qanastek/EMEA-V3 huggingface dataset:
- If you have any further questions, please ask your doctor.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Prialt is and what it is used for 2.
X’ inhu Prialt u għalxiex jintuża 2.
Before you use Prialt 3.
Qabel ma tieħu Prialt 3.
How to use Prialt 4.
Kif għandek tuża Prialt 4.
How to store Prialt 6.
Kif taħżen Prialt 6.
WHAT PRIALT IS AND WHAT IT IS USED FOR
X’ INHU PRIALT U GĦALXIEX JINTUŻA
Prialt contains a substance called ziconotide.
Prialt fih sustanza msejħa ziconotide.
This is one of a group of medicines, called analgesics or ‘ painkillers’.
Dan hu wieħed minn grupp ta ’ mediċini, imsejħa analġeżiċi jew ‘ painkillers ’.
Prialt is used for the treatment of long-term pain when your existing treatment is not effective or causes severe side effects.
Prialt jintuża għall- kura ta ’ uġigħ li jdum għal żmien twil meta l- kura eżistenti tiegħek ma tkunx effettiva jew jekk tikkawża effetti sekondarji severi.
BEFORE YOU USE PRIALT
QABEL MA TUŻA PRIALT
Do not use Prialt:
Tużax Prialt:
- If you are allergic (hypersensitive) to ziconotide or any of the other ingredients of Prialt.
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal ziconotide jew sustanzi oħra ta ’
- If you are receiving an anticancer medicine into the space around your spinal cord.
- Jekk qed tirċievi mediċina kontra l- kanċer fl- ispazju ta ’ madwar is- sinsla tiegħek.
Take special care with Prialt:
Oqgħod attent ħafna bi Prialt:
- If you are receiving Prialt via a pump worn outside your body, it is important you check once
- Jekk qed tirċievi Prialt permezz ta ’ pompa li tintlibes fuq in- naħa ta ’ barra ta ’ ġismek, hu
daily for any signs of infection at the point where the tube enters your body.
importanti li tiċċekkja darba kuljum għal kwalunkwe sinjali ta ’ infezzjoni fil- punt fejn it- tubu jidħol ġo ġismek.
- If you observe any signs of infection around the tube, such as skin redness, swelling, pain or
- Jekk tosserva kwalunkwe sinjali ta ’ infezzjoni madwar it- tubu, bħal ħmura fil- ġilda, nefħa,
discharge, you must tell your doctor immediately and seek treatment for the infection.
uġigħ jew ħruġ ta ’ likwidu, għandek tgħid lit- tabib tiegħek immedjatament u tfittex kura għall - infezzjoni.
- If you develop any tenderness in the area around the tube without signs of infection, you should
- Jekk tiżviluppa kwalunkwe sensittività fiż- żona ta ’ madwar it- tubu mingħajr l- ebda sinjali ta ’
seek advice from your doctor as soon as possible as tenderness may be an early sign of infection.
infezzjoni, għandek tfittex parir mingħand it- tabib tiegħek kemm jista ’ jkun malajr, għax is - sensittività tista ’ tkun sinjal bikri ta ’ infezzjoni.
- If you are receiving Prialt via a pump worn outside your body and any part of the infusion
- Jekk qed tirċievi Prialt permezz ta ’ pompa li tintlibes fuq in- naħa ta ’ barra ta ’ ġismek, u
tubing becomes disconnected, you must contact your doctor immediately.
kwalunkwe parti tat- tubing ta ’ l- infużjoni jinqala ’, għandek tikkuntattja lit- tabib tiegħek immedjatament.
- If you have any of the following symptoms: high temperature, headache, stiff neck, tiredness,
- Jekk ghandek xi wieħed mis- sintomi li ġejjin: temperatura għolja, uġigħ ta ’ ras, għonq iebes,
confusion, feeling sick, vomiting or occasional fits, these may be signs of meningitis.
għeja, konfużjoni, tħossok marid, rimettar jew puplesiji okkażjonali, dawn jistgħu jkunu sinjali ta ’ meninġite.
You must tell your doctor immediately if you experience any of the above symptoms.
Inti trid għid lit- tabib tiegħek immedjatament jekk ikollok xi wieħed minn dawn is- sintomi t’ hawn fuq.
- If you notice any adverse change in your thinking, mood or memory, please tell your doctor.
- Jekk tinnota kwalunkwe bidla avversa fil- ħsieb, fil- burdata jew fil- memorja tiegħek, jekk
- If you are receiving chemotherapy please tell your doctor.
- Jekk qed tirċievi l- kimoterapija, jekk jogħġbok għid it- tabib tiegħek.
- Not recommended for use in children and adolescents.
- Din il- mediċina mhijiex rakkomamdata għall- użu fit- tfal u fl- adolexxenti.
39 Taking other medicines:
Meta tuża mediċini oħra:
You may feel drowsy if you are given Prialt with certain other medicines used to treat pain.
Tista ’ tħossok bi ngħas jekk tingħata Prialt ma ’ ċerti mediċini oħrajn li jintużaw għall- kura ta ’ l- uġigħ.
If you are pregnant, think you may be pregnant, or are breast-feeding ask your doctor for advice before taking any medicine.
Jekk inti tqila, taħseb tista ’ tkun tqila, jew jekk qed tredda ’, staqsi it- tabib tiegħek għal parir qabel ma tieħu xi mediċina.
Prialt should not be used during pregnancy unless clearly necessary.
Ziconotide m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
The use of Prialt has been reported to cause confusion and drowsiness.
L- użu ta ’ Prialt kien irrappurtat li jikkawża konfużjoni u ngħas.
Ask your doctor for advice before you drive or operate machinery.
Staqsi lit- tabib tiegħek għal parir qabel ma ssuq jew tħaddem makkinarju.
HOW TO USE PRIALT
KIF GĦANDEK TUŻA PRIALT
Your treatment with Prialt will be managed by a doctor who has experience of giving medicines into the space around the spinal cord, and in the use of internal and external infusion pumps.
Il- kura tiegħek bi Prialt ser tkun immaniġġjata minn tabib li għandu esperjenza fl- għoti tal- mediċini ġol- ispazju madwar il- sinsla, u fl- użu ta ’ pompi ta ’ l- infużjoni interni u esterni.
Prialt is given as a very slow continuous injection into the space surrounding the spinal cord.
Prialt jingħata bħala injezzjoni kontinwa bil- mod ħafna ġol- ispazju ta ’ madwar is- sinsla.
The medicine will be administered continuously from a pump either implanted into your abdominal wall or placed externally in a belt pouch.
Il- mediċina ser tingħata kontinwament minn pompa li tkun jew impjantata ġo żaqqek jew li tkun impoġġija fuq barra f’ belt pouch.
Your doctor will discuss with you the kind of pump that will be most suitable for you and when you need to have your pump refilled.
It- tabib tiegħek ser jiddiskuti miegħek it- tip ta ’ pompa li tkun l- aktar adattata għalik u meta jkollok bżonn timla l- pompa mill- ġdid.
The recommended starting dose is no more than 2.4 micrograms per day.
Id- doża tal- bidu rakkomandata hi ta ’ mhux iktar minn 2. 4 mikrogrammi kuljum.
Your doctor will adjust the dose of Prialt according to the severity of your pain in dose increments of ≤ 2.4 micrograms/ day.
It- tabib tiegħek ser jaġġusta d- doża ta ’ Prialt skond is- severità ta ’ l- uġigħ tiegħek f’ inkrementi tad- doża ta ’ ≤ 2. 4 mikrogrammi/ kuljum.
The maximum dose is 21.6 micrograms/ day.
Id- doża massima hi ta ’ 21. 6 mikrogramma/ kuljum.
At the start of your treatment your doctor may increase your dose every 1 to 2 days or more.
Fil- bidu tal- kura tiegħek, it- tabib tiegħek jista ’ jżid id- doża tiegħek kuljum jew kull jumejn jew iktar.
If needed the dose may be decreased or injection stopped if the side effects are too great.
Jekk ikun hemm bżonn, id- doża tista ’ titnaqqas jew l- injezzjoni titwaqqaf jekk l- effetti sekondarji jkunu kbar wisq.
If you feel that you are still in too much pain while taking Prialt, or that the side effects are too great, talk to your doctor.
Jekk tħoss li xorta għad baqgħalek ħafna uġigħ waqt li tkun qed tieħu Prialt, jew jekk l- effetti sekondarji jkunu kbar wisq, kellem lit- tabib tiegħek.
Before giving you Prialt, your doctor might decide to slowly stop giving you opiates into your spinal cord and instead replace with alternative pain medications.
Qabel ma jagħtik Prialt, it- tabib tiegħek jista ’ jiddeċiedi li, bil- mod, jieqaf jagħtik l- opiates fis- sinsla u minflok jibdilhom b’ mediċini alternattivi ta ’ kontra l- uġigħ.
If you use more Prialt than you should:
Jekk tuża Prialt aktar milli suppost
If you receive more Prialt than your doctor intended, you may feel unwell with signs such as confusion, problems with speech, word finding difficulties, excessive shaking, light-headedness, excessive sleepiness, feeling or being sick.
Jekk tirċievi iktar Prialt minn dak li t- tabib tiegħek kien intenzjonat li jagħtik, jista ’ jkun li ma tħossokx tajjeb u jkollok sinjali ta ’ konfużjoni, problemi biex titkellem, diffikultà biex issib il- kliem, rogħda eċċessiva, sturdament, irqad eċċessiv, sensazzjoni ta ’ mard jew li tkun marid.
If this happens, consult your doctor or hospital immediately.
Jekk dan jiġri, kellem lit- tabib tiegħek jew mur l- isptar immedjatament.
Like all medicines, Prialt can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Prialt jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common reported side effects (occurring in more than 1 out of 10 patients in clinical trials) include: confusion, dizziness, blurred vision, headache, rapid back-and-forth movement of the eyes, loss or impairment of memory (forgetfulness), difficulty walking, vomiting, nausea, general weakness and drowsiness.
41 Effetti sekondarji komuni ħafna li kienu rrappurtati (li jseħħu f’ iktar minn 1 minn kull 10 pazjenti fi provi kliniċi) jinkludu: konfużjoni, sturdament, vista mċajpra, uġigħ ta ’ ras, moviment mgħaġġel ’ l hawn u ’ l hemm ta ’ l- għajnejn, telf jew indeboliment ta ’ memorja (tinsa), diffikultà biex timxi, rimettar, tqallih, dgħjufija ġenerali u ngħas.
40 Common reported side effects (occuring in more than 1 out of 100 patients in clinical trials) include:
Effetti sekondarji komuni li kienu rrappurtati (li jseħħu f’ iktar minn 1 minn kull 100 pazjent fi provi kliniċi) jinkludu:
Decreased appetite, anxiety or worsened anxiety, hallucinations, inability to fall or stay asleep, agitation, disorientation, depression or worsened depression, nervousness, mood swings, mental status changes (thinking abnormal, confusion), paranoia, irritability, worsened confusion, difficulty with learning, memory or thinking, reflexes absent or impaired, problems expressing or understanding words, slurred speech, difficulty with speech or loss of ability to speak, sluggishness, balance or coordination impaired, burning sensation, increased pain sensitivity, reduced level of consciousness (unresponsive or almost unconscious), sedation, difficulty in concentrating, problems with the sense of smell, odd or no sense of taste, shaking, pins and needles, double vision, visual disturbance, intolerance to light, tinnitus (ringing in the ears), dizziness or spinning sensation, lightheadedness or dizziness when standing, low blood pressure, shortness of breath, dry mouth, abdominal pain, worsened nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms, muscle cramp, muscle or joint pain, difficult or painful urination, difficulty starting or controlling urination, feeling jittery, falling, pain or pain exacerbated, fatigue, feeling cold, swelling of the face, legs or feet, chest pain, fever, blood chemistry changes, mental impairment and weight decreased.
Nuqqas t’ aptit, ansjetà jew ansjetà li tmur għall- agħar, alluċinazzjonijiet, ma tkunx tista ’ torqod jew tkompli torqod, aġitazzjoni, diżorjentament, depressjoni jew depressjoni li tmur għall- agħar, nervożità, tibdil fil- burdata, tibdil fl- istat mentali (taħseb b’ mod anormali, konfużjoni), paranojja, irritabilità, konfużjoni li tmur għall- agħar, diffikultà biex titgħallem, fil- memorja jew biex taħseb, assenza jew indeboliment ta ’ riflessi, problemi biex tesprimi jew tifhem il- kliem, diskors li ma jiftiehemx, diffikultà biex titkellem jew titlef il- ħila li titkellem, indolenza, indeboliment fil- bilanċ jew fil- koordinazzjoni, sensazzjoni ta ’ ħruq, żieda fis- sensittività għall- uġigħ, livell imnaqqas ta ’ koxjenza (ma jkollok rispons jew kważi mitluf minn sensik), sedazzjoni, diffikultà biex tikkonċentra, problemi fis- sens tat- togħma, ittiegħem b’ mod stramb jew l- ebda sens ta ’ togħma, rogħda, sensazzjoni bħal qisu xi ħadd qed iniggżek bil- labar, tara doppju, disturbi tal- vista, intolleranza għad- dawl, żanżin fil - widnejn (tisfir fil- widnejn), sturdament jew sensazzjoni ta ’ tidwir, sturdament jew tistordi meta tkun bilwieqfa, pressjoni tad- demm baxxa, qtugħ ta ’ nifs, ħalq xott, uġigħ addominali, tqallih li jmur għall - agħar, dijarea, stitikezza, għaraq, ħakk, dgħjufija fil- muskoli, spażmi tal- muskoli, bugħawwieġ fil - muskoli, uġigħ fil- muskoli jew fil- gogi, diffikultà jew uġigħ meta tagħmel l- awrina, diffikultà biex tibda jew tikkontrolla meta tagħmel l- awrina, tħossok nervuż/ a, taqa ’, uġigħ jew uġigħ li jiħrax, għeja kbira, tħoss il- bard, nefħa tal- wiċċ, riġlejn jew saqajn, uġigħ fis- sider, deni, tibdil fil- kimika tad - demm, indeboliment mentali u tnaqqis fil- piż.
HOW TO STORE PRIALT
KIF TAĦŻEN PRIALT
Do not use Prialt after the expiry date stated on the label and carton after EXP.
Tużax Prialt wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa tal- kartun wara JIS.
Store unopened vial in refrigerator (2°C – 8°C).
Aħżen il- kunjett mhux miftuħ fi friġġ (2°C - 8°C).
What Prialt contains
X’ fih Prialt
- The active substance is ziconotide.
- Is- sustanza attiva hi ziconotide.
- One ml solution contains 100 micrograms ziconotide (as acetate).
- 1 ml soluzzjoni fih 100 mikrogrammi ta ’ ziconotide (bħala acetate).
- One vial of 1 ml contains 100 micrograms; one vial of 2 ml contains 200 micrograms; one vial
- 1 kunjett ta ’ 1 ml fih 100 mikrogramma; 1 kunjett ta ’ 2 ml fih 200 mikrogramma; 1 kunjett ta ’
of 5 ml contains 500 micrograms.
5 ml fih 500 mikrogramma.
- The other ingredients are methionine, sodium chloride, water for injections, hydrochloric acid
- Is- sustanzi l- oħra huma methionine, sodium chloride, ilma għall- injezzjonijiet, hydrochloric
and sodium hydroxide.
acid u sodium hydroxide.
What Prialt looks like and contents of the pack
Id- dehra ta ’ Prialt u l- kontenuti tal- pakkett:
Prialt is a solution for infusion.
Prialt hu soluzzjoni għall- infużjoni.
The solution is clear and colourless.
Is- soluzzjoni hija cara u bla kulur.
Prialt is supplied in packs containing a single vial of either 1 ml, 2 ml or 5 ml.
Prialt hu fornut f’ pakketti li fihom kunjett wieħed ta ’ jew 1 ml, 2 ml jew 5 ml.
Marketing Authorisation Holder and Manufacturer
Detentur ta ’ l- Awtorizazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Marketing Authorisation Holder:
Detentur ta ’ l- Awtorizazzjoni għat- tqegħid fis- Suq:
Manufacturer:
l- Manifattur:
Eesti Eisai Ltd.
43 Eesti Österreich Eisai Ltd.
Ελλάδα Arriani Pharmaceuticals Τηλ: +30 (0) 210 668 3000
Ελλάδα Arriani Pharmaceuticals Τηλ: +30 (0) 210 668 300
This leaflet was last approved in {MM/ YYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
43 This medicine has been authorised under “ Exceptional Circumstances”.
Din il- mediċina kienet awtorizzata taħt “ Ċirkustanzi ta’ Eċċezzjoni ”.
This means that because of the rarity of the disease it has been impossible to get complete information on this medicine.
Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari, kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L - Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ kull sena u dan il- fuljett ser jiġi aġġornat, skond il- bżonn.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
44 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għall- websites oħrajn dwar mard rari u l- kura.
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku jew fil- qasam tas- saħħa:
Instructions for use and handling
Struzzjonijiet dwar l- użu u l- immaniġġjar
Prialt is supplied as a clear, colourless solution in single use vials.
Prialt hu fornut bħala soluzzjoni ċara u bla kulur, f’ kunjetti li jintużaw darba biss.
The solution should not be used if discoloured or cloudy or if particulate matter is observed.
Is - soluzzjoni m’ għandhiex tintuża jekk tkun bidlet il- kulur jew tkun imċajpra, jew jekk ikun osservat materjal f’ sura ta ’ partikuli.
Chemical and physical in-use stability has been demonstrated for 14 days at 37ºC in the Synchromed pump when the pump has not previously been exposed to the medicinal product.
L- istabbiltà kimika u fiżika waqt l- użu intweriet għal 14- il jum f’ temperatura ta ’ 37ºC fil- pompa Synchromed, meta l- pompa għandu ma kienitx esposta minn qabel għall- prodott mediċinali.
CE marked pumps equivalent to the Synchromed and CADD-Micro pump should be used to deliver ziconotide.
Pompi mmarkati CE, li huma ekwivalenti għal Synchromed u CADD- Micro pump, għandhom jintużaw biex ifornu ziconotide.
Pumps previously used to deliver other medicinal products must be washed out three times with sodium chloride 9 mg/ ml (0.9%) solution for injection (preservative-free) before being filled with ziconotide.
Pompi li qabel kienu ntużaw biex ifornu prodotti mediċinali oħrajn, iridu jinħaslu tliet darbiet bis- sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni (preservative- free) qabel ma jimtlew b ’ ziconotide.
The introduction of air into the pump reservoir or cartridge should be minimized, as oxygen can degrade ziconotide.
Id- dħul ta ’ l- arja ġol- ġibjun tal- pompa jew ġol- iskartoċċ għandu jkun imminimizzat, għax l- ossiġnu jista ’ jiddegrada ziconotide.
Prior to initiation of therapy, an internal pump must be rinsed three times with 2 ml of the solution at 25 μ g/ ml.
Qabel il- bidu tat- terapija, pompa interna trid titlaħlaħ tliet darbiet b’ 2 ml tas- soluzzjoni f’ 25 μg/ ml.
44 PACKAGE LEAFLET:
45 FULJETT TA ’ TAGĦRIF:
Ziconotide
Prialt 25 mikrogramma/ ml soluzzjoni għall- infużjoni, Ziconotide
please tell your doctor.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid, lit- tabib tiegħek.
45 Taking other medicines:
Meta tuża mediċini oħra:
Very common reported side effects (occurring in more than 1 out of 10 patients in clinical trials) include: confusion, dizziness, blurred vision, headache, rapid back-and-forth movement of the eyes, loss or impairment of memory (forgetfulness), difficulty walking, vomiting, nausea, general weakness and drowsiness.
47 Effetti sekondarji komuni ħafna li kienu rrappurtati (li jseħħu f’ iktar minn 1 minn kull 10 pazjenti fi provi kliniċi) jinkludu: konfużjoni, sturdament, vista mċajpra, uġigħ ta ’ ras, moviment mgħaġġel ’ l hawn u ’ l hemm ta ’ l- għajnejn, telf jew indeboliment ta ’ memorja (tinsa), diffikultà biex timxi, rimettar, tqallih, dgħjufija ġenerali u ngħas.
46 Common reported side effects (occuring in more than 1 out of 100 patients in clinical trials) include:
Effetti sekondarji komuni li kienu rrappurtati (li jseħħu f’ iktar minn 1 minn kull 100 pazjent fi provi kliniċi) jinkludu:
One ml solution contains 25 micrograms ziconotide (as
Soluzzjoni ta ’ 1 ml fiha 25 mikrogramma ta ’ ziconotide (bħala
acetate).
acetate).
One vial of 20 ml contains 500 micrograms.
Kunjett wieħed ta ’ 20 ml fih 500 mikrogramma.
What Prialt looks like and contents of the pack
48 Id- dehra ta ’ Prialt u il- kontenuti tal- pakkett:
The solution is clear and colourless.
Is- soluzzjoni hi ċara u bla kulur.
Prialt is supplied in packs containing a single vial of 20 ml.
Prialt hu fornut f’ pakketti li fihom kunjett wieħed ta ’ 20 ml.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq..
Ελλάδα Arriani Pharmaceuticals Τηλ: +30 (0) 210 668 3000
49 Ελλάδα Arriani Pharmaceuticals Τηλ: +30 (0) 210 668 300
49 This medicine has been authorised under “ Exceptional Circumstances”.
Din il- mediċina kienet awtorizzata taħt “ Ċirkustanzi Eċċezzjoni ”.
------------------------------------------------------------------------------------------------------------------------------
50 ------------------------------------------------------------------------------------------------------------------------------
Pumps previously used to deliver other medicinal products must be washed out three times with sodium chloride 9 mg/ ml (0.9%) solution for injection (preservative-free) before being filled with ziconotide.
Pompi li qabel kienu ntużaw biex ifornu prodotti mediċinali oħrajn, iridu jinħaslu tliet darbiet bis- sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni (preservative- free) qabel ma jimtlew b’ ziconotide.
What is Pritor?
X’ inhu Pritor?
Pritor is a medicine that contains the active substance telmisartan.
Pritor huwa mediċina li fiha s- sustanza attiva telmisartan.
What is Pritor used for?
Għalxiex jintuża Pritor?
Pritor is used in adults who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Pritor jintuża f’ adulti li jkollhom pressjoni għolja essenzjali. ‘ Essenzjali ’ tfisser li l- pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
How is Pritor used?
Kif jintuża Pritor?
Pritor is taken by mouth, with or without food.
Pritor jittieħed oralment, ma ’ jew mingħajr l- ikel.
The recommended dose is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Id- doża li normalment tiġi rrakkomandata hija 40 mg darba kuljum, iżda xi pazjenti jistgħu jibbenefikaw mill- użu ta ’ doża ta ’ 20- mg.
How does Pritor work?
Kif jaħdem Pritor?
The active substance in Pritor, telmisartan, is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Is- sustanza attiva f’ Pritor, telmisartan, huwa ‘ antagonist tar- riċettur ta ’ anġjotensina II ’, li jfisser li jimblokka l- azzjoni ta ’ ormon fil- ġisem magħruf bħala anġjotensina II.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Anġjotensina II huwa vażokonstrittur (sustanza li ddejjaq il- vini u l- arterji) qawwi.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Billi jimblokka r- riċetturi li normalment anġjotensina II jeħel magħhom, telmisartan iwaqqaf l- ormon milli jkollu effett, u dan iwassal għal tnaqqis fil- pressjoni tad- demm, u b’ hekk inaqqas ir- riskju kkawżat minn pressjoni tad- demm għolja, foshom il- puplesija.
How has Pritor been studied?
Kif ġie studjat Pritor?
Pritor has been studied in 1,647 patients who were treated with telmisartan either alone or in combination with hydrochlorothiazide.
Pritor ġie studjat f’ 1, 647 pazjent li ġew ittrattati b’ telmisartan waħdu jew flimkien ma ’ hydrochlorothiazide.
Pritor was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Pritor tqabbel ma ’ plaċobo (trattament finta) u ma ’ mediċini oħra għall- pressjoni għolja (atenolol, lisinopril, enalapril u amlodipine).
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Il- mezz ewlieni tal- effikaċja kien it- tnaqqis fil - pressjoni dijastolika (il- pressjoni mkejla bejn żewġ taħbitiet tal- qalb).
What is the risk associated with Pritor?
X’ inhu r- riskju assoċjat ma ’ Pritor?
Side effects with Pritor are not common.
L- effetti sekondarji bi Pritor m’ humiex komuni.
However, the following side effects are seen in between 1 and 10 patients in 1,000: hyperkalaemia (high blood potassium levels), syncope (fainting), insomnia (difficulty sleeping), vertigo (a spinning sensation), hypotension (low blood pressure), dyspnoea (difficulty breathing), abdominal (tummy) pain, diarrhoea, dry mouth, dyspepsia (heartburn), flatulence (gas), hyperhidrosis (excessive sweating), pruritus (itching), myalgia (muscle pain), renal impairment (kidney problems) including renal failure (kidney failure), and chest pain.
Madanakollu, dawn l- effetti sekondarji li ġejjin dehru f’ bejn pazjent 1 u 10 minn kull 1000: iperkalemija (livelli għoja ta ’ potassju fid- demm), sinkope (tħossok ħażin), insomnja (diffikultà fl- irqad), vertiġni (sensazzjoni li tħoss kollox idur), ipotensjoni (pressjoni baxxa tad- demm), dispnea (diffikultà fit- teħid tan- nifs), uġigħ addominali (fiż- żaqq), dijarrea, ħalq niexef, dispepsja (qrusa tal- istonku), flatulenza (gass), iperidrożi (għaraq eċċessiv), prurite (ħakk), mijalġja (uġigħ fil- muskolu), indeboliment renali (problemi fil- kliewi) inkluża insuffiċjenza renali (insuffiċjenza tal- kliewi) u uġigħ fis- sider.
For the full list of all side effects reported with Pritor, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati bi Pritor, ara l- Fuljett ta 'Tagħrif.
Pritor should not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients.
Pritor ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal telmisartan jew għal xi ingredjent ieħor tiegħu.
Pritor must not be used in people who have severe liver problems or bile problems.
Pritor ma għandux jintuża f' persuni li jkollhom problemi gravi fil- fwied jew problemi biljari
Why has Pritor been approved?
Għaliex ġie approvat Pritor?
The Committee for Medicinal Products for Human Use (CHMP) decided that Pritor’ s benefits are greater than its risks for the treatment of essential hypertension in adults.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Pritor huma ikbar mir- riskji tiegħu għat- trattament ta ’ pressjoni għolja essenzjali fl- adulti.
The Committee recommended that Pritor be given marketing authorisation.
Il- Kumitat irrakkomanda li Pritor jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Pritor:
Informazzjoni oħra dwar Pritor:
The European Commission granted a marketing authorisation valid throughout the European Union for Pritor on 11 December 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Pritor fil- 11 ta ’ Diċembru 1998.
The marketing authorisation was renewed on 11 December 2003 and on 11 December 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 11 ta ’ Diċembru 2003 u fil- 11 ta ’ Diċembru 2008.
The full EPAR for Pritor is available here.
L- EPAR sħiħ għal Pritor jista ’ jiġi konsultat hawnhekk.
Pritor 20 mg tablets
Pritor 20 mg pilloli
Paediatric patients Pritor is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Pritor mhuwiex rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba nuqqas ta ’ dejta dwar is - sigurtà u l- effikaċja.
• Hypersensitivity to the active substance or to any of the excipients (see section 6.1)
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1)
2 • Second and third trimester of pregnancy (see sections 4.4 and 4.6) • Lactation (see section 4.6) • Biliary obstructive disorders • Severe hepatic impairment
2 • It- tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6) • Treddigħ (ara sezzjoni 4. 6) • Disturbi ostruttivi biljari • Indeboliment sever epatiku
Pritor is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Pritor m’ għandux jingħata lil pazjenti b’ kolestasi, b’ disturbi ostruttivi tal- marrara jew li għandhom indeboliment sever epatiku (ara sezzjoni 4. 3), għax telmisartan huwa eliminat fil- biċċa l- kbira tiegħu mal- bili.
Pritor should be used only with caution in patients with mild to moderate hepatic impairment.
Pritor għandu jintuża biss bl- attenzjoni f’ pazjenti li għandhom indeboliment epatiku minn ħafif sa moderat.
When Pritor is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Meta Pritor jintuża f’ pazjenti li għandhom indeboliment fil- funzjoni renali, monitoraġġ perjodiku tal - livelli tal- potassium u tal- krejatinina tas- serum hu rakkomandat.
There is no experience regarding the administration of Pritor in patients with recent kidney transplantation.
M’ hemmx esperjenza dwar l- għoti ta ’ Pritor f’ pazjenti bi trapjant renali riċenti.
Symptomatic hypotension, especially after the first dose of Pritor, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Pressjoni baxxa ħafna sintomatika, speċjalment wara l- ewwel doża ta ’ Pritor, tista ’ sseħħ f’ pazjenti li għandhom volum u/ jew sodium li jkun tnaqqas minn terapija dijuretika vigoruża, restrizzjoni tal- melħ fid- dieta, dijarea jew rimettar.
Such conditions should be corrected before the administration of Pritor.
Dawn il- kundizzjonijiet għandhom jiġu kkoreġuti qabel l- għoti ta ’ Pritor.
Volume and/ or sodium depletion should be corrected prior to administration of Pritor.
It- tnaqqis tal- volum u/ jew tas- sodium għandu jiġi kkoreġut qabel l- għoti ta ’ Pritor.
In patients whose vascular tone and renal function depend predominantly on the activity of the renin- angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
F’ pazjenti fejn it- ton vaskulari u l- funzjoni renali jiddependu b’ mod predominanti mill- attività tas - sistema renin- angiotensin- aldosterone (eż. pazjenti b’ insuffiċjenza konġestiva severa tal- qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi ta ’ l- arterja renali), il- kura bi prodotti mediċinali oħrajn li jaffettwaw din is- sistema bħal telmisartan kienet assoċjata ma ’ pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew b’ mod rari ma ’ insuffiċjenza renali akuta (ara sezzjoni 4. 8).
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
3 Pazjenti b’ aldosteroniżmu primarju ġeneralment mhux ser jirrispondu għal prodotti mediċinali kontra l- pressjoni għolja li jaġixxu permezz ta ’ l- inibizzjoni tas- sistema renin- angiotensin.
Patients with rare hereditary problems of fructose intolerance should not take Pritor.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall- fructose m’ għandhomx jieħdu Pritor.
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti- inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
4 prodotti mediċinali oħra li jistgħu jikkawżaw ukoll l- iperkalemija (sostituti tal- melħ li fihom il - potassium, dijuretiċi li ma jneħħux potassium, inibituri ta ’ ACE, antagonisti tar- riċettur ta ’ angiotensin II, prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni (NSAIDs, li jinkludu inibituri COX- 2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim).
The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal products.
L- effett ta ’ telmisartan li jbaxxi l- pressjoni tad- demm jista ’ jiżdied bl- użu fl- istess ħin użu ta ’ prodotti mediċinali oħrajn kontra l- pressjoni għolja.
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan:
5 Ibbażat fuq il- proprjetajiet farmakoloġiċi tagħhom, jista ’ jkun mistenni li l- prodotti mediċinali li ġejjin jistgħu jżidu l- effetti ipotensivi tal- mediċini kollha kontra l- pressjoni għolja, li jinkludu telmisartan:
There are no adequate data from the use of Pritor in pregnant women.
M’ hemmx tagħrif dwar l- użu ta ’ Pritor f’ nisa tqal.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
6 Ir- reazzjonijiet avversi ġew ikklassifikati skond kategoriji ta ’ frekwenza bl- użu tal- konvenzjoni li ġejja: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħrufa (ma tistax tittieħed stima mid- data disponibbli).
Urinary tract infection including cystitis
Infezzjoni fl- apparat tal- awrina li tinkludi ċistite
Abdominal pain, diarrhoea, dry mouth, dyspepsia, flatulence Stomach upset, vomiting
Uġigħ addominali, dijarea, ħalq xott, dispepsja, gass Stonku mqalleb, rimettar
Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Telmisartan
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
8 ma jesibixxi l- ebda attività agonista parzjali għar- riċettur AT1.
There is no linear relationship between doses and plasma levels.
9 M’ hemm l- ebda relazzjoni lineari bejn id- dożi u l- livelli tal- plażma.
In both species, increased plasma renin activity and hypertrophy/ hyperplasia of the renal juxtaglomerular cells were observed.
10 Fiż- żewġ speċi, żieda fl- attività tar- renin fil- plażma u ipertrofija/ iperplasija taċ- ċelluli juxtaglomerular kienet osservata.
Blister with 14, 28, 30, 56, 90 or 98 tablets.
Folja b’ 14, 28, 30, 56, 90 jew 98 pillola.
EU/ 1/ 98/ 089/ 011 (14 tablets) EU/ 1/ 98/ 089/ 012 (28 tablets) EU/ 1/ 98/ 089/ 020 (30 tablets) EU/ 1/ 98/ 089/ 013 (56 tablets) EU/ 1/ 98/ 089/ 019 (90 tablets) EU/ 1/ 98/ 089/ 014 (98 tablets)
11 EU/ 1/ 98/ 089/ 011 (14- il pillola) EU/ 1/ 98/ 089/ 012 (28 pillola) EU/ 1/ 98/ 089/ 020 (30 pillola) EU/ 1/ 98/ 089/ 013 (56 pillola) EU/ 1/ 98/ 089/ 019 (90 pillola) EU/ 1/ 98/ 089/ 014 (98 pillola)
11 December 1998 Date of last renewal:
11 ta ’ Diċembru, 1998 Data ta ’ l- aħħar tiġdid:
11 December 2008
11 ta ’ Diċembru, 2008
Pritor 40 mg tablets
Pritor 40 mg pilloli
White oblong tablets engraved with the code number '51H '' on one side.
Pilloli bojod b’ forma oblunga li fuqhom hemm imnaqqax in- numru tal- kodiċi '51H' fuq naħa waħda.
• Hypersensitivity to the active substance or to any of the excipients (see section 6.1) • Second and third trimester of pregnancy (see sections 4.4 and 4.6)
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1)
12 • Lactation (see section 4.6) • Biliary obstructive disorders • Severe hepatic impairment
13 • It- tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6) • Treddigħ (ara sezzjoni 4. 6) • Disturbi ostruttivi biljari • Indeboliment sever epatiku
In patients whose vascular tone and renal function depend predominantly on the activity of the renin- angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan, has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
F’ pazjenti fejn it- ton vaskulari u l- funzjoni renali jiddependu b’ mod predominanti mill- attività tas - sistema renin- angiotensin- aldosterone (eż. pazjenti b’ insuffiċjenza konġestiva severa tal- qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi ta ’ l- arterja renali), il- kura bi prodotti mediċinali oħrajn li jaffettwaw din is- sistema bħal telmisartan, kienet assoċjata ma ’ pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew b’ mod rari ma ’ insuffiċjenza renali akuta (ara sezzjoni 4. 8).
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
14 Pazjenti b’ aldosteroniżmu primarju ġeneralment mhux ser jirrispondu għal prodotti mediċinali kontra l- pressjoni għolja li jaġixxu permezz ta ’ l- inibizzjoni tas- sistema renin- angiotensin.
This medicinal product contains sorbitol (E420).
Dan il- prodott mediċinali fih is sorbitol (E420).
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti- inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
15 prodotti mediċinali oħra li jistgħu jikkawżaw ukoll l- iperkalemija (sostituti tal- melħ li fihom il - potassium, dijuretiċi li ma jneħħux potassium, inibituri ta ’ ACE, antagonisti tar- riċettur ta ’ angiotensin II, prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni (NSAIDs, li jinkludu inibituri COX- 2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim).
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan:
16 Ibbażat fuq il- proprjetajiet farmakoloġiċi tagħhom, jista ’ jkun mistenni li l - prodotti mediċinali li ġejjin jistgħu jżidu l- effetti ipotensivi tal- mediċini kollha kontra l- pressjoni għolja, li jinkludu telmisartan:
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
17 Ir- reazzjonijiet avversi ġew ikklassifikati skond kategoriji ta ’ frekwenza bl- użu tal- konvenzjoni li ġejja: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna < 1/ 10, 000), mhux magħrufa (ma tistax tittieħed stima mid- data disponibbli).
Skin and subcutaneous tissue disorders
18 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
19 ma jesibixxi l- ebda attività agonista parzjali għar- riċettur AT1.
The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
20 It- tnaqqis żgħir fl- AUC mhux mistenni li jikkawża tnaqqis fl- effikaċja terapewtika.
In both species, increased plasma renin activity and hypertrophy/ hyperplasia of the renal juxtaglomerular cells were observed.
21 Fiż- żewġ speċi, żieda fl- attività tar- renin fil- plażma u ipertrofija/ iperplasija taċ- ċelluli juxtaglomerular kienet osservata.
Blister with 14, 28, 30, 56, 90, 98 or 280 tablets or perforated unit dose blisters with 28 x 1 tablets.
Folja b’ 14, 28, 30, 56, 90, 98 jew 280 pillola jew folji perforati b’ doża waħda bi 28 x 1 pilloli.
EU/ 1/ 98/ 089/ 001 (14 tablets) EU/ 1/ 98/ 089/ 002 (28 tablets) EU/ 1/ 98/ 089/ 021 (30 tablets) EU/ 1/ 98/ 089/ 003 (56 tablets) EU/ 1/ 98/ 089/ 017 (90 tablets) EU/ 1/ 98/ 089/ 004 (98 tablets) EU/ 1/ 98/ 089/ 005 (280 tablets) EU/ 1/ 98/ 089/ 015 (28 x 1 tablets)
EU/ 1/ 98/ 089/ 001 (14- il pillola) EU/ 1/ 98/ 089/ 002 (28 pillola) EU/ 1/ 98/ 089/ 021 (30 pillola) EU/ 1/ 98/ 089/ 003 (56 pillola) EU/ 1/ 98/ 089/ 017 (90 pillola) EU/ 1/ 98/ 089/ 004 (98 pillola) EU/ 1/ 98/ 089/ 005 (280 pillola) EU/ 1/ 98/ 089/ 013 (28 x 1 pillola)
Pritor 80 mg tablets
Pritor 80 mg pilloli
White oblong tablets engraved with the code number '52H 'on one side.
Pilloli bojod b’ forma oblunga li fuqhom hemm imnaqqax in- numru tal- kodiċi '52H' fuq naħa waħda.
Pritor is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Pritor mhuwiex rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba nuqqas ta ’ dejta dwar is - sigurtà u l- effikaċja.
22 • Lactation (see section 4.6) • Biliary obstructive disorders • Severe hepatic impairment
24 • It- tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6) • Treddigħ (ara sezzjoni 4. 6) • Disturbi ostruttivi biljari • Indeboliment sever epatiku
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
25 Pazjenti b’ aldosteroniżmu primarju ġeneralment mhux ser jirrispondu għal prodotti mediċinali kontra l- pressjoni għolja li jaġixxu permezz ta ’ l- inibizzjoni tas- sistema renin- angiotensin.
Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Prodotti mediċinali jew klassijiet terapewtiċi ta ’ prodotti mediċinali li jistgħu jikkawżaw l- iperkalemija huma sostituti tal- melħ li fihom il- potassium, dijuretiċi li ma jneħħux potassium, inibituri ta ’ ACE, antagonisti tar - riċettur ta ’ angiotensin II, prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni (NSAIDs, li jinkludu inibituri COX- 2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim.
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti- inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
26 prodotti mediċinali oħra li jistgħu jikkawżaw ukoll l- iperkalemija (sostituti tal- melħ li fihom il - potassium, dijuretiċi li ma jneħħux potassium, inibituri ta ’ ACE, antagonisti tar- riċettur ta ’ angiotensin II, prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni (NSAIDs, li jinkludu inibituri COX- 2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim).
Angiotensin II receptor antagonists attenuate diuretic induced potassium loss.
Telf ta ’ potassium ikkaġunat minn dijuretiċi huwa attenwat mill- antagonisti tar- riċettur ta ’ angiotensin II.
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan:
27 Ibbażat fuq il- proprjetajiet farmakoloġiċi tagħhom, jista ’ jkun mistenni li l- prodotti mediċinali li ġejjin jistgħu jżidu l- effetti ipotensivi tal- mediċini kollha kontra l- pressjoni għolja, li jinkludu telmisartan:
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
28 Ir- reazzjonijiet avversi ġew ikklassifikati skond kategoriji ta ’ frekwenza bl- użu tal- konvenzjoni li ġejja: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħrufa (ma tistax tittieħed stima mid- data disponibbli).
Skin and subcutaneous tissue disorders
29 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
30 sottotip tar- riċettur AT1, li hu responsabbli għall- azzjonijiet magħrufa ta ’ angiotensin II.
Linearity/ non-linearity:
31 Linearità/ non- linearità:
These pharmacologically- mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Dawn l- effetti mhux mixtieqa, medjati b’ mod farmakoloġiku, magħrufa minn studji dwar is- sigurtà ta ’ qabel l- użu kliniku, kemm b’ inibituri ta ’ l- enzimi li jibdlu l- angiotensin kif ukoll b’ antagonisti tar- riċettur ta ’ angiotensin II, kienu evitati
EU/ 1/ 98/ 089/ 006 (14 tablets) EU/ 1/ 98/ 089/ 007 (28 tablets) EU/ 1/ 98/ 089/ 022 (30 tablets) EU/ 1/ 98/ 089/ 008 (56 tablets) EU/ 1/ 98/ 089/ 018 (90 tablets) EU/ 1/ 98/ 089/ 009 (98 tablets) EU/ 1/ 98/ 089/ 010 (280 tablets) EU/ 1/ 98/ 089/ 016 (28 x 1 tablets)
EU/ 1/ 98/ 089/ 006 (14- il pillola) EU/ 1/ 98/ 089/ 007 (28 pillola) EU/ 1/ 98/ 089/ 022 (30 pillola) EU/ 1/ 98/ 089/ 008 (56 pillola) EU/ 1/ 98/ 089/ 018 (90 pillola) EU/ 1/ 98/ 089/ 009 (98 pillola) EU/ 1/ 98/ 089/ 010 (280 pillola) EU/ 1/ 98/ 089/ 016 (28 x 1 pillola)
32 A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
SmithKline Beecham Pharmaceuticals Manor Royal Crawley, West Sussex RH10 2QJ United Kingdom
SmithKline Beecham Pharmaceuticals Manor Royal Crawley, West Sussex RH10 2QJ Renju Unit
Pritor 20 mg tablets telmisartan
Pritor 20 mg pilloli telmisartan
14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola
Bayer HealthCare AG D-51368 Leverkusen Germany
Bayer HealthCare AG, D- 51368 Leverkusen Il- Ġermanja
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Any non 7 count blister
Kwalunkwe folja li biha ma tistax tgħodd 7 darbiet
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Pritor 40 mg tablets telmisartan
Pritor 40 mg pilloli telmisartan
14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 28 x 1 tablets
14- il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola 280 pillola 28 x 1 pilloli
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister of 7 tablets
Folja b' 7 pilloli
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Pritor 80 mg tablets telmisartan
Pritor 80 mg pilloli telmisartan
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
48 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
INFORMATION FOR THE USER Pritor 20 mg tablets Telmisartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Pritor 20 mg pilloli Telmisartan
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Pritor is and what it is used for 2.
X’ inhu Pritor u għalxiex jintuża 2.
Before you take Pritor 3.
Qabel ma tuża Pritor 3.
How to take Pritor 4.
Kif għandek tuża Pritor 4.
How to store Pritor 6.
Kif taħżen Pritor 6.
WHAT PRITOR IS AND WHAT IT IS USED FOR
X’ INHU PRITOR U GĦALXIEX JINTUŻA
Pritor belongs to a class of medicines known as angiotensin II receptor antagonists.
Pritor jagħmel parti minn klassi ta ’ mediċini magħrufa bħala antagonisti tar- riċetturi ta ’ angiotensin II.