qanastek/EMEA-V3 huggingface dataset:
AUC and C max values of valsartan are almost proportional with increasing dose over the clinical dosing range (40 to 160 mg twice a day).
Il- valuri ta ’ l- AUC u C max ta ’ valsartan huma kważi proporzjonali ma ’ żjieda fid- doża tul il- firxa ta ’ dożaġġ kliniku (40 sa 160 mg darbtejn kuljum).
The average accumulation factor is about 1.7.
Il- fattur medju ta ’ akkumulazzjoni huwa madwar 1. 7.
The apparent clearance of valsartan following oral administration is approximately 4.5 l/ h.
It- tneħħija apparenti ta ’ valsartan wara għoti orali hija madwar 4. 5 l/ h.
Age does not affect the apparent clearance in heart failure patients.
L- età ma taffettwax it- tneħħija apparenti f’ pazjenti b’ insuffiċjenza tal- qalb.
41 In Heart failure patients:
F’ pazjenti b’ insuffiċjenza tal- Qalb:
Special populations Elderly A somewhat higher systemic exposure to valsartan was observed in some elderly subjects than in young subjects; however, this has not been shown to have any clinical significance.
Popolazzjonijiet speċjali Anzjani Espożizzjoni sistemika kemmxejn ogħla għal valsartan kienet osservata f’ xi individwi anzjani meta mqabbel ma ’ individwi iżgħar; iżda, dan ma ntweriex li għandu xi sinifikanza klinika.
Impaired renal function As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
Indeboliment fil- funzjoni renali Kif mistenni għal sustanza fejn it- tneħħija renali hija responsabbli biss għal 30% tat- tneħħija totali mill- plażma, ma kienet osservata l- ebda korrelazzjoni bejn il- funzjoni renali u l- espożizzjoni sistemika għal valsartan.
Dose adjustment is therefore not required in patients with renal impairment (creatinine clearance > 10 ml/ min).
Għalhekk mhux meħtieġ aġġustament tad- doża f’ pazjenti b’ indeboliment renali (tneħħija tal- krejatinina > 10 ml/ min).
There is currently no experience on the safe use in patients with a creatinine clearance < 10 ml/ min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients (see sections 4.2 and 4.4).
Bħalissa m’ hemmx esperjenza dwar l- użu sikur f’ pazjenti bi tneħħija tal- krejatinina < 10 ml/ min u pazjenti li qed jagħmlu dijalisi, għalhekk valsartan għandu
Valsartan is highly bound to plasma protein and is unlikely to be removed by dialysis.
Valsartan huwa mwaħħal ħafna mal - proteina fil- plażma u mhux probabbli li jitneħħa permezz ta ’ dijalisi.
Hepatic impairment Approximately 70% of the dose absorbed is eliminated in the bile, essentially in the unchanged form.
Indeboliment epatiku Madwar 70% tad- doża assorbita hija eliminata fil- bili, essenzjalment f’ forma mhux mibdula.
Valsartan does not undergo any noteworthy biotransformation.
Valsartan ma jgħaddix minn xi bijotrasformazzjoni partikolari.
A doubling of exposure (AUC) was observed in patients with mild to moderate hepatic impairment compared to healthy subjects.
F’ pazjenti b’ indeboliment tal- fwied ħafif sa moderat kienet osservata espożizzjoni (AUC) doppja meta mqabbel ma ’ individwi b’ saħħithom.
However, no correlation was observed between plasma valsartan concentration versus degree of hepatic dysfunction.
Madankollu ma kienet osservata l- ebda korrelazzjoni bejn il- konċentrazzjoni ta ’ valsartan fil- plażma u l- grad ta ’ disfunzjoni epatika.
Diovan has not been studied in patients with severe hepatic dysfunction (see sections 4.2, 4.3 and 4.4).
Diovan ma kienx studjat f’ pazjenti b’ disfunzjoni epatika severa (ara sezzjonijiet 4. 2, 4. 3 u 4. 4).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Informazzjoni li mhux klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni u riskju ta ’ kanċer, ma turi l- ebda periklu speċjali għall- bnedmin.
In rats, maternally toxic doses (600 mg/ kg/ day) during the last days of gestation and lactation led to lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6).
Fil- firien, dożi tossiċi għall- omm (600 mg/ kg/ kuljum) waqt l- aħħar ġranet tat- tqala u treddiegħ wasslu għal sopravivenza aktar baxxa, żjieda aktar baxxa fil- piż u ttardjar fl- iżvilupp (stakkar tal- parti ta ’ barra tal- widna u ftuħ tal- kanal tal- widna) fil- frieħ (ara sezzjoni 4. 6).
These doses in rats (600 mg/ kg/ day) are approximately 18 times the maximum recommended human dose on a mg/ m2 basis (calculations assume an oral dose of 320 mg/ day and a 60-kg patient).
Fil- firien dawn id- dożi (600 mg/ kg/ kuljum) huma madwar 18- il darba ogħla mid- doża massima rrakkomandata fil- bniedem fuq bażi ta ’ mg/ m2 (kalkulazzjonijet jassumu doża orali ta ’ 320 mg/ kuljum u pazjent ta ’ 60- kg).
In non-clinical safety studies, high doses of valsartan (200 to 600 mg/ kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised plasma urea, and renal tubular hyperplasia and basophilia in males).
Fi studji mhux kliniċi dwar is- sigurtà, dożi għolja ta ’ valsartan (200 sa 600 mg/ kg piż tal- ġisem) ikkawżaw tnaqqis fil- parametri ta ’ ċelluli ħomor tad- demm fil- firien (eritroċiti, emoglobina, ematokrita) u evidenza ta ’ bidliet fl- emodinamika renali (urea fil- plażma kemmxejn miżjuda, u iperplasija tubulari renali u bażofilja fl- irġiel).
These doses in rats (200 and 600 mg/ kg/ day) are approximately 6 and 18 times the maximum recommended human dose on a mg/ m2 basis (calculations assume an oral dose of 320 mg/ day and a 60-kg patient).
Fil- firien dawn id- dożi (200 sa 600 mg/ kg/ kuljum) huma madwar 6 u 18- il darba ogħla mid- doża massima rrakkomandata fil- bniedem fuq bażi ta ’ mg/ m2 (kalkulazzjonijet jassumu doża orali ta ’ 320 mg/ kuljum u pazjent ta ’ 60- kg).
In marmosets at similar doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy which included raised urea and creatinine.
Fil- marmosets b’ dożi simili, il- bidliet kienu simili iżda iktar severi, speċjalment fil- kilwa fejn il- bidliet żviluppaw f’ nefropatija li kienet tinkludi żjieda fil- urea u l- krejatinina.
Hypertrophy of the renal juxtaglomerular cells was also seen in both species.
Fiż- żewġ speċi kienet osservata wkoll ipertrofija taċ- ċelluli jukstaglomerulari renali.
All changes were considered to be caused by the pharmacological action of valsartan which produces prolonged hypotension, particularly in marmosets.
Il- bidliet kollha kienu kkunsidrati li kienu kkawżati mill- azzjoni farmakoloġika ta ’ valsartan li tipproduċi pressjoni baxxa fit- tul, speċjalment fil- marmosets.
For therapeutic doses of valsartan in humans, the hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance.
Għal dożi terapewtiċi ta ’ valsartan fil- bnedmin, l- ipertrofija taċ- ċelluli jukstaglomerulari renali ma tidhirx li għandha xi rilevanza.
42 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
[To be completed nationally]
41 [Biex timtela mill- pajjiż partikolari]
No special requirements.
[Biex timtela mill- pajjiż partikolari]
43 LABELLING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Diovan and associated names (see Annex I) 40 mg film-coated tablets Valsartan Diovan and associated names (see Annex I) 40 mg capsules, hard Valsartan Diovan and associated names (see Annex I) 80 mg film-coated tablets Valsartan Diovan and associated names (see Annex I) 80 mg capsules, hard Valsartan Diovan and associated names (see Annex I) 160 mg film-coated tablets Valsartan Diovan and associated names (see Annex I) 160 mg capsules, hard Valsartan Diovan and associated names (see Annex I) 320 mg film-coated tablets Valsartan
Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg pilloli miksija b’ rita Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg kapsuli, iebsa Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg pilloli miksija b’ rita Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg kapsuli, iebsa Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg pilloli miksija b’ rita Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg kapsuli, iebsa Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 320 mg pilloli miksija b’ rita Valsartan
Each film-coated tablet contains 40 mg valsartan.
Kull pillola miksija b’ rita fiha 40 mg valsartan.
Each capsule contains 40 mg valsartan.
Kull kapsula fiha 40 mg valsartan.
Each film-coated tablet contains 80 mg valsartan.
Kull pillola miksija b’ rita fiha 80 mg valsartan.
Each capsule contains 80 mg valsartan.
Kull kapsula fiha 80 mg valsartan.
Each film-coated tablet contains 160 mg valsartan.
Kull pillola miksija b’ rita fiha 160 mg valsartan.
Each capsule contains 160 mg valsartan.
Kull kapsula fiha 160 mg valsartan.
Each film-coated tablet contains 320 mg valsartan.
Kull pillola miksija b’ rita fiha 320 mg valsartan.
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Diovan and associated names (see Annex I) 40 mg film-coated tablets Valsartan Diovan and associated names (see Annex I) 40 mg capsules, hard Valsartan Diovan and associated names (see Annex I) 80 mg film-coated tablets Valsartan Diovan and associated names (see Annex I) 80 mg capsules, hard Valsartan Diovan and associated names (see Annex I) 160 mg film-coated tablets Valsartan Diovan and associated names (see Annex I) 160 mg capsules, hard Valsartan Diovan and associated names (see Annex I) 320 mg film-coated tablets Valsartan [See Annex I - To be completed nationally]
Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg pilloli miksija b’ rita Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg kapsuli, iebsa Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg pilloli miksija b’ rita Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg kapsuli, iebsa Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg pilloli miksija b’ rita Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg kapsuli, iebsa Valsartan Diovan u ismijiet assoċjati miegħu (Ara Anness I) 320 mg pilloli miksija b’ rita Valsartan [Ara Anness I - Biex timtela mill- pajjiż partikolari]
47 PACKAGE LEAFLET
47 FULJETT TA ’ TAGĦRIF:
Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 40 mg capsules, hard Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg capsules, hard Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg capsules, hard Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I -To be completed nationally] Valsartan
Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg pilloli miksija b’ rita Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg kapsuli, iebsa Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg pilloli miksija b’ rita Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg kapsuli, iebsa Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg pilloli miksija b’ rita Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg kapsuli, iebsa Diovan u ismijiet assoċjati miegħu (Ara Anness I) 320 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari] Valsartan
What Diovan is and what it is used for 2.
X’ inhu Diovan u għalxiex jintuża 2.
Before you take Diovan 3.
Qabel ma tieħu Diovan 3.
How to take Diovan 4.
Kif għandek tieħu Diovan 4.
How to store Diovan 6.
Kif taħżen Diovan 6.
WHAT DIOVAN IS AND WHAT IT IS USED FOR
X’ INHU DIOVAN U GĦALXIEX JINTUŻA 1.
Diovan belongs to a class of medicines known as angiotensin II receptor antagonist, which help to control high blood pressure.
Diovan jagħmel parti minn klassi ta ’ mediċini magħrufa bħala antagonisti tar- riċettur ta ’ angiotensin II, li jgħinu biex jikkontrollaw pressjoni għolja tad- demm.
Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase.
Angiotensin II huwa sustanza fil- ġisem li jikkawża lill- vini u l- arterji biex jidjiequ, u b’ hekk jikkawża żjieda fil- pressjoni tad- demm tiegħek.
Diovan works by blocking the effect of angiotensin II.
Diovan jaħdem billi jimblokka l- effett ta ’ angiotensin II.
As a result, blood vessels relax and blood pressure is lowered.
Bħala riżultat, il- vini u l- artetji jirrilassaw u l - pressjoni tad- demm titbaxxa.
Diovan 40 mg film-coated tablets can be used for two different conditions:  to treat people after a recent heart attack (myocardial infarction). “ Recent” here means between 12 hours and 10 days.  to treat symptomatic heart failure.
Hawnhekk “ reċenti ” jfisser bejn 12- il siegħa u għaxart ijiem.  għall- kura ta ’ insuffiċjenza sintomatika tal- qalb.
Diovan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used.
Diovan jintuża meta grupp ta ’ mediċini msejħa inibituri ta ’ Angiotensin Converting Enzyme (ACE) (medikazzjoni għall- kura ta ’ insuffiċjenza tal- qalb) ma jistgħux jiġu wżati jew jista ’ jintuża flimkien ma ’ inibituri ta ’ ACE meta imblokkaturi tar- riċetturi beta (medikazzjoni oħra għall- kura ta ’ insuffiċjenza tal- qalb) ma jistgħux jiġu wżati.
Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up.
Sintomi ta ’ insuffiċjenza tal- qalb jinkludu qtugħ ta ’ nifs u nefħa fis- saqajn u r- riġlejn minħabba akkumulazzjoni ta ’ fluwidu.
It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body.
Hija kkawżata meta ’ l- muskolu tal- qalb ma jistax jippompja d - demm b’ saħħa biżżejjed biex jissupplixxi d- demm kollu meħtieġ madwar il- ġisem.
Diovan 40 mg capsules, hard can be used for two different conditions:  to treat people after a recent heart attack (myocardial infarction). “ Recent” here means between 12 hours and 10 days.  to treat symptomatic heart failure.
Diovan 40 mg kapsuli, iebsa jista ’ jintuża għal żewġ kundizzjonijiet differenti:  għall- kura ta ’ persuni wara attakk tal- qalb reċenti (infart mijokardijaku).
Diovan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure)
Diovan jintuża meta grupp ta ’ mediċini msejħa inibituri ta ’ Angiotensin Converting Enzyme (ACE) (medikazzjoni għall- kura ta ’
It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body.
Hija kkawżata meta l- muskolu tal- qalb ma jistax jippompja d - demm b’ saħħa biżżejjed biex jissupplixxi d- demm kollu meħtieġ madwar il- ġisem.
Diovan 80 mg film-coated tablets can be used for three different conditions:  to treat high blood pressure.
Diovan 80 mg pilloli miksija b’ rita jista ’ jintuża għal tliet kundizzjonijiet differenti:  għall- kura ta ’ pressjoni tad- demm għolja.
High blood pressure increases the workload on the heart and arteries.
Pressjoni tad- demm għolja żżid il- piż fuq il- qalb u l- arterji.
If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure.
Jekk ma tiġix ikkurata tista ’ tagħmel ħsara lill- vini u l- arterji fil- moħħ, qalb, u kliewi, u tista ’ twassal għal puplesija, insuffiċjenza tal- qalb, jew insuffiċjenza tal- kliewi.
High blood pressure increases the risk of heart attacks.
Pressjoni tad - demm għolja żżid ir- riskju ta ’ attakki tal- qalb.
Lowering your blood pressure to normal reduces the risk of developing these disorders.  to treat people after a recent heart attack (myocardial infarction). “ Recent” here means between 12 hours and 10 days.  to treat symptomatic heart failure.
Hawnhekk “ reċenti ” jfisser bejn 12- il siegħa u għaxart ijiem.  għall- kura ta ’ insuffiċjenza sintomatika tal- qalb.
Diovan 80 mg capsules, hard can be used for three different conditions:  to treat high blood pressure.
Diovan 80 mg kapsuli, iebsa jista ’ jintuża għal tliet kundizzjonijiet differenti:  għall- kura ta ’ pressjoni tad- demm għolja.
Diovan 160 mg film-coated tablets can be used for three different conditions:  to treat high blood pressure.
Diovan 160 mg pilloli miksija b’ rita jista ’ jintuża għal tliet kundizzjonijiet differenti:  għall- kura ta ’ pressjoni tad- demm għolja.
Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up.
49 Sintomi ta ’ insuffiċjenza tal- qalb jinkludu qtugħ ta ’ nifs u nefħa fis- saqajn u r- riġlejn minħabba akkumulazzjoni ta ’ fluwidu.
Diovan 160 mg capsules, hard can be used for three different conditions:  to treat high blood pressure.
Diovan 160 mg kapsuli, iebsa jista ’ jintuża għal tliet kundizzjonijiet differenti:  għall- kura ta ’ pressjoni tad- demm għolja.
If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke,
Jekk ma tiġix ikkurata tista ’ tagħmel ħsara lill- vini u l- arterji tad- demm fil- moħħ, qalb, u kliewi, u tista ’ twassal għal puplesija, insuffiċjenza tal- qalb, jew insuffiċjenza tal- kliewi.
50 heart failure, or kidney failure.
Pressjoni tad- demm għolja żżid ir- riskju ta ’ attakki tal- qalb.
High blood pressure increases the risk of heart attacks.
It- tnaqqis tal- pressjoni tad- demm tiegħek għan- normal inaqqas ir- riskju li jiżviluppaw dawn id- disturbi.  għall- kura ta ’ persuni wara attakk tal- qalb reċenti (infart mijokardijaku).
Diovan 320 mg film-coated tablets can be used  to treat high blood pressure.
Diovan 320 mg pilloli miksija b’ rita jista ’ jintuża  għall- kura ta ’ pressjoni tad- demm għolja.
Lowering your blood pressure to normal reduces the risk of developing these disorders.
It- tnaqqis tal- pressjoni tad- demm tiegħek għan - normal inaqqas ir- riskju li jiżviluppaw dawn id- disturbi.
BEFORE YOU TAKE DIOVAN
QABEL MA TIEĦU DIOVAN
Do not take Diovan:  if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Diovan.  if you have severe liver disease.  if you are more than 3 months pregnant (it is also better to avoid Diovan in early pregnancy - see pregnancy section).
Tieħux Diovan:  jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal valsartan jew sustanzi oħra ta ’ Diovan.  jekk inti għandek mard sever tal- fwied.  jekk għandek aktar minn 3 xhur tqala (ikun aħjar ukoll li tevita ’ Diovan fil- bidu tat- tqala – ara s- sezzjoni tqala).
If any of these apply to you, do not take Diovan
Jekk xi wieħed minn dawn jgħodd għalik, tieħux Diovan
Take special care with Diovan:  if you have liver disease.  if you have severe kidney disease or if you are undergoing dialysis.  if you are suffering from a narrowing of the kidney artery.  if you have recently undergone kidney transplantation (received a new kidney).  if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.  if you have severe heart disease other than heart failure or heart attack.  if you are taking medicines that increase the amount of potassium in your blood.
Oqgħod attent ħafna b’ Diovan:  jekk għandek mard tal- fwied.  jekk għandek mard sever tal- kliewi jew jekk qed tagħmel dijalisi.  jekk qed issofri minn tidjiq tal- arterja tal- kilwa.  jekk kellek trapjant reċenti ta ’ kilwa (irċevejt kilwa ġdida).  jekk qed tiġi kkurat wara attakk tal- qalb jew għal insuffiċjenza tal- qalb, it- tabib tiegħek għandu mnejn jiċċekkja l- funzjoni tal- kliewi tiegħek.  jekk għandek mard sever tal- qalb minbarra insuffiċjenza tal- qalb jew attakk tal- qalb.  jekk qed tieħu mediċini li jżidu l- ammont ta ’ potassium fid- demm tiegħek.
These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
Dawn jinkludu supplimenti tal- potassium jew sostitwenti tal- melħ li fihom potassium, mediċini li ma jitilfux potassium u eparina.
It may be necessary to check the amount of potassium in your blood at regular intervals.  if you suffer from aldosteronism.
Għandu mnejn ikun neċessarju li tiċċekkja l- ammont ta ’ potassium fid - demm tiegħek f’ intervalli regolari.  jekk issofri minn aldosteroniżmu.
This is a disease in which your adrenal glands make too much of the hormone aldosterone.
Din hija marda fejn il- glandoli adrenali tiegħek jipproduċu ammont żejjed ta ’ l- ormon aldosterone.
If this applies to you, the use of Diovan is not recommended.  if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water pills (diuretics).  the use of Diovan in children and adolescents is not recommended (below the age of 18 years).  you must tell your doctor if you think you are (or might become) pregnant.
50  jekk tlift ħafna fluwidu (deidrazzjoni) minħabba dijarea, rimettar, jew dożi għolja ta ’ pilloli ta ’ l- awrina (dijuretiċi).  l- użu ta ’ Diovan fit- tfal u l- adoloxxenti mhux irrakkomandat (taħt l- età ta ’ 18- il sena).  għandek tgħid it- tabib tiegħek jekk taħseb li inti tqila (jew tista ’ toħroġ tqila).
Diovan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Diovan mhux irrakkomandat fil- bidu tat- tqala, u m’ għandux jittieħed jekk għandek aktar minn 3 xhur tqala peress li jista ’ jikkawża ħsara serja lit- tarbija tiegħek jekk jintuża f’ dan l- istadju (ara s- sezzjoni tat- tqala).
If any of these apply to you, tell your doctor before you take Diovan.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Diovan.
51 The effect of the treatment can be influenced if Diovan is taken together with certain other medicines.
L- effett tal- kura jista ’ jkun influwenzat jekk Diovan jittieħed flimkien ma ’ ċertu mediċini oħra.
It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines.
Jista ’ jkun meħtieġ li tinbidel id- doża, li jittieħdu prekawzjonijiet oħra, jew f’ xi każijiet li jitwaqqaf it- teħid ta ’ waħda mill- mediċini.
This applies to both prescription and non-prescription medicines, especially:
Dan japplika kemm għall- meidċini bir- riċetta kif ukoll dawk mingħajr riċetta, speċjalment:
 other medicines that lower blood pressure, especially water pills (diuretics).  medicines that increase the amount of potassium in your blood.
 mediċini oħra li jbaxxu l- pressjoni tad- demm, speċjalment pilloli ta ’ l- awrina (dijuretiċi).  medicini li jżidu l- ammont ta ’ potassium fid- demm tiegħek.
These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.  certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).  lithium, a medicine used to treat some types of psychiatric illness.
Dawn jinkludu supplimenti tal - potassium, jew sostitwenti tal- melħ li fihom potassium, mediċini li ma jitilfux potassium u eparina.  ċertu tip ta ’ pilloli li jmewtu l- uġigħ imsejħa mediċini anti- infjammatorji mhux sterojdi (NSAIDs).  lithium, mediċina wżata għall- kura ta ’ xi tipi ta ’ mard psikjatriku.
In addition:  if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) is not recommended.  if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.
Barra dan:  jekk qed tiġi kkurat wara attakk tal- qalb, taħlita ma ’ inibituri ta ’ ACE (medikazzjoni għall - kura ta ’ attakk tal- qalb) mhux irrakkomandata.  jekk qed tiġi kkurat għall- insuffiċjenza tal- qalb, taħlita tripla ma ’ inbituri ta ’ ACE u imblokkaturi tar- riċetturi beta (medikazzjonijiet għall- kura ta ’ insuffiċjenza tal- qalb) mhux irrakkomandata.
In addition:  if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) is not recommended.  if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.
Barra dan: jekk qed tiġi kkurat wara attakk tal- qalb, taħlita ma ’ inibituri ta ’ ACE (medikazzjoni għall - o kura ta ’ attakk tal- qalb) mhux irrakkomandata. jekk qed tiġi kkurat għall- insuffiċjenza tal- qalb, taħlita tripla ma ’ inbituri ta ’ ACE u o imblokkaturi tar- riċetturi beta (medikazzjonijiet għall- kura ta ’ insuffiċjenza tal- qalb) mhux irrakkomandata.
Taking Diovan with food and drink You can take Diovan with or without food.
Tista ’ tieħu Diovan ma ’ l- ikel jew mingħjar ikel.
 You must tell your doctor if you think that you are (or might become) pregnant.
 Għandek tgħid lit- tabib tiegħek jekk taħseb li inti tqila (jew tista ’ toħroġ tqila).
Your doctor will normally advise you to stop taking Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan.
It- tabib tiegħek normalment se javżak biex tieqaf tieħu Diovan qabel ma toħroġ tqila jew hekk kif tkun taf li inti tqila, u se javżak biex tieħu mediċina oħra minflok Diovan.
Diovan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Diovan mhux irrakkomandat fil- bidu tat- tqala, u m’ għandux jittieħed meta jkun hemm aktar minn 3 xhur tqala, minħabba li jista ’ jikkawża ħsara serja lit- tarbija tiegħek jekk jintuża wara t- tielet xahar ta ’ tqala.
 Tell your doctor if you are breast-feeding or about to start breast-feeding.
 Għid lit- tabib tiegħek jekk qed tredda ’ jew se tibda tredda ’.
Diovan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Diovan mhux irrakkomandat għall- ommijiet li qed ireddgħu, u t- tabib tiegħek jista ’ jagħżel kura oħra għalik jekk tixtieq tredda ’, speċjalment jekk it- tarbija tiegħek għadha titwieled, jew twieldet qabel iż- żmien.
Driving and using machines Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Diovan affects you.
Qabel ma ssuq vettura, tuża għodda jew tħaddem magni, jew tagħmel attivitajiet oħra li jeħtieġu konċentrazzjoni, kun ċert li taf kif Diovan jaffettwak.
Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.
Bħal ħafna mediċini oħra wżati għall- kura ta ’ pressjoni tad- demm għolja, f’ każijiet rari Diovan jista ’ jikkawża sturdament u jaffettwa l- ħila biex tikkonċentra.
Important information about some ingredients of Diovan [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
HOW TO TAKE DIOVAN
KIF GĦANDEK TIEĦU DIOVAN
Always take Diovan exactly as your doctor has told you in order to get the best results and reduce the risk of side effects.
Biex ikollok l- aħjar riżultati u tnaqqas ir- riskju ta ’ effetti sekondarji, dejjem għandek tieħu Diovan skond il- parir eżatt tat- tabib.
People with high blood pressure often do not notice any signs of this problem.
Persuni bi pressjoni tad- demm għolja ħafna drabi ma jinnutaw l- ebda sinjal ta ’ din il - problema.
Many may feel quite normal.
Ħafna jistgħu jħossuhom pjuttost normali.
This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well.
Minħabba f’ dan huwa importanti ħafna li żżomm l- appuntamenti mat- tabib anki jekk tħossok tajjeb.
52 After a recent heart attack:
Wara attakk tal- qalb reċenti:
After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily.
Wara attakk tal- qalb reċenti l- kura ġeneralment tinbeda sa anke minn 12- il siegħa wara, ġeneralment b’ doża baxxa ta ’ 20 mg darbtejn kuljum.
You obtain the 20 mg dose by dividing the 40 mg tablet.
Inti tikseb id- doża ta ’ 20 mg billi taqsam il- pillola ta ’ 40 mg.
Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice daily.
It- tabib tiegħek se jżid din id- doża b’ mod gradwali fuq diversi ġimgħat sa massimu ta ’ 160 mg darbtejn kuljum.
The final dose depends on what you as an individual patient can tolerate.
Id- doża finali tiddependi fuq dak li inti tista ’ tittollera bħala pazjent individwali.
Diovan can be given together with other treatment for heart attack, and your doctor will decide which treatment is suitable for you.
Diovan jista ’ jingħata flimkien ma ’ kura oħra għall- attakk tal- qalb, u t- tabib tiegħek se jiddeċiedi liema kura hija xierqa għalik.
Treatment starts generally with 40 mg twice daily.
Il- kura ġeneralment tinbeda b’ 40 mg darbtejn kuljum.
Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily.
It- tabib tiegħek ser iżid id- doża b’ mod gradwali fuq diversi ġimgħat sa massimu ta ’ 160 mg darbtejn kuljum.
Diovan can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.
Diovan jista ’ jingħata flimkien ma ’ kura oħra għall- insuffiċjenza tal- qalb, u t- tabib tiegħek se jiddeċiedi liema kura hija xierqa għalik.
High blood pressure:
Pressjoni tad- demm għolja:
The usual dose is 80 mg daily.
Id- doża tas- soltu hija 80 mg kuljum.
In some cases your doctor may prescribe higher doses (e. g.
F’ xi każijiet it- tabib tiegħek jista ’ jippreskrivi dożi ogħla (eż.
160 mg or 320 mg).
160 mg jew 320 mg).
He may also combine Diovan with an additional medicine (e. g. a diuretic).
Huwa jista ’ wkoll jikkombina Diovan ma ’ mediċina oħra (eż. dijuretiku).
After a recent heart attack:
Wara attakk tal- qalb reċenti:
You can take Diovan with or without food.
Inti tista ’ tieħu Diovan ma ’ l- ikel jew mingħajr ikel.
Swallow Diovan with a glass of water.
Ibla ’ Diovan ma ’ tazza ilma.
Take Diovan at about the same time each day.
Ħu Diovan f’ madwar l- istess ħin kuljum.
If you take more Diovan than you should If you experience severe dizziness and/ or fainting, lay down and contact your doctor immediately.
Jekk ikollok sturdament qawwi u/ jew ħass ħażin, imtedd u kellem lit- tabib tiegħek minnufiħ.
If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
Jekk bi żball ħadt pilloli żejda, kellem lit- tabib, spiżjar jew sptar tiegħek.
If you forget to take Diovan Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you forget to take a dose, take it as soon as you remember.
Jekk tinsa tieħu doża, ħudha hekk kif tiftakar.
However, if it is almost time for your next dose, skip the dose you missed.
Madankollu, jekk ikun kważi sar il- ħin għad- doża li jmiss tiegħek, aqbeż id- doża li tlift.
If you stop taking Diovan Stopping your treatment with Diovan may cause your disease to get worse.
Il- waqfien tal- kura tiegħek b’ Diovan jista ’ jikkawża rkadar tal- marda tiegħek.
Do not stop taking your medicine unless your doctor tells you to.
Twaqqafx it- teħid tal - mediċina tiegħek sakemm ma jgħidlekx hekk it- tabib tiegħek.
Like all medicines, Diovan can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Diovan jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects may occur with certain frequencies, which are defined as follows:  very common: affects more than 1 user in 10  common: affects 1 to 10 users in 100  uncommon: affects 1 to 10 users in 1,000  rare: affects 1 to 10 users in 10,000  very rare: affects less than 1 user in 10,000  not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarja jistgħu jseħħu b’ ċertu frekwenzi, li huma definiti kif ġej:  komuni ħafna: jaffettwaw aktar minn persuna waħda minn kull 10 li qed jużawh  komuni: jaffettwaw minn persuna waħda sa 10 minn kull 100 li qed jużawh  mhux komuni: jaffettwaw minn persuna waħda sa 10 minn kull 1, 000 li qed jużawh  rari: jaffettwaw minn persuna waħda sa 10 minn kull 10, 000 li qed jużawh  rari ħafna: jaffettwaw inqas minn persuna waħda minn kull 10, 000 li qed jużawh  mhux magħruf: il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli.
Some symptoms need immediate medical attention:
Xi sintomi jeħtieġu attenzjoni medika immedjata:
You may experience symptoms of angioedema, such as  swollen face, tongue or throat  difficulty in swallowing  hives and difficulties in breathing
Inti jista ’ jkollok esperjenza ta ’ sintomi ta ’ anġjoedima, bħal  nefħa fil- wiċċ, ilsien jew griżmejn  diffikultà biex tibla ’  ħorriqija u diffikultajiet biex tieħu n- nifs
If you get any of these, see a doctor immediately.
Jekk ikollok xi wieħed minn dawn, ara tabib minnufih.
Common:  dizziness, postural dizziness  low blood pressure with symptoms such as dizziness  decreased kidney function (signs of renal impairment)
Komuni:  sturdament, sturdament mal- waqfien  pressjoni tad- demm baxxa b’ sintomi bħal sturdament  funzjoni tal- kliewi mnaqqsa (sinjali ta ’ indeboliment tal- kliewi)
Uncommon:  allergic reaction with symptoms such as rash, itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing (signs of angioedema)  sudden loss of consciousness  spinning sensation  severely decreased kidney function (signs of acute renal failure)  muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)  breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)  headache  cough  abdominal pain  nausea  diarrhea  tiredness  weakness
Mhux komuni:  reazzjoni allerġika b’ sintomi bħal raxx, ħakk, sturdament, nefħa fil- wiċċ jew xufftejn jew ilsien jew griżmejn, diffikultà biex tieħu n- nifs jew tibla ’, sturdament (sinjali ta ’ anġjoedima)  telf ta ’ koxjenza f’ daqqa  tħoss kollox idur bik  tnaqqis sever fil- funzjoni tal- kliewi (sinjali ta ’ insuffiċjenza renali akuta)  spażmi fil- muskoli, ritmu tal- qalb mhux normali (sinjali ta ’ iperkalimja)  qtugħ ta ’ nifs, diffikultà biex tieħu n- nifs meta mimdud, nefħa fis- saqajn jew riġlejn (sinjali ta ’ insuffiċjenza tal- qalb)  uġigħ ta ’ ras  sogħla
Not known:  rash, itching, together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/ or flu-like symptoms (signs of serum sickness)  purplished-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)  unusual bleeding or bruising (signs of thrombocytopenia)  muscle pain (myalgia)  fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia)
53  uġigħ addominali  tqalligħ  dijarea  għeja  debbulizza
54  decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can, in severe cases, lead to anaemia)  increase of level of potassium in the blood (which can, in severe cases, trigger muscle spasms, abnormal heart rhythm)  elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can, in severe cases, trigger yellow skin and eyes)  increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)
Mhux magħrufa:  raxx, ħakk, flimkien ma ’ wħud mis- sinjali jew sintomi li ġejjin: deni, uġigħ fil- ġogi, uġigħ fil - muskoli, glandoli tal- limfa minfuħa u/ jew sintomi li jixbħu lill- influwenza (sinjali tal- marda tas - serum)  ponot ħomor fil- vjola, deni, ħakk (sinjali ta ’ infjammazzjoni tal- vini u l- arterji msejħa vaskulite)  fsada jew tbenġil mhux tas- soltu (sinjali ta ’ tromboċitopenija)  uġigħ fil- muskoli (majalġja)  deni, uġigħ fil- griżmejn jew ulċeri fil- ħalq minħabba infezzjonijiet (sintomi ta ’ livell baxx ta ’ ċelluli bojod tad- demm imsejħa newtropenija)  tnaqqis fil- livell ta ’ emoglobina u tnaqqis fil- persentaġġ ta ’ ċelluli ħomor fid- demm (li f’ każijiet severi jistgħu jikkawżaw anemija)  żjieda fil- livell ta ’ potassium fid- demm (li f’ każijiet severi tista ’ tikkawża spażmi fil- muskoli, ritmu tal- qalb mhux normali)  żjieda fil- valuri tal- funzjoni tal- fwied (li tista ’ tkun indikazzjoni ta ’ ħsara fil- fwied) inkluż żjieda fil- livell ta ’ bilirubin fid- demm (li f’ każijiet severi tista ’ tikkawża sfurija fil- ġilda u l - abjad ta ’ l- għajnejn)  żjieda fil- livell ta ’ nitrogen mill- urea fid- demm u żjieda fil- livell ta ’ krejatinina fis- serum (li jistgħu jindikaw funzjoni tal- kliewi mhux normali)
The frequency of some side effects may vary depending on your condition.
Il- frekwenza ta ’ xi effetti sekondarja tista ’ tvarja skond il- kundizzjoni tiegħek.
For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in patients treated with high blood pressure than in patients treated for heart failure or after a recent heart attack.
Per eżempju, effetti sekondarja bħal sturdament, u funzjoni tal- kliewi mnaqqsa, dehru b’ mod inqas frekwenti f’ pazjenti kkurati għall- pressjoni tad- demm għolja milli f’ pazjenti kkurati għall- insuffiċjenza tal- qalb jew wara attakk tal- qalb reċenti.
HOW TO STORE DIOVAN
KIF TAĦŻEN DIOVAN
 [Storage conditions statements - To be completed nationally]  Keep out of the reach and sight of children.  Do not use Diovan after the expiry date which is stated on the pack.
 [Stqarrijiet ta ’ kundizzjonijet ta ’ ħażna - Biex timtela mill- pajjiż partikolari]  Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.  Tużax Diovan wara d- data ta ’ skadenza li tidher fuq il- pakkett.
The expiry date refers to the last day of that month.  Do not use Diovan if you notice that the pack is damaged or shows signs of tampering.  Medicines should not be disposed of via wastewater or household waste.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.  Tużax Diovan jekk tinnota li l- pakkett għandu l- ħsara jew juri sinjali li nfetaħ.  Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Diovan contains
X’ fih Diovan
What Diovan looks like and contents of the pack
Id- Dehra ta ’ Diovan u l- kontenuti tal- pakkett
[To be completed nationally]
54 [Biex timtela mill- pajjiż partikolari]
For any information about this medicine, please contact the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lid- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
This medicinal product is authorised in the Member States of the EEA under the following names:
Dan il- prodott mediċinali huwa awtorizzat fl- Istati Membri ta ’ l- EEA b’ dawn l- ismijiet:
Ref.
Londra, 18 ta ’ Frar 2009 Dok ta ’ Ref.
EMEA/ CHMP/ 137577/ 2009 EMEA/ H/ A-30/ 998
EMEA/ 150573/ 2009 EMEA/ H/ A- 30/ 998
Questions and answers on the referral for Diovan film coated tablets and hard capsules containing valsartan 40, 80, 160 or 320 mg
Mistoqsija u tweġa dwar ir- referenza għall- pilloli miksija b’ rita Diovan u kapsuli iebsa ta ’ 40, 80, 160 jew 320 mg li fihom valsartan
The European Medicines Agency (EMEA) has completed a review of Diovan (and associated names).
L- Aġenzija Ewropea għall- Mediċini (EMEA) lestiet l- analiżi ta ’ Diovan (u ismijiet assoċjati).
The Agency’ s Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diovan in the European Union (EU) and the European Economic Area (EEA).
Il- Kumitat tal- Aġenzija għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li hemm il- ħtieġa li l- informazzjoni tal- preskrizzjoni għal Diovan tkun armonizzata fl- Unjoni Ewropea (UE) u fiż- Żona Ekonomika Ewropea (ŻEE).
The review was carried out under an ‘ Article 30’ referral 1.
Ir- reviżjoni saret skont riferiment tal - ‘ Artikolu 30 ’ 1.
What is Diovan?
X’ inhu Diovan?
Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure.
Diovan jappartjeni għal klassi ta ’ mediċini magħrufa bħala antagonisti tar- riċettur ta ’ anġjotensina II, li jgħinu fil- kontroll tal- pressjoni għolja tad- demm.
Angiotensin II is a substance in the body that causes vessels to tighten, thus causing blood pressure to increase.
Anġjotensina II hija sustanza fil- ġisem li ġġiegħel lill- arterji jidjiequ, u għalhekk tiżdied il- pressjoni tad- demm.
Diovan works by blocking the effect of angiotensin II.
Diovan jaħdem billi jimblokka l- effett ta ’ anġjotensina II.
As a result, blood vessels relax and blood pressure is lowered.
B’ riżultat ta ’ dan, l- arterji tad- demm jirrilassaw u titbaxxa l- pressjoni tad- demm.
Diovan can be used to treat patients with hypertension (high blood pressure), patients who just have had a heart attack (between 12 hours and 10 days earlier), or patients with heart failure when they show signs that their heart not working fully, such as shortness of breath, and swelling of the feet and legs due to fluid build-up.
Diovan jista ’ jintuża fil- kura ta ’ pazjenti bl- ipertensjoni (pressjoni għolja tad- demm), pazjenti li għad kemm kellhom attakk tal- qalb (bejn 12- il siegħa u 10 ijiem qabel), jew pazjenti b’ insuffiċjenza tal - qalb meta dawn juru sinjali li qalbhom mhix taħdem kif suppost, bħal qtugħ ta ’ nifs, u nefħa fis- saqajn u r- riġlejn minħabba l- akkumulazzjoni ta ’ fluwidu.
In heart failure, Diovan is used when other types of medicines used in heart failure such as Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers, cannot be used.
Fl- insuffiċjenza tal- qalb, Diovan jintuża meta ma jistgħux jintużaw tipi oħra ta ’ mediċini użati fl- insuffiċjenza tal- qalb bħal inibituri tal- Enzima li Tikkonverti l- Anġjotensina (ACE) jew imblokkaturi beta.
It can be used on its own and in combination with ACE inhibitors.
Jista ’ jintuża waħdu jew f’ kombinazzjoni ma ’ inibituri ACE.
All strengths can be used in these diseases, except the lowest (40 mg) strength, which cannot be used to treat hypertension.
Id- dożi kollha jistgħu jintużaw f’ dan il- mard, ħlief għall- iżgħar (40 mg) doża, li ma tistax tintuża għall- kura tal- ipertensjoni.
The 320 mg strength was not available in all markets.
Id- doża ta ’ 320 mg ma kinitx disponibbli fis- swieq kollha.
Diovan can also be available in the EU and the EEA under other trade names:
Diovan jista ’ jkun disponibbli wkoll fl- UE u ż- ŻEE taħt ismijiet ta ’ marka oħrajn:
Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg, and Varexan.
Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg, u Varexan.
The company that markets it is Novartis.
Il - kumpanija li tqiegħdu fis- suq hija Novartis.
Why was Diovan reviewed?
Għalfejn ġie rivedut Diovan?
Diovan is authorised in the European Union (EU) via national procedures.
Diovan huwa awtorizzat fl- Unjoni Ewropea (UE) permezz ta ’ proċeduri nazzjonali.
This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Dan wassal għal nuqqas ta ’ qbil fost l- istati membri dwar il- mod kif tista ’ tintuża l- mediċina, kif jidher fid- differenzi osservati fis- Sommarji tal- Karatteristiċi tal- Prodott (SPCs), fit- tikkettar u l- fuljetti ta ’ tagħrif fil- pajjiżi fejn jinbiegħ il- prodott.
Diovan has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).
Diovan ġie identifikat bħala li jeħtieġ armonizzazzjoni mill- Grupp ta ’ Koordinazzjoni dwar ir- Rikonoxximent Reċiproku u l- Proċeduri Deċentralizzati – Bniedem (CMD( h)).
On 30 May 2008 the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Diovan in the EU and the EEA.
Fit- 30 ta ’ Mejju 2008 il- Kummissjoni Ewropea rreferiet il- każ lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) sabiex jarmonizza l- awtorizzazzjonijiet għat- tqegħid fis- suq ta ’ Diovan fl- UE u fiż- ŻEE.
1 Article 30 of Directive 2001/ 83/ EC as amended, referral on the grounds of divergent decisions adopted by member States 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
1 Artikolu 30 tad- Direttiva 2001/ 83/ KE kif emendata, referenza fuq il- bażi ta ’ deċiżjonijiet differenti adottati mill- Istati membri 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
Is- CHMP, fid- dawl tad- dejta sottomessa u d- diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- SPCs, it- tikkettar u l- fuljetti ta ’ tagħrif għandhom ikunu armonizzati madwar l- UE.
The areas harmonised include:
L- oqsma armonizzati jinkludu:
Therapeutic indications The CHMP endorsed the use of Diovan in the “ treatment of essential hypertension”.
Indikazzjonijiet terapewtiċi Is- CHMP approva l- użu ta ’ Diovan fil - “ kura ta ’ ipertensjoni essenzjali ”.
The Committee also concluded that the 320 mg dose provides a modest, but statistically significant additional reduction in blood pressure compared to 160 mg and a similarly modest increase in the rate of blood pressure control.
Il- Kumitat ikkonkluda wkoll li d- doża ta ’ 320 mg tipprovdi tnaqqis addizzjonali żgħir, iżda statistikament sinifikanti fil- pressjoni tad- demm meta mqabbla ma ’ 160 mg u żieda daqstant żgħira fir- rata tal- kontroll tal- pressjoni tad - demm.
The CHMP also discussed the indications in the treatment of heart failure and after a recent myocardial infarction (MI).
Is- CHMP iddiskuta wkoll l- indikazzjonijiet fil- kura tal- insuffiċjenza tal- qalb u wara infart mijokardijaku reċenti (MI).
The Committee noted that some Member States (MSs) had a limitation of the use of Diovan after MI to patients intolerant to ACE inhibitors.
Il- Kumitat innota li xi Stati Membri (MSs) kellhom limitazzjoni fl- użu ta ’ Diovan wara MI lil pazjenti li ma jittollerawx inibituri ACE.
But considering that valsartan given on its own is at least as effective as captopril (an ACE inhibitor) given on its own in the reduction of total mortality after an acute MI, the CHMP endorsed the harmonised indication:
Iżda meta wieħed jikkunsidra li valsartan mogħti waħdu huwa mill- inqas effettiv daqs captopril (inibitur ACE) mogħti waħdu fit- tnaqqis ta ’ mortalità totali wara MI akut, is- CHMP approva l- indikazzjoni armonizzata:
Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours – 10 days) myocardial infarction.
Il- kura ta ’ pazjenti b’ insuffiċjenza tal- qalb sintomatika jew disfunzjoni sistolika tal- ventrikolu tax- xellug asintomatika klinikament stabbli wara infart mijokardijaku reċenti (12- il siegħa – 10 ijiem).
Posology and method of administration The CHMP discussed three areas where there was a divergence: • the use of Diovan with ACE inhibitors and betablockers (triple combination) in chronic heart failure, • how to manage dose increases, • dosage recommendations in patients with renal and hepatic impairment.
Pożoloġija u metodu ta ’ kif għandu jingħata Is- CHMP iddiskuta tliet oqsma li fihom kien hemm differenzi: • l- użu ta ’ Diovan ma ’ inibituri ACE u mblokkaturi beta (kombinazzjoni tripla) f’ insuffiċjenza tal- qalb kronika, • il- ġestjoni taż- żidiet fid- dożi, • ir- rakkomandazzjonijiet ta ’ dożi għal pazjenti bi problemi renali u epatiċi.