natgillin/translations-raw huggingface dataset:
The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,835 mg) resulted in improvements from baseline in HbA1c at Week 52 and Week 104.
Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju z metforminijevim kloridom (povprečni odmerek = 1.835 mg) je v 52. tednu in 104. tednu povzročil izboljšanje glede na izhodiščne vrednosti HbA1c.
Alogliptin 25 mg once daily with a sulphonylurea (n=197)
Alogliptin 25 mg enkrat na dan s sulfonilsečnino (n=197)
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9) and is, therefore, not recommended for use in such patients (see sections 4.4 and 5.2).
Pri bolnikih s hudo okvaro jeter (ocena po Child-Pugh-u > 9) uporabe alogliptina niso raziskovali, zato njegova uporaba pri teh bolnikih ni priporočljiva (glejte poglavji 4.4 in 5.2).
The efficacy of alogliptin in patients with type 2 diabetes mellitus and ≥ 65 years old across a pooled analysis of five 26-week placebo-controlled studies was consistent with that in patients < 65 years old.
Združena analiza petih 26-tedenskih s placebom nadzorovanih študij kaže, da je učinkovitost alogliptina pri bolnikih s sladkorno boleznijo tipa 2, starih 65 let ali starejših, konsistentna z učinkovitostjo pri bolnikih, mlajših od 65 let.
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9) and is, therefore, not recommended for use in such patients (see sections 4.2 and 5.2).
Pri bolnikih s hudo okvaro jeter (ocena po Child-Pugh-u > 9) uporabe alogliptina niso raziskovali, zato njegova uporaba pri teh bolnikih ni priporočljiva (glejte poglavji 4.2 in 5.2).
Vipidia is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Zaradi pomanjkanja podatkov uporaba zdravila Vipidia pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
There is no experience of using Vipidia in pregnant women or during breast-feeding.
Pri nosečnicah ali doječih materah ni izkušenj z uporabo zdravila Vipidia.
Mean change from baseline in fasting plasma glucose at Week 26 for 25 mg alogliptin showed a reduction of 8.4 mg/dL compared to an increase of 2.2 mg/dL with placebo.
Vrednost glukoze v plazmi na tešče se je v 26. tednu v primerjavi z izhodiščem pri dodatku alogliptina v odmerku 25 mg v povprečju znižala za 8,4 mg/dl, pri dodatku placeba pa v povprečju zvišala za 2,2 mg/dl.
More patients receiving 25 mg alogliptin and metformin (48.5%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving glipizide and metformin (42.8%) (p=0.004).
Ciljne vrednosti HbA1c ≤ 7,0 % je doseglo več bolnikov, ki so prejemali alogliptin v odmerku 25 mg in metformin (48,5 %), v primerjavi z bolniki, ki so prejemali glipizid in metformin (42,8 %) (p=0,004).
Vipidia 12.5 mg film-coated tablets
Vipidia 12,5 mg filmsko obložene tablete
A total of 14,779 patients with type 2 diabetes mellitus, including 6,448 patients treated with 25 mg alogliptin and 2,476 patients treated with 12.5 mg alogliptin, participated in one phase 2 or 13 phase 3 (including the cardiovascular outcomes study) double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of alogliptin on glycaemic control and its safety.
V eno klinično študijo 2. faze in 13 dvojno slepih, s placebom ali z učinkovino nadzorovanih kliničnih študij 3. faze (vključno s študijo kardiovaskularnih izidov) je bilo vsega skupaj vključenih 14.779 bolnikov s sladkorno boleznijo tipa 2, vključno s 6.448 bolniki, ki so se zdravili z alogliptinom v odmerku 25 mg, in 2.476 bolniki, ki so se zdravili z alogliptinom v odmerku 12,5 mg.
Obtain liver function tests promptly in patients with symptoms suggestive of liver injury.
Pri bolnikih s simptomi, ki kažejo na morebitno okvaro jeter, je treba nemudoma izvesti preiskave delovanja jeter.
In the pooled pivotal phase 3 controlled clinical studies of alogliptin as monotherapy and as add-on combination therapy involving 5,659 patients, the observed adverse reactions are listed below (Table 1).
V nadaljevanju so navedeni neželeni učinki iz združenih ključnih nadzorovanih kliničnih študij 3. faze, ki so zajele 5.659 bolnikov, ki so alogliptin prejemali kot samostojno zdravilo in kot dodatno zdravilo pri kombiniranem zdravljenju (tabela 1).
Vipidia 25 mg film-coated tablets
Vipidia 25 mg filmsko obložene tablete
Treatment with 25 mg alogliptin once daily resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose compared to placebo-control at Week 26 (Table 2).
Pri zdravljenju z alogliptinom v odmerku 25 mg enkrat na dan so bila v 26. tednu dosežena statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče v primerjavi s kontrolo s placebom (tabela 2).
What Vipidia looks like and contents of the pack - Vipidia 25 mg film-coated tablets (tablets) are light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-25” printed in grey ink on one side.
Izgled zdravila Vipidia in vsebina pakiranja - Vipidia 25 mg filmsko obložene tablete (tablete) so svetlo rdeče, ovalne (približno 9,1 mm dolge in 5,1 mm široke), obojestransko izbočene, filmsko obložene tablete, z odtisnjenima sivima oznakama “TAK” in “ALG-25” na eni strani.
Vipidia 6.25 mg film-coated tablets
Vipidia 6,25 mg filmsko obložene tablete
In addition, a cardiovascular outcomes study with 5,380 patients with type 2 diabetes mellitus and a recent acute coronary syndrome event was conducted with 2,701 randomised to alogliptin and 2,679 randomised to placebo.
Poleg tega pa je bila izvedena še študija kardiovaskularnih izidov, v katero je bilo vključenih 5.380 bolnikov s sladkorno boleznijo tipa 2 in nedavnim akutnim koronarnim sindromom.
NAME OF THE MEDICINAL PRODUCT Vipidia 12.5 mg tablets alogliptin
IME ZDRAVILA Vipidia 12,5 mg tablete alogliptin
Vipidia 12.5 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin.
Ena 12,5 mg tableta vsebuje alogliptinijev benzoat v količini, ki ustreza 12,5 mg alogliptina.
Alogliptin as monotherapy
Alogliptin kot samostojno zdravilo
- Vipidia 12.5 mg film-coated tablets (tablets) are yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-12.5” printed in grey ink on one side.
- Vipidia 12,5 mg filmsko obložene tablete (tablete) so rumene, ovalne (približno 9,1 mm dolge in 5,1 mm široke), obojestransko izbočene, filmsko obložene tablete, z odtisnjenima sivima oznakama “TAK” in “ALG-12.5” na eni strani.
NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg film-coated tablets Vipidia 12.5 mg film-coated tablets Vipidia 25 mg film-coated tablets
Vipidia 6,25 mg filmsko obložene tablete Vipidia 12,5 mg filmsko obložene tablete Vipidia 25 mg filmsko obložene tablete
NAME OF THE MEDICINAL PRODUCT Vipidia 25 mg tablets alogliptin
IME ZDRAVILA Vipidia 25 mg tablete alogliptin
If you have mildly or moderately reduced liver function, the recommended dose of Vipidia is 25 mg once a day.
Če imate blago ali zmerno okvaro delovanja jeter, je priporočeni odmerek zdravila Vipidia 25 mg enkrat na dan. Zaradi pomanjkanja podatkov uporaba zdravila Vipidia pri bolnikih s hudo okvaro delovanja jeter ni priporočljiva.
Vipidia 6.25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin.
Ena 6,25 mg tableta vsebuje alogliptinijev benzoat v količini, ki ustreza 6,25 mg alogliptina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 12,5 mg alogliptina (v obliki benzoata).
Vipidia 25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 25 mg alogliptin.
Ena 25 mg tableta vsebuje alogliptinijev benzoat v količini, ki ustreza 25 mg alogliptina.
No dose adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9).
Pri bolnikih z blago do zmerno okvaro jeter (ocena po Child-Pugh-u od 5 do 9) odmerka ni treba prilagajati.
Alogliptin as add-on therapy to insulin (with or without metformin) The addition of 25 mg alogliptin once daily to insulin therapy (mean dose = 56.5 IU, with or without metformin) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Alogliptin kot dodatek k zdravljenju z insulinom (z metforminom ali brez) Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju z insulinom (povprečni odmerek = 56,5 i.e., z metforminom ali brez) je v 26. tednu povzročil statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče v primerjavi z dodatkom placeba (tabela 2).
Alogliptin has not been studied in patients undergoing peritoneal dialysis (see sections 4.4 and 5.2).
Pri bolnikih, ki se zdravijo s peritonealno dializo, uporabe alogliptina niso raziskovali (glejte poglavji 4.4 in 5.2).
- Vipidia 6.25 mg film-coated tablets (tablets) are light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-6.25” on printed in grey ink on one side.
- Vipidia 6,25 mg filmsko obložene tablete (tablete) so svetlo rožnate, ovalne (približno 9,1 mm dolge in 5,1 mm široke), obojestransko izbočene, filmsko obložene tablete, z odtisnjenima sivima oznakama “TAK” in “ALG-6.25” na eni strani.
NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg tablets alogliptin
IME ZDRAVILA Vipidia 6,25 mg tablete alogliptin
More patients receiving 25 mg alogliptin (7.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (0.8%) at Week 26.
V 26. tednu je ciljne vrednosti HbA1c ≤ 7,0 % doseglo več bolnikov, ki so prejemali alogliptin v odmerku 25 mg (7,8 %), v primerjavi z bolniki, ki so prejemali placebo (0,8 %).
Alogliptin has not been studied in patients undergoing peritoneal dialysis (see sections 4.2 and 5.2).
Pri bolnikih, ki se zdravijo s peritonealno dializo, uporabe alogliptina niso raziskovali (glejte poglavji 4.2 in 5.2).
Alogliptin as add-on therapy to a thiazolidinedione The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Alogliptin kot dodatek k zdravljenju s tiazolidindionom Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju s pioglitazonom (povprečni odmerek = 35,0 mg, v kombinaciji z metforminom ali s sulfonilsečnino ali brez) je v 26. tednu povzročil statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče v primerjavi z dodatkom placeba (tabela 2).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 25 mg alogliptina (v obliki benzoata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 6.25 mg alogliptin (as benzoate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 6,25 mg alogliptina (v obliki benzoata).
Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg alogliptin, - The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
- Pomožne snovi so: manitol, mikrokristalna celuloza, hidroksipropilceluloza, premreženi natrijev karmelozat, magnezijev stearat, hipromeloza, titanov dioksid (E171), rdeči železov oksid (E172), makrogol 8000, šelak in črni železov oksid (E172).
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9, see section 4.2).
Pri bolnikih s hudo okvaro jeter (ocena po Child-Pugh-u > 9) uporabe alogliptina niso raziskovali (glejte poglavje 4.2).
30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
V 52. tednu je ciljne vrednosti HbA1c ≤ 7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg v kombinaciji s 30 mg pioglitazona in z metforminom (33,2 %), v primerjavi z bolniki, ki so prejemali 45 mg pioglitazona in metformin (21,3 %) (p<0,001).
Your doctor may want to reduce your dose of sulphonylurea or insulin when you take any of them together with Vipidia in order to avoid too low blood sugar (hypoglycaemia) - if you have kidney disease, you can still take this medicine but your doctor may reduce the dose - if you have liver disease - if you suffer from heart failure - if you are taking insulin or an anti-diabetic medicine, your doctor may want to reduce your dose of the other anti-diabetic medicine or insulin when you take either of them together with Vipidia in order to avoid low blood sugar - if you have or have had a disease of the pancreas
- če uporabljate insulin ali jemljete drugo zdravilo za zdravljenje sladkorne bolezni, bo zdravnik odmerek drugega antidiabetika ali insulina morda zmanjšal, da bi preprečil prekomerno znižanje vrednosti sladkorja v krvi, če boste katerega od njiju jemali skupaj z zdravilom Vipidia.
Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin - The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
- Pomožne snovi so: manitol, mikrokristalna celuloza, hidroksipropilceluloza, premreženi natrijev karmelozat, magnezijev stearat, hipromeloza, titanov dioksid (E171), rumeni železov oksid (E172), makrogol 8000, šelak in črni železov oksid (E172).
Significantly more patients receiving 25 mg alogliptin (44.4%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (18.3%) at Week 26 (p<0.001).
V 26. tednu je ciljne vrednosti HbA1c ≤ 7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg (44,4 %), v primerjavi z bolniki, ki so prejemali placebo (18,3 %) (p<0,001).
Your blood sugar levels may increase when you stop taking Vipidia.
Po prenehanju jemanja zdravila Vipidia se vrednost krvnega sladkorja lahko zviša.
Hepatic effects
Učinki na jetra
Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-12.5” printed in grey ink on one side.
Rumene, ovalne (približno 9,1 mm dolge in 5,1 mm široke), bikonveksne, filmsko obložene tablete s sivima oznakama “TAK” in “ALG-12.5” na eni strani.
Significantly more patients receiving 25 mg alogliptin (34.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (18.2%) at Week 26 (p=0.002).
V 26. tednu je ciljne vrednosti HbA1c ≤ 7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg (34,8 %), v primerjavi z bolniki, ki so prejemali placebo (18,2 %) (p=0,002).
The addition of 25 mg alogliptin once daily to glyburide therapy (mean dose = 12.2 mg) resulted in statistically significant improvements from baseline in HbA1c at Week 26 when compared to the addition of placebo (Table 2).
Alogliptin kot dodatek k zdravljenju s sulfonilsečnino Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju z gliburidom (povprečni odmerek = 12,2 mg) je v 26. tednu povzročil statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c v primerjavi z dodatkom placeba (tabela 2).
At Week 104, the HbA1c reduction by 25 mg alogliptin plus metformin (-0.72%, Table 3) was greater than that produced by glipizide plus metformin (-0.59%).
V 104. tednu je bilo pri uporabi alogliptina v odmerku 25 mg in metformina zmanjšanje vrednosti HbA1c (-0,72 %, tabela 3) večje kot pri uporabi glipizida in metformina (-0,59 %) Povprečna sprememba vrednosti glukoze v plazmi na tešče glede na izhodiščno vrednost je bila v 52. tednu pri uporabi alogliptina v odmerku 25 mg z metforminom pomembno večja od tiste pri uporabi glipizida in metformina (p<0,001).
The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,847 mg) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Alogliptin kot dodatek k zdravljenju z metforminom Pri dodatku alogliptina v odmerku 25 mg enkrat na dan k zdravljenju z metforminijevim kloridom (povprečni odmerek = 1.847 mg) so bila v 26. tednu dosežena statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče v primerjavi z dodatkom placeba (tabela 2).
Light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-25” printed in grey ink on one side.
Svetlo rdeče, ovalne (približno 9,1 mm dolge in 5,1 mm široke), bikonveksne, filmsko obložene tablete s sivima oznakama “TAK” in “ALG-25” na eni strani.
Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-6.25” printed in grey ink on one side.
Svetlo rožnate, ovalne (približno 9,1 mm dolge in 5,1 mm široke), bikonveksne, filmsko obložene tablete s sivima oznakama “TAK” in “ALG-6.25” na eni strani.
Alogliptin as add-on therapy to a thiazolidinedione with metformin The addition of 25 mg alogliptin once daily to 30 mg pioglitazone and metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone and metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3).
Alogliptin kot dodatek k zdravljenju s tiazolidindionom in z metforminom Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju s 30 mg pioglitazona in z metforminijevim kloridom (povprečni odmerek = 1.867,9 mg) je v 52. tednu povzročil izboljšanja glede na izhodiščne vrednosti HbA1c.
Hepatobiliary disorders hepatic dysfunction including hepatic failure not known
Bolezni jeter, žolčnika in žolčevodov okvara delovanja jeter, vključno z odpovedjo jeter neznana
Clinically meaningful reductions in HbA1c compared to control were also observed with 25 mg alogliptin regardless of baseline background treatment.
Pri uporabi alogliptina v odmerku 25 mg so bila klinično pomembna zmanjšanja vrednosti HbA1c v primerjavi s kontrolo opažena tudi ne glede na osnovno zdravljenje v izhodišču.
Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting and rapid weight loss - if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin.
Simptomi vključujejo pretirano žejo, pogosto uriniranje, izgubo apetita, siljenje na bruhanje ali bruhanje in hitro izgubljanje telesne mase.
Its use during the first three months of pregnancy is not recommended.
Njegova uporaba ni priporočljiva v prvih treh mesecih nosečnosti.
Overall, the company presented the results of nine main studies involving a total of almost 9,000 patients with essential hypertension.
Skupno je družba predstavila rezultate devetih glavnih študij, v katere je bilo skupaj vključenih skoraj 9 000 bolnikov z esencialno hipertenzijo.
‘Essential' means that no specific cause for the hypertension can be found.
Izraz „esencialna“ pomeni, da za hipertenzijo ni očitnega vzroka.
The European Commission granted a marketing authorisation valid throughout the European Union for Riprazo HCT on 13 April 2011.
Evropska komisija je dovoljenje za promet z zdravilom Riprazo HCT, veljavno po vsej Evropski uniji, odobrila dne 13. aprila 2011.
It is available as tablets (150 mg aliskiren and 12.5 mg hydrochlorothiazide; 150 mg aliskiren and 25 mg hydrochlorothiazide; 300 mg aliskiren and 12.5 mg hydrochlorothiazide; 300 mg aliskiren and 25 mg hydrochlorothiazide).
Na voljo je v obliki tablet (150 mg aliskirena in 12,5 mg hidroklorotiazida; 150 mg aliskirena in 25 mg hidroklorotiazida; 300 mg aliskirena in 12,5 mg hidroklorotiazida; 300 mg aliskirena in 25 mg hidroklorotiazida).
The full EPAR for Riprazo HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Riprazo HCT je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It must not be used in women who are more than three months pregnant or breast-feeding.
Ne smejo ga uporabljati ženske, ki so noseče več kot tri mesece ali tiste, ki dojijo.
Aliskiren on its own has been authorised in the European Union (EU) since August 2007 as Rasilez, Sprimeo and Riprazo.
Zdravilo Aliskiren je kot samostojno zdravilo v Evropski uniji (EU) odobreno od avgusta 2007 pod imeni Rasilez, Sprimeo in Riprazo.
This is a summary of the European public assessment report (EPAR) for Riprazo HCT.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Riprazo HCT.
This authorisation was based on the authorisation of Rasilez HCT in 2009 (‘informed consent').
Odobritev je temeljila na dovoljenju za promet z zdravilom Rasilez HCT iz leta 2009 („privolitev po pojasnilu“).
The studies lasted for between eight weeks and a year, and the main measure of effectiveness was the change in blood pressure either during the resting phase of the heartbeat (diastolic) or when the chambers of the heart were contracting (systolic).
Študije so trajale od osem tednov do enega leta, glavno merilo učinkovitosti pa je bila sprememba krvnega tlaka med mirovalno fazo srčnega utripa (diastolični tlak) ali med krčenjem komor srca (sistolični tlak).
The most common side effect with Riprazo HCT (seen in between 1 and 10 patients in 100) is diarrhoea.
Najpogostejši neželeni učinek zdravila Riprazo HCT (opažen pri 1 do 10 bolnikih od 100) je driska.
It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Riprazo
Vzeti ga je treba z lahkim obrokom, najbolje vsak dan ob istem času, vendar pa se zdravilo Riprazo HCT ne sme vzeti skupaj z grenivkinim sokom.
After two to four weeks of taking Riprazo HCT, the dose can be increased in patients whose blood pressure remains uncontrolled.
Po dveh do štirih tednih jemanja zdravila Riprazo HCT se lahko odmerek poveča pri bolnikih, pri katerih krvni tlak še vedno ni uravnan.
For more information about treatment with Riprazo HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Riprazo HCT preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Most studies involved patients with mild to moderate hypertension and one involved patients with severe hypertension.
V večino študij so bili vključeni bolniki z blago do zmerno hipertenzijo, v eno pa bolniki s hudo hipertenzijo.
The CHMP decided that Riprazo HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Riprazo HCT večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Riprazo HCT is used to treat essential hypertension (high blood pressure) in adults.
Zdravilo Riprazo HCT se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
Riprazo HCT was more effective than placebo in reducing blood pressure.
Zdravilo Riprazo HCT je bilo pri zniževanju krvnega tlaka učinkovitejše od placeba.
EPAR summary for the public aliskiren / hydrochlorothiazide
Povzetek EPAR za javnost aliskiren/hidroklorotiazid
What benefit has Riprazo HCT shown during the studies?
Kakšne koristi je zdravilo Riprazo HCT izkazalo med študijami?
The dose depends on the doses of aliskiren and/or hydrochlorothiazide that the patient was taking before.
Odmerek je odvisen od odmerkov aliskirena in/ali hidroklorotiazida, ki jih je bolnik jemal prej.