qanastek/EMEA-V3 huggingface dataset:
Occasional side effects reported since the marketing of Irbesartan Hydrochlorothiazide Winthrop are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired renal function.
94 Effetti sekondarji li ġew irrapportati kultant minn meta Irbesartan Hydrochlorothiazide Winthrop tqiegħed fuq is- suq huma: uġigħ ta ’ ras, żarżir fil- widnejn, sogħla, disturbi fit- togħma, indiġestjoni, uġigħ fil- ġogi u fil- muskoli, funzjoni tal- fwied anormali u indeboliment fil- funzjoni renali.
If you think
Bħal ma jiġri b’ mediċini simili, każijiet rari ta ’ reazzjonijiet allerġiċi fil- ġilda (raxx, urtikarja), kif ukoll nefħa lokalizzata fill- wiċċ, fix- xufftejn u/ jew fl- ilsien ġew irrapportati f’ pazjenti li ħadu irbesartan.
94 you are developing such a reaction or get short of breath stop taking Irbesartan Hydrochlorothiazide Winthrop and seek immediate medical attention.
Jekk taħseb li qed tiżviluppa din ir- reazzjoni jew qed jonqoslok in- nifs tiħux Irbesartan Hydrochlorothiazide Winthrop u fittex immedjatament attenzjoni medika.
The other component of Irbesartan Hydrochlorothiazide Winthrop (hydrochlorothiazide) has been associated rarely with other more serious side effects mainly affecting the blood, the skin or the kidneys.
Il- komponent l- ieħor ta ’ Irbesartan Hydrochlorothiazide Winthrop (hydrochlorothiazide) ġie assoċjat rarament ma ’ effetti oħrajn iktar serji li jaffettwaw prinċipalment id- demm, il- ġilda jew il- kliewi.
While this was not observed with Irbesartan Hydrochlorothiazide Winthrop, occurrence of such side effects cannot be excluded.
Għalkemm dawn ma ġewx osservati b’ Irbesartan Hydrochlorothiazide Winthrop, effetti sekondarji bħal dawn ma jistgħux jiġu esklużi.
HOW TO STORE IRBESARTAN HYDROCHLOROTHIAZIDE WINTHROP
KIF TAĦŻEN IRBESARTAN HYDROCHLOROTHIAZIDE WINTHROP
Do not use Irbesartan Hydrochlorothiazide Winthrop after the expiry date which is stated on the carton and on the blister after EXP.
Tużax Irbesartan Hydrochlorothiazide Winthrop wara d- data ta ’ skadenza li tidher fuq il- kaxxa jew fuq il- folja wara JIS.
What Irbesartan Hydrochlorothiazide Winthrop contains
X’ fih Irbesartan Hydrochlorothiazide Winthrop
Each tablet of Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola ta ’ Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg fiha 150 mg irbesartan u 12. 5 mg hydrochlorothiazide.
What Irbesartan Hydrochlorothiazide Winthrop looks like and contents of the pack
Id- dehra ta ’ Irbesartan Hydrochlorothiazide Winthrop u l- kontenuti tal- pakkett
Irbesartan Hydrochlorothiazide Winthrop tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Il- pilloli Irbesartan Hydrochlorothiazide Winthrop huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2775 fuq in- naħa l- oħra.
Irbesartan Hydrochlorothiazide Winthrop tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Il- pilloli huma pprovduti f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
Not all pack sizes may be marketed.
95 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
95 Marketing Authorisation Holder SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC 174 avenue de France F-75013 Paris - France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq SANOFI PHARMA BRISTOL- MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris - Franza
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide Winthrop Pilloli 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
99 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
99 jekk inti tbati minn problemi tal- kliewi, li jinkludu trapjant tal- kliewi jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
Important information about some of the ingredients of Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop contains lactose monohydrate (see “ Further information”).
100 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop fih il- lactose monohydrate (ara “ Aktar tagħrif ”).
The usual dose of Irbesartan Hydrochlorothiazide Winthrop is one tablet a day.
Id- doża normali ta ’ Irbesartan Hydrochlorothiazide Winthrop hija ta ’ pillola waħda kuljum.
Occasional side effects reported since the marketing of Irbesartan Hydrochlorothiazide Winthrop are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired renal function.
101 Effetti sekondarji li ġew irrapportati kultant minn meta Irbesartan Hydrochlorothiazide Winthrop tqiegħed fuq is- suq huma: uġigħ ta ’ ras, żarżir fil- widnejn, sogħla, disturbi fit- togħma, indiġestjoni, uġigħ fil- ġogi u fil- muskoli, funzjoni tal- fwied anormali u indeboliment fil- funzjoni renali.
101 you are developing such a reaction or get short of breath stop taking Irbesartan Hydrochlorothiazide Winthrop and seek immediate medical attention.
Jekk taħseb li qed tiżviluppa din ir- reazzjoni jew qed jonqoslok in- nifs tiħux Irbesartan Hydrochlorothiazide Winthrop u fittex immedjatament attenzjoni medika.
Each tablet of Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola ta ’ Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg fiha 300 mg irbesartan u 12. 5 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Winthrop tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Il- pilloli Irbesartan Hydrochlorothiazide Winthrop huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2776 fuq in- naħa l- oħra.
Not all pack sizes may be marketed.
102 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
102 Marketing Authorisation Holder SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC 174 avenue de France F-75013 Paris - France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq SANOFI PHARMA BRISTOL- MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris - Franza
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
106 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
106 jekk inti tbati minn problemi tal- kliewi, li jinkludu trapjant tal- kliewi jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
Usually, your doctor will advise you to take another medicine instead of Irbesartan Hydrochlorothiazide Winthrop, as Irbesartan Hydrochlorothiazide Winthrop 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 Irbesartan Hydrochlorothiazide Winthrop, minħabba li Irbesartan Hydrochlorothiazide Winthrop mhuwiex 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 Irbesartan Hydrochlorothiazide Winthrop before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment tissostitwixxi Irbesartan Hydrochlorothiazide Winthrop qabel il- bidu ta ’ tqala.
If you become pregnant during therapy with Irbesartan Hydrochlorothiazide Winthrop, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b’ Irbesartan Hydrochlorothiazide Winthrop, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
Important information about some of the ingredients of Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop contains lactose monohydrate (see “ Further information”).
107 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop fih il- lactose monohydrate (ara “ Aktar tagħrif ”).
Occasional side effects reported since the marketing of Irbesartan Hydrochlorothiazide Winthrop are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired renal function.
108 Effetti sekondarji li ġew irrapportati kultant minn meta Irbesartan Hydrochlorothiazide Winthrop tqiegħed fuq is- suq huma: uġigħ ta ’ ras, żarżir fil- widnejn, sogħla, disturbi fit- togħma, indiġestjoni, uġigħ fil- ġogi u fil- muskoli, funzjoni tal- fwied anormali u indeboliment fil- funzjoni renali.
108 you are developing such a reaction or get short of breath stop taking Irbesartan Hydrochlorothiazide Winthrop and seek immediate medical attention.
Jekk taħseb li qed tiżviluppa din ir- reazzjoni jew qed jonqoslok in- nifs tiħux Irbesartan Hydrochlorothiazide Winthrop u fittex immedjatament attenzjoni medika.
Each film-coated tablet of Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg fiha 150 mg irbesartan u 12. 5 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Winthrop film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide Winthrop huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2875 fuq in- naħa l- oħra.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
109 Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg huma fornuti fi strixxi ta '14, 28, 56, 84 jew 98 pillola miksija b' rita.
109 Marketing Authorisation Holder SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC 174 avenue de France F-75013 Paris - France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq SANOFI PHARMA BRISTOL- MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris - Franza
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
113 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
113 jekk inti tbati minn problemi tal- kliewi, li jinkludu trapjant tal- kliewi jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
Important information about some of the ingredients of Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop contains lactose monohydrate (see “ Further information”).
114 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop fih il- lactose monohydrate (ara “ Aktar tagħrif ”).
Occasional side effects reported since the marketing of Irbesartan Hydrochlorothiazide Winthrop are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired renal function.
115 Effetti sekondarji li ġew irrapportati kultant minn meta Irbesartan Hydrochlorothiazide Winthrop tqiegħed fuq is- suq huma: uġigħ ta ’ ras, żarżir fil- widnejn, sogħla, disturbi fit- togħma, indiġestjoni, uġigħ fil- ġogi u fil- muskoli, funzjoni tal- fwied anormali u indeboliment fil- funzjoni renali.
115 you are developing such a reaction or get short of breath stop taking Irbesartan Hydrochlorothiazide Winthrop and seek immediate medical attention.
Jekk taħseb li qed tiżviluppa din ir- reazzjoni jew qed jonqoslok in- nifs tiħux Irbesartan Hydrochlorothiazide Winthrop u fittex immedjatament attenzjoni medika.
Each film-coated tablet of Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg fiha 300 mg irbesartan u 12. 5 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Winthrop film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide Winthrop huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2876 fuq in- naħa l- oħra.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
116 Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg huma fornuti fi strixxi ta '14, 28, 56, 84 jew 98 pillola miksija b' rita.
116 Marketing Authorisation Holder SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC 174 avenue de France F-75013 Paris - France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq SANOFI PHARMA BRISTOL- MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris - Franza
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
120 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
120 jekk inti tbati minn problemi tal- kliewi, li jinkludu trapjant tal- kliewi jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
Important information about some of the ingredients of Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop contains lactose monohydrate (see “ Further information”).
121 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop fih il- lactose monohydrate (ara “ Aktar tagħrif ”).
Occasional side effects reported since the marketing of Irbesartan Hydrochlorothiazide Winthrop are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired renal function.
122 Effetti sekondarji li ġew irrapportati kultant minn meta Irbesartan Hydrochlorothiazide Winthrop tqiegħed fuq is- suq huma: uġigħ ta ’ ras, żarżir fil- widnejn, sogħla, disturbi fit- togħma, indiġestjoni, uġigħ fil- ġogi u fil- muskoli, funzjoni tal- fwied anormali u indeboliment fil- funzjoni renali.
122 you are developing such a reaction or get short of breath stop taking Irbesartan Hydrochlorothiazide Winthrop and seek immediate medical attention.
Jekk taħseb li qed tiżviluppa din ir- reazzjoni jew qed jonqoslok in- nifs tiħux Irbesartan Hydrochlorothiazide Winthrop u fittex immedjatament attenzjoni medika.
Each film-coated tablet of Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg fiha 300 mg irbesartan u 25 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Winthrop film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide Winthrop huma roża, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2788 fuq in- naħa l- oħra.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
123 Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg huma fornuti fi strixxi ta '14, 28, 56, 84 jew 98 pillola miksija b' rita.
123 Marketing Authorisation Holder SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC 174 avenue de France F-75013 Paris - France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq SANOFI PHARMA BRISTOL- MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris - Franza
What is Irbesartan Krka?
X’ inhu Irbesartan Krka?
Irbesartan Krka is a medicine that contains the active substance irbesartan.
Irbesartan Krka huwa mediċina li fiha s- sustanza attiva irbesartan.
It is available as white, oval tablets (75, 150 and 300 mg).
Huwa disponibbli f’ pilloli ovali bojod (75, 150 u 300 mg).
This means that Irbesartan Krka is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Aprovel.
Irbesartan Krka huwa ‘ mediċina ġenerika ’ li jfisser li Irbesartan Krka hija simili għall - ‘ mediċina ta ’ referenza ’ diġà awtorizzata fl- Unjoni Ewropea (UE) li jisimha Aprovel.
For more information on generic medicines, see the question-and-answer document here.
Għal aktar informazzjoni dwar il- mediċini ġeneriċi, kkonsulta d- dokument mistoqsija- u- tweġiba hawn.
What is Irbesartan Krka used for?
Għal xiex jintuża Irbesartan Krka?
Irbesartan Krka 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.
Irbesartan Krka jintuża għall- pazjenti li jbatu minn ipertensjoni essenzjali (pressjoni tad- demm għolja). ‘ Essenzjali ’ tfisser li l- pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
Irbesartan Krka is also used to treat renal (kidney) disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Irbesartan Krka jintuża wkoll għat- trattament tal- mard renali (tal- kliewi) f’ pazjenti b’ ipertensjoni u b’ dijabete mellitu tat- tip 2 (dijabete li mhix dipendenti mill- insulina).
Irbesartan Krka is not recommended for use in patients below 18 years of age.
Irbesartan Krka mhuwiex rakkomandat għall- użu f’ pazjenti taħt l- età ta ’ 18- il sena.
How is Irbesartan Krka used?
Kif jintuża Irbesartan Krka?
Irbesartan Krka is taken by mouth, with or without food.
Irbesartan Krka jittieħed b’ mod orali, anki fuq stonku vojt.
The usual recommended dose is 150 mg once a day.
Id- doża normalment rakkomandata hija 150 mg darba kuljum.
If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension 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 oħra għall- ipertensjoni, bħal l - idroklorotijażide (hydrochlorothiazide).
A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Doża inizjali ta ’ 75 mg tista ’ tintuża fil- pazjenti li għaddejjin minn emodijaliżi (teknika ta ’ tisfija tad- demm) jew f’ pazjenti li għandhom iktar minn 75 sena.
In patients with hypertension and type 2 diabetes, Irbesartan Krka is added to other treatments for hypertension.
Fil- pazjenti b’ ipertensjoni u b’ dijabete tat- tip 2, Irbesartan Krka 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 Krka work?
Kif jaħdem Irbesartan Krka?
The active substance in Irbesartan Krka, 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 Krka, irbesartan, hija tip ta ’ ‘ antagonist tar- riċetturi tal- anġjotensina II ’ li tfisser li jimblokka l- azzjoni tal- ormon fil- ġisem imsejjaħ anġjotensina II.
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 magħhom l - anġjotensina II teħel normalment, irbesartan iwaqqaf l- ormon milli jkollu effett, b’ hekk iħalli l- arterji u l- vini jitwessgħu.
This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Dan jippermetti li titbaxxa l- pressjoni tad- demm u b’ hekk jitnaqqas ir- riskju kkawżat mill- pressjoni tad- demm għolja, bħal ma hi l- puplesija.
How has Irbesartan Krka been studied?
Kif ġie studjat Irbesartan Krka?
Because Irbesartan Krka is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (i. e. that the two medicines produce the same levels of the active substance in the body).
Minħabba li Irbesartan Krka huwa mediċina ġenerika, l- istudji ġew limitati għal testijiet biex jiġi determinat li huwa bijoekwivalenti għall- mediċina ta ’ referenza (huma jipproduċu l- istess livelli ta ’ sustanza attiva fil- ġisem).
What are the benefit and risk of Irbesartan Krka?
X’ inhu l- benefiċċju u r- riskju ta ’ Irbesartan Krka?
Because Irbesartan Krka is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Minħabba li Irbesartan Krka huwa mediċina ġenerika u bijoekwivalenti għall- mediċina ta ’ referenza, il- benefiċċju u r- riskju tiegħu huma meqjusa analogi għal dawk tal- mediċina ta ’ referenza.
Why has Irbesartan Krka been approved?
Għaliex ġie approvat Irbesartan Krka?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Irbesartan Krka has been shown to have comparable quality and to be bioequivalent to Aprovel.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, b’ mod konformi mar- rekwiżiti tal- UE, intwera li Irbesartan Krka għandu kwalità komparabbli ma ’ u li huwa bijoekwivalenti għal Aprovel.
Therefore, the CHMP’ s view was that, as for Aprovel, the benefit outweighs the identified risk.
Għaldaqstant, il- fehma tas- CHMP kienet li, bħal fil- każ ta ’ Aprovel, il - benefiċċji huma ogħla mir- riskji identifikati.
The Committee recommended that Irbesartan Krka be given marketing authorisation.
Il- Kumitat irrakkomanda li Irbesartan Krka jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Irbesartan Krka:
Aktar tagħrif dwar Irbesartan Krka:
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Krka to Krka, d. d., Novo mesto on 1 December 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Irbesartan Krka lil Krka, d. d., Novo mesto fi 1 ta ’ Diċembru 2008.
The full EPAR for Irbesartan Krka can be found here.
L- EPAR sħiħ għal Irbesartan Krka jista ’ jiġi kkonsultat hawn.
Irbesartan Krka 75 mg film-coated tablets
Irbesartan Krka 75 mg pilloli miksijin b’ rita
Each film-coated tablet contains 75 mg irbesartan (as hydrochloride).
Kull pillola miksija b’ rita fiha 75 mg irbesartan (b ’ hydrochloride).
Mannitol content is below the threshold of the Excipient guideline's annex.
Kull pillola miksija b’ rita fiha 4mg castor oil Il- kontenut ta 'Mannitol huwa inqas minn dak stabbilit fl- Anness tal- Linja Gwida dwar Sustanzi Mhux Attivi.
White, oval tablets.
Pilloli bojod, ovali.
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).
4. 1 Indikazzjonijiet terapewtiċi
The usual recommended initial and maintenance dose is 150 mg once daily, with or without food.
Id- doża li ġeneralment irrikmandata fil- bidu u ta ’ manteniment hija ta ’ 150 mg darba kuljum, ma ’ l- ikel jew mingħajru.
Irbesartan Krka at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Irbesartan Krka 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 Krka can be increased to 300 mg, or other anti-hypertensive agents can be added.
F’ pazjenti li mhumiex ikkontrollati b’ mod insufficjenti b’ 150 mg darba kuljum, id- doża ta ’ Irbesartan Krka 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 Krka (see section 4.5).
B' mod partikolari, iż- żjieda ta 'dijuretiku bħal hydrochlorothiazide ntwera li jkollha effett ta' tisħiħ ma 'Irbesartan Krka (ara sezzjoni 4. 5).
The demonstration of renal benefit of Irbesartan Krka 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 Krka 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).
No dosage adjustment is necessary in patients with impaired renal function.
2 M’ hemmx bżonn ta 'aġġustament tad- doża f’ pazjenti b’ indeboliment renali.
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 4.4).
Wieħed għandu jikkonsidra doża inqas fil- bidu (75 mg) f’ pazjenti li qed jagħmlu l- emodijalisi (ara sezzjoni 4. 4).
No dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
M’ hemmx bżonn ta 'aġġustament tad- doża f’ pazjenti b’ indeboliment epatiku ħafif għal moderat.
2 Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Pazjenti AnzjaniGħalkemm għanda tingħata konsiderazzjoni meta tinbeda l’ kura b’ 75mg f’ pazjenti minn 75 sena, m’ hemmx bżonn ta 'aġġustament tad- doża f ’ dawn il- pazjenti.
Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.8, 5.1 and 5.2).
Irbesartan mhux irrakkomandat għall- użu fit- tfal u l- addoloxxenti peress li m' hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjonijiet 4. 8, 5. 1 u 5. 2).
Hypersensitivity to the active substance, or to any of the excipients (see section 6.1).
Sensittività eċċessiva għas- sustanza attiva, jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1).
Second and third trimester of pregnancy (see sections 4.4 and 4.6).
It- tieni u t - tielet trimestru tat- tqala (ara sezzjoni 4. 4 u 4. 6).
Intravascular volume depletion:
Tnaqqis fil- volum intravaskulari:
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Pressjoni baxxa sintomatika, speċjalment wara l- ewwel doża, tista ’ tinħass f’ pazjenti li jbatu minn tnaqqis ta ’ volum u/ jew ta 'sodju minħabba terapija dijuretika qawwija, dieta ristretta mill- melħ, dijarea jew rimettar.
Such conditions should be corrected before the administration of Irbesartan Krka.
Dawn il- kondizzjonijiet għandhom jiġu kkoreġuti qabel tinbeda l- kura b’ Irbesartan Krka.
Renovascular hypertension:
Pressjoni għolja renovaskulari:
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Hemm riskju ikbar ta ’ pressjoni baxxa severa u ta ’ insuffiċjenza renali meta pazjenti li għandhom stenosi bilaterali ta ’ l- arterja renali jew stenosi ta ’ l- arterja b’ kilwa waħda taħdem, jiġu kkurati bi prodotti mediċinali li jaffettwaw is- sistema renin- angiotensin- aldosterone.
While this is not documented with Irbesartan Krka, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Għalkemm m’ hemm xejn dokumentat li dan isir b’ Irbesartan Krka, effetti simili għandhom ikunu antiċipati b’ antagonisti tar- riċetturi angiotensin - II.
Renal impairment and kidney transplantation:
Indeboliment renali u trapjant tal- kliewi:
When Irbesartan Krka is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Meta Irbesartan Krka jintuża f’ pazjenti b’ indeboliment renali, hija irrikmandata osservanza perjodika tal - livelli tal- potassju u tal- kreatinina fis- serum.
There is no experience regarding the administration of Irbesartan Krka in patients with a recent kidney transplantation.
M’ hemmx esperjenza fuq l- għoti ta 'Irbesartan Krka lil pazjenti li reċentement kellhom trapjant tal- kliewi.
Hypertensive patients with type 2 diabetes and renal disease:
Pazjenti bi pressjoni għolja li għandhom dijabete ta ’ tip 2 u mard renali:
The effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
L- effetti ta ’ irbesartan kemm fuq il- proċessi renali kif ukoll dawk kardjovaskulari ma kinux l- istess fis - settijiet tas- sotto gruppi kollha, f’ analiżi li saret fl- istudju ma ’ pazjenti b’ mard renali avvanzat.
Hyperkalemia:
Iperkalimja:
As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur during the treatment with Irbesartan Krka, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
Bħalma jiġri bi prodotti mediċinali oħra li jaffettwaw is- sistema ta ’ renin- angiotensinaldosterone, iperkalimja tista ’ sseħħ waqt il- kura b ’ Irbesartan Krka, speċjalment fil- preżenza t’ indeboliment renali, protejnurja ovvja minħabba mard renali dovut għad- dijabete, u/ jew insuffiċjenza tal- qalb.
The combination of lithium and Irbesartan Krka is not recommended (see section 4.5).
3 It- teħid ta 'litju u Irbesartan Krka fliemkin mhuwiex rakkomandat (ara sezzjoni 4. 5).
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Stenosi tal- valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva:
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Bħal fil- każ ta ’ vażodilaturi oħra, kawtella speċjali hija indikata f’ pazjenti li jbatu minn stenosi tal- valv mitrali u aortiku jew kardjomijopatija ipertrofika ostruttiva.
Primary aldosteronism:
Aldosteroniżmu primarju:
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għal prodotti mediċinali ta ’ kontra l - pressjoni għolja li jaħdmu billi jimpedixxu s- sistema renin- angiotensin.
Therefore, the use of Irbesartan Krka is not recommended.
Għalhekk, l- użu ta ’ Irbesartan Krka mhuwiex irrikmandat.
3 In patients whose vascular tone and renal function depend predominantly on the activity of the renin- angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
F’ pazjenti li għandhom it- ton vaskulari u l- funzjoni renali tagħhom jiddependu l- aktar mill- attività tas - sistema renin- angiotesin- aldosterone (p. e. pazjenti li jbatu minn insuffiċjenza tal- qalb konġestiva jew mard renali, inkluż stenosi ta ’ l- arterja renali), il- kura b’ inibituri ta ’ enzimi li jikkonvertu angiotensin jew antagonisti tar- riċetturi t ’ angiotensin- II li jaffettwaw din is- sistema ġew assoċjati ma ’ pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza akuta renali.
As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Bħal ma jiġri b’ kull mediċina kontra il - pressjoni għolja, it- tnaqqis eċċessiv ta ’ pressjoni f’ pazjenti li jbatu minn kardjopatija iskemika jew minn mard kardjovaskulari iskemiku jista ’ jwassal għal infart mijokardijaku jew għal attakk ta ’ puplesija.
As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
Kif osservat f’ inibituri ta ’ enzimi li jikkonvertu angiotensin, irbesartan u l- antagonisti ta ’ angiotensin l - oħrajn huma apparentament inqas effettivi biex iniżżlu l- pressjoni f’ nies suwed milli f’ dawk li mhumiex suwed, possibilment minħabba li hemm prevelanza ogħla ta ’ renin baxx f’ popolazzjoni ta ’ razza sewda bi pressjoni għolja (ara sezzjoni 5. 1).
Pregnancy:
Tqala
Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
AIIRAs m’ għandux jinbeda waqt it- tqala sakemm kura bil- AIIRAs hi kkonsidrata essenzjali, pazjenti li qedin jipjanaw it- tqala għandom jingħataw kura alternativa li ghanda profil ta ’ sikurezza stabilita.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Meta tqala hi djanostikata, kura bil AIIRAs għandu jitwaqaf immedjat u fejn hemm bzonn tinbeda kura alternativa oħra (ara sezzjoni 4. 3 u 4. 6).
Irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Irbesartan ġie studjat f' popalazzjonijiet ta 'tfal bejn is- 6 snin u s- 16- il sena imma it- tagħrif kurrenti mhuwiex biżżejjed biex jappoġġja estensjoni ta' l- użu fuq tfal sakemm ikun hemm aktar tagħrif disponibbli (ara sezzjonijiet 4. 8, 5. 1 u 5. 2).
This medicinal product contains castor oil which may cause stomach upset and diarrhoea.
Dan il- prodott mediċinal fih iż- żejt ir- rignu li jista 'jikkawża taqlib fl- istonku u dijarea.
Diuretics and other antihypertensive agents:
Dijuretiċi u mediċini oħra kontra l- pressjoni għolja:
Other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan Krka has been safely administered with other antihypertensive agents, such as beta-blockers, long- acting calcium channel blockers, and thiazide diuretics.
Mediċini oħra kontra l- pressjoni għolja jistgħu jżidu l- effetti ta ’ tnaqqis fil- pressjoni ta ’ irbesartan; madankollu Irbesartan Krka 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 Krka (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 Krka (ara sezzjoni 4. 4).
Potassium supplements and potassium-sparing diuretics:
Supplimenti tal- potassium u dijuretiċi li ma jnixxux il- potassju:
Based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Ibbażat fuq l- esperjenza bl- użu ta ’ prodotti mediċinali oħra li jaffettwaw lis- sistema ta ’ renin- angiotensin, l- użu konkomitanti ta ’ dijuretiċi li ma jnixxux il- potassju, supplimenti tal- potassium, sostituti tal- melħ li
Rreversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Żjidiet riversibbli tal- konċentrazzjonijiet u tossiċità ta ’ lithium fis- serum ġew irrapportati waqt l - amministrazzjoni konkomitanti ta ’ lithium ma ’ inibituri ta ’ enzimi li jikkonvertu angiotensin.
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Jekk tinħass il- ħtieġa ta ’ din il- kombinazzjoni, monitoraġġ b’ attenzjoni tal- livelli tal - lithium fis- serum hija irrikmandata.
Non-steroidal anti-inflammatory medicinal products:
Mediċini anti- infjammatorji mhux sterojdi:
When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory medicinal products (i. e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Meta jingħataw antagonisti ta 'angiotensin II flimkien ma' mediċini anti- infjammatorji mhux sterojdi (i. e. inibituri COX- 2 selettivi, acetylsalicylic acid (> 3 g/ kuljum) u NSAIDs mhux selettivi), jista 'jkun hemm attenwazzjoni ta' l- effett kontra l- pressjoni għolja.
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Bħalma jseħħ bl- inibituri ACE, l- użu konkomitanti ta 'antagonisti ta' angiotensin II u NSAIDs jista 'jirriżulta f' żjieda fir- riskju li teħżien il- funzjoni renali, inkluża l- possibbilità ta' insuffiċjenza renali akuta, u żjieda fil- potassium fis- serum, speċjalment f' pazjenti li diġà kellhom funzjoni renali batuta.
4 consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Il - pazjenti għandhom ikunu idrati biżżejjed u għandha tingħata kunsiderazzjoni għall- monitoraġġ tal - funzjoni renali wara li tinbeda kura konkomitanti, u kull ċertu żmien wara.
Additional information on irbesartan interactions:
Aktar informazzjoni dwar l- interazzjonijiet ta 'irbesartan:
In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Fi studji kliniċi, il- farmakokinetika ta 'irbesartan mhix affettwata minn hydrochlorothiazide.
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Irbesartan jiġi metabolizzat prinċipalment b’ CYP2C9 u b’ mod inqas estensiv b’ glukoronidazzjoni.
The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
L- uzu ta’ AIIRAs mhux irrakmandat waqt l- ewwel timestru tat- tqala (ara sezzjoni 4. 4).
The use of AIIRAs is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and 4.4).
L- Uzu ta’ AIIRAs huwa kontra indikat fit- tieni u t- tielet trimestru tat- tqala (ara sezzjoni 4. 3 u 4. 4)
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Evidenża Epidemjoloġiċi rigward ir- riskju tat- teratoġeniċita wara esponiment ta ’ inibituri ACE waqt l - ewwel timestru ta’ tqala, għadu mhux konkluz; izda zieda zgħira fir- riskju mhux esklud.
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors( AIIRAs), similar risks may exist for this class of medicinal products.
Għalkemm mhemx dejta epidemjoloġika kontrolata fuq ir- riskju b’ antagonisti tar- riċetturi t’ angiotensin II (AIIRAs), riskji simili ġeww assoċjati ma din il- klassi ta ’ mediċina.
Unless continued ARB therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Filwaqt li tkomplija tal- kura hija meqjusa essenzjali, pazjenti li qegħdin jipjanaw it- tqala għanda tingħata kura alternativa b’ mediċina kontra l - pressjoni għolja b’ profil ta’ sikurezza stabilit għal- uzu waqt it- tqala.
When pregnancy is diagnosed, treatment with AIIRAsshould be stopped immediately and, if appropriate, alternative therapy should be started.
Kura b’ AIIRAs għandu jitwaqqaf immedjatament u fejn jeħtieg tingħata kura alternativa.
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Esponiment b’ kura AIIRAs waqt it- tieni u it- tielet trimestru hu magħruf li jinduċi fetosiċita fuq il- fetu (nuqqas fil- funzjoni renali, oligohydramnios, tardjar tal- ossifikazzjoni tal- kranju) tosiċita neonatali (insuffiċjenza renali, pressjoni baxxa u Iperkalaemia).
(see also section 5.3)
(Ara wkoll sezzjoni 5. 3)
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk kien hemm espożizzjoni għal AIIRAs mit- tieni trimestru tat- tqala, huwa rakkomandat li l- funzjoni renali u l- kranju jiġu ċċekkjati b' Ultrasound.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
Tfal ckejknin li ommħom ikunu ħadu l- AIIRAs għandhom jiġu osservati mill- qrib għal pressjoni baxxa (ara wkoll sezzjonijiet 4. 3 u 4. 4).
Lactation:
5 Treddigħ:
Irbesartan Krka is contraindicated (see section 4.3) during breast-feeding.
Irbesartan Krka huwa kontra- indikat (ara sezzjoni 4. 3) waqt it- treddigħ.
Irbesartan is excreted in the milk of lactating rats.
Irbesartan jiġi eliminat fil- ħalib ta ’ firien li jreddgħu.
When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Waqt is- sewqan jew tħaddim ta ’ magni, wieħed għandu jżomm kont li xi kultant jista ’ jħoss xi sturdament jew għeja waqt kura kontra l - pressjoni għolja.
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%).
Fi studji kliniċi kkontrollati bi plaċebo f’ pazjenti bi pressjoni għolja, l- inċidenza totali ta ’ effetti avversi ma kinetx differenti bejn dawk li ħadu irbesartan (56. 2%) u l- grupp li ħa l- plaċebo (56. 5%).
Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3%) than for placebo-treated patients (4.5%).
Twaqqif minħabba xi effetti avversi kliniċi jew tal- laboratorju kienu inqas frekwenti fil- pazjenti kkurati b’ irbesartan (3. 3%) milli fil- pazjenti kkurati bil- plaċebo (4. 5%).
The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
L- inċidenza ta ’ effetti avversi ma kinetx relatata mad- doża (doża li ngħatat fil- firxa rrikmandata), sess, età, razza, jew mat- tul tal- kura.
5 In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i. e., uncommon) but in excess of placebo.
F’ pazjenti dijabetiċi bi pressjoni għolja b’ mikroalbuminurja u funzjoni normali tal- kliewi, sturdament ortostatiku u pressjoni baxxa ortostatika ġew irrapportati f’ 0. 5% tal- pazjenti (jiġifieri mhux komuni) iżda iżjed milli fil- grupp tal- plaċebo.
The following table presents the adverse medicinal product reactions that were reported in placebo- controlled trials in which 1,965 hypertensive patients received irbesartan.
It- tabella li ġejja tippreżenta r- reazzjonijiet avversi tal- mediċina li ġew irrappurtati fi provi kliniċi kkontrollati bi plaċebo li fihom 1, 965 pazjent bi pressjoni għolja rċevew irbesartan.
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
It- termini mmarkati bi stilla (*) jirreferu għar- reazzjonijiet avversi li ġew irrappurtati b’ mod addizzjonali f ’ > 2% tal- pazjenti dijabetiċi bi presssjoni għolja b’ insuffiċjenza renali kronika u proteinurja ċara u iżjed milli fil- grupp tal - plaċebo.
Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Iperkalimja * ġrat iktar frekwenti f’ pazjenti dijabetiċi ikkurati b’ irbesartan milli bil - plaċebo.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
F’ pazjenti dijabetiċi bi pressjoni għolja b’ mikroalbuminurja u b’ funzjoni renali normali, iperkalimja (≥ 5. 5mEq/ L) ġrat f’ 29. 4% (jiġifieri komuni ħafna) tal - pazjenti fil- grupp li ħadu 300 mg ta ’ irbesartan u fi 22% tal- pazjenti fil- grupp tal - plaċebo.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
F’ pazjenti dijabetiċi bi pressjoni għolja b’ insuffiċenzja renali kronika u bi protejnurja li tidher, iperkalimja (≥ 5. 5 mEq/ L) ġrat f’ 46. 3% tal- pazjenti fil- grupp ta ’ irbesartan u f’ 26. 3% tal- pazjenti fil- grupp tal- plaċebo.
significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
żidiet sinifikanti tal- creatine kinase fil- plażma ġew osservati frekwentement (1. 7%) f’ individwi li ħadu l- kura b’ irbesartan.
None of these increases were associated with identifiable clinical musculoskeletal events.
F’ 1. 7% tal -
In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
6 pazjenti bi pressjoni għolja b’ mard dijabetiku avanzat renali kkurati b’ irbesartan, kien osservat tnaqqis fl- emoglobina *, li ma kienx klinikament sinifikanti.
Uncommon: tachycardia
Mhux komuni: takikardija