qanastek/EMEA-V3 huggingface dataset:
EU/ 1/ 97/ 049/ 010 14 tablets EU/ 1/ 97/ 049/ 001 28 tablets EU/ 1/ 97/ 049/ 002 56 tablets EU/ 1/ 97/ 049/ 013 56 x 1 tablets EU/ 1/ 97/ 049/ 003 98 tablets
EU/ 1/ 97/ 049/ 010 14- il pillola EU/ 1/ 97/ 049/ 001 28 pillola EU/ 1/ 97/ 049/ 002 56 pillola EU/ 1/ 97/ 049/ 013 56 x 1 pillola EU/ 1/ 97/ 049/ 003 98 pillola
67 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
73 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
74 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Karvea 150 mg tablets irbesartan
Karvea 150 mg pilloli irbesartan
EU/ 1/ 97/ 049/ 011 14 tablets EU/ 1/ 97/ 049/ 004 28 tablets EU/ 1/ 97/ 049/ 005 56 tablets EU/ 1/ 97/ 049/ 014 56 x 1 tablets EU/ 1/ 97/ 049/ 006 98 tablets
EU/ 1/ 97/ 049/ 011 14- il pillola EU/ 1/ 97/ 049/ 004 28 pillola EU/ 1/ 97/ 049/ 005 56 pillola EU/ 1/ 97/ 049/ 014 56 x 1 pillola EU/ 1/ 97/ 049/ 006 98 pillola
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
77 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Karvea 300 mg tablets irbesartan
Karvea 300 mg pilloli irbesartan
EU/ 1/ 97/ 049/ 012 14 tablets EU/ 1/ 97/ 049/ 007 28 tablets EU/ 1/ 97/ 049/ 008 56 tablets EU/ 1/ 97/ 049/ 015 56 x 1 tablets EU/ 1/ 97/ 049/ 009 98 tablets
EU/ 1/ 97/ 049/ 012 14- il pillola EU/ 1/ 97/ 049/ 007 28 pillola EU/ 1/ 97/ 049/ 008 56 pillola EU/ 1/ 97/ 049/ 015 56 x 1 pillola EU/ 1/ 97/ 049/ 009 98 pillola
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
79 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Karvea 75 mg film-coated tablets irbesartan
Karvea 75 mg pilloli miksijin b' rita irbesartan
14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 30 pillola 56 pillola 56 X 1 pilloli 84 pillola 90 pillola 98 pillola
EU/ 1/ 97/ 049/ 016 14 tablets EU/ 1/ 97/ 049/ 017 28 tablets EU/ 1/ 97/ 049/ 034 30 tablets EU/ 1/ 97/ 049/ 018 56 tablets EU/ 1/ 97/ 049/ 019 56 x 1 tablets EU/ 1/ 97/ 049/ 031 84 tablets EU/ 1/ 97/ 049/ 037 90 tablets EU/ 1/ 97/ 049/ 020 98 tablets
EU/ 1/ 97/ 049/ 016 14- il pillola EU/ 1/ 97/ 049/ 017 28 pillola EU/ 1/ 97/ 049/ 034 30 pillola EU/ 1/ 97/ 049/ 018 56 pillola EU/ 1/ 97/ 049/ 019 56 x 1 pillola EU/ 1/ 97/ 049/ 031 84 pillola EU/ 1/ 97/ 049/ 037 90 pillola EU/ 1/ 97/ 049/ 020 98 pillola
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
83 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Karvea 150 mg film-coated tablets irbesartan
Karvea 150 mg pilloli miksijin b' rita irbesartan
EU/ 1/ 97/ 049/ 021 14 tablets EU/ 1/ 97/ 049/ 022 28 tablets EU/ 1/ 97/ 049/ 035 30 tablets EU/ 1/ 97/ 049/ 023 56 tablets EU/ 1/ 97/ 049/ 024 56 x 1 tablets EU/ 1/ 97/ 049/ 032 84 tablets EU/ 1/ 97/ 049/ 038 90 tablets EU/ 1/ 97/ 049/ 025 98 tablets
EU/ 1/ 97/ 049/ 021 14- il pillola EU/ 1/ 97/ 049/ 022 28 pillola EU/ 1/ 97/ 049/ 035 30 pillola EU/ 1/ 97/ 049/ 023 56 pillola EU/ 1/ 97/ 049/ 024 56 x 1 pillola EU/ 1/ 97/ 049/ 032 84 pillola EU/ 1/ 97/ 049/ 038 90 pillola EU/ 1/ 97/ 049/ 025 98 pillola
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
85 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
86 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Karvea 300 mg film-coated tablets irbesartan
Karvea 300 mg pilloli miksijin b' rita irbesartan
EU/ 1/ 97/ 049/ 026 14 tablets EU/ 1/ 97/ 049/ 027 28 tablets EU/ 1/ 97/ 049/ 036 30 tablets EU/ 1/ 97/ 049/ 028 56 tablets EU/ 1/ 97/ 049/ 029 56 x 1 tablets EU/ 1/ 97/ 049/ 033 84 tablets EU/ 1/ 97/ 049/ 039 90 tablets EU/ 1/ 97/ 049/ 030 98 tablets
EU/ 1/ 97/ 049/ 026 14- il pillola EU/ 1/ 97/ 049/ 027 28 pillola EU/ 1/ 97/ 049/ 036 30 pillola EU/ 1/ 97/ 049/ 028 56 pillola EU/ 1/ 97/ 049/ 029 56 x 1 pillola EU/ 1/ 97/ 049/ 033 84 pillola EU/ 1/ 97/ 049/ 039 90 pillola EU/ 1/ 97/ 049/ 030 98 pillola
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
88 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
84 PACKAGE LEAFLET:
90 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Karvea 75 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvea 75 mg pilloli irbesartan
What Karvea is and what it is used for 2.
X' inhu Karvea u għalxiex jintuża 2.
Before you take Karvea 3.
Qabel ma tieħu Karvea 3.
How to take Karvea 4.
Kif għandek tieħu Karvea 4.
How to store Karvea 6.
Kif taħżen Karvea 6.
WHAT KARVEA IS AND WHAT IT IS USED FOR
X' INHU KARVEA U GĦALXIEX JINTUŻA
Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists.
Karvea jappartjeni għall- grupp ta ’ mediċini magħrufa bħala antagonisti tar- riċetturi angiotensin- II.
Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Karvea jipprevjeni li angiotensin- II tingħaqad ma ’ dawn ir- riċetturi, u jwassal il- vini tad- demm biex jirrilassaw u b’ hekk il- pressjoni tinżel.
Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Karvea inaqqas ir- rata tat- tnaqqis tal- funzjoni tal- kliewi f’ pazjenti bi pressjoni għolja u b’ dijabete ta 'tip 2.
Karvea is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Karvea jintuża biex jikkura pressjoni għolja tad- demm (pressjoni għolja) biex jipproteġi lill- kliewi f’ pazjenti bi pressjoni għolja ħafna, b’ dijabete ta ’ tip 2 u b’ evidenza mit- testijiet tal- laboratorju ta ’ indeboliment fil- funzjoni tal- kliewi.
BEFORE YOU TAKE KARVEA
QABEL MA TIEĦU KARVEA
Do not take Karvea if you are allergic (hypersensitive) to irbesartan or any other ingredients of Karvea during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding
Tiħux Karvea jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal irbesartan jew sustanzi oħra ta 'Karvea matul l- aħħar sitt xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ jekk qegħda tredda ’
Karvea should not be given to children and adolescents (under 18 years).
Karvea m’ għandux jingħata lit- tfal u adoloxxenti (taħt it- 18- il sena).
Take special care with Karvea Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Karvea for diabetic kidney disease.
Oqgħod attent ħafna b' Karvea Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik: jekk ikollok rimettar jew dijarea eċċessiva jekk tbati minn problemi fil- kliewi jekk tbati minn problemi tal- qalb jekk tirċievi Karvea għal mard tal- kliewi dijabetiku.
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you are going to have an operation (surgery) or be given anaesthetics You must tell your doctor if you think that you are (or might become) pregnant.
F' dan il- każ, it- tabib tiegħek jista ’ jagħmel testijiet regolari tad- demm, speċjalment biex ikejjel il- livelli tal- potassium fid- demm f’ każ li il- funzjoni tal- kliewi tkun bagħtuta jekk tkun se tagħmel xi operazzjoni (kirurġija) jew tkun se tingħata xi loppju Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
Karvea is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Karvea mhuwiex rakkomandat kmieni matul it- tqala u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek wara l- ewwel 3 xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ.
85 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
91 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Karvea does not usually interact with other medicines.
Ġeneralment, Karvea ma għandux effetti ma ’ mediċini oħra.
Taking Karvea with food and drink Karvea can be taken with or without food.
Meta tieħu Karvea ma 'l- ikel u max- xorb Karvea jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Usually, your doctor will advise you to take another medicine instead of Karvea, as Karvea is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek jagħtik parir li tieħu mediċina oħra minflok Karvea, minħabba li Karveamhuwiex rakkomandat kmieni matul it- tqala, u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek jekk jintuża wara l- ewwel 3 xhur tat- tqala.
Appropriate antihypertensive drug must usually replace Karvea before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment tissostitwixxi Karveaqabel il- bidu ta ’ tqala.
Your doctor will normally advise you to stop taking Karvea as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Karvea malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with Karvea, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ Karvea, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
Karvea is unlikely to affect your ability to drive or use machines.
Sewqan u tħaddim ta 'magni Mhux mistenni li Karvea itellfek milli issuq jew tħaddem magni.
Important information about some of the ingredients of Karvea Karvea contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Karvea Karvea fih lactose.
If you have been told by your doctor that you have an intolerance to some sugars (e. g. lactose), contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li inti ma tittollerax xi zokkor (eż. lactose), għid lit - tabib qabel tieħu din il- mediċina.
HOW TO TAKE KARVEA
KIF GĦANDEK TIEĦU KARVEA
Always take Karvea exactly as your doctor has told you.
Dejjem għandek tieħu Karvea skond il- parir tat- tabib.
Method of administration Karvea is for oral use.
Metodu ta ’ għoti Karvea huwa għal użu mill- ħalq.
You can take Karvea with or without food.
Tista ’ tieħu Karvea ma ’ l- ikel kif ukoll mingħajr ikel.
It is important that you continue to take Karvea until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu Karvea sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.
Patients with high blood pressure The usual dose is 150 mg once a day (two tablets a day).
Pazjenti bi pressjoni tad- demm għolja ħafna Id- doża normali hija 150 mg darba kuljum (żewġ pilloli kuljum).
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pazjenti bi pressjoni tad- demm għolja u b' dijabete ta 'tip 2 b’ mard tal- kliewi F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (erba ’ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
86 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
92 It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
If you take more Karvea than you should If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu Karvea aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If a child swallows some tablets, contact your doctor immediately.
It- tfal ma għandhomx jieħdu Karvea Karvea ma għandux jingħata lil tfal ta ’ taħt it- 18- il sena. jekk tifel/ tifla jibla/ tibla xi pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If you forget to take Karvea If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Karvea Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu id- doża li jmiss bħas- soltu.
Like all medicines, Karvea can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Karvea jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.
Jekk ikollok kwalunkwe sintomu minn dawn li ġejjin jew inkella ssofri minn qtugħ ta ’ nifs, tiħux aktar Karvea u kkuntattja lit- tabib tiegħek minnufih.
Side effects reported in clinical studies for patients treated with Karvea were:
L- effetti sekondarji rrappurtati fl- istudji kliniċi għall- pazjenti kkurati b’ Karvea kienu:
Some undesirable effects have been reported since marketing of Karvea but the frequency for them to occur is not known.
Xi effetti sekondarji ġew irrappurtati minn mindu Karvea tqiegħed fis- suq iżda l- frekwenza li jseħħu biha mhix magħrufa.
These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Dawn l- effetti mhux mixtieqa huma: uġigħ ta 'ras, disturbi fit- togħma, żarżir fil - widnejn, bugħawwieġ, uġigħ fil- ġogi u fil- muskoli, funzjoni tal- fwied anormali, livelli għoljin ta ’ potassium fid- demm, funzjoni tal- kliewi indebolita, u infjammazzjoni tal- vini ż- żgħar li taffettwa l - ġilda (kundizzjoni magħrufa bħala leukocytoclastic vasculitis).
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.
93 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE KARVEA
KIF TAĦŻEN KARVEA
Do not use Karvea after the expiry date which is stated on the carton and on the blister after EXP.
Tużax Karvea wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- folja wara JIS.
What Karvea contains The active substance is irbesartan.
X' fih Karvea Is- sustanza attiva hi irbesartan.
Each tablet of Karvea 75 mg contains 75 mg irbesartan.
Kull pillola ta ’ Karvea 75 mg fiha 75 mg ta ’ irbesartan.
What Karvea looks like and contents of the pack Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Id- dehra ta ’ Karvea u l- kontenuti tal- pakkett Il- pilloli Karvea 75 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2771 imnaqqax fuq in- naħa l- oħra.
Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Karvea 75 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
88 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
94 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
90 PACKAGE LEAFLET:
96 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Karvea 150 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvea 150 mg pilloli irbesartan
91 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
97 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Patients with high blood pressure The usual dose is 150 mg once a day.
Pazjenti bi pressjoni tad- demm għolja ħafna Id- doża normali hija 150 mg darba kuljum.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pazjenti bi pressjoni tad- demm għolja u b' dijabete ta 'tip 2 b’ mard tal- kliewi F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (żewġ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
92 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
98 It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
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.
99 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Each tablet of Karvea 150 mg contains 150 mg irbesartan.
Kull pillola ta ’ Karvea 150 mg fiha 150 mg ta ’ irbesartan.
What Karvea looks like and contents of the pack Karvea 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Id- dehra ta ’ Karvea u l- kontenuti tal- pakkett Il- pilloli Karvea 150 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2772 imnaqqax fuq in- naħa l- oħra.
Karvea 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Karvea 150 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
94 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
101 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
96 PACKAGE LEAFLET:
103 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Karvea 300 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvea 300 mg pilloli irbesartan
97 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
104 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pazjenti bi pressjoni tad- demm għolja u b' dijabete ta 'tip 2 b’ mard tal- kliewi F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
98 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
105 It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
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.
106 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Each tablet of Karvea 300 mg contains 300 mg irbesartan.
Kull pillola ta ’ Karvea 300 mg fiha 300 mg ta ’ irbesartan.
What Karvea looks like and contents of the pack Karvea 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Id- dehra ta ’ Karvea u l- kontenuti tal- pakkett Il- pilloli Karvea 300 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2773 imnaqqax fuq in- naħa l- oħra.
Karvea 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Karvea 300 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
100 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
108 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
102 PACKAGE LEAFLET:
110 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Karvea 75 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvea 75 mg pilloli miksijin b’ rita irbesartan
103 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
111 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Karvea is unlikely to affect your ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Mhux mistenni li Karvea itellfek milli issuq jew tħaddem magni.
104 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
112 It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu Karvea aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Karvea Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu id- doża li jmiss bħas- soltu.
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.
113 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Karvea looks like and contents of the pack Karvea 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Id- dehra ta ’ Karvea u l- kontenuti tal- pakkett Il- pilloli Karvea 75 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2871 imnaqqax fuq in- naħa l- oħra.
Karvea 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets.
Karvea 75 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b’ rita.
106 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
114 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
108 PACKAGE LEAFLET:
116 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Karvea 150 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvea 150 mg pilloli miksijin b’ rita irbesartan
109 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
117 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
110 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
118 It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
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.
119 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Karvea looks like and contents of the pack Karvea 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Id- dehra ta ’ Karvea u l- kontenuti tal- pakkett Il- pilloli Karvea 150 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2872 imnaqqax fuq in- naħa l- oħra.
Karvea 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets.
Karvea 150 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b’ rita.
112 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
121 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
114 PACKAGE LEAFLET:
123 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Karvea 300 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvea 300 mg pilloli miksijin b’ rita irbesartan
115 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
124 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
116 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
125 It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
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.
126 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Karvea looks like and contents of the pack Karvea 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Id- dehra ta ’ Karvea u l- kontenuti tal- pakkett Il- pilloli Karvea 300 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2873 imnaqqax fuq in- naħa l- oħra.
Karvea 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets.
Karvea 300 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b’ rita.
118 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
128 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
What is Karvezide?
X’ inhu Karvezide?
Karvezide is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Karvezide huwa mediċina li fiha żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
What is Karvezide used for?
Għalxiex jintuża Karvezide?
Karvezide is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Karvezide jintuża f’ adulti li jkollhom ipertensjoni essenzjali (pressjoni għolja tad- demm) li ma tkunx ikkontrollata adegwatament b’ irbesartan jew b’ hydrochlorothiazide waħedhom. ‘ Essenzjali ’ tfisser li l- pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
How is Karvezide used?
Kif jintuża Karvezide?
Karvezide is taken by mouth, with or without food.
Karvezide jittieħed mill- ħalq, ma ’ l- ikel jew fuq stonku vojt.
The dose of Karvezide to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Id- doża ta ’ Karvezide li għandha tintuża tiddependi mid- doża ta ’ irbesartan jew ta ’ hydrochlorothiazide li l- pazjent ikun qed jieħu qabel.
Karvezide may be added to other treatments for hypertension.
Karvezide jista ’ jiżdied ma ’ trattamenti oħra għall- pressjoni għolja.
How does Karvezide work?
Kif jaħdem Karvezide?
Karvezide contains two active substances, irbesartan and hydrochlorothiazide.
Karvezide fih żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
Irbesartan is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Irbesartan hu ‘ antagonist tar- riċetturi ta ’ angiotensin II ’, li jfisser li jimblokka l- azzjoni ta ’ ormon fil - ġisem magħruf bħala angiotensin II.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Angiotensin II huwa vażokostrittur (sustanza li ddejjaq il- vini u l - arterji) qawwi.
By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Billi jimblokka r- riċetturi li normalment jeħel magħhom angiotensin II, irbesartan iwaqqaf l- ormon milli jkollu effett, u jħalli l- arterji u l- vini jitwessgħu.
It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Jaħdem billi jżid il- produzzjoni tal- awrina, inaqqas l- ammont ta ’ fluwidu fid- demm u jbaxxi l- pressjoni.
By lowering the blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Bit- tnaqqis tal- pressjoni tad- demm, jitnaqqas ir - riskju kkawżat mill- pressjoni għolja, bħar- riskju li wieħed ikollu puplesija.
How has Karvezide been studied?
Kif ġie studjat Karvezide?
Karvea/ Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Karvezide.
Reproduction is authorised provided the source is acknowledged. użat ma ’ hydrochlorothiazide bħala pilloli separati ntużaw b’ appoġġ għall- użu ta ’ Karvezide.
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Il - mezz ewlieni tal- kejl tal- effikaċja kien it- tnaqqis fil- pressjoni dijastolika (il- pressjoni mkejla bejn żewġ taħbitiet tal- qalb).
What benefit has Karvezide shown during the studies?
Liema benefiċċju wera Karvezide waqt l- istudji mwettqa?
Karvezide was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Karvezide kien iktar effikaċi mill- plaċebo (trattament finta) u minn hydrochlorothiazide waħdu fit - tnaqqis tal- pressjoni dijastolika.
What is the risk associated with Karvezide?
X’ inhu r- riskju assoċjat ma ’ Karvezide?
The most common side effects with Karvezide (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles).
L- iktar effett sekondarju komuni ma ’ Karvezide (li deher f’ bejn pazjent wieħed u 10 minn kull 100) huma l- isturdament, dardir jew remettar, awrinar mhux normali, għeja, u żidiet fil- livelli ta ’ nitroġenu fl- urea tad- demm (BUN, prodott tat- tkissir tal- proteini), kreatinina (prodott tat- tkissir tal- muskoli) u kreatina kinażi (creatine kinase, enzim fil- muskoli).
For the full list of all side effects reported with Karvezide, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurati ma ’ Karvezide, ara l- Fuljett ta ’ Tagħrif.
Karvezide should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Karvezide m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal irbesartan, hydrochlorothiazide, sulfonamides, jew għal xi sustanza oħra tiegħu.
Karvezide should also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Karvezide lanqas ma għandu jintuża f’ pazjenti li jkollhom problemi severi fil- fwied, fil- kliewi jew fis- sistema biljari, livelli baxxi wisq ta ’ potassju, u livelli għoljin wisq ta ’ kalċju.
Care must be taken when using Karvezide with other medicines that have an effect on blood potassium levels.
Wieħed għandu joqgħod attent meta juża Karvezide ma ’ mediċini oħrajn li jista ’ jkollhom effett fuq il - livell tal- potassju fid- demm.
Why has Karvezide been approved?
Għaliex ġie approvat Karvezide?
The Committee for Medicinal Products for Human Use (CHMP) decided that Karvezide’ s benefits are greater than its risks for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Karvezide huma ikbar mir- riskji tiegħu għat- trattament ta ’ ipertensjoni essenzjali f’ pazjenti adulti li l - pressjoni tad- demm tagħhom mhijiex ikkontrollata adegwatament fuq irbesartan jew hydrochlorothiazide waħedhom.
The Committee recommended that Karvezide be given marketing authorisation.
Il- Kumitat irrakkomanda li Karvezide jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Karvezide:
Iktar tagħrif dwar Karvezide:
The European Commission granted a marketing authorisation valid throughout the EU for Karvezide to Bristol-Myers Squibb Pharma EEIG on 16 October 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal Karvezide lil Bristol- Myers Squibb Pharma EEIG fis- 16 ta ’ Ottubru 1998.
The marketing authorisation was renewed on 16 October 2003 and on 16 October 2008.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fis- 16 ta ’ Ottubru 2003 u fis- 16 ta ’ Ottubru 2008.
The full EPAR for Karvezide is available here.
L- EPAR sħiħ għal Karvezide jista ’ jiġi kkonsultat hawn.
Karvezide 150 mg/ 12.5 mg tablets.
Karvezide 150 mg/ 12. 5 mg pilloli.
Karvezide can be taken once daily, with or without food.
Karvezide jista ’ jittieħed darba kuljum, ma ’ l- ikel jew waħdu.
Karvezide 150 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; Karvezide 300 mg/ 12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Karvezide 150 mg/ 12.5 mg.
Karvezide 150 mg/ 12. 5 mg jista ’ jingħata f ’ pazjenti, fejn il- pressjoni mhix qed tiġi kkontrollata sew b’ hydrochlorothiazide jew irbesartan 150 mg waħidhom; Karvezide 300 mg/ 12. 5 mg jista ’ jingħata lill- pazjenti li mhux qed ikunu kkontrollati b’ mod suffiċjenti b’ irbesartan 300 mg jew b’ Karvezide 150 mg/ 12. 5 mg.
Karvezide 300 mg/ 25 mg may be administered in patients insufficiently controlled by Karvezide 300 mg/ 12.5 mg.
Karvezide 300 mg/ 25 mg jista ’ jingħata lil pazjenti li ma jkunux qed jiġu kkontrollati b’ mod suffiċjenti b’ Karvezide 300 mg/ 12. 5 mg.
When necessary, Karvezide may be administered with another antihypertensive medicinal product (see section 4.5).
Meta neċessarju, Karvezide jista jingħata ma ’ prodott mediċinali ieħor kontra l- pressjoni għolja (ara sezzjoni 4. 5).
Renal impairment: due to the hydrochlorothiazide component, Karvezide is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/ min).
Indeboliment renali: minħabba li fih il- komponent ta ’ hydrochlorothiazide, Karvezide mhux irrikmandat għall- pazjenti b’ disfunzjoni renali severa (tneħħija tal- krejatinina < 30 ml/ min).
Karvezide is not indicated in patients with severe hepatic impairment.
Karvezide mhux indikat f’ pazjenti b’ indeboliment epatiku sever.
No dosage adjustment of Karvezide is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
M’ hemmx bżonn aġġustar fid - doża ta ’ Karvezide f’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 4. 3).
2 Elderly patients: no dosage adjustment of Karvezide is necessary in elderly patients.
2 Pazjenti anzjani: m’ hemmx bżonn aġġustar fid- doża ta ’ Karvezide f’ pazjenti anzjani.
Karvezide is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Karvezide m’ huwiex rakkomandat għall- użu fit- tfal u l- adoloxxenti minħabba nuqqas ta ’ tagħrif dwar is- sigurtà u l- effikaċja.
Karvezide has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Karvezide kien rarament assoċjat ma ’ pressjoni baxxa sintomatika f’ pazjenti bi pressjoni għolja mingħajr fatturi ta ’ riskju oħra għall- pressjoni baxxa.
Such conditions should be corrected before initiating therapy with Karvezide.
Dawn il- kondizzjonijiet għandhom jiġu korretti qabel tinbeda il- kura b’ Karvezide.
While this is not documented with Karvezide, a similar effect should be anticipated.
Għalkemm m’ hemm xejn dokumentat li dan isir b’ Karvezide, effetti simili għandhom ikunu mistennija.
Renal impairment and kidney transplantation: when Karvezide is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Indeboliment renali u trapjant tal- kliewi: meta Karvezide jintuża f’ pazjenti b’ indeboliment tal- funzjoni renali, hija rrikmandata osservazzjoni perjodika tal- livelli tal- potassium fis- serum, tal- krejatinina u tal - uric acid.
There is no experience regarding the administration of Karvezide in patients with a recent kidney transplantation.
M’ hemmx esperjenza meta Karvezide jingħata lill- pazjenti li riċentament kellhom trapjant tal- kliewi.
Karvezide should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Karvezide m’ għandux jintuża f’ pazjenti b’ indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3).
There is no clinical experience with Karvezide in patients with hepatic impairment.
Għad m’ hemmx esperjenza klinika b’ Karvezide f’ pazjenti b’ indeboliment epatiku.
Therefore, the use of Karvezide is not recommended.
Għalhekk, mhux irrikmandat l- użu ta ’ Karvezide.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Karvezide, minimal or no effects were reported.
3 Żidiet fil- livelli tal- kolesterol u tat- trigliċeridi ġew assoċjati mat- terapija dijuretika thiazide; madankollu b’ doża ta ’ 12. 5 mg ta ’ Karvezide, l- effetti li ġew irrapportati kienu minimi jew xejn.
Conversely, due to the irbesartan component of Karvezide hyperkalaemia might occur, especially in the presence of renal impairment and/ or heart failure, and diabetes mellitus.
Għal kuntrarju, minħabba li Karvezide fih irbesartan, jista jkun hemm iperkalimja speċjalment fil - preżenza ta ’ indeboliment renali u/ jew insuffiċenza tal- qalb u dijabete.
Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Karvezide (see section 4.5).
Id- dijuretiċi li ma jnaqqsux il- potassium, supplimenti tal- potassium jew sostituti li fihom il- potassium għandhom jingħataw b’ attenzjoni flimkien ma ’ Karvezide (ara sezzjoni 4. 5).
Lithium: the combination of lithium and Karvezide is not recommended (see section 4.5).
Lithium: mhux irrikmandat l- użu flimkien ta ’ lithium u Karvezide (ara sezzjoni 4. 5).
Other antihypertensive agents: the antihypertensive effect of Karvezide may be increased with the concomitant use of other antihypertensive agents.
Mediċini oħra kontra l- pressjoni għolja: l- effett ta ’ Karvezide kontra l- pressjoni għolja jista ’ jiżdied meta jingħata flimkien ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja.
Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Karvezide.
U wkoll, tneħħija renali ta ’ lithium titnaqqas b’ thiazides u għalhekk, ir- riskju ta ’ tossiċita ’ minn lithium tista ’ tiżdied b’ Karvezide.
Therefore, the combination of lithium and Karvezide is not recommended (see section 4.4).
Għalhekk, il- kombinazzjoni ta ’ lithium u Karvezide mhiex irrikkmandata (ara sezzjoni 4. 4).
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Karvezide is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
Prodotti mediċinali affettwati b’ tibdil tal- potassium fis- serum: osservazzjoni perjodika tal - potassium fis- serum hija rrikmandata meta Karvezide jiġi mogħti flimkien ma ’ prodotti mediċinali oħra affettwati b’ disturbi tal- potassium fis- serum (p. e. digitalis glycosides, antiarritmiċi).
Since Karvezide contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Billi Karvezide fih hydrochlorothiazide, mhux irrikkmandat waqt l- ewwel trimestru tat- tqala.
Karvezide is contraindicated during breast-feeding.
Karvezide huwa kontra- indikat waqt it- treddigħ.
Based on its pharmacodynamic properties, Karvezide is unlikely to affect this ability.
Skond il- kwalitajiet farmakodinamiċi tiegħu, Karvezide mhux suppost li jkollu effett fuq din il- ħila.
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Karvezide.
Aktar tagħrif fuq komponenti individwali: minbarra r- reazzjonijiet avversi msemmijin hawn fuq għal dan il- prodott kombinat, reazzjonijiet avversi oħrajn li ġew irrapportati ma ’ wieħed minn dawn il - komponenti individwali jistgħu jkunu reazzjonijiet avversi potenzjali ma ’ Karvezide.
Tables 2 and 3 below detail the adverse reactions reported with the individual components of Karvezide.
It- Tabelli 2 u 3 taħt jiddeskrivu fid- dettall ir- reazzjonijiet avversi rrapportati mal- komponenti individwali ta ’ Karvezide.
No specific information is available on the treatment of overdose with Karvezide.
M’ hemmx biżżejjed informazzjoni speċifika fuq il- kura ta ’ doża eċċessiva ta ’ Karvezide.
Karvezide is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
9 Karvezide huwa kombinazzjoni ta ’ antagonist ta ’ riċettur angiotensin- II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Karvezide 150 mg/ 12.5 mg were 100%.
Meta mkejla permezz ta ’ osservazzjoni tal- pressjoni ambulatorja l- effetti mill- inqas għal aktar ta ’ Karvezide 150 mg/ 12. 5 mg kienu 100%.
The trough to peak effects measured by cuff during office visits were 68% and 76% for Karvezide 150 mg/ 12.5 mg and Karvezide 300 mg/ 12.5 mg, respectively.
L- effetti mill - inqas għal aktar mkejla mid- dirgħajn waqt il- viżti għand it- tabib kienu 68% u 76% għal Karvezide 150 mg/ 12. 5 mg u Karvezide 300 mg/ 12. 5 mg, rispettivament.
Although not specifically studied with the Karvezide, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Għalkemm ma ġiex speċifikament studjat b’ Karvezide, il- pressjoni ma reġgħetx għoliet kemm b’ irbesartan jew b’ hydrochlorothiazide.
There is no difference in response to Karvezide, regardless of age or gender.
Ir- rispons għal Karvezide ma jiddependix mill- età u lanqas mis- sess.
Efficacy and safety of Karvezide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
L- effikaċja u s- sigurtà ta ’ Karvezide bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b’ aktar minn ċentru wieħed, b’ mod każwali, double - blind, ikkontrollat b’ mod attiv ta ’ 8 ġimgħat, parallel- arm.
Following oral administration of Karvezide, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Wara li jingħata mill- ħalq Karvezide il- biodisponibilità assoluta orali hija 60 - 80% u 50 - 80% għal irbesartan u hydrochlorothiazide, rispettivament.
Food does not affect the bioavailability of Karvezide.
L- ikel ma jaffettwax il- biodisponibilità ta ’ Karvezide.
Peak plasma concentration occurs at 1.5-2 hours after oral administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.
Il- konċentrazzjoni fil- plażma tilħaq l- ogħla livell 1. 5 - 2 sigħat wara li tingħata mill - ħalq għal irbesartan u 1 - 2. 5 sigħat għal hydrochlorothiazide.
16 October 1998 Date of last renewal:
16 ta ’ Ottubru 1998 Data ta ’ l- aħħar tiġdid:
Karvezide 300 mg/ 12.5 mg tablets.
Karvezide 300 mg/ 12. 5 mg pilloli.
15 Elderly patients: no dosage adjustment of Karvezide is necessary in elderly patients.
15 Pazjenti anzjani: m’ hemmx bżonn aġġustar fid- doża ta ’ Karvezide f’ pazjenti anzjani.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Karvezide, minimal or no effects were reported.
16 Żidiet fil- livelli tal- kolesterol u tat- trigliċeridi ġew assoċjati mat- terapija dijuretika thiazide; madankollu b’ doża ta ’ 12. 5 mg ta ’ Karvezide, l- effetti li ġew irrapportati kienu minimi jew xejn.
Karvezide is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
22 Karvezide huwa kombinazzjoni ta ’ antagonist ta ’ riċettur angiotensin- II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
Karvezide 150 mg/ 12.5 mg film-coated tablets.
Karvezide 150 mg/ 12. 5 mg pilloli miksijin b' rita.
28 Elderly patients: no dosage adjustment of Karvezide is necessary in elderly patients.
Pazjenti anzjani: m’ hemmx bżonn aġġustar fid- doża ta ’ Karvezide f’ pazjenti anzjani.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Karvezide, minimal or no effects were reported.
Żidiet fil- livelli tal- kolesterol u tat- trigliċeridi ġew assoċjati mat- terapija dijuretika thiazide; madankollu b’ doża ta ’ 12. 5 mg ta ’ Karvezide, l- effetti li ġew irrapportati kienu minimi jew xejn.
Karvezide is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Karvezide huwa kombinazzjoni ta ’ antagonist ta ’ riċettur angiotensin- II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
Karvezide 300 mg/ 12.5 mg film-coated tablets.
Karvezide 300 mg/ 12. 5 mg pilloli miksijin b' rita.
41 Elderly patients: no dosage adjustment of Karvezide is necessary in elderly patients.
Pazjenti anzjani: m’ hemmx bżonn aġġustar fid- doża ta ’ Karvezide f’ pazjenti anzjani.
Karvezide 300 mg/ 25 mg film-coated tablets.
Karvezide 300 mg/ 25 mg pilloli miksijin b' rita.