’ numru limitat ta ’ pazjenti li kellhom fatturi ta` riskju, bħal dawk bil- preżenza tal- pnewmokokki fiċ- ċirkolazzjoni tad- demm, jew dawk li Pr
In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years. lP
kellhom ’ l fuq minn 65 sena.
Experience of treatment of infections caused by penicillin/ or erythromycin resistant S. pneumoniae is limited, but so far, clinical efficacy and eradication rates have been similar compared with the na
Esperjenza tal- kura ta ’ infezzjonijiet kawżati minn S. pneumoniae reżistenti għall- penicillin / jew l - erythromycin hija limitata, iżda s’ issa, l- effikaċja klinika u r- rati ta ’ eradikazzjoni tal- mikrobu kienu simili meta mqabbla ma` dawk fejn il- kura ta infezzjonijiet b S. pneumoniae sensittivi għall - antibijotiċi.
Caution should be taken when S. aureus is the suspected pathogen and there is a likelihood of erythromycin resistance based on local epidemiology. i
Trid tittieħed kawtela meta S. aureus huwa suspettat li qed jikkaġuna l- infezzjoni u hemm probabiltà li jkun reżistenti għall- erythromycin skond l- epidemjoloġija tal- post.
L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the dic
4 L. pneumophila huwa sensittiv ħafna għal telithromycin in vitro, madankollu, l- esperjenza klinika fil - kura tal- pulmonite ikkaġunata minn Legionella hija limitata.
treatment of pneumonia caused by legionella is limited.
Influenzae.
As for macrolides, H. influenzae is classified as intermediately susceptible.
t 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu
Me
za l- effett farmaċewtiku tal- prodott
4.5 Interaction with other medicinal products and other forms of interaction
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmċewtiku tal- prodott fl -
Interaction studies have only been performed in adults.
riz adulti.
• Effect of Levviax on other medicinal product
to • Effetti ta Levviax fuq prodotti mediċinali oħra
4 Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
aw Telithromycin huwa impeditur ta` CYP3A4 u impeditur dgħajjef ta ’ CYP2D6.
Hence, Levviax should not be used during treatment with medicinal products that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or adverse events can be closely monitored.
Għalhekk, Levviax m’ għandux jintuża waqt il- kura bi prodotti mediċinali li huma
ed substrate should be made during treatment with Levviax.
x substrati ta ’ CYP3A4, sakemm il- livelli fil- plażma tas- substrat ta ’ CYP3A4, l- effikaċja u l- okkorrenzi
Medicinal products with a potential to prolong QT interval
du avversi jistgħu jkunu osservati mill- qrib.
ris Levviax is expected to increase the plasma levels of cisapride, pimozide, astemizole and terfenadine.
Alternattivament, il- kura bis- substrati ta ’ CYP3A4 trid titwaqqaf waqt il- kura b ’ Levviax. ħa Prodotti mediċinali bil- potenzjal li jtawwlu l- intervall tal- QT Levviax huwa mistenni li jżid il- livelli fil- plażma ta ’ cisapride, pimozide, astemizole u terfenadine.
Concomitant administration of Levviax
Dan jista ’ jtawwal l- intervall tal- QT, arritmji kardijaċi, inkluża takikardja tal- ventrikoli, fibrillazzjoni ’ g tal- ventrikoli, u torsades de pointes.
tho and any of these medicinal products is contraindicated (see section 4.3).
(ara sezzjoni 4. 3). im
Caution is warranted when Levviax is administered to patients taking other medicinal products with the potential to prolong QT interval (see section 4.4).
Il- kawtela hija neċessarja meta l - Levviax jingħata lill- pazjenti li qed jieħdu prodotti mediċinali oħra li jistgħu jtawwlu l- intervall tal- QT (ara sezzjoni 4. 4). li l
au Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Levviax and
Id- derivattivi alkalojdi ta ’ ergot (bħal ergotamine u dihydroergotamine) Permezz t’ estrapolazzjoni mill- erythromycin A u l- josamycin, l- użu ta ’ Levviax u d- derivattivi na
r alkaloid derivatives could lead to severe vasoconstriction (“ ergotism”) with possibly necrosis of the
alkalojdi flimkien jistgħu jwasslu għal spażmu sever ta ’ l- arterji (ergotiżmu), li jista ’ jwassal għall - nekrożi ta ’ l- estremitajiet.
The combination is contraindicated (see section 4.3).
Statins Meta simvastatin ingħata flimkien ma` Levviax kien hemm żieda ta ’ 5. 3- il draba fil- livell ta` ed
Statins lon When simvastatin was coadministered with Levviax, there was a 5.3 fold increase in simvastatin Cmax, an 8.9 fold increase in simvastatin AUC, a 15-fold increase in simvastatin acid Cmax and an 11-fold increase in simvastatine acid AUC.
simvastatin Cmax, u żieda ta ’ 8. 9- il draba fil- livell ta ’ simvastatin AUC, u 15- il darba aktar fil- livell ta ’ simvastatine acid Cmax, u żieda ta ’ 11- il darba l- AUC ta` simvastatin acid.
Levviax no
Studji in vivo ta ’ interazzjoni ma ’ statins oħra ma sarux, iżda Levviax jista ’ jikkawża interazzjoni simili ma` lovastatin u tm
should not be used concomitantly with simvastatin, atorvastastin and lovastatin.
Levviax m’ għandux jintuża flimkien ma ’ simvastatin, atorvastatin u lovastatin.
Treatment with these agents should be interrupted during Levviax treatment.
Il- kura b’ dawn is - sustanzi għandha titwaqqaf waqt il- kura b` Levviax.
Cerivastatin should be used with caution and patients should be carefully monitored for signs and symptoms of myopathy. t uc
Serivastatin għandu jintuża b’ kawtela, u l- pazjenti ot
Benzodiazepins When midazolam was coadministered with Levviax, midazolam AUC was increased 2.2-fold after intravenous administration of midazolam and 6.1-fold after oral administration.
Benzodajażepini Meta midazolam ingħata flimkien ma` Levviax, l- AUC ta` midazolam żdiedet 2. 2- il darba wara li ngħata fil- vina u 6. 1- il darba meta ngħata mill- ħalq.
The midazolam half- rod
Il- half life ta ’ midazolam żdiedet b’ madwar 2. 5- il Pr
life was increased about 2.5-fold.
darba.
Oral administration of midazolam concomitantly with Levviax should be avoided.
Il- forma orali ta` midazolam flimkien ma` Levviax għandu jkun evitat.
For lP
L- istess kawtela tapplika għall- benżodijażepini oħra li huma metaboliżzati minn CYP3A4 (partikolarment triazolam, iżda anke f’ dimensjoni anqas l- alprazolam).
those benzodiazepins which are not metabolized by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Levviax is unlikely. na
Għal dawk il- benżodijażepini li mhux metaboliżzati minn CYP3A4 (temazepam, nitrażepam, lorazepam) interazzjoni ma` Levviax mhux probabbli.
immunosuppressive agents, cyclosporin, tacrolimus or sirolimus levels must be carefully monitored dic
Għalhekk, meta jibda jingħata telithromycin f’ pazjenti li diġa qed jieħdu kwalunkwe wieħed minn dawn il- prodotti li jissoprimu l- immunità, il- livelli ta ’ cyclosporin, tacrolimus u sirolimus għandhom ikunu segwiti b’ kawtela, u d- dożi tagħhom jitnaqqsu skond il- ħtieġa.
When metoprolol (a CYP2D6 substrate) was coadministered with Levviax, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
t za Metoprolol Meta metoprolol (substrat ta ’ CYP2D6) kien ingħata flimkien ma ’ Levviax, metoprolol Cmax u l- AUC żdiedu b’ madwar 38%; madankollu, ma kienx hemm effett fuq il- half life ta` l- eliminazzjoni ta`
In these patients, co-administration of Levviax and metoprolol, a CYP2D6 substrate, should be considered with caution.
to Metoprolol, li hu substrat ta ’ CYP2D6, meta jintuża ma` Levviax għandu jingħata b`kawtela f`dawn il - pazjenti.
5 Levviax has been shown to increase the plasma concentrations of digoxin.
aw Digoxin Levviax intwera li jżid il- livelli ta ’ digoxin fil- plażma.
The plasma trough levels, Cmax, AUC and renal clearance were increased by 20%, 73%, 37% and 27% respectively, in healthy volunteers.
Ma kienx
There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
x hemm tibdil sinifikanti fil- parametri ta ’ l- ECG u l- anqas dehru sinjali ta ’ tossiċità b`digoxin.
Nevertheless, monitoring of serum digoxin level should be considered during concomitant administration of digoxin and Levviax.
Mandankollu, il- livelli ta` digoxin fis- serum jridu jkun mkejla meta digoxin jingħata ma` Levviax.
ed Theophylline There is no clinically relevant pharmacokinetic interaction of Levviax and theophylline administered as extended release formulation.
Ma kienx hemm interazzjoni famakokinetika rilevanti ta ’ Levviax meta ingħata ma` theophylline fil - forma li tinħall bil- mod.
However, the co-administration of both medicinal products should be
Madankollu, meta jingħataw flimkien dawn iż- żewġ prodotti mediċinali għandu jkun distanzjat b’ siegħa biex ikunu evitati effetti kollaterali diġestivi mhux mixtieqa, bħad - ’ g dardir u r- rimettar. im
ris separated by one hour in order to avoid possible digestive side effects such as nausea and vomiting.
Antikoagulanti Orali Żieda fl- attività ta ’ l- antikoagulanti kienet rapportata f’ pazjenti ittrattati simultanjament bl - antikoagulanti u l- antibijotiċi, inkluż telithromycin.
Oral anticoagulants
Il- mekkaniżmi m’ humiex magħrufa għal kollox. li l
Although Levviax has no clinically relevant pharmacokinetic or pharmacodynamic interaction with warfarin after single dose administration, more frequent monitoring of prothrombin time/ INR
Għalkemm ma kienx hemm interazzjoni farmakokinetika u farmakodinamika meta ingħatat doża waħda ta` Levviax ma` warfarin, għandu jkun ikkunsidrat l- immoniterjar aktar spiss tal - prothrombin time/ INR (International Normalised Ratio) waqt il- kura konkomitanti. na
au (International Normalised Ratio) values should be considered during concomitant treatment.
Kontraċettivi orali M’ hemx interazzjoni farmakodinamika jew farmakokinetika klinikament relevanti b’ dożi baxxi tal - iċi
Oral contraceptives
kontraċettivi orali tat- tip tliet fażijiet f’ suġgetti f’ saħħithom. ed
r There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose
• Effetti ta ’ prodotti mediċinali oħra fuq Levviax
ge triphasic oral contraceptives in healthy subjects.
Meta jingħata f’ dożi repetuti ma` rifampicin u telithromycin, is- Cmax u l- AUC ta` telithromycin kienu tm
• Effect of other medicinal products on Levviax lon During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
mnaqqsin b’ medja ta ’ 79% u 86%, rispettivament.
The no
L - ot
induction gradually decreases during 2 weeks after cessation of treatment with CYP3A4 inducers.
induzzjoni tonqos gradwalment f’ temp ta ’ ġimgħatejn mill- waqfien tal- kura b’ indutturi ta ’ CYP3A4.
Levviax should not be used during and 2 weeks after treatment with CYP3A4 inducers.
Levviax m’ għandux jintuża waqt u ġimgħatejn wara t- trattament bl- indutturi ta ’ CYP3A4. od
Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that t uc
Studji ta interazzjoni ma` itraconazole u ketoconazole, żewġ impedituri ta ’ CYP3A4, urew li l- livelli massimi ta` telithromycin fil- plażma żdiedu, rispettivament, b ’ 1. 22 u 1. 51- il darba, u l- AUC b’ 1. 54 u Pr
maximum plasma concentrations of telithromycin were increased respectively by 1.22 and 1.51 fold and AUC by respectively 1.54 fold and 2.0 fold.
2. 0- il darba, rispettivament.
These changes in the pharmacokinetics of telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well rod
Dawn it- tibdiliet fl- effetti farmakokinetiċi ta` telithromycin ma jwasslux biex id- doża jkollha tkun mibdula, għax l- esponiment għal telithromycin tibqa ’ sew fil- limiti tat - tolleranza.
Ranitidine (taken 1 hour before Levviax) and antacid containing aluminium and magnesium hydroxide lP
6 Ranitidine (meta jittieħed siegħa qabel Levviax) u sustanzi kontra l- aċidu fl- istonku li għandhom aluminium u magnesium hydroxide, m’ għandhomx effetti kliniċi rilevanti fuq il- farmakokinetiċi ta` telithromycin.
has no clinically relevant influence on telithromycin pharmacokinetics.
4. 6 Tqala u Treddigħ
4.6 Pregnancy and lactation na
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ Levviax waqt it- tqala.
Studies in animals have shown reproductive toxicity (see section 5.3).
t sistema riproduttiva (ara sezzjoni 5. 3).
Levviax i
Levviax
should not be used during pregnancy unless clearly necessary. dic
za m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Telithromycin jinsab fil- ħalib ta ’ l- annimali li qegħdin ireddgħu, f’ livelli ta ’ 5 darbiet aktar minn dawk
Corresponding data for humans is not available.
riz tal- livelli fil- plażma ta ’ l- omm.
Levviax should not be used by Me
M’ hemmx tagħrif korrispondenti għall- bniedem.
breast-feeding women.
Levviax m’ għandux jintuża f’ nisa li qed ireddgħu.
4.7 Effects on ability to drive and use machines
to 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Levviax may cause undesirable effects such as visual disturbances which may reduce the capacity for the completion of certain tasks.
aw Levviax jista ’ jikkawża effetti mhux mixtieqa bħal disturbi fil- vista, li jistgħu itelfu biex jintemmu ċerti attivitajiet.
Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a 6 motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with Levviax.
x Minħabba problemi potenzjali fil- vista jew telf mis- sensi, il- pazjenti għandhom jippruvaw inaqqsu mill- attivitajiet bħal sewqan ta ’ karozza, tħaddim ta ’ makkinarju kbir jew jagħmlu attivatijiet oħra ta ’