qanastek/EMEA-V3 huggingface dataset:
Treatment of heart failure • The usual starting dose is 1.25 mg once daily. • Your doctor will adjust the amount you take. • The maximum dose is 10 mg daily.
Kura ta 'insuffiċjenza tal- qalb • Normalment id- doża tal- bidu hija 1. 25 mg darba kuljum. • It- tabib tiegħek jaġġusta l- ammont li tieħu. • Id- doża massima hija 10 mg kuljum.
Two administrations per day are preferable.
Huwa ppreferut li jingħata darbtejn kuljum.
Treatment after you have had a heart attack • The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily. • Your doctor will adjust the amount you take. • The usual dose is 10 mg daily.
Kura wara li kellek attakk tal- qalb • Normalment id- doża tal- bidu hija 1. 25 mg darba kuljum sa 2. 5 mg darbtejn kuljum. • It- tabib tiegħek jaġġusta l- ammont li tieħu. • Normalment id- doża hija 10 mg kuljum.
Elderly Your doctor will reduce the initial dose and adjust your treatment more slowly.
Anzjani It- tabib tiegħek inaqqaslek id- doża tal- bidu u jaġġustalek il- kura aktar bil- mod.
If you take more TRITACE than you should Tell a doctor or go to the nearest hospital casualty department straight away.
Jekk tieħu TRITACE aktar milli suppost Għid lil tabib jew mur fl- eqreb emerġenza mill- ewwel.
Do not drive to the hospital, get somebody else to take you or call for an ambulance.
Issuqx sa l- isptar, għid lil xi ħadd ieħor biex jieħdok jew ċempel lill- ambulanza.
Take the medicine pack with you.
Ħu l- pakkett tal- mediċina miegħek.
This is so the doctor knows what you have taken.
Dan sabiex it- tabib ikun jaf x' ħadt.
If you forget to take TRITACE • If you miss a dose, take your normal dose when it is next due. • Do not take a double dose to make up for a forgotten tablet/ capsule.
Jekk tinsa tieħu TRITACE • Jekk tinsa tieħu doża, ħu d- doża tas- soltu meta jkun jerġa 'jmissek. • Tiħux doża doppja biex tagħmel tajjeb għall- pillola/ kapsula li nsejt tieħu.
Like all medicines, TRITACE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, TRITACE jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Stop taking TRITACE and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment: • Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes.
Jekk tinnota xi wieħed mill- effetti sekondarji serji li ġejjin, waqqaf TRITACE u ara tabib mill - ewwel – jista 'jkollok bżonn kura medika urġenti:
This could be a sign of a severe allergic reaction to TRITACE • Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform).
Dan jista 'jkun sinjal ta' reazzjoni allerġika serja għal < TRITACE u ismijiet assoċjati miegħu > • Reazzjonijiet tal- ġilda serji fosthom raxx, ulċeri f' ħalqek, iggravar ta 'mard tal- ġilda diġà eżistenti, ħmura, bżieżaq jew stakkar tal- ġilda (bħal sindromu ta' Stevens- Johnsons, nekroliżi tossika tal- ġilda jew eritema multiforma).
Tell your doctor immediately if you experience: • Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke • Shortness of breath or a cough.
Għid lit- tabib tiegħek minnufih jekk tesperjenza: • Rata mgħaġġla tal- qalb, taħbit tal- qalb irregolari jew qawwi (palpitazzjonijiet), uġigħ fis- sider, rassa f' sidrek jew problemi aktar serji fosthom attakk tal- qalb jew puplesija • Qtugħ ta 'nifs jew sogħla.
These could be signs of lung problems • Bruising more easily, bleeding for longer than normal, any sign of bleeding (e. g. bleeding from the gums), purple spots blotching on the skin or getting infections more easily than usual, sore throat and
Dawn jistgħu jkunu sinjali ta 'problemi tal- pulmun • Titbenġel malajr, tinfasad għat- tul aktar mis- soltu, xi sinjal ta' fsada (eż. fsada mill- ħanek), tbajja 'vjola li joħorġu fil- ġilda jew tieħu infezzjonijiet aktar faċilment mis- soltu, griżmejk juġgħuk u deni, tħossok għajjien, debboli, sturdut jew ikollok ġilda pallida.
These can be signs of blood or bone marrow problems • Severe stomach pain which may reach through to your back.
Dawn jistgħu jkunu sinjali ta 'problemi fid- demm jew mudullun • Uġigħ qawwi fl- istonku li jista' jinfirex għal daharek.
This could be a sign of pancreatitis (inflammation of the pancreas). • Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice).
Dan jista 'jkun sinjal ta' pankreatite (infjammazzjoni tal- pankreas). • Deni, tkexkix, għeja, telf ta 'aptit, uġigħ fl- istonku, tqalligħ, sfura fil- ġilda jew għajnejk (suffejra).
These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.
Dawn jistgħu jkunu sinjali ta 'problemi tal- fwied bħall- epatite (infjammazzjoni tal - fwied) jew ħsara fil- fwied.
Please tell your doctor if any of the following gets serious or lasts longer than a few days.
Jekk jogħġbok għid lit- tabib tiegħek jekk xi wieħed minn dawn li ġejjin jiggravaw jew idumu aktar minn ftit jiem.
Common (affects less than 1 in 10 people) • Headache or feeling tired • Feeling dizzy.
Komuni (jaffettwa anqas minn 1 minn kull 10 persuni) • Uġigħ ta 'ras jew tħossok għajjien • Tħossok sturdut.
This is more likely to happen when you start taking TRITACE or start taking a higher dose • Fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly • Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath • Stomach or gut pain, diarrhoea, indigestion, feeling or being sick • Skin rash with or without raised area • Chest pain • Cramps or pain in your muscles • Blood tests showing more potassium than usual in your blood.
Dan huwa aktar probabbli meta tibda tieħu TRITACE jew tibda tieħu doża akbar • Ħass ħażin, ipotensjoni (pressjoni baxxa mhux normali), speċjalment meta tqum bil- wieqfa jew tqum bil- qiegħda f' salt • Sogħla vojta xotta, infjammazzjoni tas- sinus (sinożite) jew bronkite, qtugħ ta 'nifs • Uġigħ fl- istonku jew fl- imsaren, dijarea, indiġestjoni, tqalligħ jew rimettar • Raxx fil- ġilda b' ġilda mtalla' jew le • Uġigħ fis- sider • Bugħawwieġ jew uġigħ fil- muskoli • Testijiet tad- demm li juru ammonti ta 'potassju aktar mis- soltu fid- demm tiegħek.
Uncommon (affects less than 1 in 100 people) • Balance problems (vertigo) • Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia) • Loss or change in the way things taste • Sleep problems • Feeling depressed, anxious, more nervous than usual or restless • Blocked nose, difficulty breathing or worsening of asthma • A swelling in your gut called “ intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea • Heartburn, constipation or dry mouth • Passing more water (urine) than usual over the day • Sweating more than usual • Loss or decrease of appetite (anorexia) • Increased or irregular heartbeatsSwollen arms and legs.
Mhux komuni (jaffettwa anqas minn 1 minn kull 100 persuna) • Problemi tal- bilanċ (vertiġini) • Ħakk u sensazzjonijiet fil- ġilda mhux tas- soltu bħal titrix, tnemnim, tingiż, ħruq jew tkexkix fil - ġilda (parasteżija) • Telf jew bidla fit- togħma ta 'xi affarijiet • Problemi ta' rqad • Tħossok imdejjaq, ansjuż, aktar nervuż mis- soltu u bla sabar • Imnieħrek miżdud, diffikultà biex tieħu nifs jew iggravar ta 'ażma • Nefħa fl- imsaren imsejħa "anġjoedima intestinali" li tippreżenta b' sintomi bħal uġigħ addominali, rimettar u dijarea • Ħruq ta' stonku, stitikezza jew ħalq xott • Tagħmel l- ilma (awrina) aktar mis- soltu f' ġurnata • Tegħreq aktar mis- soltu • Telf jew nuqqas ta 'aptit (anoressija) • Taħbit tal- qalb mgħaġġel jew irregolari Dirgħajn u saqajn minfuħin.
This may be a sign of your body holding onto more water than usual • Flushing • Blurred vision • Pain in your joints • Fever • Sexual inability in men, reduced sexual desire in men or women • An increased number of certain white blood cells (eosinophilia) found during a blood test • Blood tests showing changes in the way your liver, pancreas or kidneys are working.
Jista 'jkun sinjal li ġismek qieghed iżomm aktar ilma mis- soltu
Rare (affects less than 1 in 1,000 people) • Feeling shaky or confused • Red and swollen tongue • Severe flaking or peeling of the skin, itchy, lumpy rash • Nail problem (e. g. loosening or separation of a nail from its bed)
44 • Fawra • Vista mċajpra • Uġigħ fil- ġogi • Deni • Inabbilità sesswali fl- irġiel, nuqqas ta 'ħajra sesswali fl- irġiel jew nisa • Numru ogħla ta' tip ta 'ċelluli tad- demm bojod (eosinofilja) jinstab f' test tad- demm • Testijiet tad- demm li juru tibdil fil- mod ta' kif jaħdmu il- fwied, il- pankreas jew il- kliewi tiegħek.
44 • Skin rash or bruising • Blotches on your skin and cold extremities • Red, itchy, swollen or watery eyes • Disturbed hearing and ringing in your ears • Feeling weak • Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin.
Rari (jaffettwa anqas minn 1 minn kul 1, 000 persuna) • Tħossok imħawwad jew mhux sod fuq saqajk • Ilsien aħmar u minfuħ • Tfarfir jew tqaxxir tal- ġilda gravi, raxx bil- ħakk u bil- boċoċ • Problemi tad- dwiefer (eż. difer li jinħall jew jinqala 'mill- qiegħ) • Raxx fil- ġilda jew tbenġil • Tbabar fil- ġilda u estremitajiet kesħin • Għajnejn ħomor, jikluk, minfuħin jew idemmgħu • Problemi ta' smigħ u żarżir f' widnejk • Tħossok debboli • Testijiet tad- demm li juru tnaqqis fin- numru ta 'ċelluli tad- demm ħomor, celluli tad- demm bojod jew plejtlits jew fl- ammont ta' emoglobina.
Very rare (affects less than 1 in 10,000 people) • Being more sensitive to the sun than usual.
Rari ħafna (jaffettwa anqas minn 1 minn kull 10, 000 persuna) • Tkun sensittiv għax- xemx aktar mis- soltu.
Other side effects reported:
Effetti sekondarji oħra rrapportati:
Please tell your doctor if any of the following gets serious or lasts longer than a few days. • Difficulty concentrating • Swollen mouth • Blood tests showing too few blood cells in your blood • Blood tests showing less sodium than usual in your blood • Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon) • Breast enlargement in men • Slowed or impaired reactions • Burning sensation • Change in the way things smell • Hair loss.
Jekk jogħġbok għid lit- tabib tiegħek jekk xi wieħed minn dawn li ġejjin jiggravaw jew idumu aktar minn ftit jiem. • Diffikultà biex tikkonċentra • Ħalq minfuħ • Testijiet tad- demm juru ftit wisq ċelluli tad- demm fid- demm tiegħek • Testijiet tad- demm juru anqas sodium mis- soltu fid- demm tiegħek • Swaba 'ta' l- idejn u tas- saqajn jibdlu l- kulur meta tħoss il- bard u jnemnmu jew juġgħu meta tħossok sħun (fenomenu ta 'Raynaud) • Jikber is- sider fl- irġiel • Tirreaġixxi aktar bil- mod jew b' mod batut • Sensazzjoni ta' ħruq • Bidla f' kif jinxtammu l- affarijiet • Jaqagħlek xagħrek.
HOW TO STORE TRITACE
KIF TAĦŻEN TRITACE
What TRITACE. contains [To be completed nationally]
X’ fih TRITACE [Biex timtela mill- pajjiż partikolari]
What TRITACE looks like and contents of the pack Tablets, hard capsules [To be completed nationally]
Id- Dehra ta ’ TRITACE u l- kontenuti tal- pakkett Pilloli, kapsuli iebsin
This medicinal product is authorised in the Member States of the EEA under the following names:
Dan il- prodott mediċinali huwa awtorizzat fl- istati membri ta 'l- EEA b' dawn l- ismijiet:
45 Austria:
L- Awstrija:
Triatec 1.25 mg comprimés, Triatec 2.5 mg comprimés, Triatec 5 mg comprimés, Triatec 10 mg comprimés Triateckit 2.5 mg comprimés, Triateckit 5 mg comprimés, Triateckit 10 mg comprimés Ramikit 2.5 mg comprimés, Ramikit 5 mg comprimés, Ramikit 10 mg comprimés Triatec faible 1.25 mg gélules Triatec 2.5 mg gélules, Triatec 5 mg gélules Ramipril Winthrop 1.25 mg comprimés, Ramipril Winthrop 2.5 mg comprimés, Ramipril Winthrop 5 mg comprimés, Ramipril Winthrop 10 mg comprimés
Triatec 1. 25 mg comprimés, Triatec 2. 5 mg comprimés, Triatec 5 mg comprimés, Triatec 10 mg comprimés Triateckit 2. 5 mg comprimés, Triateckit 5 mg comprimés, Triateckit 10 mg comprimés Ramikit 2. 5 mg comprimés, Ramikit 5 mg comprimés, Ramikit 10 mg comprimés Triatec faible 1. 25 mg gélules
Latvia:
Il- Latvja:
Tritace 1.25 mg tabletten/ comprimés/ Tabletten, Tritace 2.5 mg tabletten/ comprimés/ Tabletten, Tritace 5 mg tabletten/ comprimés/ Tabletten, Tritace 10 mg tabletten/ comprimés/ Tabletten, Tritace 10 mg capsules/ gellules/ Kapseln Ramace 1.25 mg tabletten/ comprimés/ Tabletten, Ramace 2.5 mg tabletten/ comprimés/ Tabletten, Ramace 5 mg tabletten/ comprimés/ Tabletten
Tritace 1. 25 mg tabletten/ comprimés / Tabletten, Tritace 2. 5 mg tabletten/ comprimés / Tabletten, Tritace 5 mg tabletten/ comprimés / Tabletten, Tritace 10 mg tabletten/ comprimés / Tabletten, Tritace 10 mg capsules/ gellules/ Kapseln
This leaflet was last approved in {MM/ YYYY} [To be completed nationally]
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS} [Biex timtela mill- pajjiż partikolari]
48
48 Dan il- fuljett ma fihx it- tagħrif kollu dwar il- mediċina tiegħek.
Ref.
Londra, 18 ta ’ Marzu 2009 Dok ta ’ Ref.
EMEA/ CHMP/ 233264/ 2009
EMEA/ 202971/ 2009
Questions and answers on the referral for Tritace tablet and hard capsules containing ramipril 1.25 mg, 2.5 mg, 5 mg and 10 mg
Mistoqsijiet u tweġibiet dwar ir- referenza għall- pilloli u l- kapsuli iebsin Tritace li fihom ramipril 1. 25 mg, 2. 5 mg, 5 mg u 10 mg
The European Medicines Agency (EMEA) has completed a review of Tritace.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) temmet reviżjoni ta ’ Tritace.
The Agency’ s Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tritace in the European Union (EU) and the European Economic Area (EEA).
Il- Kumitat tal- Aġenzija għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li hemm ħtieġa li l - informazzjoni tal- preskrizzjoni għal Tritace tkun armonizzata fl- Unjoni Ewropea (UE) u fiż- Żona Ekonomika Ewropea (ŻEE).
The review was carried out under an ‘ Article 30’ referral 1.
Ir- reviżjoni saret skont referenza tal - ‘ Artikolu 30 ’ 1.
What is Tritace?
X’ inhu Tritace?
Tritace is used to treat hypertension and symptomatic heart failure.
Tritace jintuża fil- kura tal- ipertensjoni (pressjoni għolja) u tal- insuffiċjenza tal- qalb sintomatika.
Tritace is also used to prevent cardiovascular disease in patients who are at cardiovascular risk (such as patients who already have coronary artery disease), and to prevent any further heart attack (acute myocardial infarction [MI]) in patients who have already had one.
Tritace jintuża wkoll fil- prevenzjoni ta ’ mard kardjovaskulari f’ pazjenti li qegħdin f’ riskju kardjovaskulari (bħalma huma pazjenti li diġà jbatu minn mard tal- arterji koronarji), u biex jipprevjeni aktar attakki tal- qalb (infart mijokardiku akut - acute myocardial infarction [MI]) f’ pazjenti li diġà esperjenzaw wieħed.
The active substance in Tritace, ramipril, is an angiotensin- converting enzyme (ACE) inhibitor.
Is- sustanza attiva fi Tritace, ramipril, hija inibitur tal- enzima li tikkonverti l - anġjotensina (ACE).
ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
L- inibituri ACE jbaxxu l- produzzjoni tal- anġjotensina IIhttp: // en. wikipedia. org/ wiki/ Angiotensin_ II, vasokostrittur qawwi (sustanza li ddejjaq l- arterji u l - vini tad- demm).
When the production of angiotensin II is lowered, the blood vessels relax and widen.
Meta titbaxxa l- produzzjoni tal- anġjotensina II, l- arterji tad- demm jirrilassaw u jitwessgħu.
This allows the heart to pump blood more easily, and the blood flow increases due to more blood being pumped into and through larger passageways.
Dan jgħin lill- qalb tippompja d- demm b’ mod aktar faċli; u l- fluss tad- demm jiżdied minħabba li aktar demm ikun qiegħed jiġi ppumpjat ġo u minn passaġġi usa ’.
Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
Tritace ilu awtorizzat fl- UE sa mill- 1989, l- ewwel fi Franza u mbagħad fil- pajjiżi li ġejjin: fl- Awstrija, fil- Belġju, fil- Bulgarija, f’ Ċipru, fir- Repubblika Ċeka, fid- Danimarka, fl- Estonja, fil- Finlandja, fi Franza, fil- Ġermanja, fil- Greċja, fl- Ungerija, fl- Irlanda, fl- Italja, fil- Latvja, fil- Litwanja, fil - Lussemburgu, fl- Olanda, fin- Norveġja, fil- Polonja, fil- Portugall, fir- Rumanija, fis- Slovakja, fis - Slovenja, fi Spanja, fl- Iżvezja u fir- Renju Unit.
Tritace can also be available in the EU and the EEA under other trade names:
Tritace jista ’ wkoll ikun disponibbli fl- UE u fiż- ŻEE taħt ismijiet kummerċjali oħrajn:
The company that markets it is Sanofi-aventis
Il- kumpanija li tikkummerċjalizzah hija Sanofi- aventis
Why was Tritace reviewed?
Għaliex ġie rivedut Tritace?
Tritace is authorised in the European Union (EU) via national procedures.
Tritace huwa awtorizzat fl- Unjoni Ewropea (UE) permezz ta ’ proċeduri nazzjonali.
This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Dan wassal għal diverġenzi fost l- Istati Membri dwar il- mod kif tista ’ tintuża l- mediċina, kif jidher fid- differenzi osservati fis- Sommarji tal- Karatteristiċi tal- Prodott (SPCs), fit- tikketta u fil- fuljett ta ’ tagħrif fil- pajjiżi fejn jiġi kummerċjalizzat il- prodott.
Tritace has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).
Tritace ġie identifikat li jeħtieġ armonizzazzjoni mill- Grupp ta ’ Koordinazzjoni dwar il- Proċeduri Reċiproċi u Deċentralizzati – Bniedem (CMD( h)).
On 3 January 2008 the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Tritace in the EU and the EEA.
Fit- 3 ta ’ Jannar 2008 il- Kummissjoni Ewropea rreferiet il- kwistjoni lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) sabiex jarmonizza l- awtorizzazzjonijiet għat- tqegħid fis - suq għal Tritace fl- UE u fiż- ŻEE.
1 Article 30 of Directive 2001/ 83/ EC as amended, referral on the grounds of divergent decisions adopted by member States 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
1 Artikolu 30 tad- Direttiva 2001/ 83/ KE kif emendata, referenza abbażi ta ’ deċiżjonijiet diverġenti adottati mill - Istati Membri 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
Fid- dawl tad- dejta sottomessa u d- diskussjoni xjentifika fi ħdan il- Kumitat, is- CHMP kien tal- opinjoni li l- SPCs, it- tikketta u l- fuljetti ta ’ tagħrif għandhom ikunu armonizzati madwar l- UE.
• The CHMP agreed on the indication:
• Is- CHMP qabel fuq l- indikazzjoni:
Treatment of hypertension. • When considering the indication in heart failure, the CHMP took into consideration previous harmonisations referrals for other ACE-inhibitors (enalapril, perindopril and lisinopril), and agreed on the indication:
Kura tal- pressjoni għolja. • Meta kkunsidra l- indikazzjoni fl- insuffiċjenza tal- qalb, is- CHMP ikkunsidra referenzi ta ’ armonizzazzjonijiet preċedenti għal inibituri- ACE (enalapril, perindopril u lisinopril), u qabel fuq l- indikazzjoni:
Treatment of symptomatic heart failure. • The CHMP also discussed the indications in the treatment of cardiovascular secondary prevention, and primary prevention in high-risk patients, and endorsed the harmonised indication:
Kura tal- insuffiċjenza tal- qalb sintomatika. • Is- CHMP iddiskuta wkoll l- indikazzjonijiet fil- kura ta ’ prevenzjoni sekondarja kardjovaskulari, u prevenzjoni primarja f’ pazjenti f’ riskju għoli, u approva l- indikazzjoni armonizzata:
Cardiovascular prevention: reduction 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. • For the secondary prevention after MI in patients with heart failure, the CHMP endorsed the harmonised indication:
Prevenzjoni kardjovaskulari: tnaqqis tal- morbożità u tal- mortalità kardjovaskulari f’ pazjenti bi: i) mard kardjovaskulari aterotrombotiku manifest (passat ta ’ mard koronarju tal- qalb jew puplesija, jew mard vaskulari periferiku) jew ii) dijabete b’ mill- inqas fattur wieħed ta ’ riskju kardjovaskulari. • Għall- prevenzjoni sekondarja wara MI f’ pazjenti b’ insuffiċjenza tal- qalb, is- CHMP approva l - indikazzjoni armonizzata:
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.
Prevenzjoni sekondarja wara infart mijokardijaku akut: tnaqqis tal - mortalità mill- fażi akuta ta ’ infart mijokardijaku f’ pazjenti b’ sinjali kliniċi ta ’ insuffiċjenza tal - qalb meta mibdi > 48 siegħa wara infart mijokardijaku akut.
The CHMP also noted that Tritace had an indication for nephroprotection in some countries.
Is- CHMP innota wkoll li Tritace kellu indikazzjoni għan- nefroprotezzjoni f’ ċerti pajjiżi.
After discussion the CHMP agreed on including the harmonised indication:
Wara diskussjoni, is- CHMP qabel li jinkludi l- indikazzjoni armonizzata:
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/ day
Kura ta ’ mard renali • Nefropatija dijabetika glomerulari inizjali kif definita mill- preżenza ta ’ mikroalbuminarja • Nefropatija dijabetika glomerulari manifesta kif definita permezz ta ’ makroproteinurija f’ pazjenti b’ mill- inqas fattur wieħed ta ’ riskju kardjovaskulari • Nefropatija mhux dijabetika glomerulari manifesta kif definita permezz ta ’ makroproteinurija ≥ 3g/ ġurnata
The CHMP discussed the areas where there was a divergence identified in the dose recommendations per indication:
Is- CHMP iddiskuta l- oqsma fejn ġiet identifikata diverġenza fir- rakkomandazzjonijiet tad- dożi għal kull indikazzjoni:
For each indication, the posology is presented as starting dose, titration schedule, maintenance dose and maximum dose.
Għal kull indikazzjoni, il- pożoloġija hija ppreżentata bħala doża inizjali, skeda ta ’ titrazzjoni, doża ta ’ manutenzjoni u doża massima.
The CHMP endorsed six contraindications: • Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1) • History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs (Angiotensin II Receptor Antagonists)) • Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5) • Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney • 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) • Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
Is- CHMP approva sitt kontraindikazzjonijiet: • Ipersensittività għas- sustanza attiva, għal kwalunkwe sustanza mhux attiva jew għal kwalunkwe inibitur ACE (Enzima li Tikkonverti l- Anġjotensina) ieħor (ara sezzjoni 6. 1) • Passat ta ’ anġjoedema (ereditarja, idjopatika jew dovuta għal anġjodema preċedenti b’ inibituri ACE jew AIIRAs (Antagonisti tar- Riċettur tal- Angjotensina II - Angiotensin II Receptor Antagonists)) • Kuri ekstrakorporali (extracorporeal) li jwasslu għal kuntatt ta ’ demm ma ’ uċuħ iċċarġjati b’ mod negattiv (ara sezzjoni 4. 5) • Stenożi sinifikanti tal- arterja renali bilaterali jew stenożi tal- arterja renali f’ kilwa waħda funzjonanti • It- tieni u t- tielet trimestru ta ’ tqala (ara sezzjonijiet 4. 4 u 4. 6) • Ramipril m’ għandux jintuża f’ pazjenti bi stati ipotensivi jew stati emodinamikament instabbli.
The CHMP noted that there were contraindications present in one or several local SPCs.
Is- CHMP innota li kien hemm kontraindikazzjonijiet preżenti f’ SPC lokali wieħed jew aktar.
The CHMP agreed adding a seventh contraindication:
Is - CHMP qabel li jżid is- seba ’ kontraindikazzjoni:
Ramipril must not be used in patients in patients with hypotensive or haemodynamically unstable states
Ramipril m’ għandux jintuża f’ pazjenti bi stati ipotensivi jew stati emodinamikament instabbli
4.4 Special warnings and special precautions for use
Paġna 2/ 3 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Is- CHMP iddeċieda li jinkludi taħt din is- sezzjoni il- kliem armonizzat: • Tqala: inibituri ACE bħal ramipril, jew Antagonisti tar- Riċettur tal- Angjotensina II (AIIRAs) m’ għandhomx jinbdew waqt it- tqala.
Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti- hypertensive treatments which have an established safety profile for use in pregnancy.
Diment li kura kontinwa bl- inibitur ACE / AIIRAs ma tkunx meqjusa essenzjali, il- pazjenti li qed jippjanaw xi tqala għandhom jingħataw kuri alternattivi kontra l- ipertensjoni li għandhom profil ta ’ sigurtà stabbilit għall- użu waqt it- tqala.
When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6). • Hypotension and renal dysfunction after acute myocardial infarction occurred more frequently with ramipril than placebo in the target population in the AIRE study.
Meta tiġi dijanjostikata tqala, il- kura bl- inibituri ACE / AIIRAs għandha titwaqqaf minnufih, u, jekk ikun xieraq, għandha tinbeda kura alternattiva (ara sezzjonijiet 4. 3 u 4. 6). • L- ipotensjoni u indeboliment tal- funzjoni renali wara infart mijokardijaku akut seħħew aktar spiss b’ ramipril milli bi plaċebo fil- popolazzjoni fil- mira fl- istudju AIRE.
Therefore the CHMP agreed on including the wording:
Għalhekk is- CHMP qabel li jżid il- kliem:
Transient or persistent heart failure post MI • Surgery:
Insuffiċjenza tal- qalb temporanja jew persistenti wara MI • Intervent kirurġiku:
It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery. • Hyperkalaemia • Neutropenia/ agranulocytosis • Cough
Huwa rrakkomandat li l- kura b’ inibituri tal- enzima li tikkonverti l - anġjontensina bħal ramipril għandha titwaqqaf fejn hu possibbli ġurnata qabel l- intervent kirurġiku. • Iperkalemija • Newtropenija/ agranuloċitożi • Sogħla
The CHMP recommended a contra indication only for the second and third trimester of pregnancy.
Is- CHMP irrakkomanda kontraindikazzjoni għat- tieni u t- tielet trimestru tat- tqala biss.
This is in line with the recommendation of the CHMP’ s Pharmacovigilance Working Party on the use of ACE inhibitors in pregnancy.
Dan b’ konformità mar- rakkomandazzjoni tal- Grupp ta ’ Ħidma Farmakoviġilanti tas- CHMP dwar l- użu ta ’ inibituri ACE waqt it- tqala.
The European Commission issued a decision on 6 March 2009.
Il- Kummissjoni Ewropea ħarġet deċiżjoni fis- 6 ta ’ Marzu 2009.
Opinion date:
Tweġibiet tal- kumpanija pprovduti nhar 28 Data tal- opinjoni:
Dr Ian Hudson (UK) Prof János Borvendég (HU) 24 January 2008 28 April 2008, 24 October 2008 18 December 2008
It- tabib Ian Hudson (UK) Profs János Borvendég (HU) 24 ta ’ Jannar 2008 ta ’ April 2008, 24 ta ’ Ottubru 2008 18 ta ’ Diċembru 2008
Page 3/ 3
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KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJI TAL- KARATTERISTIĊI TAL- PRODOTT, IT- TIKKETTA U L- FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
7 ANNEX II
7 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TRITAZIDE AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ TRITAZIDE U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Tritazide contains Ramipril, a second-generation nonsulfhydryl angiotensin converting enzyme inhibitor (ACE-I), and Hydrochlorothiazide (HCTZ), a thiazide diuretic.
Tritazide fih Ramipril, inibitur tal- enzima ta ’ konverżjoni tal- anġjotensina (ACE- I) tat- tieni ġenerazzjoni, u Idroklorotijazide (Hydrochlorothiazide, HCTZ), dijuretiku tijazidiku.
Tritazide 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.
Tritazide ġie inkluż fil- lista ta ’ prodotti għall- armonizzazzjoni tas- Sommarju tal- Karatteristiċi tal- Prodotti (SPC), magħmula mill- CMD( h), skont l- Artikolu 30( 2) tad- Direttiva 2001/ 83/ KE, kif emendata, billi il - prodott mediċinali msemmi hawn fuq ma għandux l- istess SPC fl- Istati Membri kollha, fl- Iżlanda u n - Norveġja.
Critical Evaluation A number of areas of disharmony in the product information for Tritazide have been evaluated by the CHMP and a revised PI was adopted.
Evalwazzjoni kritika Numru ta ’ oqsma ta ’ diskrepanzi fl- informazzjoni dwar il- prodott għal Tritazide ġew evalwati mis - CHMP u ġiet adottata PI riveduta.
The main areas for harmonisation were as follows:
L- oqsma ewlenin għall- armonizzazzjoni kienu kif ġej:
4.1 Therapeutic Indication
4. 1 Indikazzjoni Terapewtika
The combination is indicated for the treatment of hypertension in all Member States where licensed, although it is noted that terms including essential hypertension, arterial hypertension and arterial essential hypertension are used.
Il- kombinazzjoni hija indikata għat- trattament tal- ipertensjoni fl- Istati Membri kollha fejn il- prodott huwa awtorizzat, għalkemm hu osservat li huma inklużi t- termini inklużi l- ipertensjoni essenzjali, l - ipertensjoni arterjuża u l- ipertensjoni arterjuża essenjali.
The CHMP pointed out that this indication is limited to essential hypertension and the positioning of the indications is add-on therapy when each monotherapy has failed.
Is- CHMP ġibed l- attenzjoni li din l - indikazzjoni hija limitata għall- ipertensjoni essenzjali u l- pożizzjonament tal- indikazzjonijiet hija terapija addizzjonali li tiġi applikata meta kull monoterapija tkun falliet.
The combination 2.5mg / 12.5mg led to greater reduction in blood pressure than the treatment with individual components, and the combination of 5mg/ 25mg produced a better therapeutic effect than doubling the ramipril dose to 10mg.
Il- kombinazzjoni 2. 5 mg / 12. 5 mg wasslet għal tnaqqis akbar fil- pressjoni tad- demm mit- trattament bil- komponenti individwali, u l- kombinazzjoni ta ’ 5 mg/ 25 mg ipproduċiet effett terapewtiku aħjar milli meta ġiet irduppjata d- doża ta ’ ramipril għal 10 mg.
Considering that no major concern can be established concerning the safety, efficacy and clinical adverse event of the ramipril/ HCTZ combination in non responders to HCTZ and ramipril alone, the CHMP adopted the following two harmonised wordings for indications: -Treatment of essential hypertension -This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Wara li ikkunsidra li ma jista ’ jiġi stabbilit l- ebda tħassib li jikkonċerna s- sigurtà, l- effikaċja u episodju kliniku avvers tal- kombinazzjoni ramipril/ HCTZ f’ dawk li ma jirrispondux għal HCTZ u ramipril waħdu, is- CHMP adotta ż- żewġ testi segwenti użati għall- indikazzjonijiet: - Trattament tal- ipertensjoni essenzjali - Din il- kombinazzjoni b’ doża fissa hija indikata f’ pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata b’ mod adegwat b’ ramipril waħdu jew b’ idroklorotijazide waħedha.
4.2 Posology and Method of Administration
4. 2 Pożoloġija u Metodu ta ’ Kif Jingħata
In most cases the initial dose is the same, but there are differences with respect to subsequent titration (both in terms of frequency of increase and maximum daily dose).
F’ ħafna każijiet, id- doża inizjali hija l- istess, iżda hemm differenzi fir- rigward tat- titolazzjoni sussegwenti (kemm f’ termini tal- frekwenza ta ’ żieda kif ukoll f’ termini tad- doża massima ta ’ kuljum).
Considering a paucity of trial data assessing titration steps with the combination the posology has been amended.
Wara l- kunsiderazzjoni ta ’ nuqqas ta ’ dejta tal- provi li tivvaluta l- passi tat- titolazzjoni mal - kombinazzjoni, il- pożoloġija ġiet emendata.
The CHMP adopted the harmonised wording: “ The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Is- CHMP adotta t- test armonizzat: “ Id- doża għandha tkun individwalizzata skont il- profil tal- pazjent (ara sezzjoni 4. 4) u l- kontroll tal - pressjoni tad- demm.
The administration of the fixed combination of ramipril and hydrochlorothiazide is usually recommended after dosage titration with one of the individual components.
L- għoti tal- kombinazzjoni fissa ta ’ ramipril u idroklorotijazide hija ġeneralment rakkomandata wara t- titolazzjoni tad- dożaġġ ma ’ wieħed mill- komponenti individwali.
TRITAZIDE and associated names should be started at the lowest available dosage.
TRITAZIDE u l- ismijiet assoċjati għandhom jinbdew fl- aktar dożaġġ baxx disponibbli.
If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily”
Jekk ikun hemm bżonn, id- doża tista ’ tiżdied progressivament biex tinkiseb il- pressjoni tad- demm fil- mira; id - dożi massimi permessi huma 10 mg ramipril u 25 mg idroklorotijazide kuljum ”
4.3 Contra-indications
4. 3 Kontraindikazzjonijiet
The majority of the contraindications are related to use of ramipril as a component of the Tritazide.
Il- maġġoranza tal- kontraindikazzjonijiet huma relatati mal- użu ta ’ ramipril bħala komponent tat - Tritazide.
They are extended with the contraindications of HCTZ.
Dawn huma estiżi mal- kontraindikazzjonijiet ta ’ HCTZ.
There were however some contraindications with HCTZ labelled in some local SPC’ s and not proposed in the harmonised SPC.
Madankollu kien hemm xi kontraindikazzjonijiet ma ’ HCTZ tikkettati f’ xi SPCs lokali u mhux proposti fl- SPC armonizzat.
There were other contraindications in local SPC-s like acute hypertension or primary aldosteronism but they are not contraindications but rather non-indication in Europe.
Kien hemm xi kontraindikazzjonijiet oħrajn f’ SPC- s lokali bħall- ipertensjoni akuta jew aldosteroniżmu primarju iżda dawn mhumiex kontraindikazzjonijiet iżda non- indikazzjoni fl- Ewropa.
The CHMP adopted the harmonised wording for the contra-indictations:
Is- CHMP adotta t- test armonizzat għall- kontraindikazzjonijiet:
9 -Hypersensitivity to the active substance or to any other ACE (Angiotensin Converting Enzyme) inhibitor, hydrochlorothiazide, other thiazide diuretics, sulphonamides or any of the excipients of TRITAZIDE and associated names (see section 6.1).
konverżjoni tal- anġjotensina), għall- idroklorotijazide, għad- dijuretiċi tijazidiċi oħra, għas -
- History of hereditary or idiopathic angioedema
- Storja ta ’ anġjoedema ereditarja jew idjopatika;
- Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see
- Trattament ekstrakorporali li jwasslu għall- kuntatt tad- demm ma ’ wċuħ iċċarġjati negattivament
section 4.5)
(ara s- sezzjoni 4. 5);
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
- Stenożi bilaterali sinifikanti tal- arterja renali jew stenożi tal- arterja renali fl- unika kiljwa li taħdem;
- -2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6)
- It- 2 u t- 3 trimestru tat- tqala (ara s- sezzjoni 4. 4 u 4. 6);
- Lactation (see section 4.6)
- Treddigħ (ara s- sezzjoni 4. 6);
- Severe impairment of renal function with a creatinine clearance below 30 ml/ min in undialysed
- Ħsara gravi tal- funzjoni renali b’ eliminazzjoni ta ’ kreatinina taħt it- 30ml/ min f’ pazjenti mhux
patients
dijalizzati;
- Clinically relevant electrolyte disturbances which may worsen following treatment with TRITAZIDE
- Disturbi elettrolitiċi rilevanti klinikament li jistgħu jaggravaw wara t- trattament bi TRITAZIDE (ara
(see section 4.4)
s- sezzjoni 4. 4);
- Severe impairment of liver function, hepatic encephalopathy
- Indeboliment gravi tal- funzjoni epatika, enċefalopatija epatika.
4.4 Special warnings and precautions for use
4. 4 Twissijiet u prekawzjonijiet speċjali għall- użu
The CHMP included under this session the warning about Primary Hyperaldosteronism, therefore adopted the following harmonised wording: “ The combination ramipril + hydrochlorothiazide does not represent a treatment of choice for primary hyperaldosteronism.
Taħt din is- sessjoni s- CHMP inkluda t- twissija dwar l- Iperaldosteroniżmu Primarju, u għalhekk adotta t- test armonizzat li ġej: “ Il- kombinazzjoni ramipril + idroklorotijazide ma tirrappreżentax trattament ta ’ għażla għal iperaldosteroniżmu primarju.
The CHMP also noted the importance to insert a paragraph regarding cough in line with the warning of previously harmonised ACE-I, therefore agreed the following: “ Cough has been reported with the use of ACE inhibitors.
Jekk ramipril + idroklorotijazide tintuża f’ pazjent b’ iperaldosteroniżmu primarju, allura jkun hemm bżonn ta ’ monitoraġġ bir- reqqa tal- livell tal - potassju fil- plażma. ” Is- CHMP innota wkoll l- importanza li jiddaħħal paragrafu rigward is- sogħla skont it- twissija tal- ACE - I armonizzata qabel, u għalhekk qabel fuq is- segwenti: “ Ġiet rappurtata sogħla bl- użu tal- ACE inibituri.
Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy.
Karatteristikament, is- sogħla mhijiex produttiva, persisenti u tgħib wara li titwaqqaf it- terapija.
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough”
Sogħla indotta mill- ACE inibituri għandha tkun ikkunsidrata bħala parti mid- dijanjożi differenzjali tas- sogħla ”
The CHMP also adopted a harmonised wording regarding pregnancy and lactation under this section (see SPC).
Is- CHMP adotta wkoll test armonizzat rigward it- tqala u t- treddigħ taħt din is- sezzjoni (ara l- SPC)
4.5 Interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l - effett farmaċewtiku tal- prodott
The list of products which interact or may interact with Tritazide is acceptable.
Il- lista ta ’ prodotti li jinteraġixxu jew li jistgħu jinteraġixxu ma ’ Tritazide hija aċċettabbli.
The CHMP adopted the proposed interactions under this section.
Is- CHMP adotta l- interazzjonijiet proposti taħt din is- sezzjoni.
The CHMP recommended a contraindication only for the second and third trimester of pregnancy in line with PhVWP wording on use of AEC-I in pregnancy.
Is- CHMP irrakkomanda kontraindikazzjoni biss għat- tieni u t- tielet trimestru tat- tqala f’ konformità mat- test tal- PhVWP fuq l- użu ta ’ AEC- inibituri fit- tqala.
This change of the text is to ensure it doesn’ t suggest an immediate artificial abortion, which is not justified by the clinical experiences collected till now.
Din il- bidla fit- test hija biex tassigura li ma tissuġġerixxix abort artifiċjali immedjat, li mhuwiex iġġustifikat mill- esperjenzi kliniċi miġburin s’ issa..
In conclusions, the CHMP adopted a harmonised wording in line with PhVWP wording on use of AEC-I in pregnancy.
F’ konklużjoni s- CHMP adotta test armonizzat konformi ma ’ dak tal- PhVWP dwar l- użu tal - ACE- inibituri fit- tqala.
In conclusion, the CHMP adopted a harmonised wording according to the PhVWP recommendations: “ Tritazide is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
It- test adottat mis- CHMP huwa wieħed armonizzat abbażi tar - rakkomandazzjonijiet tal- PhVWP. “ Tritazide mhuwiex rakkomandat matul l- ewwel trimestru tat- tqala (ara s- sezzjoni 4. 4) u huwa kontraindikat matul it- tieni u t- tielet trimestri tat- tqala (ara s- sezzjoni 4. 3).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Il- provi epidemjoloġiċi relatati mar- riskju ta ’ teratoġeniċità wara l- espożizzjoni għall- ACE inibituri waqt l- ewwel trimestru tat- tqala ma kinux konkludenti; madankollu ma jistax jiġi eskluż żieda żgħira tar- riskju.
Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established 10 safety profile for use in pregnancy.
Sakemm it- tkomplija tat- terapija bl- ACE inibituri titqies essenzjali, il- pazjenti li biħsiebhom joħorġu tqal għandhom jgħaddu għal trattamenti antipertensivi alternattivi li għandhom profil ta ’ sigurtà stabbilit għall- użu waqt it- tqala.
When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Meta t- tqala tiġi dijanjostikata, it- trattament bl- ACE inibituri għandu jitwaqqaf immedjatament u, jekk xieraq, għandha tinbeda terapija alternattiva.
(See also 5.3'Preclinical safety data ').
9 L- espożizzjoni għat- terapija bl- ACE inibituri / antagonisti tar- riċetturi tal- anġjotensina II (AIIRA) waqt it- tieni u t- tielet trimestru jinduċi fetotossiċità umana (tnaqqis fil- funzjoni renali, oligoidramnju, ittardjar tal- ossifikazzjoni tal- kranju) u tossiċità neonatali (insuffiċjenza renali, ipotensjoni, iperkaljemija) (ara wkoll 5. 3 ‘ Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina ’).