qanastek/EMEA-V3 huggingface dataset:
As with other blood pressure lowering medicinal products, the effect of irbesartan may be reduced when you take non-steroidal anti-inflammatory medicinal products (for example, ibuprofen).
Bħal b’ mediċini oħra li jniżżlu l- pressjoni għolja, l- effett t’ irbesartan jista ’ jonqos meta tieħu mediċini ta ’ kontra l- infjammazzjoni li mhumiex sterojdi.
The tablets should be swallowed with a drink of water.
Meta tieħu Irbesartan Krka ma 'l- ikel u max- xorb Irbesartan Krka jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
You must tell your doctor if you think that you are (or might become) pregnant.
Għandek tgħarraf lit- tabib tiegħek jekk taħseb li int (jew tista 'tinqabad) tqila.
Usually, your doctor will advise you to take another medicine instead of Irbesartan Krka, as Irbesartan Krka is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Ġeneralment, it- tabib tiegħek ser jagħtik parir tuża mediċina oħra minflok Irbesartan Krka, peress li Irbesartan Krka mhux rakkomandat fil- bidu tat- tqala, u jista 'jikkawża ħsara serja fit- tarbija tiegħek wara 3 xhur ta' tqala.
Appropriate antihypertensive medicinal product must usually replace Irbesartan Krka before starting a pregnancy.
Prodott mediċinali xieraq ta 'kontra l- pressjoni għandu ġeneralment jissostitwixxi Irbesartan Krka qabel il- bidu tat- tqala.
The product should not be used during the 2nd and 3rd trimester of pregnancy, or while breast-feeding.
Il- prodott m' għandux jintuża wat it- 2ni u t- 3et trimestri ta 'tqala, jew waqt li qed tredda'
Your doctor will normally advise you to stop taking Irbesartan Krka as soon as you know you are pregnant.
It- tabib tiegħek ġeneralment ser jagħtik parir biex tieqaf tieħu Irbesartan Krka hekk kif issir taf li nqbadt tqila.
If you become pregnant during therapy with Irbesartan Krka, please inform and see your doctor without delay.
Jekk tinqabad tqila waqt li qed tieħu t- terapija ta 'Irbesartan Krka, jekk jogħġbok għarraf lit- tabib tiegħek mingħajr dewmien.
Driving and using machines Irbesartan Krka is unlikely to affect your ability to drive or use machines.
Sewqan u tħaddim ta 'magni Mhux mistenni li Irbesartan Krka itellfek milli issuq jew tħaddem magni.
However, occasionally dizziness or tiredness may occur during treatment of high blood pressure.
Madanakollu, xi kultant sturdament u għeja jistgħu jinħassu waqt il- kura ta ’ kontra il- pressjoni għolja.
If you experience these symptoms, you should consult your doctor before driving or using machines.
Jekk tesperjenza dawn, għandek tirreferi lit- tabib tiegħek qabel ma tipprova dawn l- attivitajiet.
Important information about some of the ingredients of Irbesartan Krka This medicinal product contains castor oil which may cause stomach upset and diarrhoea.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Irbesartan Krka
HOW TO TAKE IRBESARTAN KRKA
KIF GĦANDEK TIEĦU IRBESARTAN KRKA
Always take Irbesartan Krka exactly as your doctor has told you.
Dejjem għandek tieħu Irbesartan Krka skond il- parir tat- tabib.
- The usual dose in high blood pressure is 150 mg once a day (two tablets a day).
- Id- doża normali f’ pressjoni gholja hija 150 mg darba kuljum (żewġ pilloli kuljum).
The dose may
Iktar tard, id- doża
later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.
tista ’ tiżdied għal 300 mg (erba ’ pilloli kuljum) darba kuljum jiddependi fuq l- effett fuq il- pressjoni.
48 The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
- L- effett massimu biex tinżel il- pressjoni tad- demm għandu jintlaħaq 4- 6 ġimgħat wara li tinbeda l- kura.
- In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred
- F’ pazjenti bi pressjoni għolja u b' dijabete ta 'tip 2, doża ta ’ manteniment ta ’ 300 mg (erba ’ pilloli
maintenance dose for the treatment of associated kidney disease.
kuljum) hija ppreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
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.
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.
Irbesartan Krka is for oral use and is taken with or without food.
Irbesartan Krka hu għal użu orali u jista jitieħed ma jew mingħajr l- ikel.
The tablets should be swallowed with a glass of water.
Inti tista ’ tieħu Irbesartan Krka ma ’ l- ikel jew fuq stonku vojt.
You should try to take your daily dose at about the same time each day.
Inti għandek tipprova tieħu d- doża ta ’ kuljum kważi fl- istess ħin.
It is important that you continue to take Irbesartan Krka until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu Irbesartan Krka sakemm jgħidlek it- tabib.
If you take more Irbesartan Krka than you should If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.
Jekk tieħu Irbesartan Krka aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, jew jekk tifel/ tifla jibla ’ / tibla ’ xi ftit, informa mill- ewwel lit- tabib tiegħek.
If you forget to take Irbesartan Krka If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Irbesartan Krka Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu d- doża li jmiss bħas- soltu.
Like all medicines, Irbesartan Krka can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Irbesartan Krka jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Komuni ħafna: ta ’ lanqas 1 minn kull 10 pazjenti jew aktar Komuni: ta ’ lanqas 1 minn kull 100 pazjent u anqas minn 1 minn kull 10 pazjenti Mhux komuni: ta ’ lanqas 1 minn kull 1000 pazjent u anqas minn 1 minn kull 100 pazjent
Side effects reported in clinical studies for patients treated with irbesartan were:
L- effetti sekondarji rrappurtati fl- istudji kliniċi għall- pazjenti kkurati b ’ Irbesartan Krka kienu:
Common: dizziness, feeling sick/ vomiting, and fatigue.
Komuni: sturdament, dardir/ rimettar u għeja.
In patients with high blood pressure and type 2 diabetes with renal disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, and pain in joints or muscles were also reported.
F’ pazjenti bi pressjoni għolja tad- demm u dijabete ta ’ tip 2 b’ mard tal- kliewi, kienu rrappurtati wkoll sturdament speċjalment meta tqum minn pożizzjoni mimduda jew bil- qiegħda, pressjoni baxxa tad- demm meta tqum minn pożizzjoni mimduda jew bilqiegħda u wġigħ fil- ġogi jew fil- muskoli.
Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/ heartburn, sexual dysfunction (problems with sexual performance), chest pain.
54 Mhux komuni: taħbit tal- qalb aktar mgħaġġel, fwawar, sogħla, dijarea, indiġestjoni/ qrusa fl- istonku, problemi ta ’ funzjoni sesswali (problemi fl- attività sesswali), uġigħ fis- sider.
In addition your doctor may identify abnormal changes in your blood components such as creatine kinase increased (common).
Barraminhekk it- tabib tiegħek jista ’ jidentifika bidliet anormali fil- komponenti tad- demm tiegħek bħal żieda fil- livell ta ’ creatine kinase (komuni).
Moreover, if you suffer from high blood pressure and type 2 diabetes with renal disease, your doctor may identify the following changes in your blood components: potassium increased (very common), haemoglobin decreased (common).
Barra dan, jekk inti tbati minn pressjoni għolja tad- demm u dijabete ta ’ tip 2 b’ mard renali, it- tabib tiegħek jista ’ jidentifika l- bidliet li ġejjin fil- komponenti tad- demm tiegħek: żieda fil- potassju (komuni ħafna), tnaqqis fl- emoglobina (komuni).
Some undesirable effects have been reported since marketing of irbesartan but the frequency for them to occur is not known.
Xi effetti mhux mixtieqa ġew irrappurtati minn mindu Irbesartan Krka 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, liver function abnormal, increased blood potassium levels, impaired renal 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 renali indebolita, u infjammazzjoni tal- vini ż- żgħar li taffettwa l- ġilda (kundizzjoni magħrufa bħala leukocytoclastic vasculitis).
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/ or tongue have been reported in patients taking irbesartan.
Bħal ma jiġri b’ mediċini simili, każijiet rari ta ’ reazzjonijiet allerġiċi tal- ġilda (raxx, urtikarja), kif ukoll nefħa lokalizzata fil- wiċċ, fix- xufftejn u/ jew fl- ilsien ġew irrapportati f’ pazjenti li ħadu irbesartan.
If you think you are developing such a reaction or get short of breath stop taking irbesartan and seek immediate medical attention.
Jekk taħseb li qed tiżviluppa xi reazzjoni jew qed jonqoslok in- nifs tiħux Irbesartan Krka u fittex immedjatament attenzjoni medika.
49 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE IRBESARTAN KRKA
KIF TAĦŻEN IRBESARTAN KRKA
Do not use Irbesartan Krka after the expiry date which is stated on the carton and on the blister after EXP.
Tużax Irbesartan Krka wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- folja wara JIS.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lillispiżjar dwar kif għandek tarmi mediċini li m' għandekx bżonn.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall- protezzjoni ta 'l - ambjent.
What Irbesartan Krka contains
X' fih Irbesartan Krka
- The active substance is irbesartan.
- Is- sustanza attiva hi irbesartan.
Each film-coated tablet contains 75 mg irbesartan (as
Kull pillola miksija b’ rita li fiha 75 mg ta ’ irbesartan (b ’
hydrochloride).
hydrochloride)..
- The other ingredients are mannitol, hydroxypropylcellulose, low-substituted hydroxypropyl
- Is- sustanzi l- oħra huma mannitol, hydroxypropylcellulose, low- substituted hydroxypropyl
cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000, castor oil, hydrogenated in the core of tablet and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in film-coating.
cellulose (LH- 21), low- substituted hydroxypropyl cellulose (LH- 11), talc, macrogol 6000, castor oil, idroginata fil- qalba tal- pillola u polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 u talc fir- rita.
What Irbesartan Krka looks like and contents of the pack Irbesartan Krka 75 mg film-coated tablets are: white, oval film-coated tablets.
55 Il- pilloli Irbesartan Krka 75 mg miksija b’ rita huma: bojod, ovali, u miksija b’ rit.
Irbesartan Krka 75 mg film-coated tablets: available in boxes of 14, 28, 56, 84 and 98 film-coated tablets in blister packs and in boxes of 56 x 1 film-coated tablets in perforated unit dose blister pack.
Il- pilloli Irbesartan Krka 75 mg miksijin b’ rit: jigu f’ kaxxi 14, 28, 56, 84 and 98 pilloli miksijin b’ rit fi folji u fil- kaxxi b’ 56 x 1 pillola ta ’ doża waħda miksija b’ rita f’ pakkett b' folja pperforata.
Marketing Authorisation Holder and Manufacturer
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Tel.: +420 (0)221 115 150 Danmark KRKA Sverige AB Tlf: +46 (0)8 643 67 66 (SE)
Tel.: +420 (0) 221 115 150 Danmark KRKA Sverige AB Tlf: +46 (0) 8 643 67 66 (SE) Deutschland TAD Pharma GmbH Tel.: +49 (0) 4721 6060 Eesti KRKA, d. d., Novo mesto Eesti filiaal Tel.: +372 (0) 6 597 365 Ελλάδα KRKA, d. d., Novo mesto Tel.: +30 (0) 210 9581143 España KRKA, d. d., Novo mesto Tel.: +34 (0) 61 5089 809
Tel: +46 8 643 67 66 Nederland KRKA, d. d., Novo mesto Tel.: +32 3 321 63 52 (BE)
Tel.: +351 (0) 21 46 43 650
Deutschland TAD Pharma GmbH Tel.: +49 (0)4721 6060 Eesti KRKA, d. d., Novo mesto Eesti filiaal Tel.: +372 (0)6 597 365 Ελλάδα KRKA, d. d., Novo mesto Tel.: +30 210 9581143 España KRKA, d. d., Novo mesto Tel.: +34 (0)61 5089 809 France KRKA, d. d., Novo mesto Tél: +32 (0)3 321 63 52 (BE)
France KRKA, d. d., Novo mesto Tél: +32 3 321 63 52 (BE)
Tel.: +351 (0)21 46 43 650 România KRKA, d. d., Novo mesto Reprezentanţ a pentru România Tel.: +402 (0)1 310 66 05
România KRKA, d. d., Novo mesto Reprezentanţa pentru România Tel.: +402 (0) 1 310 66 05
Italia KRKA, d. d., Novo mesto Tel.: +39 069448827 Κύπρος KRKA, d. d., Novo mesto Τηλ: +30 (0)210 9581143 (EL) Latvija KRKA, d. d., Novo mesto Tel.: +371 (0)733 8610 Lietuva KRKA, d. d., Novo mesto Tel.: +370 5 362 2740
56 Italia KRKA, d. d., Novo mesto Tel.: +39 069448827 Κύπρος KRKA, d. d., Novo mesto Τηλ: +30 (0) 210 9581143 (EL) Latvija KRKA, d. d., Novo mesto Tel.: +371 (0) 733 8610 Lietuva KRKA, d. d., Novo mesto Tel.: +370 (0) 5 362 7420
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f '
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu /
51 PACKAGE LEAFLET:
57 FULJETT TA 'TAGĦRIF:
Irbesartan Krka 150 mg film-coated tablets Irbesartan
Irbesartan Krak 150 mg pilloli irbesartan
What Irbesartan Krka is and what it is used for 2.
X' inhu Irbesartan Krka u għalxiex jintuża 2.
In the
- jekk tbati minn problemi fil- kliewi jekk tirċievi Irbesatan Krka għal marda renali dijabetika.
latter case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function,
F' dan il- każ, it- tabib tiegħek jista ’ jagħmel testijiet regolari tad- demm, speċjalment biex ikejjel il -
- if you are to undergo any surgery or receive anaesthetics, you should also tell your doctor that
58 livelli tal- potassium fid- demm f’ każ li l- funzjoni tal- kliewi tkun batuta.
you are taking Irbesartan Krka.
-
52 You must tell your doctor if you think that you are (or might become) pregnant.
- jekk għandek tagħmel xi tip ta 'kirurġija jew tirċievi xi loppju, għandek tgħid lit- tabib tiegħek
Irbesartan Krka is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section Pregnancy and breastfeeding).
dwar dan ukoll
Important information about some of the ingredients of Irbesartan Krka This medicinal product contains castor oil which may cause stomach upset and diarrhoea.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Irbesartan Krka Irbesartan Krka fih castor oil (ara "Aktar tagħrif"). li jista jikaġuna stonku mqalleb jew dijarea.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib
53 The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
- L- effett massimu biex tinżel il- pressjoni tad- demm għandu jintlaħaq 4- 6 ġimgħat wara li tinbeda l- kura.
Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/ heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Mhux komuni: taħbit tal- qalb aktar mgħaġġel, fwawar, sogħla, dijarea, indiġestjoni/ qrusa fl- istonku, problemi ta ’ funzjoni sesswali (problemi fl- attività sesswali), uġigħ fis- sider.
Moreover, if you suffer from high blood pressure and type 2 diabetes with renal disease, your doctor may identify the following changes in your blood components: potassium increased (very common), haemoglobin decreased (common).
Barra dan, jekk inti tbati minn pressjoni għolja tad- demm u dijabete ta ’ tip 2 b’ mard renali, it- tabib tiegħek jista ’ jidentifika l- bidliet li ġejjin fil- komponenti
54 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Each film-coated tablet contains 150 mg irbesartan (as
Kull pillola miksija b’ rita li fiha 150 mg ta ’ irbesartan (b ’
What Irbesartan Krka looks like and contents of the pack Irbesartan Krka 150 mg film-coated tablets are: white, oval film-coated tablets.
Il- pilloli Irbesartan Krka 150 mg miksija b’ rita huma: bojod, ovali, u miksija b’ rit.
Irbesartan Krka 150 mg film-coated tablets: available in boxes of 14, 28, 56, 84 and 98 film-coated tablets in blister packs and in boxes of 56 x 1 film-coated tablets in perforated unit dose blister pack.
Il- pilloli Irbesartan Krka 75 mg miksijin b’ rit: jigu f’ kaxxi 14, 28, 56, 84 and 98 pilloli miksijin b’ rit fi folji u fil- kaxxi b’ 56 x 1 pillola ta ’ doża waħda miksija b’ rita f’ pakkett b' folja pperforata.
Marketing Authorisation Holder and Manufacturer
61 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Italia KRKA, d. d., Novo mesto Tel.: +39 069448827 Κύπρος KRKA, d. d., Novo mesto Τηλ: +30 (0)210 9581143 (EL) Latvija KRKA, d. d., Novo mesto Tel.: +371 (0)733 8610 Lietuva KRKA, d. d., Novo mesto Tel.: +370 5 362 2740
Italia KRKA, d. d., Novo mesto Tel.: +39 069448827 Κύπρος KRKA, d. d., Novo mesto
Suomi/ Finland KRKA Sverige AB Puh/ Tel: +46 (0)8 643 67 66 (SE) Sverige KRKA Sverige AB Tel: +46 (0)8 643 67 66 (SE) United Kingdom KRKA Pharma Dublin, Ltd.
Suomi/ Finland KRKA Sverige AB Puh/ Tel: +46 (0) 8 643 67 66 (SE) Sverige KRKA Sverige AB
56 PACKAGE LEAFLET:
63 FULJETT TA 'TAGĦRIF:
Irbesartan Krka 300 mg film-coated tablets Irbesartan
Irbesartan Krka 300 mg pilloli irbesartan
latter case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function,
64 demm, speċjalment biex ikejjel il- livelli tal- potassium fid- demm f’ każ li l- funzjoni tal- kliewi tkun batuta.
57 You must tell your doctor if you think that you are (or might become) pregnant.
Għandhekk tgħid lit- tabib jekk inti tqila jew taħseb li tista tigi tqila.
58 The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
- L- effett massimu biex tinżel il- pressjoni tad- demm għandu jintlaħaq 4- 6 ġimgħat wara li tinbeda l- kura.
Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/ heartburn, sexual dysfunction (problems with sexual performance), chest pain.
66 Mhux komuni: taħbit tal- qalb aktar mgħaġġel, fwawar, sogħla, dijarea, indiġestjoni/ qrusa fl- istonku, problemi ta ’ funzjoni sesswali (problemi fl- attività sesswali), uġigħ fis- sider.
59 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Each film-coated tablet contains 300 mg irbesartan (as
Kull pillola miksija b’ rita li fiha 300 mg ta ’ irbesartan (b ’
What Irbesartan Krka looks like and contents of the pack Irbesartan Krka 300 mg film-coated tablets are: white, oval film-coated tablets.
67 Il- pilloli Irbesartan Krka 300 mg miksija b’ rita huma: bojod, ovali, u miksija b’ rit.
Irbesartan Krka 300 mg film-coated tablets: available in boxes of 14, 28, 56, 84 and 98 film-coated tablets in blister packs and in boxes of 56 x 1 film-coated tablets in perforated unit dose blister pack.
Il- pilloli Irbesartan Krka 75 mg miksijin b’ rit: jigu f’ kaxxi 14, 28, 56, 84 and 98 pilloli miksijin b’ rit fi folji u fil- kaxxi b’ 56 x 1 pillola ta ’ doża waħda miksija b’ rita f’ pakkett b' folja pperforata.
Italia KRKA, d. d., Novo mesto Tel.: +39 069448827 Κύπρος KRKA, d. d., Novo mesto Τηλ: +30 (0)210 9581143 (EL) Latvija KRKA, d. d., Novo mesto Tel.: +371 (0)733 8610 Lietuva KRKA, d. d., Novo mesto Tel.: +370 5 362 2740
68 Italia KRKA, d. d., Novo mesto Tel.: +39 069448827 Κύπρος KRKA, d. d., Novo mesto Τηλ: +30 (0) 210 9581143 (EL) Latvija KRKA, d. d., Novo mesto Tel.: +371 (0) 733 8610 Lietuva KRKA, d. d., Novo mesto Tel.: +370 (0) 5 362 7420
What is Irbesartan Winthrop?
X' inhu Irbesartan Winthorp?
Irbesartan Winthrop is a medicine that contains the active substance irbesartan.
Irbesartan Winthorp huwa mediċina li fiha s- sustanza attiva irbesartan.
This medicine is the same as Aprovel, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Aprovel, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Aprovel has agreed that its scientific data can be used for Irbesartan Winthrop.
Il - kumpanija li tipproduċi Aprovel qablet li t- tagħrif xjentifiku tagħha jista 'jintuża għal Irbesartan Winthorp.
What is Irbesartan Winthrop used for?
Għal xiex jintuża Irbesartan Winthorp?
Irbesartan Winthrop is used in patients who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
'Essenzjali' tfisser li l- pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
Irbesartan Winthrop is also used to treat renal (kidney) disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Irbesartan Winthorp jintuża wkoll għat- trattament tal- mard renali (tal- kliewi) f' pazjenti b' ipertensjoni u b' dijabete mellitu tat- tip 2 (dijabete li mhix dipendenti fuq l- insulina).
Irbesartan Winthrop is not recommended for use in patients below 18 years of age.
Irbesartan Winthorp mhuwiex rakkomandat għall- użu f' pazjenti taħt l- età tat- 18- il sena.
How is Irbesartan Winthrop used?
Kif jintuża Irbesartan Winthorp?
Irbesartan Winthrop is taken by mouth, with or without food.
Irbesartan Winthorp jittieħed b' mod orali, anki fuq stonku vojt.
If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other antihypertensive medicines can be added, such as hydrochlorothiazide.
Jekk il- pressjoni tad- demm ma tkunx ikkontrollata adegwatament, id - doża tista 'tiżdied għal 300 mg kuljum jew inkella jistgħu jingħataw mediċini antipertensivi oħra, bħal l- idroklorotijażide (hydrochlorothiazide).
In patients with hypertension and type 2 diabetes, Irbesartan Winthrop is added to other treatments for hypertension.
Fil- pazjenti b' ipertensjoni u b' dijabete tat- tip 2, Irbesartan Winthorp jiżdied ma 'trattamenti oħra għall - ipertensjoni.
Treatment is started at 150 mg, once a day and is usually increased to 300 mg once a day.
It- trattament jinbeda b' doża ta '150 mg darba kuljum u normalment tiżdied għal 300 mg darba kuljum.
How does Irbesartan Winthrop work?
Kif jaħdem Irbesartan Winthorp?
The active substance in Irbesartan Winthrop, irbesartan, 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' Irbesartan Winthorp, irbesartan, hija tip ta '' antagonist tar- riċetturi ta 'l- anġjotensina II' li tfisser li jimblokka l- azzjoni ta 'l- ormon fil- ġisem imsejjaħ anġjotensina II.
How has Irbesartan Winthrop been studied?
Kif ġie studjat Irbesartan Winthorp?
Irbesartan Winthrop was originally studied in 11 trials for its effects on blood pressure.
Irbesartan Winthorp ġie għall- ewwel studjat fi 11- il prova li saru biex jivvalutaw l- effetti tiegħu fuq il - pressjoni tad- demm.
Irbesartan Winthrop was compared with placebo (a dummy treatment) in 712 patients, and compared with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Irbesartan Winthorp tqabbel mal- plaċebo (trattament finta) f' 712- il pazjent u tqabbel ma 'mediċini antipertensivi oħra (atenolol, enalapril jew amlodipina) fi 823 pazjent.
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Il- kejl ewlieni ta 'l - effikaċja kien it- tnaqqis tal- pressjoni tad- demm dijastolika (pressjoni tad- demm mkejla bejn żewġ taħbitiet tal- qalb).
Irbesartan Winthrop was used for two years or more.
Għat- trattament tal- mard tal- kliewi, Irbesartan Winthorp ġie eżaminat f' żewġ studji fuq skala kbira li involvew total ta '2, 326 pazjent bid- dijabete tat- tip 2, li damu sentejn jieħdu l- mediċina jew aktar.
The second study looked at whether Irbesartan Winthrop increased the time taken until the patients ’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
L- għan tat- tieni studju kien dak li jeżamina jekk Irbesartan Winthorp għenx biex ittardja l- mument li fih il- pazjenti rduppjaw il- livelli ta 'kreatinina fid- demm (markatur tal- marda tal - kliewi), biex ittardja l- bżonn ta' trapjant ta 'kilwa jew dijaliżi jew tawwal iż- żmien qabel il- mewt tal - pazjent.
In this study, Irbesartan Winthrop was compared with placebo and with amlodipine.
F' dan l- istudju, Irbesartan Winthorp tqabbel mal- plaċebo u ma 'l- amlodipina.
What benefit has Irbesartan Winthrop shown during the studies?
X' benefiċċji wera Irbesartan Winthorp waqt l- istudji mwettqa?
In the blood pressure studies, Irbesartan Winthrop was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Fl- istudji dwar il- pressjoni tad- demm, irriżulta li Irbesartan Winthorp kien aktar effikaċi mill- plaċebo biex inaqqas il- pressjoni tad- demm dijastolika u kellu effetti simili għall- mediċini antipertensivi oħra.
In the first kidney disease study, Irbesartan Winthrop was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Fl- ewwel studju dwar il- mard tal- kliewi, Irbesartan Winthorp irriżulta aktar effikaċi mill- plaċebo biex inaqqas ir- riskju ta 'ħsara tal- kliewi skond it- tneħħja tal- proteina.
In the second kidney disease study, Irbesartan Winthrop reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Fit- tieni studju dwar il- mard tal - kliewi, Irbesartan Winthorp naqqas b' 20% meta mqabbel mal- plaċebo r- riskju (tnaqqis relattiv) ta 'rduppjar tal- livelli ta' kreatinina fid- demm, tal- bżonn ta 'trapjant ta' kilwa jew ta 'dijaliżi, jew taż - żmien qabel il- mewt tal- pazjent matul l- istudju.
What is the risk associated with Irbesartan Winthrop?
X' inhuma r- riskji assoċjati ma 'Irbesartan Winthorp?
The most common side effects with Irbesartan Winthrop (seen between 1 and 10 patients in a 100) are dizziness, nausea (feeling sick) or vomiting, fatigue (tiredness) and increases in blood creatine kinase levels (an enzyme found in muscles).
L- effetti sekondarji l- aktar komuni b' Irbesartan Winthorp (li dehru f' bejn pazjent 1 u 10 minn 100) huma sturdament, nawżea (dardir) jew remettar, għeja kbira u żieda fil- livelli ta 'kreatina kinażi fid - demm (creatine kinase, enzima li tinsab fil- muskoli).
In addition, more than 1 patient in 100 with type 2 diabetes and kidney disease have the following side effects: hyperkalaemia (high blood potassium levels), orthostatic dizziness (dizziness when standing up), orthostatic hypotension (low blood pressure when standing up) and musculoskeletal (joint) pain.
Barra minn hekk, f' aktar minn pazjent wieħed minn 100 bid- dijabete tat- tip 2 u mard tal- kliewi kellhom dawn l- effetti sekondarji: iperkaljemija (livelli għoljin ta 'potassju fid- demm), sturdament ortostatiku (sturdament meta l- pazjent iqum bil - wieqfa), ipotensjoni ortostatika (pressjoni tad- demm baxxa meta l- pazjent iqum bil- wieqfa) kif ukoll uġigħ muskoloskeletriku (fil- ġogi).
For the full description of all side effects reported with Irbesartan Winthrop, see the Package Leaflet.
Għad- deskrizzjoni sħiħa ta 'l- effetti sekondarji rrappurtati b' Irbesartan Winthorp, ara l- Fuljett ta' Tagħrif.
Irbesartan Winthrop should not be used in people who may be hypersensitive (allergic) to irbesartan or any of the other ingredients.
Irbesartan Winthorp ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal irbesartan jew għal xi ingredjent ieħor tiegħu.
Why has Irbesartan Winthrop been approved?
Għaliex ġie approvat Irbesartan Winthorp?
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Winthrop’ s benefits are greater than its risks for the treatment of hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Irbesartan Winthorp huma ogħla mir- riskji tiegħu għat- trattament ta' l- ipertensjoni u tal- mard renali f' pazjenti li jbatu minn ipertensjoni u mid- dijabete mellitu tat- tip 2.
The Committee recommended that Irbesartan Winthrop be given marketing authorisation.
Il- Kumitat irrakkomanda li Irbesartan Winthorp jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Irbesartan Winthrop:
Aktar tagħrif dwar Irbesartan Winthorp:
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Winthrop to Sanofi Pharma Bristol-Myers Squibb SNC on 19 January 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- UE kollha għal Irbesartan Winthorp lil Sanofi Pharma Squibb Pharma SNC fid- 19 ta 'Jannar 2007.
The full EPAR for Irbesartan Winthrop is available here.
L- EPAR sħiħ għal Irbesartan Winthorp jista 'jiġi kkonsultat hawn.
Irbesartan Winthrop 75 mg tablets.
Irbesartan Winthrop 75 mg pilloli.
Irbesartan Winthrop at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Irbesartan Winthrop b’ doża ta ’ 150 mg darba kuljum ġeneralment jipprovdi kontroll aħjar matul l- 24 siegħa għall- pressjoni tad- demm minn 75 mg.
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Winthrop can be increased to 300 mg, or other anti-hypertensive agents can be added.
F’ pazjenti li mhumiex ikkontrollati biżżejjed b’ 150 mg darba kuljum, id- doża ta ’ Irbesartan Winthrop tista ’ tiżdied għal 300 mg, jew jistgħu jiġu miżjudin mediċini oħrajn ta ’ kontra l- pressjoni għolja.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan Winthrop (see section 4.5).
B' mod partikolari, iż- żjieda ta 'dijuretiku bħal hydrochlorothiazide ntwera li jkollha effett ta' tisħiħ ma 'Irbesartan Winthrop (ara sezzjoni 4. 5).
The demonstration of renal benefit of Irbesartan Winthrop in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see section 5.1).
Il- benefiċċju renali muri b’ Irbesartan Winthrop f’ pazjenti b’ dijabete ta ’ tip 2 li għandhom pressjoni għolja huwa bbażat fuq studji fejn irbesartan intuża flimkien ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja kif meħtieġ, biex jintlaħaq il- livell mixtieq ta ’ pressjoni (ara sezzjoni 5. 1).
Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Winthrop.
Tnaqqis fil- volum intravaskulari: tnaqqis fil- volum u/ jew ta ’ sodju għandu jiġi kkoreġut qabel ma jingħata Irbesartan Winthrop.
Such conditions should be corrected before the administration of Irbesartan Winthrop.
Dawn il- kondizzjonijiet għandhom jiġu kkoreġuti qabel tinbeda l- kura b’ Irbesartan Winthrop.
While this is not documented with Irbesartan Winthrop, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Għalkemm m’ hemm xejn dokumentat li dan isir b’ Irbesartan Winthrop, effetti simili għandhom ikunu antiċipati b’ antagonisti tar- riċetturi angiotensin- II.
Renal impairment and kidney transplantation: when Irbesartan Winthrop is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Indeboliment renali u trapjant tal- kliewi: meta Irbesartan Winthrop jintuża f’ pazjenti b’ indeboliment renali, hija irrikmandata osservanza perjodika tal- livelli tal- potassju u tal- krejatinina fis- serum.
There is no experience regarding the administration of Irbesartan Winthrop in patients with a recent kidney transplantation.
M’ hemmx esperjenza fuq l- għoti ta 'Irbesartan Winthrop lil pazjenti li reċentement kellhom trapjant tal- kliewi.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan Winthrop, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
Iperkalimja: bħalma jiġri b’ mediċini oħra li jaffettwaw is- sistema ta ’ renin- angiotensin- aldosterone, iperkalimja tista ’ sseħħ waqt il- kura b’ Irbesartan Winthrop, speċjalment fil- preżenza t’ indeboliment renali, proteinuria ovvja minħabba mard renali dovut għad- dijabete, u/ jew insuffiċjenza tal- qalb.
Lithium: the combination of lithium and Irbesartan Winthrop is not recommended (see section 4.5).
Lithium: it- taħlit ta 'litju u Irbesartan Winthrop mhuwiex rakkomandat (ara sezzjoni 4. 5).
Therefore, the use of Irbesartan Winthrop is not recommended.
Għalhekk, l- użu ta ’ Irbesartan Winthrop mhuwiex irrikmandat.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan Winthrop has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Dijuretiċi u mediċini oħra kontra l- pressjoni għolja: mediċini oħra kontra l- pressjoni għolja jistgħu jżidu l- effetti ta ’ tnaqqis fil- pressjoni ta ’ irbesartan; madankollu Irbesartan Winthrop ingħata mingħajr periklu ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja, bħal beta- blockers, imblokkaturi tal- kanali ta ’ calcium li jaħdmu fit- tul, u dijuretiċi thiazides.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan Winthrop (see section 4.4).
Kura li ssir qabel b' dożi għoljin ta 'dijuretiċi tista' tirriżulta f' nuqqas fil- volum u riskju ta 'pressjoni baxxa meta tinbeda l- kura b' Irbesartan Winthrop (ara sezzjoni 4. 4).
Irbesartan Winthrop is contraindicated (see section 4.3) during lactation.
Irbesartan Winthrop huwa kontra- indikat (ara sezzjoni 4. 3) waqt it- treddigħ.
In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Fil- perjodu ta '26 ġimgħa ta' din il- prova open- label, l- aktar anomaliji frekwenti tal- laboratorju li ġew osservati kienu żidiet fil- kreatina (6. 5%) u valuri għoljin ta 'CK fi 2% tat- tfal riċevituri.
No specific information is available on the treatment of overdose with Irbesartan Winthrop.
M’ hemmx biżżejjed informazzjoni speċifika disponibbli fuq il- kura tad- doża eċċessiva b’ Irbesartan Winthrop.
The blood pressure lowering effect of Irbesartan Winthrop is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
L- effett li għandu Irbesartan Winthrop li jbaxxi l- pressjoni jidher fi żmien 1- 2 ġimgħat, bl- effett massimu jseħħ f’ 4- 6 ġimgħat wara li tinbeda t- terapija.
After withdrawal of therapy, blood pressure gradually returns toward baseline.
Wara li titwaqqaf it- terapija, il- pressjoni gradwalment tirritorna lejn il - linja bażi.
The efficacy of Irbesartan Winthrop is not influenced by age or gender.
L- effikaċja ta ’ Irbesartan Winthrop ma hijiex influwenzata bl- età jew sess.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Winthrop, amlodipine and placebo.
8 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan Winthrop, amlodipine u plaċebo.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging from 1.0-3.0 mg/ dl, the long-term effects (mean 2.6 years) of Irbesartan Winthrop on the progression of renal disease and all-cause mortality were examined.
F’ 1, 715- il pazjent bi pressjoni għolja u b’ dijabete tip 2, proteinuria ≥ 900 mg/ jum u krejatinina fis- serum li tvarja minn 1. 0 - 3. 0 mg/ dl, ġew eżaminati l- effetti fit- tul (medja ta ’ 2. 6 sena) ta ’ Irbesartan Winthrop fuq l- avvanz ta ’ mard renali u l- kawżi kollha ta ’ mortalità.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan Winthrop, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Il- pazjenti ngħataw doża aġġustata minn 75 mg għal doża ta ’ manteniment ta ’ 300 mg ta ’ Irbesartan Winthrop, minn 2. 5 mg għal 10 mg ta ’ amlodipine, jew plaċebo skond kemm felħu.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Irbesartan b’ mod sinifikattiv naqqas ir- riskju relattiv fl- endpoint primarju kombinat fejn il- krejatinina fis- serum tirdoppja, mard renali fl- aħħar stadju (ESRD) jew mortalità mill- kawżi kollha.
When the individual components of the
Madwar 33% tal- pazjenti fil- grupp t’ irbesartan laħqu l- endpoint primarju renali kompost mqabbel ma ’ 39% u 41% fil- gruppi tal- plaċebo u amlodipine [20% tnaqqis relattiv tar- riskju kontra l- plaċebo (p = 0. 024) u 23% tnaqqis relattiv tar- riskju mqabbel ma ’ amlodipine (p = 0. 006)].
8 primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Meta il- komponenti individwali ta ’ l- endpoint primarju ġew analiżżati, l - ebda effett fil- mortalità mill- kawżi kollha ma ġie osservat, fil- waqt li tendenza posittiva fit- tnaqqis f’ ESRD u tnaqqis sinifikanti fil- krejatinina fis- serum milli tirdoppja ġew osservati.
The study examined the long-term effects (2 years) of Irbesartan Winthrop on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/ day, and an increase in UAER of at least 30% from baseline).
L- istudju eżamina l- effetti fit- tul (sentejn) ta ’ Irbesartan Winthrop fuq il- progressjoni għal proteinuria klinikali (li tidher) (ir- rata ta ’ tneħħija t’ albumina ma ’ l- urina (UAER) > 300 mg/ jum, u żjieda f ’ UAER ta ’ l- inqas 30% mill - linja bażi).
Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Mediċini kontra l- pressjoni għolja addizzjonali (li jeskludu inibituri t’ ACE, antagonisti tar- riċetturi angiotensin- II u dihydropyridine calcium blockers) ġew miżjuda skond il- ħtieġa biex igħinu fl- ilħuq ta 'l- għan tal - pressjoni.
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Waqt li pressjoni simili ġiet milħuqa fil- gruppi kollha tal- kura, inqas individwi fil - grupp t’ irbesartan 300 mg (5. 2%) minn dawk bil- plaċebo (14. 9%) jew fil- grupp t’ irbesartan 150 mg (9. 7%) laħqu l- endpoint ta ’ proteinuria li tidher, li jfisser 70% ta ’ tnaqqis fir- risku relattiv meta mqabbel mal- plaċebo (p = 0. 0004) għal doża l- għolja.
Regression to normoalbuminuria (< 30 mg/ day) was more frequent in the Irbesartan Winthrop 300 mg group (34%) than in the placebo group (21%).
Rigressjoni għal albuminuria normali (< 30 mg/ jum) kienet iktar frekwenti fil- grupp ta ’ Irbesartan Winthrop 300 mg (34%) milli fil- grupp tal- plaċebo (21%).
Irbesartan Winthrop 150 mg tablets.
Irbesartan Winthrop 150 mg pilloli.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Winthrop, amlodipine and placebo.
19 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan Winthrop, amlodipine u plaċebo.
18 primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Meta il- komponenti individwali ta ’ l- endpoint primarju ġew analiżżati, l - ebda effett fil- mortalità mill- kawżi kollha ma ġie osservat, fil- waqt li tendenza posittiva fit- tnaqqis f’ ESRD u tnaqqis sinifikanti fil- krejatinina fis- serum milli tirdoppja ġew osservati.
Irbesartan Winthrop 300 mg tablets.
Irbesartan Winthrop 300 mg pilloli.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Winthrop, amlodipine and placebo.
30 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan Winthrop, amlodipine u plaċebo.
28 primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Meta il- komponenti individwali ta ’ l- endpoint primarju ġew analiżżati, l - ebda effett fil- mortalità mill- kawżi kollha ma ġie osservat, fil- waqt li tendenza posittiva fit- tnaqqis f’ ESRD u tnaqqis sinifikanti fil- krejatinina fis- serum milli tirdoppja ġew osservati.
Irbesartan Winthrop 75 mg film-coated tablets.
Irbesartan Winthrop 75 mg pilloli miksijin b’ rita.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Winthrop, amlodipine and placebo.
41 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan Winthrop, amlodipine u plaċebo.
38 primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Meta il- komponenti individwali ta ’ l- endpoint primarju ġew analiżżati, l - ebda effett fil- mortalità mill- kawżi kollha ma ġie osservat, fil- waqt li tendenza posittiva fit- tnaqqis f’ ESRD u tnaqqis sinifikanti fil- krejatinina fis- serum milli tirdoppja ġew osservati.
Irbesartan Winthrop 150 mg film-coated tablets.
Irbesartan Winthrop 150 mg pilloli miksijin b’ rita.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Winthrop, amlodipine and placebo.
52 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan Winthrop, amlodipine u plaċebo.
49 primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Meta il- komponenti individwali ta ’ l- endpoint primarju ġew analiżżati, l - ebda effett fil- mortalità mill- kawżi kollha ma ġie osservat, fil- waqt li tendenza posittiva fit- tnaqqis f’ ESRD u tnaqqis sinifikanti fil- krejatinina fis- serum milli tirdoppja ġew osservati.
Irbesartan Winthrop 300 mg film-coated tablets.
Irbesartan Winthrop 300 mg pilloli miksijin b’ rita.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Winthrop, amlodipine and placebo.
63 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan Winthrop, amlodipine u plaċebo.
60 primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Meta il- komponenti individwali ta ’ l- endpoint primarju ġew analiżżati, l - ebda effett fil- mortalità mill- kawżi kollha ma ġie osservat, fil- waqt li tendenza posittiva fit- tnaqqis f’ ESRD u tnaqqis sinifikanti fil- krejatinina fis- serum milli tirdoppja ġew osservati.
The PSUR cycle of Irbesartan Winthrop is aligned with the cross-referred product, APROVEL, until otherwise specified.
Iċ- ċiklu tal- PSUR ta ’ Irbesartan Winthrop huma allinjat mal- prodott cross- referred, APROVEL, sakemm mhux speċifikat mod ieħor.
Irbesartan Winthrop 75 mg tablets irbesartan
Irbesartan Winthrop 75 mg pilloli irbesartan
EU/ 1/ 06/ 376/ 001 14 tablets EU/ 1/ 06/ 376/ 002 28 tablets EU/ 1/ 06/ 376/ 003 56 tablets EU/ 1/ 06/ 376/ 004 56 x 1 tablets EU/ 1/ 06/ 376/ 005 98 tablets
EU/ 1/ 06/ 376/ 001 14- il pillola EU/ 1/ 06/ 376/ 002 28 pillola EU/ 1/ 06/ 376/ 003 56 pillola EU/ 1/ 06/ 376/ 004 56 x 1 pillola EU/ 1/ 06/ 376/ 005 98 pillola
Irbesartan Winthrop 150 mg tablets irbesartan
Irbesartan Winthrop 150 mg pilloli irbesartan
EU/ 1/ 06/ 376/ 006 14 tablets EU/ 1/ 06/ 376/ 007 28 tablets EU/ 1/ 06/ 376/ 008 56 tablets EU/ 1/ 06/ 376/ 009 56 x 1 tablets EU/ 1/ 06/ 376/ 010 98 tablets
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Irbesartan Winthrop 300 mg tablets irbesartan
Irbesartan Winthrop 300 mg pilloli irbesartan
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Irbesartan Winthrop 75 mg film-coated tablets irbesartan
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EU/ 1/ 06/ 376/ 016 14- il pillola EU/ 1/ 06/ 376/ 017 28 pillola EU/ 1/ 06/ 376/ 018 56 pillola EU/ 1/ 06/ 376/ 019 56 x 1 pillola EU/ 1/ 06/ 376/ 020 84 pillola EU/ 1/ 06/ 376/ 021 98 pillola
Irbesartan Winthrop 150 mg film-coated tablets irbesartan
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Irbesartan Winthrop 300 mg film-coated tablets irbesartan
Irbesartan Winthrop 300 mg pilloli miksijin b' rita irbesartan
EU/ 1/ 06/ 376/ 028 14 tablets EU/ 1/ 06/ 376/ 029 28 tablets EU/ 1/ 06/ 376/ 030 56 tablets EU/ 1/ 06/ 376/ 031 56 x 1 tablets EU/ 1/ 06/ 376/ 032 84 tablets EU/ 1/ 06/ 376/ 033 98 tablets
EU/ 1/ 06/ 376/ 028 14- il pillola EU/ 1/ 06/ 376/ 029 28 pillola EU/ 1/ 06/ 376/ 030 56 pillola EU/ 1/ 06/ 376/ 031 56 x 1 pillola EU/ 1/ 06/ 376/ 032 84 pillola EU/ 1/ 06/ 376/ 033 98 pillola
INFORMATION FOR THE USER Irbesartan Winthrop 75 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Winthrop 75 mg pilloli irbesartan
What Irbesartan Winthrop is and what it is used for 2.
X' inhu Irbesartan Winthrop u għalxiex jintuża 2.
Before you take Irbesartan Winthrop 3.
Qabel ma tieħu Irbesartan Winthrop 3.
How to take Irbesartan Winthrop 4.
Kif għandek tieħu Irbesartan Winthrop 4.
How to store Irbesartan Winthrop 6.
Kif taħżen Irbesartan Winthrop 6.
WHAT IRBESARTAN WINTHROP IS AND WHAT IT IS USED FOR
X' INHU IRBESARTAN WINTHROP U GĦALXIEX JINTUŻA
Irbesartan Winthrop belongs to a group of medicines known as angiotensin-II receptor antagonists.
Irbesartan Winthrop jappartjeni għall- grupp ta ’ mediċini magħrufa bħala antagonisti tar- riċetturi angiotensin- II.