natgillin/translations-raw huggingface dataset:
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections
Dvojno zaviranje renin-angiotenzin-aldosteronskega sistema (RAAS) Uporaba kombinacije telmisartana in aliskirena je kontraindicirana pri bolnikih s sladkorno boleznijo ali ledvično okvaro (GFR < 60 ml/min/1,73 m2), pri drugih bolnikih pa je ne priporočajo (glejte poglavji 4.3, 4.4).
Anaemia Thrombocytopenia, eosinophilia
trombocitopenija, eozinofilija
What Onduarp looks like and contents of the pack Onduarp 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Izgled zdravila Onduarp in vsebina pakiranja Tablete Onduarp po 40 mg/5 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A1 na eni strani in znak podjetja na drugi strani.
- The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine,
črni železov oksid (E 172), rumeni železov oksid (E 172), magnezijev stearat, koruzni škrob,
Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side.
Modra in bela dvoslojna tableta ovalne oblike z oznako A2 in logom podjetja na drugi strani.
Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate).
Ena tableta vsebuje 40 mg telmisartana in 5 mg amlodipina (kot besilat).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/5 mg
Pretisni omot s 7 tabletami - 40 mg/5 mg
Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as besylate).
Ena tableta vsebuje 80 mg telmisartana in 10 mg amlodipina (kot besilat).
Pain
bolečina
Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as besylate).
Ena tableta vsebuje 80 mg telmisartana in 5 mg amlodipina (kot besilat).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg
Pretisni omot s 7 tabletami - 40 mg/10 mg
• if you suffer from low heart output because of a serious heart problem.
• če imate nenadno poslabšanje črpalne sposobnosti srca z odpovedjo krvnega obtoka,
Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as besylate).
Ena tableta vsebuje 40 mg telmisartana in 10 mg amlodipina (kot besilat).
What Onduarp looks like and contents of the pack Onduarp 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side.
Izgled zdravila Onduarp in vsebina pakiranja Tablete Onduarp po 40 mg/10 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A2 na eni strani in znak podjetja na drugi strani.
The recommended dose is one tablet a day.
Priporočeni odmerek zdravila Onduarp je ena tableta na dan. Tableto poskušajte vzeti vsak dan ob isti uri.
Onduarp showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic dose range of −21.8/−16.5 mmHg (40 mg/5 mg), −22.1/−18.2 mmHg (80 mg/5 mg),
Zdravilo Onduarp je odvisno od velikosti odmerkov, ki so bili znotraj terapevtskega razpona odmerjanja, znižalo sistolični in diastolični krvni tlak, in sicer za -21,8/-16,5 mm Hg (40 mg/5 mg), -22,1/-18,2 mm Hg (80 mg/5 mg), -24,7/-20,2 mm Hg (40 mg/10 mg) in -26,4/-20,1 mm Hg (80 mg/10 mg).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/5 mg
Pretisni omot za enkratni odmerek z 10 tabletami - 80 mg/5 mg
Hepatic function abnormal, liver disorder2 Skin and subcutaneous tissue disorders Uncommon: Rare:
Bolezni jeter, žolčnika in žolčevodov Redki:
Read the package leaflet for further information.
Podrobnejše informacije so v priloženem navodilu.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg
Pretisni omot s 7 tabletami - 80 mg/5 mg
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets telmisartan/amlodipine
IME ZDRAVILA Onduarp 40 mg/5 mg tablete telmisartan/amlodipin
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg
Pretisni omot za enkratni odmerek z 10 tabletami - 80 mg/10 mg
Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood.
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov): okužba sečnega mehurja, žalost (depresija), tesnoba, nespečnost, omedlevica, okvara živcev v dlaneh ali stopalih, zmanjšan otip, nenormalen okus, tresenje, bruhanje, povečanje dlesni, nelagodje v trebuhu, suha usta, ekcem (kožno obolenje), pordela koža, izpuščaj, bolečina v hrbtu, bolečina v nogi, bolečina v nogah, potreba po mokrenju ponoči, slabo počutje (bolehnost), zvišana raven sečne kisline v krvi.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/004 (360 (4 x 90 x 1) tablet)
−15.0/−10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus −6.2/−5.7 mmHg, −11.1/−8.0 mmHg with amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 42 %, 56.7 % with amlodipine 5 mg and 10 mg).
Po 8 tednih zdravljenja sta obe kombinaciji statistično značilno učinkoviteje znižali sistolični in diastolični krvni tlak kot odmerka amlodipina (-13,6/-9,4 mm Hg, -15,0/-10,6 mm Hg pri 40 mg/5 mg, 80 mg/5 mg v primerjavi z -6,2/-5,7 mm Hg, -11,1/-8,0 mm Hg pri amlodipinu po 5 mg in 10 mg), odstotek uravnanega diastoličnega krvnega tlaka pa je bil večji v primerjavi z monoterapijama (56,7 %, 63,8 % pri kombinacijah 40 mg/5 mg in 80 mg/5 mg v primerjavi z 42 %, 56,7 % pri amlodipinu v odmerkih po 5 mg in 10 mg).
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/006 (360 (4 x 90 x 1) tablets)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/006 (360 (4 x 90 x 1) tablet)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/10 mg
VMESNA OVOJNINA PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - BREZ MODREGA OKENCA - 80 mg/10 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/5 mg
VMESNA OVOJNINA PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - BREZ MODREGA OKENCA - 80 mg/5 mg
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets telmisartan/amlodipine
IME ZDRAVILA Onduarp 80 mg/5 mg tablete telmisartan/amlodipin
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets telmisartan/amlodipine
IME ZDRAVILA Onduarp 40 mg/10 mg tablete telmisartan/amlodipin
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg
Pretisni omot s 7 tabletami - 80 mg/10 mg
Blood creatine phosphokinase increased, haemoglobin decreased 1: the event may be a chance finding or related to a mechanism currently not known 2: most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
1 dogodek je lahko naključen ali povezan s še neznanim mehanizmom2 o večini primerov nenormalnega jetrnega delovanja ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih reakcij
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 40 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 40 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 80 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 80 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets telmisartan/amlodipine
IME ZDRAVILA Onduarp 80 mg/10 mg tablete telmisartan/amlodipin
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/10 mg
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 40 mg/10 mg
MARKETING AUTHORISATION NUMBERS EU/1/11/729/001 (28 tablets)
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/11/729/001 (28 tablet)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/10 mg
ZUNANJE OZNAČEVANJE PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - Z MODRIM OKENCEM - 80 mg/10 mg
MARKETING AUTHORISATION NUMBERS EU/1/11/729/002 (28 tablets)
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/11/729/002 (28 tablet)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/5 mg
ZUNANJE OZNAČEVANJE PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - Z MODRIM OKENCEM - 80 mg/5 mg
Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Modra in bela dvoslojna tableta ovalne oblike z oznako A1 na eni strani in znak podjetja na drugi strani.
Activated charcoal may be useful in the treatment of overdose of both telmisartan and amlodipine.
Po zaužitju prevelikega odmerka telmisartana in amlodipina je lahko koristno dajanje aktivnega oglja.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/005 (28 tablets)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/005 (28 tablet)
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/003 (28 tablets)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/003 (28 tablet)
What Onduarp looks like and contents of the pack Onduarp 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side.
Tablete Onduarp po 80 mg/5 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A3 na eni strani in znak podjetja na drugi strani.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/001 (28 tablets)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/001 (28 tablet)
Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side.
Modra in bela dvoslojna tableta ovalne oblike z oznako A3 na eni strani in znak podjetja na drugi strani.
What Onduarp looks like and contents of the pack Onduarp 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side.
Tablete Onduarp po 80 mg/10 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A4 na eni strani in znak podjetja na drugi strani.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/002 (28 tablets)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/002 (28 tablet)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 40 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side.
Modra in bela dvoslojna tableta ovalne oblike z oznako A4 na eni strani in znak podjetja na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 40 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 80 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
Renal impairment including acute renal failure General disorders and administration site conditions Rare:
Ušesne bolezni, vključno z motnjami labirinta Občasni:
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 80 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
This study population is considered representative of the patients in the EU.
Populacija študije se šteje za reprezentativno za bolnike v EU.
Therefore, these results do not provide robust evidence of efficacy.
Zato ti rezultati ne zagotavljajo robustnih dokazov učinkovitosti.
This study did not raise any concern in terms of safety.
Študija ni vzbudila zadržkov v zvezi z varnostjo.
To be used in dental offices only by dental professionals.'
Uporabljajo ga lahko le zobozdravniki v zobozdravniških ordinacijah.“
The study population consisted of 983 adults ranging in age from 18 and 80 years and with a mean age of 43 years.
Populacija študije je obsegala 983 odraslih oseb, starih od 18 do 80 let, s povprečno starostjo 43 let.
The following indication was agreed by the CHMP:
CHMP je potrdil naslednjo indikacijo:
The positive results seen in this study relate only in the female subgroup which was not based on a pre-defined subgroup analysis but a post-hoc analysis.
Pozitivni rezultati v tej študiji se nanašajo samo na žensko podskupino, ki ni temeljila na vnaprej opredeljeni analizi podskupin, ampak na post-hoc analizi.
Prevention of Adult Caries Study (PACS)
Študija preprečevanja kariesa pri odraslih (PACS)
Although the results may not be statistically significant, there was no evidence of an interaction, and thus there are sufficient statistical evidence to grant an indication for all surfaces in the high-risk population, and not just root surfaces.
Čeprav rezultati morda niso statistično pomembni, ni bilo dokazov o interakciji, zato je dovolj statističnih dokazov, da se odobri indikacija za vse površine v populaciji z visokim tveganjem, ne le za površine korenin.
The objecting Member State was of the view that the evidence provided was not considered compelling enough even in the high-risk adult population.
Ugovarjajoča država članica je menila, da se predloženi dokazi tudi pri odraslih z velikim tveganjem ne štejejo za dovolj pomembne.
It is intended to be applied to the surface of permanent teeth in four weekly applications in the first month of treatment, followed by a single application at month six.
Zdravilo se nanaša na površino trajnih zob vsake štiri tedne v prvem mesecu zdravljenja in nato še enkrat v šestem mesecu.
Overall summary of the scientific evaluation of Prevora
Splošni povzetek znanstvenega vrednotenja zdravila Prevora
Therefore, when considered in addition to the previously submitted data, there is now sufficient evidence to conclude that the risk-benefit is positive in the proposed indication.
Zato je zdaj ob upoštevanju predhodno predloženih podatkov dovolj dokazov za zaključek, da je razmerje med koristmi in tveganji za predlagano indikacijo pozitivno.
The two clinical studies initially submitted by the MAH to support the proposed indication were:
Klinični študiji, ki ju je imetnik dovoljenja za promet z zdravilom prvotno predložil za podporo predlagani indikaciji, sta bili:
The MAH, CHX Technologies Europe Ltd submitted to CHMP for consideration the results of another study, the Prevention of Adult Caries Study (PACS), to confirm the results seen to date.
Imetnik dovoljenja za promet z zdravilom, družba CHX Technologies Europe Ltd, je CHMP v presojo predložila rezultate druge študije, študije preprečevanja kariesa pri odraslih (Prevention of Adult Caries Study, PACS), da bi potrdili do zdaj zbrane rezultate.
The significance of this preventive effect increases for high risk participants, for both all tooth surfaces and for coronal surfaces.
Pomen tega preventivnega učinka se povečuje pri preiskovancih z velikim tveganjem, tako za vse zobne površine kot za površine krone.
It was concluded that the indication in patients at high-risk should be maintained and that the result seen with coronal surfaces should also be reflected.
Zaključili so, da je treba indikacijo pri bolnikih z visokim tveganjem ohraniti in da je treba upoštevati rezultat za površine krone.
• and scientific discussion within the Committee the CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics and package leaflet are set out in Annex III for Prevora
• in znanstvene razprave znotraj Odbora je CHMP priporočil odobritev dovoljenja za promet z zdravilom Prevora, katerega povzetek glavnih značilnosti zdravila in navodilo za uporabo sta navedena v Dodatku III.
However, when the result in high-risk patients is considered, a significant difference is seen between active and placebo.
Če pa se upošteva rezultat pri bolnikih z visokim tveganjem, je vidna pomembna razlika med zdravilno učinkovino in placebom.
Therefore, Prevora appears to have a negative effect, resulting in more cavities in the at lowrisk population.
Zato je videti, da ima zdravilo Prevora negativen učinek, kar povzroči več kavitet v populaciji z majhnim tveganjem.
The pivotal study included a total of 79 subjects on active.
V ključno študijo je bilo vključenih skupno 79 preiskovancev.
In addition, the new trial also suggests a benefit for coronal surfaces, and no apparent differences between root and coronal surfaces.
Poleg tega novo preskušanje nakazuje tudi koristi za površine krone ter nobene jasne razlike med površinami korenine in krone.
Dental caries is a bacterial based chronic disease.
Zobna gniloba je kronična bolezen, ki jo povzročajo bakterije.
When risk (as measured by the number of cavities at screening) is added to the ANOVA model to account for the bimodal distribution of disease in this study population at both screening and during the study, an overall clinical effect of 36.8% at p = 0.04 is observed.
Če se tveganje (izmerjeno s številom kavitet v fazi presejanja) doda v model ANOVA, da se upošteva bimodalna porazdelitev bolezni v populaciji te študije v fazi presejanja in med študijo, ugotovimo skupni klinični učinek 36,8 odstotka z vrednostjo p = 0,04.
Benefit-risk assessment
Ocena koristi in tveganj
A 24.5% reduction for all tooth surfaces (root plus coronal surfaces) was seen with a p-value of 0.0322 [95% confidence interval (CI) of 0.62 - 0.98].
Ugotovili so 24,5-odstotno zmanjšanje na vseh zobnih površinah (površine korenine in krone) z vrednostjo p 0,0322 [95-odstotni interval zaupanja (IZ): 0,62-0,98].
There is no evidence of a difference in the point estimates for coronal and all surfaces which suggest that the results for root surfaces should be of a similar magnitude.
Ni dokazov o razliki med točkovnimi ocenami za površine krone in vse površine, kar nakazuje, da bi morali biti rezultati za površine korenine enakega reda velikosti.
Clinical Study #002 (Dundee Adolescent Study)
Klinična študija št. 2 (študija pri mladostnikih, Dundee)
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION AND AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
PRILOGA II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE IN DOPOLNITEV POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
This is a Phase III, multi-centre, placebo-controlled, double-blinded, prospective study.
Ta študija je multicentrična, s placebom nadzorovana, dvojno slepa, prospektivna študija III. faze.
The primary endpoint was the number of new cavities (coronal plus root surfaces) per participant, as measured at the end-of-study visit.
Primarni cilj študije je bilo število novih kavitet (na površinah krone in korenine) na preiskovanca, izmerjeno ob zadnjem kontrolnem obisku v študiji.
A double-blind, randomised, multi-centred, controlled trial conducted in adults at risk of dental caries.
Dvojno slepo, randomizirano, multicentrično, kontrolirano preskušanje pri odraslih s tveganjem zobne gnilobe.
The medicinal product, Prevora 100 mg/ml is a 10% w/v chlorhexidine dental solution indicated to reduce dental caries in permanent teeth of adolescents and adults.
Zdravilo Prevora 100 mg/ml je 10-odstotna (w/v) dentalna raztopina klorheksidina, ki se uporablja za zmanjšanje zobne gnilobe na stalnih zobeh mladostnikov in odraslih.
These were patients between the ages of 11 and 13 years with evidence of past or current caries experience and elevated levels of salivary Streptococcus mutants.
To so bili bolniki, stari od 11 do 13 let, z dokazano zobno gnilobo v preteklosti ali v času preskušanja ter zvišanimi ravnmi Streptococcus mutants v slini.
The CHMP assessing the apparent “reverse” treatment effect for at low-risk population explained this issue by the relative absence of high risk participants (those with 3+ cavities at screening) in the placebo groups where as the high-risk population (at risk population) had a higher baseline rate of cavities.
CHMP je po vrednotenju navideznega „nasprotnega“ učinka zdravljenja v populaciji z majhnim tveganjem to vprašanje razložil z relativno odsotnostjo preiskovancev z visokim tveganjem (osebe s tremi kavitetami ali več v fazi presejanja) v skupini, ki je prejemala placebo, medtem ko je imela populacija z velikim tveganjem (populacija s tveganjem) višjo izhodiščno stopnjo kavitet.
‘Prevora 100mg/ml Dental Solution is an antiseptic solution which is applied topically to the dentition of patients for the prevention of coronal and root caries in adult patients at high-risk of dental caries (e.g. xerostomia sufferers or those with 3 or more caries at the start of the treatment plan).
„Zdravilo Prevora 100 mg/ml dentalna raztopina je antiseptična raztopina, ki se nanese topično na zobovje bolnikov za preprečevanje zobne gnilobe na kroni in koreninah pri odraslih bolnikih z visokim tveganjem zobne gnilobe (npr. bolniki s kserostomijo ali 3 ali več karioznimi lezijami na začetku načrta zdravljenja).
It consists of a chlorhexidine coating solution (Stage 1) and an inert sealant coating (Stage 2) which is applied after the application of the chlorhexidine solution.
Sestavlja ga raztopina klorheksidina za oblogo (1. stopnja) in inertna tesnilna obloga (2. stopnja), ki se nanese po nanosu raztopine klorheksidina.
A 3-year randomised double-blind trial in at-risk adolescent patients to evaluate the efficacy and safety of Prevora 100mg/ml Dental Solution in reducing caries increment.
Triletno randomizirano, dvojno slepo preskušanje pri mladostnikih s tveganjem za razvoj bolezni, s katerim so ocenjevali učinkovitost in varnost zdravila Prevora 100 mg/ml dentalna raztopina pri zmanjševanju napredovanja zobne gnilobe.
The results were considered not compelling enough due to the unsupportive nature of the adolescent study (below).
Rezultati se niso šteli za dovolj pomembne, ker študija na mladostnikih ne podpira zdravila (v nadaljevanju).