qanastek/EMEA-V3 huggingface dataset:
directly in the mouth; mixed with a spoonful of cold or room temperature soft food (for example, applesauce, ice cream, carrots and rice).
48 direttament fil- ħalq; o JEW imħallta ma 'mgħarfa ikel artab kiesaħ jew fit- temperatura tal- kamra (per eżempju, o zalza tat- tuffieħ, ġelat, karrotti u ross).
• Mix all of the contents of the SINGULAIR granules into a spoonful of cold or room temperature soft food, taking care to see that the entire dose is mixed with the food.
• Ħallat il- kontenut kollu tal- granuli SINGULAIR ġewwa mgħarfa ikel artab kiesaħ jew fit - temperatura tal- kamra, u oqgħod attent/ a biex tara li d- doża sħiħa titħallat ma 'l- ikel.
46 • Be sure the child is given the entire spoonful of the granule/ food mixture immediately (within 15 minutes).
• Kun ċert/ a li t- tifel/ tifla tiegħek jingħataw l- imgħarfa sħiħa tat- taħlita ta 'granuli u ikel immedjatament (fi żmien 15- il minuta).
Never store any granule/ food mixture for use at a later time.
M' għandek qatt taħżen xi taħlita ta 'granuli u ikel għal użu aktar tard.
• SINGULAIR granules are not intended to be dissolved in liquid.
• Il- granuli SINGULAIR mhumiex intenzjonati biex jinħallu fil- likwidu.
However, your child may take liquids after swallowing the SINGULAIR granules.
Madankollu, it- tifel/ tifla tiegħek jistgħu jieħdu likwidi wara li jibilgħu l- granuli SINGULAIR.
• SINGULAIR granules can be taken without regard to the timing of food intake.
• Il- granuli SINGULAIR jistgħu jittieħdu mingħajr każ tal- ħin ta 'l- inġestjoni ta' l- ikel.
If your child takes more SINGULAIR than he/ she should
Jekk it- tifel/ tifla tiegħek jieħdu aktar SINGULAIR milli suppost
Contact your child’ s doctor immediately for advice.
Ikkuntattja lit- tabib tat- tifel/ tifla tiegħek immedjatament għal parir.
There were no side effects reported in the majority of overdose reports.
Ma kienu rrappurtati l- ebda effetti sekondarji fil- maġġoranza tar- rapporti ta 'doża eċċessiva.
The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
L- aktar sintomi frekwenti rrappurtati b' doża eċċessiva fl- adulti u t- tfal kienu jinkludu wġigħ addominali, ngħas, għatx, uġigħ ta 'ras, rimettar, u attività eċċessiva.
If you forget to give SINGULAIR to your child
Jekk tinsa tagħti SINGULAIR lit- tifel/ tifla tiegħek
Try to give SINGULAIR as prescribed.
Ipprova agħti SINGULAIR skond ir- riċetta tat- tabib.
However, if your child misses a dose, just resume the usual schedule of one sachet once daily.
Madankollu, jekk it- tifel/ tifla tiegħek ifallu doża, sempliċement kompli bl- iskeda tas- soltu ta 'qartas wieħed darba kuljum.
Do not give a double dose to make up for a forgotten dose.
Tagħtix doża doppja biex tpatti għal doża li tkun insejt.
If your child stops taking SINGULAIR
Jekk it- tifel/ tifla tiegħek jieqfu jieħdu SINGULAIR
SINGULAIR can treat your child's asthma only if he/ she continues taking it.
SINGULAIR jista 'jikkura biss l- ażżma tat- tifel/ tifla tiegħek jekk it- tifel/ tifla tiegħek ikomplu jeħduh.
It is important for your child to continue taking SINGULAIR for as long as your doctor prescribes.
Huwa importanti li t- tifel/ tifla tiegħek ikomplu jieħdu SINGULAIR għal kemm jgħidilhom it- tabib tiegħek.
It will help control your child’ s asthma.
Dan jgħin biex tiġi kkontrollata l- ażżma tat- tifel/ tifla tiegħek.
Like all medicines, SINGULAIR can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, SINGULAIR jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In clinical studies with SINGULAIR 4 mg granules, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to SINGULAIR were: • diarrhoea • hyperactivity • asthma • scaly and itchy skin • rash Additionally, the following side effects were reported in clinical studies with either SINGULAIR 10 mg film-coated tablets, 5 mg or 4 mg chewable tablets: • abdominal pain • headache • thirst These were usually mild and occurred at a greater frequency in patients treated with SINGULAIR than placebo (a pill containing no medication).
Fi studji kliniċi b' SINGULAIR 4 mg granuli, l- aktar effetti sekondarji rrappurtati b' mod komuni (li jseħħu f’ għallinqas pazjent 1 minn kull 100 u f’ inqas minn pazjent pedjatriku 1 ikkurat minn kull 10) maħsuba li huma relatati ma 'SINGULAIR kienu: dijarea • attività eċċessiva • ażżma • ġilda qxur qxur u li tieklok • raxx •
47 Additionally, while the medicine has been on the market, the following have been reported: • allergic reactions including rash, swelling of the face, lips, tongue, and/ or throat which may cause difficulty in breathing or swallowing, itching, and hives; • tiredness, restlessness, agitation including aggressive behaviour, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, drowsiness, hallucinations, dream abnormalities, including nightmares and trouble sleeping, pins and needles/ numbness, seizure; • feeling unwell, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhoea, hepatitis; • increased bleeding tendency, bruising, tender red lumps under the skin most commonly on your shins (erythema nodosum), palpitations; • swelling.
Barra dan, waqt li l- mediċina kienet fis- suq, kienu rrappurtati dawn li ġejjin: reazzjonijiet allerġiċi fosthom raxx, nefħa tal- wiċċ, tax- xufftejn, ta 'l- ilsien, u/ jew tal- gerżuma li • tista' tikkawża diffikultà biex tieħu n- nifs jew biex tibla ', ħakk, u ħorriqija għeja, irrekwitezza, aġitazzjoni li tinkludi mġiba aggressiva, irritabilità, rogħda, depressjoni, • ħsibijiet u azzjonijiet relatati ma ’ suwiċidju (f’ każijiet rari ħafna), sturdament, ngħas, alluċinazzjonijiet, abnormalitajiet tal- ħolm, fosthom inkubi u diffikultà biex torqod, tingiż/ tnemnim, aċċessjonijiet sensazzjoni ta' mard, uġigħ fil- ġogi jew fil- muskoli, bugħawwiġijiet, ħalq xott, dardir, rimettar, • indiġestjoni, dijarea, epatite tendenza akbar ta 'fsada, tbenġil, nefħiet ħomor sensittivi taħt il- ġilda l- aktar komuni fuq il - • qażba tas- sieq (erythema nodosum) palpitazzjonijiet; nefħa. •
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/ or rash (Churg-Strauss syndrome) have been reported.
F' pazjenti ażżmatiċi ttrattati b' montelukast, ġew irrappurtati każijiet rari ħafna ta 'kombinazzjoni ta' sintomi bħal mard jixbah lill- influwenza, tingiż jew traqqid tad- dirgħajn u tas- saqajn, taħżin tas - sintomi pulmonari u/ jew raxx (sindrome ta 'Churg- Strauss).
You must tell your doctor right away if your child gets one or more of these symptoms.
Għid lit- tabib tiegħek mill- ewwel jekk it - tifel/ tifla tiegħek ikollhom xi wieħed jew iżjed minn dawn is- sintomi.
Ask your doctor or pharmacist for more information about side effects.
Staqsi lit- tabib jew lill- ispiżjar tiegħek għal aktar tagħrif dwar l- effetti sekondarji.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your child’ s 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 għid lit- tabib jew lill- ispiżjar tat- tifel/ tifla tiegħek.
HOW TO STORE SINGULAIR
KIF TAĦŻEN SINGULAIR
• Do not use this medicine after the date shown by the six numbers following EXP on the sachet.
• Tużax din il- mediċina wara d- data murija bis- sitt numri wara JIS fuq il- qartas.
The first two numbers indicate the month; the last four numbers indicate the year.
L- ewwel żewġ numri jindikaw ix- xahar; l- aħħar erba 'numri jindikaw is- sena.
This medicine expires at the end of the month shown.
Din il- mediċina tiskadi fl- aħħar tax- xahar indikat.
• Store in the original package in order to protect from light and moisture.
• Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl u mill- umdità.
• Medicines should not be disposed of via wastewater or household waste.
• Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- dranaġġ jew ma' l- iskart domestiku.
What SINGULAIR contains
X' fih SINGULAIR
• The active substance is montelukast.
Is- sustanza attiva hi montelukast.
Each sachet of granules contains montelukast sodium which corresponds to 4 mg of montelukast. • The other ingredients are:
Is- sustanzi l- oħra huma:
Mannitol, hyprolose (E 463), and magnesium stearate.
Mannitol, hyprolose (E 463), u magnesium stearate. •
What SINGULAIR looks like and contents of the pack
50 Id- dehra ta 'SINGULAIR u l- kontenuti tal- pakkett
4 mg SINGULAIR granules are white granules.
4 mg SINGULAIR granuli huma granuli bojod.
Marketing Authorization Holder and Manufacturer
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq {Trid timtela mill- pajjiż konċernat}
{To be completed nationally}
L- informazzjoni hija mogħtija minn {Trid timtela mill- pajjiż konċernat}
48 This medicinal product is authorized in the Member States of the EEA under the following names:
Dan il- prodott mediċinali huwa awtorizzat fl- Istati Membri taż- ŻEE taħt l- ismijiet li ġejjin:
Bulgaria, Cyprus, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Norway, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom:
Il- Bulgarija, Ċipru, l- Estonja, il- Finlandja, il- Ġermanja, il- Greċja, l- Islanda, l- Irlanda, l- Italja, il - Latvja, il- Litwanja, il- Lussemburgu, Malta, in- Norveġja, il- Portugall, ir- Rumanija, is- Slovenja, Spanja, l- Isvezja, ir- Renju Unit
Italy:
L- Italja
This leaflet was last approved in {DD. MM. YYYY.}
Dan il- fuljett kien approvat l- aħħar f '{JJ. XX. SSSS.}
49 PACKAGE LEAFLET:
51 FULJETT TA 'TAGĦRIF:
SINGULAIR 4 mg chewable tablets montelukast
SINGULAIR 4 mg pilloli li tomgħodhom montelukast
Leukotrienes cause narrowing and swelling of airways in the lungs.
Il - leukotrienes jikkawżaw tidjiq u nefħa tal- passaġġi ta 'l- arja fil- pulmuni.
By blocking leukotrienes, SINGULAIR improves asthma symptoms and helps control asthma.
Billi jimblokka l- leukotrienes, SINGULAIR itejjeb is- sintomi ta 'l- ażżma u jgħin fil- kontroll ta' l- ażżma.
• SINGULAIR is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy. • SINGULAIR may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids. • SINGULAIR also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
• SINGULAIR jintuża għat- trattament ta 'pazjenti ta ’ bejn sentejn u 5 snin li ma jkunux ikkontrollati adegwatament bil- medikazzjoni tagħhom u jkollhom bżonn terapija addizzjonali. • SINGULAIR jista' jintuża wkoll bħala trattament alternattiv għal kortikosterojdi meħuda man - nifs għal pazjenti minn 2 sa 5 snin li ma jkunux ħadu riċentement kortikosterojdi orali għall - ażżma tagħhom u wrew li mhumiex kapaċi jużaw kortikosterojdi meħuda man- nifs. • SINGULAIR jgħin ukoll biex jimpedixxi t- tidjiq tal- passaġġi ta 'l- arja kkawżat mill- eżerċizzju għal pazjenti li għandhom sentejn u aktar.
This narrowing of airways worsens and improves in response to various conditions. • sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise. • swelling (inflammation) in the lining of the airways.
Dan it- tidjiq tal - passaġġi ta 'l- arja jeħżien u jitjieb bi tweġiba għal diversi kundizzjonijiet. • passaġġi ta' l- arja sensittivi li jirreaġixxu għal ħafna affarijiet, bħal duħħan tas - sigarretti, polline, arja kiesħa, jew eżerċizzju • nefħa (infjammazzjoni) fil- kisja tal- passaġġi ta 'l- arja.
50 Symptoms of asthma include:
52 Is- sintomi ta 'l- ażżma jinkludu:
• If your child is on anti-asthma medicines, be aware that if he/ she develops a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/ or rash, you should consult your doctor.
• Jekk it- tifel/ tifla tiegħek ikun/ tkun qed jieħu mediċini kontra l- ażżma, kun af li jekk jiżviluppa/ tiżviluppa taħlita ta 'sintomi bħal mard jixbah lill- influwenza, tingiż jew traqqid tad - dirgħajn u tar- riġlejn, taħżin tas- sintomi pulmonari, u/ jew raxx, inti għandek tikkonsulta lit - tabib tiegħek.
Some medicines may affect how SINGULAIR works, or SINGULAIR may affect how your child’ s other medicines work.
Ċerti mediċini jistgħu jaffettwaw il- mod kif jaħdem SINGULAIR, jew SINGULAIR jista 'jaffettwa l - mod kif jaħdmu mediċini oħra fuq it- tifel/ tifla tiegħek.
SINGULAIR 4 mg chewable tablets should not be taken immediately with food; they should be taken at least 1 hour before or 2 hours after food.
SINGULAIR 4 mg pilloli li tomgħodhom m' għandhomx jittieħdu immedjatament ma 'l- ikel; għandhom jittieħdu mill- anqas siegħa qabel jew sagħtejn wara l- ikel.
Pregnancy and breast-feeding This subsection is not applicable for the SINGULAIR 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
53 Tqala u treddigħ Din is- subsezzjoni ma tapplikax għal SINGULAIR 4 mg pilloli li tomgħodhom billi huma intenzjonati għall- użu fi tfal minn 2 sa 5 snin, madankollu l- informazzjoni li ġejja hija rilevanti għas- sustanza attiva, montelukast.
51 Use in pregnancy
Użu fit- tqala
Driving and using machines This subsection is not applicable for the SINGULAIR 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Sewqan u tħaddim ta 'magni Din is- subsezzjoni ma tapplikax għas- SINGULAIR 4 mg pilloli li tomgħodhom billi huma intenzjonati għall- użu fi tfal minn 2 sa 5 snin, madankollu l- informazzjoni li ġejja hija rilevanti għas - sustanza attiva, montelukast.
Important information about some of the ingredients of SINGULAIR
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'SINGULAIR
SINGULAIR chewable tablets contain aspartame, a source of phenylalanine.
Il- pilloli li tomgħodhom SINGULAIR fihom aspartame, li huwa sors ta 'phenylalanine.
If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each 4-mg chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
Jekk it - tifel/ tifla tiegħek għandu/ għandha fenilketonurja (disturb rari, ereditarju tal- metaboliżmu), inti għandek tikkunsidra li kull pillola li tomgħodha ta '4 mg fiha phenylalanine (ekwivalenti għal 0. 674 mg phenylalanine għal kull pillola li tomgħodha ta' 4 mg).
For children who have problems consuming a chewable tablet, an oral granule formulation is available. • Your child should take only one tablet of SINGULAIR once a day as prescribed by your doctor. • It should be taken even when your child has no symptoms or if he/ she has an acute asthma attack. • Always have your child take SINGULAIR as your doctor has told you.
Għal tfal li għandhom problemi biex jieħdu pillola li tintmgħad, hemm formolazzjoni ta ’ granuli li tittieħed mill- ħalq disponiblli. • It- tifel/ tifla tiegħek għandhom jieħdu pillola waħda biss ta 'SINGULAIR darba kuljum kif ordnat mit- tabib tiegħek. • Hija għandha tittieħed anki meta t- tifel/ tifla tiegħek ma jkollhom l- ebda sintomi jew jekk jagħtihom attakk akut ta' l- ażżma. • It- tifel/ tifla tiegħek għandhom jieħdu SINGULAIR skond il- parir tat- tabib.
You should check with your child’ s doctor or pharmacist if you are not sure. • To be taken by mouth
Dejjem għandek taċċerta ruħek mat- tabib jew ma 'l- ispiżjar tiegħek jekk ikollok xi dubju. • Għandha tittieħed mill- ħalq
For children 2 to 5 years of age:
Għal tfal minn 2 sa 5 snin:
One 4 mg chewable tablet daily to be taken in the evening.
Pillola waħda li tomgħodha ta '4 mg kuljum li trid tittieħed filgħaxija.
SINGULAIR 4 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
SINGULAIR 4 mg pilloli li tomgħodhom m' għandhomx jittieħdu immedjatament ma 'l- ikel; huma għandhom jittieħdu mill- anqas siegħa qabel jew sagħtejn wara l- ikel.
If your child is taking SINGULAIR, be sure that he/ she does not take any other medicines that contain the same active ingredient, montelukast.
Jekk it- tifel/ tifla tiegħek qegħdin jieħdu SINGULAIR, kun żgur/ a li huwa/ hija ma jeħdux mediċini oħra li fihom l- istess sustanza attiva, montelukast.
For children 2 to 5 years old, SINGULAIR 4 mg chewable tablets and 4 mg granules are available.
Għal tfal ta ’ bejn sentejn u 5 snin, hemm disponibbli pilloli li tomgħodhom SINGULAIR 4 mg u granuli ta ’ 4 mg.
For children 6 to 14 years old, SINGULAIR 5 mg chewable tablets are available.
54 Għal tfal ta ’ bejn is- 6 snin u l- 14- il sena, hemm disponibbli pilloli li tomgħodhom SINGULAIR 5 mg.
The SINGULAIR 4 mg chewable tablet is not recommended below 2 years of age.
Il- pillola li tomgħodha SINGULAIR 4 mg mhijiex rakkomandata għal tfal taħt is- sentejn.
52 If your child takes more SINGULAIR than he/ she should
Jekk it- tifel/ tifla tiegħek jieħdu aktar SINGULAIR milli suppost
However, if your child misses a dose, just resume the usual schedule of one tablet once daily.
Madankollu, jekk it- tifel/ tifla tiegħek ifallu doża, sempliċement kompli bl- iskeda tas- soltu ta 'pillola waħda darba kuljum.
SINGULAIR can treat your child’ s asthma only if he/ she continues taking it.
SINGULAIR jista 'jikkura biss l- ażżma tat- tifel/ tifla tiegħek jekk huwa/ hija ikomplu jeħduh.
It is important for your child to continue taking SINGULAIR for as long as your doctor prescribes.
Importanti għat- tifel/ tifla tiegħek li tkompli tieħu SINGULAIR għal kemm jgħidlek it- tabib tiegħek.
In clinical studies with SINGULAIR 4 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to SINGULAIR were: • abdominal pain • thirst Additionally, the following side effect was reported in clinical studies with SINGULAIR 10 mg film- coated tablets and 5 mg chewable tablets: • headache These were usually mild and occurred at a greater frequency in patients treated with SINGULAIR than placebo (a pill containing no medication).
Fi studji kliniċi b' SINGULAIR 4 mg pilloli li tomgħodhom, l- aktar effetti sekondarji rrappurtati b' mod komuni (li jseħħu f’ għallinqas pazjent 1 minn kull 100 u f’ inqas minn pazjent pedjatriku 1 ikkurat minn kull 10) maħsuba li huma relatati ma 'SINGULAIR kienu: uġigħ addominali • għatx • Barra minn hekk, l- effett sekondarju segwenti ġie rrappurtat fi studji kliniċi b' SINGULAIR 10 mg pilloli miksijin b' rita u 5 mg pilloli li tomgħodhom: uġigħ ta' ras • Ġeneralment dawn kienu ħfief u seħħew fi frekwenza akbar f' pazjenti ttrattati b' SINGULAIR milli bi plaċebo (pillola li ma fihiex medikazzjoni).
Additionally, while the medicine has been on the market, the following have been reported: • allergic reactions including rash, swelling of the face, lips, tongue, and/ or throat which may cause difficulty in breathing or swallowing, itching, and hives; • tiredness, restlessness, agitation including aggressive behaviour, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, drowsiness, hallucinations, dream abnormalities, including nightmares and trouble sleeping, pins and needles/ numbness, seizure; • feeling unwell, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhoea, hepatitis; • increased bleeding tendency, bruising, tender red lumps under the skin most commonly on your shins (erythema nodosum), palpitations; • swelling.
Barra dan, waqt li l- mediċina kienet fis- suq, kienu rrappurtati dawn li ġejjin: • reazzjonijiet allerġiċi fosthom raxx, nefħa tal- wiċċ, tax- xufftejn, ta 'l- ilsien, u/ jew tal- gerżuma li tista' tikkawża diffikultà biex tieħu n- nifs jew biex tibla ', ħakk, u ħorriqija • għeja, irrekwitezza, aġitazzjoni li tinkludi mġiba aggressiva, irritabilità, rogħda, depressjoni, ħsibijiet u azzjonijiet relatati ma ’ suwiċidju (f’ każijiet rari ħafna), sturdament, ngħas, alluċinazzjonijiet, abnormalitajiet tal- ħolm, fosthom inkubi u diffikultà biex torqod, tingiż/ tnemnim, aċċessjonijiet • sensazzjoni ta' mard, uġigħ fil- ġogi jew fil- muskoli, bugħawwiġijiet, ħalq xott, dardir, rimettar, indiġestjoni, dijarea, epatite
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms
55 • tendenza akbar ta 'fsada, tbenġil, nefħiet ħomor sensittivi taħt il- ġilda l- aktar komuni fuq il - qażba tas- sieq (erythema nodosum) palpitazzjonijiet; • nefħa.
53 and/ or rash (Churg-Strauss syndrome) have been reported.
F' pazjenti ażżmatiċi ttrattati b' montelukast, ġew irrappurtati każijiet rari ħafna ta 'kombinazzjoni ta' sintomi bħal mard jixbah lill- influwenza, tingiż jew traqqid tad- dirgħajn u tas- saqajn, taħżin tas - sintomi pulmonari u/ jew raxx (sindrome ta 'Churg- Strauss).
• Do not use this medicine after the date shown by the six numbers following EXP on the blister.
• Tużax din il- mediċina wara d- data murija bis- sitt numri wara JIS fuq il- folja.
• The active substance is montelukast.
• Is- sustanza attiva hi montelukast.
Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
Kull pillola fiha montelukast sodium li jikkorrespondi għal 4 mg ta ’ montelukast. • Is- sustanzi l- oħra huma:
Mannitol, microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E951), and magnesium stearate.
Mannitol, microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E951), u magnesium stearate.
What SINGULAIR looks like and contents of the pack
Id- dehra ta 'SINGULAIR u l- kontenuti tal- pakkett
4 mg SINGULAIR chewable tablets are pink, oval, biconvex with SINGULAIR engraved on one side and MSD 711 on the other.
Il- pilloli li tomgħodhom ta '4 mg SINGULAIR huma roża, ovali, bikonvessi b' SINGULAIR imnaqqax fuq naħa, MSD 711 fuq in- naħa l- oħra.
7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Folji (mingħajr il- ġranet tal- ġimgħa indikati), f’ pakketti ta ’: pilloli ta ’ 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 u 200.
Blisters (unit doses), in packages of:
Folji (doża waħda), f’ pakketti ta ’:
This medicinal product is authorized in the Member States of the EEA under the following names:
56 Dan il- prodott mediċinali huwa awtorizzat fl- Istati Membri taż- ŻEE taħt l- ismijiet li ġejjin:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovak Republic, Spain, Sweden, United Kingdom
L- Awstrija, il- Belġju, il- Bulgarija, Ċipru; ir- Repubblika Ċeka, id- Danimarka, l- Estonja, il- Finlandja, il- Ġermanja, il- Greċja, l- Ungerija, l- Islanda, l- Irlanda, l- Italja, il- Latvja, il- Litwanja, il- Lussemburgu, Malta, l- Olanda, in- Norveġja, il- Polonja, il- Portugall, ir- Rumanija, is- Slovenja, ir- Repubblika Slovakka, Spanja, l- Isvezja, ir- Renju Unit
London, 11 July 2008 Doc.
Londra, 11 ta 'Lulju 2008 Dok.
EMEA/ CHMP/ 411086/ 2008
EMEA/ CHMP/ 411078/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Singulair and associated names
OPINJONI WARA REFERENZA SKOND L- ARTIKOLU 30 GĦAL Singulair u ismijiet assoċjati
International Non-Proprietary Name (INN): montelukast
Denominazzjoni Komuni Internazzjonali (DKI): montelukast
BACKGROUND INFORMATION Singulair and associated names, 4mg, chewable tablets and oral granules, is a leukotriene-1 receptor antagonist used for the add-on treatment (concomitantly with inhaled steroids), as alternative monotherapy to low-dose inhaled corticosteroids, and to prevent exercise-induced bronchoconstriction.
INFORMAZZJONI ĠENERALI Singulair u ismijiet assoċjati, 4 mg, pilloli li jintmagħdu u granuli orali, huwa antagonista tar- riċetturi leukotriene- 1 użat għat- trattament addizzjonali (flimkien ma 'sterojdi inalati), bħala monoterapija alternattiva għall- kortikosterojdi inalati b' dożaġġ baxx u għall- prevenzjoni tal- bronkokostrizzjoni mqanqla mill- eżerċizzju.
On 13 September 2007, Merck Sharp & Dohme presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Singulair and associated names.
Fit- 13 ta 'Settembru 2007 Merck Sharp & Dohme ippreżentat referenza lill- EMEA skond l- Artikolu 30 tad - Direttiva 2001/ 83/ KE, kif emendata, sabiex tarmonizza s- Sommarji tal- Karatteristiċi tal- Prodott (SPC), it - Tikketta u l- Fuljett ta' Tagħrif awtorizzati fuq livell nazzjonali li jinkludu l- aspetti dwar il- kwalità tal- prodott mediċinali Singulair u ismijiet assoċjati.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Singulair and associated names approved across EU Member States, with respect to the following indications:
Il- bażi għar- referenza kienet li kien hemm diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) li inkludew aspetti dwar il- kwalità ta 'Singulair u ismijiet assoċjati approvati fl- Istati Membri ta' l- UE kollha, fir- rigward ta 'l- indikazzjonijiet li ġejjin:
Treatment of asthma as add-on therapy in patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “ as-needed” short acting β -agonists provide inadequate clinical control of asthma; as an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids; prophylaxis of asthma in paediatric patients in which the predominant component is exercise-induced bronchoconstriction.
Trattament ta 'l- ażma bħala terapija addizzjonali f' pazjenti b' ażma persistenti minn ħafifa għal moderata li mhumiex adegwatament ikkontrollati bil- kortikosterojdi inalati u li fihom l- β- agonisti b' effett qasir li jittieħdu "skond il- bżonn" jipprovdu kontroll kliniku inadegwat ta' l- ażma; bħala opzjoni ta 'trattament alternattiva għall- kortikosterojdi b' dożaġġ baxx li jittieħdu bin- nifs għall- pazjenti b' ażma ħafifa persistenti li ma għandhomx storja reċenti ta' attakki ta 'l- ażma serji li għalihom kellhom bżonn l- użu tal- kortikosterojdi orali u li jkunu wrew li mhumiex kapaċi jużaw kortikosterojdi li jittieħdu man- nifs; fil- profilassi ta' l- ażma f' pazjenti pedjatriċi li fihom il- komponent predominanti huwa l- bronkokostrizzjoni mqanqla mill- eżerċizzju.
The procedure started on 20 September 2007.
Il- proċedura bdiet fl- 20 ta 'Settembru 2007.
The Marketing Authorisation Holder provided supplementary information on 6 December 2007.
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq ipprovda tagħrif supplimentari fis- 6 ta' Diċembru 2007.
During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Matul il- laqgħa tiegħu li saret fil- 21 - 24 ta 'April, is- CHMP, fid- dawl tat- tagħrif kumplessiv ippreżentat u tad- diskussjoni xjentifika fi ħdan il- Kumitat, kien ta' l- opinjoni li l- proposta għal armonizzazzjoni ta 'l- SPC, it- Tikketta u l- Fuljett ta' Tagħrif li inkludew l- aspetti dwar il- kwalità kienet aċċettabbli u għalhekk għandhom jiġu emendati.
The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Singulair and associated names.
Is- CHMP ta opinjoni pożittiva fl- 24 ta 'April 2008 fejn irrakkomanda l- armonizzazzjoni ta' l- SPC, it- Tikketta u l- Fuljett ta 'Tagħrif li inkludew l- aspetti dwar il- kwalità għal Singulair u ismijiet assoċjati.
The list of product names concerned is given in Annex I.
Il- lista ta 'l- ismijiet tal- prodotti kkonċernati hija mogħtija f' Anness I.
The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Il- konklużjonijiet xjentifiċi huma pprovduti fl- Anness II flimkien ma 'l- SPC, it- Tikketta u l- Fuljett ta' Tagħrif emendati f' Anness III.
A Decision was issued by the European Commission on 11 July 2008.
Id- Deċiżjoni nħarġet mill- Kummissjoni Ewropea fil- 11 ta 'Lulju 2008.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TAL- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWA TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, DETENTURI TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
1 Member State EU/ EEA
1 Numru ta ’ l - EU/ EEA
Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni Isem inventat għat- tqegħid fis- Suq
SANOFI-AVENTIS GMBH
SANOFI- AVENTIS GMBH Tritace 1, 25 mg- Tabletten OSTERREICH Tritace 2, 5 mg- Tabletten SATURN Tower Tritace 5 mg- Tabletten Leonard- Bernstein- Straße 10 Tritace 10 mg- Tabletten A- 1220 Vienna L- Awstrija
2.5 mg 5 mg 10 mg
L- Awstrija
AstraZeneca Österreich GmbH Schwarzenbergplatz 7
AstraZeneca Österreich GmbH HYPREN Schwarzenbergplatz 7 A- 1037 Wien L- Awstrija
2,5mg 5mg
L- Awstrija
AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien Austria
AstraZeneca Österreich GmbH HYPREN Schwarzenbergplatz 7 A- 1037 Wien L- Awstrija
SANOFI-AVENTIS BELGIUM Culliganlaan 1C B-1831 Diegem Belgium
SANOFI- AVENTIS BELGIUM Tritace 1, 25 mg, comprimés Culliganlaan 1C Tritace 2, 5 mg, comprimés B- 1831 Diegem Tritace 5 mg, comprimés Il- Belġju Tritace 10 mg, comprimés
Tazko 5 mg, comprimés à liberation prolongée
Tazko 5 mg, comprimés à liberation Boulevard de la Plaine, 9 prolongée B- 1050 Bruxelles
prolonged-release tablet
Pillola li terħi l - mediċina bil- mod
oral
Użu orali
Tazko 2,5 mg, comprimés à liberation prolongée
Tazko 2, 5 mg, comprimés à liberation Boulevard de la Plaine, 9 prolongée B- 1050 Bruxelles
SANOFI-AVENTIS BELGIUM Culliganlaan 1C B-1831 Diegem Belgium
SANOFI- AVENTIS BELGIUM Tritace 10 Culliganlaan 1C B- 1831 Diegem Il- Belġju
2 Member State EU/ EEA
2 Numru ta ’ l - EU/ EEA
Marketing Authorisation Holder (Invented) name
Id- Detentur ta ’ l- Awtorizzazzjoni Isem inventat għat- tqegħid fis- Suq
NV AstraZeneca SA Ramace 1,25 mg Egide Van Ophemstraat 110 Ramace 2,5 mg B-1180 Brussels Ramace 5 mg Belgium
B- 1180 Brussels Ramace 5 mg Il- Belġju
8, Sofia 1303 Bulgaria
8, Sofia 1303 Il- Bulgarija
SANOFI-AVENTIS CYPRUS LTD Triatec 14 Charalambou Mouskou street 2015 – Nicosia Cyprus
SANOFI- AVENTIS CYPRUS LTD Triatec 14 Charalambou Mouskou street 2015 – Nicosia Ċipru
Czech Republic
Ir- Repubblika Ċeka Ir- Repubblika Ċeka
Tritace 1.25 Evropská 2590/ 33c Tritace 2.5 16000 Praha 6 Tritace 5 Czech Republic Tritace 10
Evropská 2590/ 33c 16000 Praha 6 Ir- Repubblika Ċeka AVENTIS PHARMA DEUTSCHLAND GMBH Industriepark Höchst 65926 Frankfurt am Main Il- Ġermanja
Capsule
Pillola Kapsula
Oral
Użu orali Użu orali
SANOFI-AVENTIS DENMARK Triatec A/ S Slotsmarken 13 DK-2970 Hoersholm Denmark
SANOFI- AVENTIS DENMARK Triatec A/ S Slotsmarken 13 DK- 2970 Hoersholm Id- Danimarka
SANOFI-AVENTIS DENMARK Triatec A/ S Slotsmarken 13 DK-2970 Hoersholm
SANOFI- AVENTIS DENMARK Triatec A/ S Slotsmarken 13 DK- 2970 Hoersholm Id- Danimarka
3 Member State EU/ EEA
3 Numru ta ’ l - EU/ EEA
SANOFI-AVENTIS ESTONIA OÜ Cardace Pärnu mnt.
Pärnu mnt.
139 E/ 2 11317 Tallinn Estonia
139 E/ 2 11317 Tallinn L- Estonja
5 mg 10 mg
10 mg
SANOFI-AVENTIS Cardace DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Germany
SANOFI- AVENTIS Cardace DEUTSCHLAND GMBH Industriepark Hoechst D- 65926 Frankfurt am Main Il- Ġermanja
SANOFI-AVENTIS OY Cardace Huopalahdentie 24 00350 Helsinki Finland
SANOFI- AVENTIS OY Cardace Huopalahdentie 24 00350 Helsinki Il- Finlandja
SANOFI-AVENTIS OY Ramipril medgenerics Huopalahdentie 24 Ramipril medgenerics 00350 Helsinki Ramipril medgenerics Finland Ramipril medgenerics
SANOFI- AVENTIS OY Ramipril medgenerics Huopalahdentie 24 Ramipril medgenerics 00350 Helsinki Ramipril medgenerics Il- Finlandja Ramipril medgenerics
SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France
SANOFI AVENTIS FRANCE 1- 13, boulevard Romain Rolland 75014 Paris Franza
SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland
SANOFI AVENTIS FRANCE 1- 13, boulevard Romain Rolland 75014 Paris Franza
Member State EU/ EEA
Numru ta ’ l - EU/ EEA
75014 Paris Triatec 5 mg, gélule France
SANOFI AVENTIS FRANCE RAMIPRIL WINTHROP 1. 25 MG
France RAMIPRIL WINTHROP 5 MG, COMPRIME SECABLE
1- 13, boulevard Romain Rolland RAMIPRIL WINTHROP 2. 5 MG, F- 75014 Paris COMPRIME SECABLE
RAMIPRIL WINTHROP 10 MG, COMPRIME SECABLE
RAMIPRIL WINTHROP 5 MG, Franza COMPRIME SECABLE RAMIPRIL WINTHROP 10 MG, COMPRIME SECABLE
SANOFI-AVENTIS Ramipril protect 2,5 mg Tabletten DEUTSCHLAND GMBH Ramipril protect 5 mg Tabletten Industriepark Hoechst Ramipril protect 10 mg Tabletten D-65926 Frankfurt am Main Ramipril protect startset Germany
Ramipril protect 2, 5 mg Tabletten Ramipril protect 5 mg Tabletten Ramipril protect 10 mg Tabletten Ramipril protect startset
WINTHROP ARZNEIMITTEL Ramilich 2.5 mg Tabletten GmbH Ramilich 5 mg Tabletten Urmitzer Str.
5 56218 Mülheim- Kärlich Il- Ġermanja
WINTHROP ARZNEIMITTEL RamiWin 2,5 mg Tabletten GmbH RamiWin 5 mg Tabletten Urmitzer Str.
5 56218 Mülheim- Kärlich Il- Ġermanja
AVENTIS PHARMA Delix 1,25 mg Tabletten
AVENTIS PHARMA DEUTSCHLAND GmbH 65926 Frankfurt am Main
5 Member State EU/ EEA
5 Numru ta ’ l - EU/ EEA
DEUTSCHLAND GmbH 65926 Frankfurt am Main Germany
Il- Ġermanja
AVENTIS PHARMA Delix 1,25 mg Kapseln DEUTSCHLAND GmbH Delix P 2,5 mg Kapseln 65926 Frankfurt am Main Delix P 5 mg Kapseln Germany Delix P 10 mg Kapseln
AVENTIS PHARMA Delix 1, 25 mg Kapseln DEUTSCHLAND GmbH Delix P 2, 5 mg Kapseln 65926 Frankfurt am Main Delix P 5 mg Kapseln Il- Ġermanja Delix P 10 mg Kapseln
AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
AstraZeneca GmbH Vesdil 1, 25 mg Kapseln Tinsdaler Weg 183 Vesdil 2, 5 mg kapseln 22880 Wedel Vesdil 5 mg Kapseln Il- Ġermanja
AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel
AstraZeneca GmbH Vesdil 1, 25 mg Tabletten Tinsdaler Weg 183 Vesdil 2, 5 mg Tabletten 22880 Wedel Vesdil N 2, 5 mg Tabletten Il- Ġermanja Vedil 5 mg Tabletten Vesdil N 5 mg Tabletten Vesdil protect 10 mg Tabletten
Germany
Il- Greċja
SANOFI-AVENTIS AEBE 348, Syngrou Av. - Building A 176 74 Kallithea Greece
SANOFI- AVENTIS AEBE Triatec 348, Syngrou Av. - Building A 176 74 Kallithea Il- Greċja
Tritace mite 1.25 mg tablet Tritace 2.5 mg tablet Tritace 5 mg tablet Tritace 10 mg tablet
Tritace 5 mg tablet L- Ungerija Tritace 10 mg tablet
SANOFI-AVENTIS PRIVATE CO LTD H-1045 Budapest Tó u.
SANOFI- AVENTIS PRIVATE CO Ramipril prevent 1. 25 mg tablet LTD Ramipril prevent 2. 5 mg tablet H- 1045 Budapest Tó u.
Ramipril prevent 1.25 mg tablet Ramipril prevent 2.5 mg tablet Ramipril prevent 5 mg tablet Ramipril prevent 10 mg tablet
Ramipril prevent 5 mg tablet L- Ungerija Ramipril prevent 10 mg tablet
Ramipril - Zentiva 1.25mg
Zentiva HU Kft Ramipril - Zentiva 1. 25mg Népfürdo u. 22 Ramipril - Zentiva 2. 5mg 1138 Budapest Ramipril - Zentiva 5mg L- Ungerija Ramipril - Zentiva 10mg
6
6 Numru ta ’ l - EU/ EEA
Népfürdo u.22 Ramipril - Zentiva 2.5mg 1138 Budapest Ramipril - Zentiva 5mg Hungary Ramipril - Zentiva 10mg -
-
2.5 mg 5 mg 10 mg
Użu orali
Citywest Tritace 1.25mg tablets Business Campus, Dublin 24, Tritace 2.5mg tablets Ireland Tritace 5mg tablets Tritace 10mg tablets
Citywest Tritace 1. 25mg tablets Business Campus, Dublin 24, L - Tritace 2. 5mg tablets Irlanda Tritace 5mg tablets Tritace 10mg tablets
Tritace 1.25mg capsules Citywest Business Campus Tritace 2.5mg capsules Dublin 24 Tritace 5mg capsules Ireland Tritace 10mg capsules
Tritace 1. 25mg capsules Citywest Business Campus Tritace 2. 5mg capsules Dublin 24 Tritace 5mg capsules L- Irlanda Tritace 10mg capsules
Loavel 1.25mg Citywest Business Campus Loavel 2.5mg Dublin 24 Loavel 5mg Ireland Loavel 10mg
Loavel 1. 25mg Citywest Business Campus Loavel 2. 5mg Dublin 24 Loavel 5mg L- Irlanda Loavel 10mg
Loavel 1.25mg capsules Citywest Business Campus Loavel 2.5mg capsules Dublin 24 Loavel 5mg capsules Ireland Loavel 10mg capsules
Loavel 1. 25mg capsules Citywest Business Campus Loavel 2. 5mg capsules Dublin 24 Loavel 5mg capsules L- Irlanda Loavel 10mg capsules
Ramipril 1.25mg tablets Citywest Business Campus Ramipril 2.5mg tablets Dublin 24 Ramipril 5mg tablets Ireland Ramipril 10mg tablets
Ramipril 1. 25mg tablets Citywest Business Campus Ramipril 2. 5mg tablets Dublin 24 Ramipril 5mg tablets L- Irlanda Ramipril 10mg tablets
Ramipril 1.25mg capsules Citywest Business Campus Ramipril 2.5mg capsules Dublin 24 Ramipril 5mg capsules Ireland Ramipril 10mg capsules
Ramipril 1. 25mg capsules Citywest Business Campus Ramipril 2. 5mg capsules Dublin 24 Ramipril 5mg capsules L- Irlanda Ramipril 10mg capsules
SANOFI-AVENTIS SPA Triatec 1,25 Viale Bodio, 37/ b Triatec 20158 Milano Triatec 5
SANOFI- AVENTIS SPA Triatec 1, 25 Viale Bodio, 37/ b Triatec 20158 Milano Triatec 5 L- Italja Triatec
Unipril 1,25 mg compresse Unipril 2,5 mg compresse Unipril 5 mg compresse Unipril 10 mg compresse
AstraZeneca S. p. A Unipril 1, 25 mg compresse Palazzo Volta Via Francesco Sforza Unipril 2, 5 mg compresse 20080 Basiglio (MI) Unipril 5 mg compresse L- Italja Unipril 10 mg compresse
Viale Dell’ Arte, 69 I – 00144 Roma Italy
Quark Viale Dell ’ Arte, 69 Quark I – 00144 Roma Quark L- Italja Quark
sanofi-aventis Latvia SIA Kr. Valdemara 33-8 LV1010 - Riga Latvia
sanofi- aventis Latvia SIA Cardace Kr. Valdemara 33- 8 LV1010 - Riga Il- Latvja
UAB SANOFI-AVENTIS LIETUVA A.
UAB SANOFI- AVENTIS Cardace LIETUVA A.
6/ 2 LT-09310 Vilnius Lithuania
6/ 2 LT- 09310 Vilnius Il- Litwanja
SANOFI-AVENTIS BELGIUM Culliganlaan 1C B-1831 Diegem
SANOFI- AVENTIS BELGIUM Tritace Culliganlaan 1C B- 1831 Diegem Il- Belġju
8 Member State EU/ EEA
8 Numru ta ’ l - EU/ EEA
Tablet
-
SANOFI-AVENTIS Tritace 1.25 NETHERLANDS B. V.
SANOFI- AVENTIS Tritace 1. 25 NETHERLANDS B. V.
Tritace 2.5 Kampenringweg 45 D-E (toren D Tritace 5 en E) Tritace 10 NL-2803 PE Gouda The Netherlands
Tritace 2. 5 Kampenringweg 45 D- E (toren D Tritace 5 en E) Tritace 10 NL- 2803 PE Gouda L- Olanda
Box 2043 NL-2800 BD Gouda The Netherlands Netherlands
Box 2043 NL- 2800 BD Gouda L- Olanda L- Olanda
Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda The Netherlands
Kampenringweg 45 D- E (toren D en E) NL- 2803 PE Gouda L- Olanda
SANOFI-AVENTIS NORGE AS Strandveien 15 P. O. Box 133 NO-1325 Lysaker Norway
SANOFI- AVENTIS NORGE AS Strandveien 15 P. O. Box 133 NO- 1325 Lysaker In- Norveġja
SANOFI-AVENTIS NORGE AS Strandveien 15 P. O. Box 133 NO-1325 Lysaker
SANOFI- AVENTIS NORGE AS Strandveien 15 P. O. Box 133 NO- 1325 Lysaker In- Norveġja
Norway
Franza
SANOFI-AVENTIS Tritace 2.5 DEUTSCHLAND GMBH Tritace 5 D-65926 Frankfurt am Main Tritace 10 Germany
SANOFI- AVENTIS Tritace 2. 5 DEUTSCHLAND GMBH Tritace 5 D- 65926 Frankfurt am Main Tritace 10 Il- Ġermanja
Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740- 244 Porto Salvo Il- Portugall
AVENTIS PHARMA Tritace DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Germany
AVENTIS PHARMA Tritace DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Il- Ġermanja
Zenra 2.5 Bulevardul Theodor Pallady, nr.
Zenra 2. 5 Bulevardul Theodor Pallady, nr.
50, Zenra 5 sector 3 Zenra 10 Bucuresti ROMANIA
50, Zenra 5 sector 3 Zenra 10 Bucuresti IR- RUMANIJA
10 Member State EU/ EEA
10 Numru ta ’ l - EU/ EEA
Tritace 1,25 mg teblete Dunajska cesta 119 Tritace 2,5 mg tablete 1000 Ljubljana Tritace 5 mg tablete Slovenia Tritace 10 mg tablete Tritace Startset
Tritace 1, 25 mg teblete Dunajska cesta 119 Tritace 2, 5 mg tablete 1000 Ljubljana Tritace 5 mg tablete Is- Slovenja Tritace 10 mg tablete Tritace Startset
Acovil Josep Pla 2 08019 Barcelona Spain
Acovil Josep Pla 2 08019 Barcelona Spanja
sanofi-aventis AB Triatec Box 14142 167 14 Bromma Sweden
sanofi- aventis AB Triatec Box 14142 167 14 Bromma L- Isvezja
WINTHROP MEDICAMENTS 1-13, Boulevard Romain Roland F-75014 Paris France
WINTHROP MEDICAMENTS 1- 13, Boulevard Romain Roland F- 75014 Paris Franza
AstraZeneca Sverige SE-151 85 Södertälje Sweden
AstraZeneca Sverige SE- 151 85 Södertälje L- Isvezja
AstraZeneca Sverige SE-151 85 Södertälje Sweden
AstraZeneca Sverige SE- 151 85 Södertälje
AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH
AVENTIS PHARMA LTD Tritace 1. 25 mg tablets 50 Kings Hill Avenue Tritace 2. 5 mg tablets Kings Hill Tritace 5 mg Tablets West Malling Tritace 10 mg tablets Kent ME19 4AH
Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK United Kingdom
Sanofi- aventis One Onslow Street Guildford Surrey GU1 4YS UK Ir- Renju Unit
Aventis Pharma 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH Or Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS
AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill
12 Member State EU/ EEA
12
Marketing Authorisation Holder
Numru ta ’ l - EU/ EEA
(Invented) name
Id- Detentur ta ’ l- Awtorizzazzjoni Isem inventat għat- tqegħid fis- Suq
AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH
West Malling Kent ME19 4AH
13 Member State EU/ EEA
13 ANNESS II
Marketing Authorisation Holder (Invented) name
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJI TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
14 ANNEX II
14 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TRITACE AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ TRITACE U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Tritace contains ramipril, a second-generation nonsulfhydryl angiotensin converting enzyme inhibitor (ACE-I).
Tritace fih ramipril, inibitur tal- enzima ta ’ konverżjoni tal- anġjotensina mhux sulfidrilika (nonsulfhydryl angiotensin converting enzyme inhibitor) (ACE- I) tat- tieni ġenerazzjoni.
Tritace was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/ 83/ EC, as amended, as the above-mentioned medicinal product does not have the same SPC across EU Member States, Iceland and Norway.
Tritace ġie inkluż fil- lista tal- prodotti għall- armonizzazzjoni tas- Sommarju tal- Karatteristiċi tal- Prodott (SPC), imfassla mis- CMD( h), f’ konformità mal- Artikolu 30( 2) tad- Direttiva 2001/ 83/ KE, kif emendat, minħabba li l- prodott mediċinali ma għandux l- istess SPC fl- Istati Membri tal- UE kollha, fl- Iżlanda u fin- Norveġja.
Critical Evaluation A number of areas of disharmony in the product information for Tritace have been evaluated by the CHMP and a revised product information was adopted.
Evalwazzjoni kritika Numru ta ’ oqsma ta ’ diskrepanza fl- informazzjoni tal- prodott għal Tritace ġew evalwati mis- CHMP u ġiet adottata informazzjoni riveduta dwar il- prodott.
The main areas for harmonisation were: the sections 4.1, 4.2, 4.3, 4.4 and 4.6 of the summary of product information (SPC).
L- oqsma prinċipali għall- armonizzazzjoni kienu: is- sezzjonijiet 4. 1, 4. 2, 4. 3, 4. 4 u 4. 6 tas- sommarju tal- karatteristiċi tal- prodott (SPC).
4.1 Therapeutic Indication
4. 1 Indikazzjonijiet terapewtiċi
The current indication of ramipril in hypertension differs among the EU countries.
L- indikazzjoni attwali ta ’ ramipril fl- ipertensjoni tvarja fost il- pajjiżi tal- UE.
The CHMP adopted the harmonised indication: “ Treatment of hypertension”.
Is- CHMP adotta l - indikazzjoni armonizzata: “ Trattament tal- ipertensjoni ”.
Regarding the therapeutic indications for heart failure, the MAH proposed the wording: “ Treatment of congestive heart failure”.
Rigward l- indikazzjonijiet terapewtiċi għall- insuffiċjenza kardijaka, il- MAH ippropona t- test: “ Trattament għal insuffiċjenza kardijaka konġestiva ”.
The CHMP, considering the previous harmonisations referrals for enalapril, perindopril and lisinopril, adopted the harmonised indication: “ Treatment of symptomatic heart failure”.
Is- CHMP, wara li kkunsidra r- referenzi tal - armonizzazzjonijiet preċedenti għal enalapril, perindopril u lisinopril, adotta l- indikazzjoni armonizzata “ Trattament għal insuffiċjenza kardijaka sintomatika ”.
The indication for cardiovascular prevention is justified by the results of HOPE study.
L- indikazzjoni għal prevenzjoni kardjovaskulari hija ġġustifikata mir- riżultati tal- istudju HOPE.
There are differences, however, in the results obtained from various trials (HOPE, EUROPA, PEACE, and PART 2).
Madankollu, hemm differenzi fir- riżultati miksubin minn diversi provi (HOPE, EUROPA, PEACE, u PART 2).
The Rapporteurs are of the opinion that amended wording, the lower age limit of 55 years, is recommended.
Ir- relaturi huma tal- opinjoni li għandha tiġi rakkomandata emenda tat- test biex l- anqas limitu tal- età tkun 55 sena.
Selective inclusion of one secondary endpoint- all cause mortality- is not recommended.
L- inklużjoni selettiva ta ’ endpoint sekondarju - mortalità minn kwalunkwe kawża - mhijiex rakkomandata.
The CHMP adopted the following: “ Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or ii) diabetes with at least one cardiovascular risk factor”.
Is- CHMP adotta li ġej: “ Prevenzjoni kardjovaskulari: tnaqqis fil- morbidità u fil- mortalità kardjovaskulari bi: i) mard kardjovaskulari aterotrombotiku evidenti (storja ta ’ mard koronarju tal- qalb jew puplesija, jew mard vaskulari periferiku) jew ii) dijabete b’ tal- inqas fattur kardjovaskulari ta ’ riskju wieħed ”.
The nephroprotection indication presented the major area of disagreement.
L- indikazzjoni ta ’ nefroprotezzjoni ppreżentat il- qasam maġġuri ta ’ nuqqas ta ’ qbil.
In conclusion, the CHMP agreed the following indication: “ Treatment of renal disease -Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria -Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor -Manifest glomerular non-diabetic nephropathy as defined by macroproteinuria ≥ 3g/ da”
Bħala konklużjoni, is- CHMP qabel fuq l- indikazzjoni li ġejja: “ Trattament għal mard renali - Nefropatija dijabetika glomerulari tal- bidu kif iddefinita mill- preżenza ta ’ mikroalbuminurja
The MAH proposed indication “ Secondary prevention after MI in patients with heart failure” has been justified on the basis of the:
L- indikazzjoni proposta mill- MAH “ Prevenzjoni sekondarja wara MI f’ pazjenti b’ insuffiċjenza kardijaka ” ġiet iġġustifikata fuq il- bażi ta ’:
Acute Infarction Ramipril Efficacy Study (AIRE).
L- Istudju tal- Effikaċja ta ’ Ramipril f’ Infart Akut (AIRE).
Considering the available data the CHMP adopted the following indication: “ Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction”.
Wara li kkunsidra d- dejta disponibbli, is- CHMP adotta l- indikazzjoni li ġejja: “ Prevenzjoni sekondarja wara infart mijokardijaku akut: tnaqqis fil- mortalità mill- fażi akuta ta ’ infart mijokardijaku f’ pazjenti b’ sinjali kliniċi ta ’ insuffiċjenza kardijaka meta mibdi > 48 siegħa wara infart mijokardijaku akut ”.
4.2 Posology and Method of Administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata