qanastek/EMEA-V3 huggingface dataset:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
109 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.
Take the number of tablets following your doctor’ s instructions. • General dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) each day. • Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Eżempju:
Example: if your daily dose is 1,000 mg, you must take one tablet in the morning and one tablet in the evening.
Jekk id- doża tiegħek hija 1, 000 mg kuljum, trid tieħu pillola waħda filgħodu u pillola waħda filgħaxija.
Keppra 100 mg/ ml oral solution and Keppra 250 mg tablets are presentations more appropriate to young children.
Keppra 100 mg/ ml soluzzjoni orali u Keppra 250 mg pilloli huma għamliet iżjed adattati għat- tfal żgħar.
110 If you stop taking Keppra:
110 M’ għandekx tieħu doża doppja biex tpatti għal xi pillola li tkun insejt tieħu.
If stopping treatment, as with other antiepileptic medicines, Keppra should be discontinued gradually to avoid an increase of seizures.
Jekk tieqaf tieħu Keppra Bħal ma jsir b' mediċini oħra kontra l- epilessija, jekk tkun ser twaqqaf it- trattament, għandek tnaqqas Keppra bil- mod biex ma jkunx hemm żieda fl- aċċessjonijiet.
Very common side effects (> 10%) reported with Keppra are: • somnolence (sleepiness); • asthenia/ fatigue (tiredness).
L- effetti mhux mixtieqa komuni ħafna (> 10%) rappurtati b’ Keppra huma: ħedla ta ’ ngħas; astenja (għajja).
Common side effects (> 1% - 10%) reported with Keppra are: • nervous system disorders: dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity), ataxia (impaired coordinated movements), tremor (involuntary trembling), amnesia (loss of memory), balance disorder (equilibrium disorder), disturbance in attention (loss of concentration), memory impairment (forgetfulness); • psychiatric disorders: agitation, depression, emotional instability/ mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), thinking abnormal (slow thinking, unable to concentrate); • digestive disorders: abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting; • nutrition disorders: anorexia (loss of appetite), weight increase; • ear and labyrinth disorders: vertigo (sensation of rotation); • eye disorders: diplopia (double vision), vision blurred; • musculoskeletal and connective tissue disorders: myalgia (muscle pain); • injury: accidental injury; • infections: infection, nasopharyingitis; • respiratory disorders: cough (increase of pre-existing cough); • skin disorders: rash, eczema, pruritus; • blood disorders: decreased number of blood platelets.
Effetti komuni (> 1% - 10%) mhux mixtieqa li ġew rappurtati b’ Keppra huma: • Mard fis- sistema nervuża: sturdament (sensazzjoni li ser taqa '), aċċessjoni, uġigħ ta' ras, iperkinesja (iperattivita`), ataksja (movimenti mhux ko- ordinati), rogħda, amneżija (telf ta 'memorja), telf tal- bilanċ (mard ta ’ l- ekwilibriju), disturbi f’ attenzjoni (telf ta ’ konċentrazzjoni), telf ta ’ memorja (nisi); • Mard psikjatriċi: aġitazzjoni, depressjoni, instabilità emozzjonali / tibdil fil- burdata, ostilità jew aggressjoni, nuqqas ta' rqad, nervożiżmu jew irritabilità, disturbi fil- personalita`, (problemi fl - imġieba), ħsieb abnormali (ħsieb bil- mod, ma tistax tikkonċentra); • Mard gastro- intestinali: uġigħ f’ addomenu, dardir, indiġestjoni, dijarrea, rimettar; • Mard fin- nutrizzjoni: anoressija (telf t' aptit); żieda fil- piz • Mard fil- widna u fil- parti ta 'ġewwa tal- widna: vertigo (tħoss kollox idur bik); • Mard fil- għajn: viżjoni doppja, viżjoni mċajpra; • Mard muskolu- skeltrali u tal- connective tissue: majalġja (uġigħ fil- muskoli) • Korriment: korriment aċċidentali; • Infezzjonijiet: infezzjoni, nażo- farinġite • Mard respiratorju: żieda fis- sogħla • Mard tal- ġilda: raxx, ekżema, ħakk. • Mard fid- demm: livell baxx ta' plejtlets fid- demm.
Other side effects reported with Keppra are: • nervous system disorders: paraesthesia (tingling) • psychiatric disorders: abnormal behaviour, anger, anxiety, confusion, hallucination, mental disorder; suicide, suicide attempt and suicidal ideation; • digestive disorders: pancreatitis, hepatic failure, hepatitis, liver function test abnormal; • nutrition disorders: weight loss; • skin disorders: hair loss; • blood disorders: decreased number of red blood cells, and/ or white blood cells.
Effetti mhux mixtieqa oħra huma: • Mard fis- sistema nervuża: parastesja (tingis); • Mard psikjatriċi: mġieba mhux normali, rabja, ansjetà, konfużjoni, depressjoni, alluċinazzjoniji, mard mentali, suwiċidju, attentat ta ’ suwiċidju u ħsibijiet ta ’ suwiċidju; • Mard diġestivi: pankreatite, insuffiċjenza tal- fwied, epatite, test tal- funzjoni tal- fwied abnormali; • Mard marbut man- nutrizzjoni: telf ta ’ piz; Xi effetti mhux mixtieqa bħal tħeddil, għajja u sturdament jistgħu jkunu iżjed komuni fil- bidu tat - trattament u meta tiżdied id- doża.
111 The expiry date refers to the last day of the month.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
What Keppra contains • The active substance is called levetiracetam.
X’ fih Keppra: • Is- sustanza attiva hi levetiracetam.
Opadry 85F32004 (Polyvinyl alcohol-part. hydrolyzed, Titanium dioxide (E171), Macrogol 3350, Talc, Iron oxide yellow (E172)).
Opadry 85F32004 (Polyvinyl alcohol- part. hydrolyzed, Titanium dioxide (E171), Macrogol 3350, Talc, iron oxide yellow (E 172)).
Each tablet contains 500 mg of levetiracetam.
Kull pillola fiha 500 mg ta 'levetiracetam.
What Keppra looks like and contents of the pack The film-coated tablets are yellow, oblong, scored and debossed with the code “ ucb” and “ 500” on one side.
Id- Dehra tal- prodott u d- daqs tal- pakkett: l- pilloli miksija b' rita huma sofor, tawwalin, maqtuha minn nofs u mnaqqxa bil- kodiċi “ ucb ” u “ 500 ” fuq naħa waħda.
The cardboard boxes contain 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Il- kaxxi tal- kartun fihom 10, 20, 30, 50, 60, 100, 120 u 200 pillola miksija b' rita.
España UCB Pharma, S. A.
112 Portugal España UCB Pharma (Produtos Farmacêuticos), Lda UCB Pharma, S. A.
INFORMATION FOR THE USER
113 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Keppra 750 mg film-coated tablets Levetiracetam
Keppra 750mg pilloli miksija b’ rita Levetiracetam
Keppra 750 mg film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Keppra 750 mg pilloli miksija b 'rita hija mediċina għal kontra l- epilessija (użata biex tittratta l - aċċessjonijiet f- epilessija).
Keppra is used in patients who are already taking another antiepileptic medicine • in the treatment of partial seizures in adults and children from 4 years age • in the treatment of myoclonic seizures in pateints from 12 years of age with Juvenile Myoclonic Epilepsy • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age
Keppra huwa wżat f ’ pazjenti li diga ’ ikunu qiegħdin jieħdu mediċini oħra għal kontra l- epilessija • fit- trattament ta 'aċċessjonijiet tat- tip parzjali f ’ adulti u tfal minn 4 snin. • fit- trattament ta ’ aċċessjonijiet tat- tip mijokloniċi f ’ pazjenti minn 12 snin b’ epilessija tat- tip Mijoklonika li tibda fiż- żgħożija • fit- trattament ta ’ aċċessjonijiet primarji u ġeneralizzati tat- tip tonic- clonic f’ adulti u addoloxxenti minn 12 il- sena
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
114 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.
E 110 coloring agent may cause allergic reactions.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Keppra Is- sustanza li tagħti l- kulur E 110, tista ’ tikkawża reazzjonijiet allerġiċi.
Take the number of tablets following your doctor’ s instructions. • General dose: between 1,000 mg and 3,000 mg each day. • Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Eżempju:
Example: if your daily dose is 1,500 mg, you must take one tablet in the morning and one tablet in the evening.
Jekk id- doża tiegħek hija 1, 500 mg kuljum, trid tieħu pillola waħda filgħodu u pillola waħda filgħaxija.
Keppra 100 mg/ ml oral solution and Keppra 250 mg tablets are presentations more appropriate to young children.
Keppra 100 mg/ ml soluzzjoni orali u Keppra 250 mg pilloli huma għamliet iżjed adattati għat - tfal żgħar.
Contact your doctor if you have missed one or more doses.
115 Jekk tinsa tieħu Keppra Għarraf it- tabib tiegħek jekk insejt tieħu doża waħda jew iżjed.
Common side effects (> 1% - 10%) reported with Keppra are: • nervous system disorders: dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity), ataxia (impaired coordinated movements), tremor (involuntary trembling), amnesia (loss of memory), balance disorder (equilibrium disorder), disturbance in attention (loss of concentration), memory impairment (forgetfulness); • psychiatric disorders: agitation, depression, emotional instability/ mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), thinking abnormal (slow thinking, unable to concentrate); • digestive disorders: abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting; • nutrition disorders: anorexia (loss of appetite), weight increase; • ear and labyrinth disorders: vertigo (sensation of rotation); • eye disorders: diplopia (double vision), vision blurred; • musculoskeletal and connective tissue disorders: myalgia (muscle pain); • injury: accidental injury; • infections: infection, nasopharyngitis; • respiratory disorders: cough (increase of pre-existing cough); • skin disorders: rash, eczema, pruritus; • blood disorders: decreased number of blood platelets;
Effetti komuni (> 1% - 10%) mhux mixtieqa li ġew rappurtati b’ Keppra huma: • Mard fis- sistema nervuża: sturdament (sensazzjoni li ser taqa '), aċċessjoni, uġigħ ta' ras, iperkinesja (iperattivita`), ataksja (movimenti mhux ko- ordinati), rogħda, amneżija (telf ta 'memorja), telf tal- bilanċ (mard ta ’ l- ekwilibriju), disturbi f’ attenzjoni (telf ta ’ konċentrazzjoni), telf ta ’ memorja (nisi); • Mard psikjatriċi: aġitazzjoni, depressjoni, instabilità emozzjonali / tibdil fil- burdata, ostilità jew aggressjoni, nuqqas ta' rqad, nervożiżmu jew irritabilità, disturbi fil- personalita`, (problemi fl - imġieba), ħsieb abnormali (ħsieb bil- mod, ma tistax tikkonċentra); • Mard gastro- intestinali: uġigħ f’ addomenu, dardir, indiġestjoni, dijarrea, rimettar; • Mard fin- nutrizzjoni: anoressija (telf t' aptit); żieda fil- piz • Mard fil- widna u fil- parti ta 'ġewwa tal- widna: vertigo (tħoss kollox idur bik); • Mard fil- għajn: viżjoni doppja, viżjoni mċajpra; • Mard muskolu- skeltrali u tal- connective tissue: majalġja (uġigħ fil- muskoli) • Korriment: korriment aċċidentali; • Infezzjonijiet: nażo- farinġite • Mard respiratorju: żieda fis- sogħla • Mard tal- ġilda: raxx, ekżema, ħakk. • Mard fid- demm: livell baxx ta' plejtlets fid- demm.
Other side effects reported with Keppra are: • nervous system disorders: paraesthesia (tingling); • psychiatric disorders: abnormal behaviour, anger, anxiety, confusion, hallucination, mental disorder; suicide, suicide attempt and suicidal ideation; • digestive disorders: pancreatitis, hepatic failure, hepatitis, liver function test abnormal; • nutrition disorders: weight loss; • skin disorders: hair loss; • blood disorders: decreased number of red blood cells, and/ or white blood cells.
Effetti mhux mixtieqa oħra huma: • Mard fis- sistema nervuża: parastesja (tingis); • Mard psikjatriċi: mġieba mhux normali, rabja, ansjetà, konfużjoni, depressjoni, alluċinazzjoniji, mard mentali, suwiċidju, attentat ta ’ suwiċidju u ħsibijiet ta ’ suwiċidju; • Mard diġestivi: pankreatite, insufffiċjenza tal- fwied, epatite, test tal- funzjoni tal- fwied abnormali; • Mard marbut man- nutrizzjoni: telf ta ’ piz; Xi effetti mhux mixtieqa bħal tħeddil, għajja u sturdament jistgħu jkunu iżjed komuni fil- bidu tat - trattament u meta tiżdied id- doża.
HOW TO STORE KEPPRA • Keep out of the reach and sight of children. • This medicinal product does not require any special storage conditions..
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Dan il- prodott mediċinali m’ għandux bżonn ebda ħtiġijiet speċjali għall- ħażna.
116 Do not use after the expiry date stated on the carton box and blister after EXP:.
116 M’ għandekx tuża wara d- data ta ’ skadenza li tidher fuq il- kaxxa u l- folja, wara JIS:.
Opadry 85F23452 (Polyvinyl alcohol-part. hydrolyzed, Titanium dioxide (E171), Macrogol 3350, Talc, sunset yellow FCF aluminium lake (E110), Iron oxide red (E172)).
Opadry 85F23452 (Polyvinyl alcohol- part. hydrolyzed, Titanium dioxide (E171), Macrogol 3350, Talc, sunset yellow FCF aluminium lake (E 110), iron oxide red (E172)).
Each tablet contains 750 mg of levetiracetam.
Kull pillola fiha 750 mg ta 'levetiracetam.
What Keppra looks like and contents of the pack The film-coated tablets are orange, oblong, scored and debossed with the code “ ucb” and “ 750” on one side.
Id- Dehra tal- prodott u d- daqs tal- pakkett: l- pilloli miksija b' rita huma oranġjo, tawwalin, maqtuha minn nofs u mnaqqxa bil- kodiċi “ ucb ” u “ 750 ” fuq naħa waħda.
The cardboard boxes contain 20, 30, 50, 60, 80, 100 and 200 film-coated tablets.
Il- kaxxi tal- kartun fihom 20, 30, 50, 60, 80, 100 u 200 pillola miksija b' rita.
Eesti UCB Pharma Oy Finland
Eesti UCB Pharma Oy Finland Tel: +358- 9 2290 100
Τηλ: +30 / 2109974000
117 Polska Ελλάδα UCB Pharma Sp. z o. o.
Suomi/ Finland UCB Pharma Oy Finland Puh/ Tel: + 358 9 229 0100
Suomi/ Finland UCB Pharma Oy Finland Puh/ Tel: + 358 / 9- 2290 100
INFORMATION FOR THE USER
118 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Keppra 1000 mg film-coated tablets Levetiracetam
Keppra 1000mg pilloli miksija b’ rita Levetiracetam
Keppra 1000 mg film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Keppra 1000 mg pilloli miksija b 'rita hija mediċina għal kontra l- epilessija (użata biex tittratta l - aċċessjonijiet f- epilessija).
Keppra is used in patients who are already taking another antiepileptic medicine • in the treatment of partial seizures in adults and children from 4 years age • in the treatment of myoclonic seizures in patients from 12 years of age wit Juvenile Myoclonic Epilepsy, • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age
Keppra huwa wżat f ’ pazjenti li diga ’ ikunu qiegħdin jieħdu mediċini oħra għal kontra l- epilessija • fit- trattament ta 'aċċessjonijiet tat- tip parzjali f ’ adulti u tfal minn 4 snin. • fit- trattament ta ’ aċċessjonijiet tat- tip mijokloniċi f ’ pazjenti minn 12 snin b’ epilessija tat- tip Mijoklonika li tibda fiż- żgħożija • fit- trattament ta ’ aċċessjonijiet primarji u ġeneralizzati tat- tip tonic- clonic f’ adulti u addoloxxenti minn 12 il- sena
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
119 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.
Example: if your daily dose is 2,000 mg, you must take one tablet in the morning and one tablet in the evening.
Jekk id- doża tiegħek hija 2, 000 mg kuljum, trid tieħu pillola waħda filgħodu u pillola waħda filgħaxija.
120 If you stop taking Keppra:
120 M’ għandekx tieħu doża doppja biex tpatti għal xi pillola li tkun insejt tieħu.
Common side effects (> 1% - 10%) reported with Keppra are: • nervous system disorders: dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity), ataxia (impaired coordinated movements), tremor (involuntary trembling), amnesia (loss of memory), balance disorders (equilibrium disorder), disturbance in attention (loss of concentration), memory impairment (forgetfulness); • psychiatric disorders: agitation, depression, emotional instability/ mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), thinking abnormal (slow thinking, unable to concentrate); • digestive disorders: abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting; • nutrition disorders: anorexia (loss of appetite), weight increase; • ear and labyrinth disorders: vertigo (sensation of rotation); • eye disorders: diplopia (double vision), vision blurred; • musculoskeletal and connective tissue disorders: myalgia (muscle pain); • injury: accidental injury; • infections: infection, nasopharyingitis; • respiratory disorders: cough (increase of pre-existing cough); • skin disorders: rash, eczema, pruritus; • blood disorders: decreased number of blood platelets.
Effetti komuni (> 1% - 10%) mhux mixtieqa li ġew rappurtati b’ Keppra huma: • Mard fis- sistema nervuża: sturdament (sensazzjoni li ser taqa '), aċċessjoni, uġigħ ta' ras, iperkinesja (iperattivita`), ataksja (movimenti mhux ko- ordinati), rogħda, amneżija (telf ta 'memorja), telf tal- bilanċ (mard ta ’ l- ekwilibriju), disturbi f’ attenzjoni (telf ta ’ konċentrazzjoni), telf ta ’ memorja (nisi); • Mard psikjatriċi: aġitazzjoni, depressjoni, instabilità emozzjonali / tibdil fil- burdata, ostilità jew aggressjoni, nuqqas ta' rqad, nervożiżmu jew irritabilità, disturbi fil- personalita`, (problemi fl - imġieba), ħsieb abnormali (ħsieb bil- mod, ma tistax tikkonċentra); • Mard gastro- intestinali: uġigħ f’ addomenu, dardir, indiġestjoni, dijarrea, rimettar; • Mard fin- nutrizzjoni: anoressija (telf t' aptit); żieda fil- piz • Mard fil- widna u fil- parti ta 'ġewwa tal- widna: vertigo (tħoss kollox idur bik); • Mard fil- għajn: viżjoni doppja, viżjoni mċajpra; • Mard muskolu- skeltrali u tal- connective tissue: majalġja (uġigħ fil- muskoli) • Korriment: korriment aċċidentali; • Infezzjonijiet: nażo- farinġite • Mard respiratorju: żieda fis- sogħla • Mard tal- ġilda: raxx, ekżema, ħakk. • Mard fid- demm: livell baxx ta' plejtlets fid- demm.
Other side effects reported with Keppra are: • nervous system disorders: paraesthesia (tingling); • psychiatric disorders: abnormal behaviour, anger, anxiety, confusion, hallucination, mental disorder; suicide, suicide attempt and suicidal ideation; • digestive disorders: pancreatitis, hepatic failure, hepatitis, liver function test abnormal; • nutrition disorders: weight loss; • skin disorders: hair loss; • blood disorders: decreased number of red blood cells, and/ or white blood cells.
Effetti mhux mixtieqa oħra huma: • Mard fis- sistema nervuża: parastesja (tingis); • Mard psikjatriċi: mġieba mhux normali, rabja, ansjetà, konfużjoni, depressjoni, alluċinazzjoniji, mard mentali, suwiċidju, attentat ta ’ suwiċidju u ħsibijiet ta ’ suwiċidju; • Mard diġestivi: pankreatite, insuffiċjenza tal- fwied, epatite, test tal- funzjoni tal- fwied abnormali; • Mard marbut man- nutrizzjoni: telf ta ’ piz; Xi effetti mhux mixtieqa bħal tħeddil, għajja u sturdament jistgħu jkunu iżjed komuni fil- bidu tat - trattament u meta tiżdied id- doża.
• Keep out of the reach and sight of children. • This medicinal product does not require any special storage conditions..
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Dan il- prodott mediċinali m’ għandux bżonn ebda ħtiġijiet speċjali għall- ħażna.
121 The expiry date refers to the last day of the month.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
What Keppra contains • The active substance is called levetiracetam. • The other ingredients are:
Sustanzi oħra jinkludu:
Opadry 85F18422 (Polyvinyl alcohol-part. hydrolyzed, Titanium dioxide (E171), Macrogol 3350, Talc).
Opadry 85F18422 (Polyvinyl alcohol- part. hydrolyzed, Titanium dioxide (E171), Macrogol 3350, Talc).
Each tablet contains 1,000 mg of levetiracetam.
Kull pillola fiha 1000 mg ta 'levetiracetam.
What Keppra looks like and contents of the pack The film-coated tablets are white, oblong, scored and debossed with the code “ ucb” and“ 1000” on one side.
Id- Dehra tal- prodott u d- daqs tal- pakkett: l- pilloli miksija b' rita huma bojod, tawwalin, maqtuha minn nofs u mnaqqxa bil- kodiċi “ ucb ” u “ 1000 ” fuq naħa waħda.
The cardboard boxes contain 10, 20, 30, 50, 60, 100 and 200 film-coated tablets.
Il- kaxxi tal- kartun fihom 10, 20, 30, 50, 60, 100 u 200 pillola miksija b' rita.
España UCB Pharma, S. A.
122 Portugal España UCB Pharma (Produtos Farmacêuticos), Lda UCB Pharma, S. A.
INFORMATION FOR THE USER
123 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
- This medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni
Keppra 100 mg/ ml oral solution is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Keppra 100 mg/ ml soluzzjoni orali hija mediċina għal kontra l- epilessija (użata biex tittratta l - aċċessjonijiet f- epilessija).
Keppra is used alone for the treatment of partial seizures in patients from 16 years of age
Keppra huwa wżat waħdu fit- trattament ta 'aċċessjonijiet tat- tip parzjali f' pazjenti minn 16 il- sena.
Keppra is used in patients who are already taking another antiepileptic medicine • in the treatment of partial seizures in adults and children from 4 years age • in the treatment of myoclonic seizures in patients from 12 years of age with Juvenile Myoclonic Epilepsy, • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age
Keppra huwa wżat f ’ pazjenti li diga ’ ikunu qiegħdin jieħdu mediċini oħra għal kontra l- epilessija • fit- trattament ta 'aċċessjonijiet tat- tip parzjali f ’ adulti u tfal minn 4 snin. • fit- trattament ta ’ aċċessjonijiet tat- tip mijokloniċi f ’ pazjenti minn 12 snin b’ epilessija tat- tip Mijoklonika li tibda fiż- żgħożija • fit- trattament ta ’ aċċessjonijiet primarji u ġeneralizzati tat- tip tonic- clonic f’ adulti u addoloxxenti minn 12 il- sena
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra 124 Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Keppra oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Keppra Keppra soluzzjoni orali fih parahydroxybenzoate (E218) u propylparahydroxybenzoate (E216) li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jista ’ jkun jieħdu iż- żmien biex jidhru).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib qallek li għandek intolleranza għal xi tipi ta ’ zokkor, kellem lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Take the oral solution following your doctor’ s instructions. • General dose: between 1,000 mg (10 ml) and 3,000 mg (30 ml) each day. • Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Eżempju:
Example: if your daily dose is 1,000 mg, you must take 500 mg (equal to 5 ml) in the morning and 500 mg (equal to 5 ml) in the evening.
Jekk id- doża tiegħek hija 1, 000 mg kuljum, trid tieħu 500g (ugwali għal 5 ml) filgħodu u 500g (ugwali għal 5 ml) filgħaxija.
Give to your child the amount of oral solution following your doctor’ s instructions. • General dose: between 20 mg/ kg and 60 mg/ kg each day. • Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Għati lit- tifla/ tifel tiegħek l- ammont ta 'soluzzjoni orali kif jgħidlek it- tabib. • Doża normali: bejn 20 mg/ kg u 60 mg/ kg kuljum. • Keppra trid tittieħed darbtejn kuljum, darba filgħodu u darba filgħaxija, bejn wieħed u ieħor fl - istess ħin kuljum.
Example: for a general dose of 20 mg/ kg each day, you must give your 15 kg child 150 mg (equal to 1.5 ml) in the morning and 150 mg (equal to 1.5 ml) in the evening.
Eżempju: għal doża ġenerali ta ’ 20 mg/ kg kuljum, trid tgħati lit- tifel / tifla tiegħek li tiżen 15 kg, 150 mg (ugwali għal 1. 5 ml) filgħodu u 150 mg (ugwali għal 1. 5 ml) filgħaxija.
Keppra oral solution may be diluted in a glass of water.
Kif jittieħed Is- soluzzjoni orali Keppra tista ’ tiġi dilwita f ’ tazza ilma.
125 • Empty the contents of the syringe in a glass of water by pushing the piston to the bottom (figure) • Drink the whole contents of the glass • Wash the syringe with water (figure) • Close the bottle with the plastic screw cap.
Struzzjonijiet għall- użu: • Iftaħ il- flixkun: agħfas l- għatu u dawru kontra l- arloġġ (figura) • Daħħal is- siringa fil- flixkun (figura) • Imla s- siringa bil- likwidu billi tiġbed il- planġer sal- livell tal- marka li tikkorrispondi għall - kwantità f 'mg li kitiblek it- tabib (figura) • Oħroġ is- siringa mill- flixkun (figura) • Battal il- kontenut tas- siringa f' tazza ilma billi tagħfas il- planġer sat- tarf (figura) 125 • Ixrob it- tazza kollha • Aħsel is- siringa fl- ilma (figura) • Agħlaq il- flixkun bl- għatu tal- kamin tal- plastik.
Should your doctor decide to stop your Keppra treatment, he/ she will instruct you about the gradual withdrawal of Keppra.
Jekk it- tabib jiddeċidi li jwaqqaf it- trattament tiegħek b’ Keppra, huwa/ hija jgħidlek kif għandek tnaqqas il- mediċina bil- mod.
Contact your doctor if you took more Keppra than you should.
Jekk tieħu Keppra aktar milli suppost għandek Għarraf lit- tabib tiegħek jekk ħadt iżjed Keppra milli jmissek.
Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal xi doża li tkun insejt tieħu.
Common side effects (> 1% - 10%) reported with Keppra are:
Effetti komuni (> 1% - 10%) mhux mixtieqa li ġew rappurtati b’ Keppra huma: • Mard fis- sistema nervuża: sturdament (sensazzjoni li ser taqa '), aċċessjoni, uġigħ ta' ras, iperkinesja (iperattivita`), ataksja (movimenti mhux ko- ordinati), rogħda, amneżija (telf ta '
126 • nervous system disorders: dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity), ataxia (impaired coordinated movements), tremor (involuntary trembling), amnesia (loss of memory), balance disorder (equilibrium disorder), disturbance in attention (loss of concentration), memory impairment (forgetfulness); • psychiatric disorders: agitation, depression, emotional instability/ mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), thinking abnormal (slow thinking, unable to concentrate); • digestive disorders: abdominal pain; nausea, dyspepsia (indigestion), diarrhoea, vomiting; • nutrition disorders: anorexia (loss of appetite), weight increase; • ear and labyrinth disorders: vertigo (sensation of rotation); • eye disorders: diplopia (double vision), vision blurred; • musculoskeletal and connective tissue disorders: myalgia (muscle pain); • injury: accidental injury; • infections: infection, nasopharyngitis; • respiratory disorders: cough (increase of pre-existing cough); • skin disorders: rash, eczema, pruritus; • blood disorders: decreased number of blood platelets.
126 memorja), telf tal- bilanċ (mard ta ’ l- ekwilibriju), disturbi f’ attenzjoni (telf ta ’ konċentrazzjoni), telf ta ’ memorja (nisi); • Mard psikjatriċi: aġitazzjoni, depressjoni, instabilità emozzjonali / tibdil fil- burdata, ostilità jew aggressjoni, nuqqas ta 'rqad, nervożiżmu jew irritabilità, disturbi fil- personalita`, (problemi fl - imġieba), ħsieb abnormali (ħsieb bil- mod, ma tistax tikkonċentra); • Mard gastro- intestinali: uġigħ f’ addomenu, dardir, indiġestjoni, dijarrea, rimettar; • Mard fin- nutrizzjoni: anoressija (telf t' aptit); żieda fil- piz • Mard fil- widna u fil- parti ta' ġewwa tal- widna: vertigo (tħoss kollox idur bik); • Mard fil- għajn: viżjoni doppja, viżjoni mċajpra; • Mard muskolu- skeltrali u tal- connective tissue: majalġja (uġigħ fil- muskoli) • Korriment: korriment aċċidentali; • Infezzjonijiet: nażo- farinġite • Mard respiratorju: żieda fis- sogħla • Mard tal- ġilda: raxx, ekżema, ħakk. • Mard fid- demm: livell baxx ta 'plejtlets fid- demm.
• Keep out of the reach and sight of children. • Due to sensitivity to light, store in the original container.
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Minħabba sensitivita` għad- dawl, aħżen fil- kontenitur oriġinali.
Do not use after the expiry date stated on the cardboard box and bottle after EXP:.
M’ għandekx tuża wara d- data ta ’ skadenza li tidher fuq il- kaxxa u l- flixkun, wara JIS:.
Do not use after 2 months of first opening the bottle.
Tużax iżjed minn xagħrejn wara li jinfetaħ il- flixkun l- ewwel darba.
What Keppra contains • The active substance is called levetiracetam. • The other ingredients are: sodium citrate, Citric acid monohydrate, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Ammonium glycyrrhizate, Glycerol (E422), Maltitol (E965), Acesulfame potassium (E950), Grape flavour, Purified water.
Sustanzi oħra jinkludu: sodium citrate, Citric acid monohydrate, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Ammonium glycyrrhizate, Glycerol (E422), Maltitol (E965), Acesulfame potassium (E950), Grape flavour, Ilma purifikat.
Keppra is packed in a 300 ml glass bottle in a cardboard box.
Keppra huwa ppakkjat fi flixkun tal- ħġieg ta ’ 300 ml f’ kaxxa tal- kartun.
Each ml contains 100 mg of levetiracetam.
Kull ml fih 100 mg ta 'levetiracetam.
What Keppra looks like and contents of the pack Keppra 100 mg/ ml oral solution is a clear liquid.
Keppra 100 mg/ ml soluzzjoni orali huwa likwidu ċar.
127 The 300 ml glass bottle of Keppra is packed in a cardboard box containing a graduated oral syringe.
Il - flixkun tal- ħġieg ta ’ 300 ml ta ’ Keppra huwa ppakkjat f’ kaxxa tal- kartun li fiha siringa orali mmarkata bil- kejl.
NextPharma SAS, 17 Route de Meulan, F-78520 Limay, France.
NextPharma SAS, 17 Route de Meulan, F- 78520 Limay, Franża.
UCB Pharma Oy Finland Puh/ Tel: + 358 9-229 0100
Suomi/ Finland UCB Pharma Oy Finland Puh/ Tel: + 358 / 9- 2290 100
Κύπρος Lifepharma (Z. A. M.) Ltd Τηλ: + 357 22 34 74 40
128 Lifepharma (Z. A. M.) Ltd Τηλ: + 357 22 34 74 40
INFORMATION FOR THE USER
129 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina.
Before you use Keppra 3.
Qabel ma ’ tuża Keppra 3.
How to use Keppra 4.
Kif għandek tuża Keppra 4.
Keppra concentrate is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Il- konċentrat Keppra hija mediċina għal kontra l- epilessija (użata biex tittratta l- aċċessjonijiet f - epilessija).
Keppra is used alone in the treatment of partial seizures in patients from 16 years of age,
Keppra huwa wżat waħdu fit- trattament ta 'aċċessjonijiet tat- tip parzjali f' pazjenti minn 16 il- sena.
Keppra concentrate is an alternative for patients when administration of the antiepileptic oral Keppra medicine is temporarily not feasible.
Il- konċentrat Keppra huwa alternattiva għal pazjenti li temporanjament ma ’ jistgħux jieħdu mediċina mill- ħalq.
BEFORE YOU USE KEPPRA
QABEL MA ’ TUŻA KEPPRA
Do not use Keppra: • if you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Keppra.
Tużax Keppra • jekk tbati minn allerġija (sensittività eċċessiva) għal levetiracetam jew sustanzi oħra ta ’ Keppra.
However, there is limited experience on long term effects in children. • If you notice an increase in seizure severity (e. g. increased number), please contact your doctor.
Madanakollu, hemm esperjenza limitata fl- effetti fit- tul fuq it- tfal. • Jekk tinnota xi żieda fis- severita` ta ’ l- aċċessjonijiet (ez. żieda fin - numru), jekk jogħġbok, għarraf lit- tabib tiegħek.
130 • A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves.
130 • Numru żgħir ta ’ nies fuq trattament b’ mediċini ta ’ kontra l- epilessija bħal Keppra kellhom ħsibijiet li jweġġgħu jew joqtlu lilhom infushom.
You may take Keppra with or without food.
Meta tuża Keppra ma ’ l- ikel u max- xorb Tista 'tieħu Keppra kemm fuq l- ikel u kemm fuq stonku vojt.
As a safety precaution, do not use Keppra with alcohol.
Bħala prekawzjoni għas- sigurta`, tixrobx alkoħol meta tuża Keppra.
Important information about some of the ingredients of Keppra Other ingredients include sodium acetate, glacial acetic acid, sodium chloride, water for injection
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Keppra Sustanzi oħra jinkludu Sodium acetate, Glacial acetic acid, Sodium chloride, Ilma għall- injezzjoni Din il- mediċina fiha 0. 313 mmol (jew 7. 196 mg) ta ’ sodju f’ kull vjala.
This should be taken into consideration if you are on a controlled sodium diet.
Dan għandek tqisu jekk inti pazjent fuq dieta nieqsa mis- sodju.
HOW TO USE KEPPRA
KIF GĦANDEK TUŻA KEPPRA
The intravenous formulation is an alternative to your oral administration.
L- għamla li tittieħed minn ġol- vina hija alternattiva għal dik orali.
Conversion to or from oral to intravenous administration can be done directly without titration.
Biex taqleb il- mod li tintuza minn dik orali għal ġol- vina jew viċe versa, m’ hemmx għalfejn titrazzjoni.
Your total daily dose and frequency of administration remain identical.
Id- doża totali kuljum u l - frekwenza tibqa l- istess.
Dosage in adults and adolescents (12 to 17 years) weighing 50 kg or more: • General dose: between 1,000 mg and 3,000 mg each day. • Keppra must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Ħu n- numru ta 'pilloli kif jgħidlek it- tabib. • Doża normali: bejn 1, 000 mg u 3, 000 mg kuljum. • Keppra trid tittieħed darbtejn kuljum, darba filgħodu u darba filgħaxija, bejn wieħed u ieħor fl - istess ħin kuljum.
Dosage in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg: • General dose: between 20 mg/ kg and 60 mg/ kg each day. • Keppra must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Għati lit- tifla/ tifel tiegħek in- numru ta 'pilloli kif jgħidlek it- tabib. • Doża normali: bejn 20 mg/ kg u 60 mg/ kg kuljum. • Keppra trid tittieħed darbtejn kuljum, darba filgħodu u darba filgħaxija, bejn wieħed u ieħor fl - istess ħin kuljum.
Keppra is administered as an intravenous infusion by a healthcare professional.
Kif tużaħ u r- rotta fejn jista ’ jingħata Keppra jingħata bħala infużjoni minn ġol- vina minn professjonista fil- qasam tas- saħħa.
Keppra will be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes.
Keppra jiġi dilwit f ’ mill- inqas 100 ml ta ’ dilwent kompattibli u jittieħed b’ infużjoni f ’ 15 il- minuta.
For medical or healthcare professionals, more detailed direction for the proper use of Keppra is provided in section 6.
F’ sezzjoni 6, hemm struzzjonijiet iżjed dettaljati għal professjonisti fil- qasam mediku jew tas- saħħa, ta ’ kif Keppra għandu jintuża sew,
131 • Keppra is used as a chronic treatment.
131 Kemm għandu jdum it- trattament • Keppra huwa wżat bħala trattament għal marda kronika.
Should your doctor decide to stop your Keppra treatment, he/ she will instruct you about the gradual withdrawal of Keppra. • There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.
Jekk it- tabib jiddeċidi li jwaqqaf it- trattament tiegħek b’ Keppra, huwa jgħidlek kif għandek tnaqqas il- mediċina bil- mod. • M’ hemmx esperjenza bl- użu ta ’ levetiracetam li jittieħed minn ġol- vina għal iżjed minn 4 ijiem.
POSSIBLE SIDE EFFECTS Like all medicines, Keppra can cause side effects, although not everybody gets them.
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
Common side effects (> 1% - 10%) reported with Keppra are: • nervous system disorders: dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity), ataxia (impaired coordinated movements), tremor (involuntary trembling), amnesia (loss of memory), balance disorder (equilibrium disorder), disturbance in attention (loss of cocentration), memory impairment (forgetfulness); • psychiatric disorders: agitation, depression, emotional instability/ mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), thinking abnormal (slow thinking, unable to concentrate); • digestive disorders: abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting; • nutrition disorders: anorexia (loss of appetite), weight increase; • ear and labyrinth disorders: vertigo (sensation of rotation); • eye disorders: diplopia (double vision), vision blurred; • musculoskeletal and connective tissue disorders: myalgia (muscle pain); • injury: accidental injury; • infections: infection, nasopharyngitis; • respiratory disorders: cough (increase of pre-existing cough); • skin disorders: rash; eczema, pruritus; • blood disorders: decreased number of blood platelets.
Effetti komuni (> 1% - 10%) mhux mixtieqa li ġew rappurtati b’ Keppra huma: • Mard fis- sistema nervuża: sturdament (sensazzjoni li ser taqa '), aċċessjoni, uġigħ ta' ras, iperkinesja (iperattivita`), ataksja (movimenti mhux ko- ordinati), rogħda, amneżija (telf ta 'memorja), telf tal- bilanċ (mard ta ’ l- ekwilibriju), disturbi f’ attenzjoni (telf ta ’ konċentrazzjoni), telf ta ’ memorja (nisi); • Mard psikjatriċi: aġitazzjoni, depressjoni, instabilità emozzjonali / tibdil fil- burdata, ostilità jew aggressjoni, nuqqas ta' rqad, nervożiżmu jew irritabilità, disturbi fil- personalita`, (problemi fl - imġieba), ħsieb abnormali (ħsieb bil- mod, ma tistax tikkonċentra); • Mard gastro- intestinali: uġigħ f’ addomenu, dardir, indiġestjoni, dijarrea, rimettar; • Mard fin- nutrizzjoni: anoressija (telf t' aptit); żieda fil- piz • Mard fil- widna u fil- parti ta 'ġewwa tal- widna: vertigo (tħoss kollox idur bik); • Mard fil- għajn: viżjoni doppja, viżjoni mċajpra; • Mard muskolu- skeltrali u tal- connective tissue: majalġja (uġigħ fil- muskoli) • Korriment: korriment aċċidentali; • Infezzjonijiet: nażo- farinġite • Mard respiratorju: żieda fis- sogħla • Mard tal- ġilda: raxx, ekżema, ħakk. • Mard fid- demm: livell baxx ta' plejtlets fid- demm.
132 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok kellem lit- tabib jew spiżjar tiegħek.
• Keep out of the reach and sight of children. • This medicinal product does not require any special storage conditions.
132 • Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Dan il- prodott mediċinali m’ għandux bżonn ebda ħtiġijiet speċjali għall- ħażna.
Do not use after the expiry date stated on the vial and carton box after EXP:
M’ għandekx tuża wara d- data ta ’ skadenza li tidher fuq il- vjala u l- kaxxa, wara JIS:.
What Keppra contains • The active substance is called levetiracetam. • The other ingredients are: sodium acetate, glacial acetic acid, sodium chloride, water for injection Keppra concentrate is contained in a 5 ml glass vial, which is closed with a Teflon faced stopper and sealed with an aluminium/ polypropylene flip off seal.
Sodium acetate, Glacial acetic acid, Sodium chloride, Ilma għall - injezzjoni Il- konċentrat Keppra issibu fi vjali tal- ħġieġ ta ’ 5 ml, b' għatu b’ wiċċ tat- Teflon u ssiġillati b’ tap li jinqala tal- aluminjum / polypropylene.
Each ml of solution for infusion contains 100 mg of levetiracetam.
Kull ml ta ’ soluzzjoni għall- infużjoni fih 100 mg ta ’ levetiracetam.
What Keppra looks like and contents of the pack Keppra concentrate for solution for infusion (Keppra concentrate) is a clear, colorless, sterileliquid.
Il- konċentrat Keppra għal soluzzjoni għall- infużjoni (konċentrat Keppra) huwa likwidu ċar, bla kulur u sterili.
Keppra concentrate 5 ml vial is packed in a cardboard box of 10 vials.
Il- vjala ta ’ 5 ml tal- konċentrat Keppra issibhom f’ kaxxi tal- kartun ta ’ 10 vjali.
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’ Alleud, Belgium or UCB Pharma S. p. A., Via Praglia, 15, I-10044 Pianezza, Italy.
UCB Pharma SA, Chemin du Foriest, B- 1420 Braine- l- Alleud, Belġju jew UCB Pharma S. p. A., Via Praglia, 15, I- 10044 Pianezza, Italy.
133 Eesti Österreich UCB Pharma Oy Finland Tel: +358 9 229 0100
Österreich Eesti UCB Pharma GmbH UCB Pharma Oy Finland Tel: +43 / (0) 129180- 0 Tel: +358- 9 2290 100
UCB Pharma GmbH Tel: +43 / (0) 129180-0
Ελλάδα
Ελλάδα UCB Α .Ε.
133 UCB Α. Ε.
Latvija UCB Pharma Oy Finland Tel: + 358 9 229 0100
UCB Pharma Oy Finland Tel: + 358- 9 2290 100
< -------------------------------------------------------------------------------------------------------------------------- --
< ---------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
Dan t- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku u tas- saħħa:
Direction for the proper use of Keppra is provided in section 3.
Struzzjonijiet għall- użu sew ta ’ Keppra issibhom f’ sezzjoni 3.
134 One vial of Keppra concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ ml).
Vjala waħda ta ’ Keppra fiha 500 mg ta ’ levetiracetam (5 ml ta ’ konċentrat ta ’ 100 mg/ ml).
See Table 1 for the recommended preparation and administration of Keppra concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg in two divided doses.
Ara iskeda 1 għall- preparazzjoni rikkmandata kif ukoll il- metodu rikmandat ta ’ kif jingħata l- konċentrat Keppra biex tilħaq doża totali ta ’ 500mg, 1000 mg, 2000 mg, jew 3000 mg kuljum, f’ żewġt dożi separati.
Table 1.
134 Skeda 1.
Volume of Diluent
Volum ta ’ dilwent
Infusion Time
Ħin tal - infużjoni
Frequency of administration
Frekwenza ta ’ kif jingħata
500 mg/ day
Doża totali ta ’ kuljum
5 ml (one 5 ml vial) 10 ml (two 5 ml vials) 15 ml (three 5 ml vials)
2. 5 ml (nofs vjala ta ’ 5 ml) 5 ml (vjala waħda ta ’ 5 ml) 10 ml (żewġt vjali ta ’ 5 ml) 15 ml (tlett vjali ta ’ 5 ml)
15 minutes 15 minutes 15 minutes
15 minuti 15 minuti 15 minuti 15 minuti
Twice daily Twice daily Twice daily
Darbtejn kuljum Darbtejn kuljum Darbtejn kuljum Darbtejn kuljum
1000 mg/ day 2000 mg/ day 3000 mg/ day
500 mg/ ġurnata 1000 mg / ġurnata 2000 mg / ġurnata 3000 mg / ġurnata
In use shelf life: from a microbiological point of view, the product should be used immediately after dilution.
Mill- lat mikrobijoloġoku, il- prodott għandu jintuża immedjatament wara li jiġi jilwit.
Keppra concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15- 25°C.
Il- konċentrat Keppra instab li kien fiżikament kompattibli u kimikament stabli meta mħallat ma ’ dawn id- dilwenti għal mill- inqas 24 siegħa u meta maħżun f ’ basktijiet tal- PVC f’ temperatura ta ’ l- ambjent kontrollata ta ’ 15- 25°C.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek.
What is Ketek?
X’ inhu Ketek?
Ketek is a medicine containing the active substance telithromycin.
Ketek huwa mediċina li fiha s- sustanza attiva telithromycin.
It is available as orange, oblong tablets containing 400 mg telithromycin.
Jiġi bħala pilloli oranġjo rettangulari li jkun fihom 400 mg telithromycin.
What is Ketek used for?
Għal xiex jintuża?
Ketek is used to treat adult patients with mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
Ketek jintuża biex jittratta pazjenti adulti b' pulmonite li ttieħdet fil- komunità (barra mill- isptar) ħafifa jew moderata.
It is also used to treat adults with the following infections when they are caused by bacteria that are or could be resistant (insensitive) to beta-lactams or macrolides (types of antibiotic): • acute exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the lungs); • acute sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the nose and eyes).
Jintuża wkoll biex jittratta adulti b’ dawn l- infezzjonijiet meta jkunu kkawżati minn batterji li huma jew jistgħu jkunu reżistenti (insensittivi) għall- beta- lactams jew makrolidi (tipi ta ’ antibijotiċi): • Taħrix akut tal- bronkite kronika (infjammazzjoni fit- tul tal- pajpijiet tan- nifs fil- pulmuni); • Sinusite akuta (infezzjoni fil- qosor tas- sinus, passaġġi mimlija bl- arja fil- għadam ta ’ madwar l - imniffsejn u l- għajnejn).
Ketek is also used to treat patients aged 12 years or over who have tonsillitis or pharyngitis (infections of the tonsils or throat) caused by the bacterium Streptococcus pyogenes.
Ketek jintuża wkoll fit- trattament ta ’ pazjenti ta ’ 12- il sena jew iktar li jkollhom tonsillite jew farinġite (infezzjonijiet tat- tunsilli jew tal- gerżuma) ikkawżati mill- batterju Streptococcus pyogenes.
It is used when beta-lactams are not appropriate, in countries or regions where there are high levels of resistance to macrolides.
Jintuża meta ma jkunux jistgħu jingħataw il- beta- lactams, f’ pajjiżi jew f’ reġjuni fejn ikun hemm livelli għoljin ta ’ reżistenza għall- makrolidi.
Prescribers should consider official guidance on the use of antibacterial agents and local levels of resistance to antibiotics.
Min jippreskrivi jrid jikkunsidra l- gwidi uffiċjali fuq l- użu ta ’ aġenti antibatteriċi u l- livelli lokali ta ’ reżistenza għall- antibijotiċi.
How is Ketek used?
Kif jintuża Ketek?
The recommended dose of Ketek is 800 mg (two tablets) once a day.
Id- doża rakkomandata ta ’ Ketek hija 800 mg (żewġ pilloli) darba kuljum.
The tablets should be swallowed whole with water, with or without food.
Il- pilloli għandhom jinbelgħu sħaħ ma ’ l- ilma, ma ’ jew mingħajr l- ikel.
Taking Ketek at bedtime may reduce the potential impact of side effects such as visual disturbances and loss of consciousness.
Meta Ketek jittieħed qabel l- irqad jista ’ jonqos l - impatt potenzjali ta ’ l- effetti sekondarji bħad- disturbi fil- vista u li wieħed jintilef minn sensih.
For pneumonia, the tablets should be taken for seven to 10 days.
Għall - pulmonite, il- pilloli għandhom jittieħdu għal bejn seba ’ u għaxart ijiem.
For the other infections, they are taken for five days.
Għal infezzjonijiet oħra, jittieħdu għal ħamest ijiem.
A lower dose may be needed in patients who have severe kidney problems together with certain liver problems.
Jista ’ jkun hemm bżonn tingħata doża iżgħar f’ pazjenti li jkollhom problemi severi fil- kliewi flimkien ma ’ xi problemi tal- fwied.
How does Ketek work?
Kif jaħdem Ketek?
The active substance in Ketek, telithromycin, is an antibiotic belonging to the class ‘ ketolides’.
Is- sustanza attiva f’ Ketek, telithromycin, hija antibijotiku fil- klassi magħrufa bħala ‘ ketolidi ’.
These are closely related to the macrolides.
Dawn huma relatati mill- qrib mal- makrolidi.
The full list of
Telithromycin jaħdem billi jimblokka r- ribożomi tal- batterji (il - partijiet taċ- ċelloli fejn jiġu prodotti l- proteini), u b’ hekk jinibixxi l- kobor tal- batterji.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Il- lista sħiħa ta ’ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.