FrancophonIA/ELRC3.0 huggingface dataset:
English: Dual blockade of the renin-angiotensin-aldosterone system The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Danish: Dobbelthæmning af renin-angiotensin-aldosteronsystemet Brug af telmisartan i kombination med aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: How to take Onduarp
Danish: Sådan skal du tage Onduarp
English: INFORMATION IN BRAILLE Onduarp 80 mg/10 mg
Danish: INFORMATION I BRAILLESKRIFT Onduarp 80 mg/10 mg
English: After 8 weeks of treatment, each of the combination treatments was statistically significantly superior to amlodipine monotherapy in reducing diastolic and systolic blood pressure (−11.1/−9.2 mmHg, −11.3/ −9.3 mmHg with 40 mg/10 mg, 80 mg/10 mg versus −7.4/−6.5 mmHg with amlodipine 10 mg) and higher diastolic blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg).
Danish: Efter 8 ugers behandling var hver af kombinationerne statistisk signifikant overlegen amlodipin som monoterapi, for så vidt angik reduktion af diastolisk og systolisk blodtryk (-11,1/-9,2 mmHg, -11,3/-9,3 mmHg med 40 mg/10 mg, 80 mg/10 mg over for -7,4/-6,5 mmHg med amlodipin 10 mg).
English: INFORMATION IN BRAILLE Onduarp 80 mg/5 mg
Danish: INFORMATION I BRAILLESKRIFT Onduarp 80 mg/5 mg
English: INFORMATION IN BRAILLE Onduarp 40 mg/5 mg
Danish: INFORMATION I BRAILLESKRIFT Onduarp 40 mg/5 mg
English: INFORMATION IN BRAILLE Onduarp 40 mg/10 mg
Danish: INFORMATION I BRAILLESKRIFT Onduarp 40 mg/10 mg
English: 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),
Danish: Onduarp viste dosisrelateret reduktion i systolisk/diastolisk blodtryk i dosisintervallerne -21,8/-16,5 mmHg (40 mg/5 mg), -22,1/-18,2 mmHg (80 mg/5 mg), -24,7/-20,2 mmHg (40 mg/10 mg) og -26,4/-20,1 mmHg (80 mg/10 mg).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/10 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton - 40 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/10 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton - 80 mg/10 mg
English: If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/5 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton - 80 mg/5 mg
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets
Danish: LÆGEMIDLETS NAVN Onduarp 40 mg/5 mg tabletter
English: Change of bowel habit Pancreatitis, gastritis
Danish: Pankreatitis, gastritis
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets
Danish: LÆGEMIDLETS NAVN Onduarp 40 mg/10 mg tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/5 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton - 40 mg/5 mg
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets
Danish: LÆGEMIDLETS NAVN Onduarp 80 mg/5 mg tabletter
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Unit dose-blister af 10 tabletter - 80 mg/10 mg
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/005 (28 tablets) EU/1/11/729/006 (36 (4 x 90 x 1) tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/11/729/005 (28 tabletter) EU/1/11/729/006 (36 (4 x 90 x 1) tabletter)
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets
Danish: LÆGEMIDLETS NAVN Onduarp 80 mg/10 mg tabletter
English: Micturition disorder, pollakiuria
Danish: Vandladningsforstyrrelser, pollakisuri
English: Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Danish: Samtidig brug af telmisartan og aliskiren er kontraindiceret hos patienter med nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/5 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Unit dose-blister af 10 tabletter - 80 mg/5 mg
English: In the factorial design trial the oedema rates were 1.3% with Onduarp 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Onduarp 40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg.
Danish: De ødemrelaterede hændelser (perifert ødem, udbredt ødem og ødem) var konsistent lavere hos patienter, der fik Onduarp, end hos patienter, der modtog amlodipin 10 mg. I studiet med faktuelt design var ødemfrekvensen 1,3% med Onduarp 40 mg/5 mg og 80 mg/5 mg, 8,8% med Onduarp 40 mg/10 mg og 80 mg/10 mg og 18,4% med amlodipin 10 mg.
English: In patients with mild to moderate hepatic impairment Onduarp should be administered with caution.
Danish: Der skal udvises forsigtighed ved brug af Onduarp til patienter med let til moderat nedsat leverfunktion.
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/003 (28 tablets) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/11/729/003 (28 tabletter) EU/1/11/729/004 (360 (4 x 90 x 1) tabletter)
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate).
Danish: Hver tablet indeholder 40 mg telmisartan og 5 mg amlodipin (som besilat).
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as besylate).
Danish: Hver tablet indeholder 80 mg telmisartan og 5 mg amlodipin (som besilat).
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as besylate).
Danish: Hver tablet indeholder 40 mg telmisartan og 10 mg amlodipin (som besilat).
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as besylate).
Danish: Hver tablet indeholder 80 mg telmisartan og 10 mg amlodipin (som besilat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort med 7 tabletter - 40 mg/10 mg
English: Package leaflet: Information for the user Onduarp 40 mg/5 mg tablets Telmisartan/Amlodipine
Danish: Indlægsseddel: Information til brugeren Onduarp 40 mg /5 mg tabletter telmisartan/amlodipin
English: Package leaflet: Information for the user Onduarp 40 mg/10 mg tablets Telmisartan/Amlodipine
Danish: Indlægsseddel: Information til brugeren Onduarp 40 mg /10 mg tabletter telmisartan/amlodipin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort med 7 tabletter - 80 mg/5 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/006 (360 (4 x 90 x 1) tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/729/006 (360 (4 x 90 x 1) tabletter)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort med 7 tabletter - 80 mg/10 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/729/004 (360 (4 x 90 x 1) tabletter)
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets telmisartan/amlodipine
Danish: LÆGEMIDLETS NAVN Onduarp 40 mg/5 mg tabletter telmisartan/amlodipin
English: 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.
Danish: Onduarp 80 mg/5 mg tabletter er blå og hvide ovale tolagstabletter præget med produktkoden A3 og firmalogo på den anden side.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/5 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort med 7 tabletter - 40 mg/5 mg
English: Package leaflet: Information for the user Onduarp 80 mg/5 mg tablets Telmisartan/Amlodipine
Danish: Indlægsseddel: Information til brugeren Onduarp 80 mg /5 mg tabletter telmisartan/amlodipin
English: Package leaflet: Information for the user Onduarp 80 mg/10 mg tablets Telmisartan/Amlodipine
Danish: Indlægsseddel: Information til brugeren Onduarp 80 mg /10 mg tabletter telmisartan/amlodipin
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets telmisartan/amlodipine
Danish: LÆGEMIDLETS NAVN Onduarp 40 mg/10 mg tabletter telmisartan/amlodipin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 40 mg telmisartan og 5 mg amlodipin (som amlodipinbesilat).
English: 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.
Danish: Onduarp 40 mg/5 mg tabletter er blå og hvide ovale tolagstabletter præget med produktkoden A1 og firmalogo på den anden side.
English: - 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, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol (E420).
Danish: gul jernoxid (E172), magnesiumstearat, majsstivelse, meglumin, mikrokrystallinsk cellulose,
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/001 (28 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/11/729/001 (28 tabletter)
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/002 (28 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/11/729/002 (28 tabletter)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 80 mg telmisartan og 5 mg amlodipin (som amlodipinbesilat).
English: - in adult patients who already receive telmisartan and amlodipine from separate tablets and who wish to take instead the same doses in one tablet for convenience.
Danish: Onduarp bruges til at behandle højt blodtryk - hos voksne patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin - hos voksne patienter, der allerede får telmisartan og amlodipin fra 2 forskellige tabletter, og som ønsker at gøre behandlingen lettere ved i stedet at tage de samme doser i én tablet
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 40 mg telmisartan og 10 mg amlodipin (som amlodipinbesilat).
English: 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.
Danish: Onduarp 40 mg/10 mg tabletter er blå og hvide ovale tolagstabletter præget med produktkoden A2 og firmalogo på den anden side.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 80 mg telmisartan og 10 mg amlodipin (som amlodipinbesilat).
English: −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).
Danish: Der blev tillige set en bedre blodtrykskontrol af diastolisk blodtryk sammenlignet med monoterapi (56,7%, 63,8% med henholdsvis 40 mg/5 mg og 80 mg/5 mg over for 42%, 56,7% med amlodipin henholdsvis 5 mg og 10 mg).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 40 mg telmisartan og 5 mg amlodipin (som amlodipinbesilat)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 40 mg telmisartan og 10 mg amlodipin (som amlodipinbesilat)
English: 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.
Danish: Onduarp 80 mg/10 mg tabletter er blå og hvide ovale tolagstabletter præget med produktkoden A4 og firmalogo på den anden side.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 80 mg telmisartan og 10 mg amlodipin (som amlodipinbesilat)
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets telmisartan/amlodipine
Danish: LÆGEMIDLETS NAVN Onduarp 80 mg /10 mg tabletter telmisartan/amlodipin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 80 mg telmisartan og 5 mg amlodipin (som amlodipinbesilat)
English: 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
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre etiket til bundtet multipakning med 360 tabletter (4 pakninger af 90 x 1 tabletter) - med Blue Box - 80 mg/5 mg
English: 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
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre etiket til bundtet multipakning med 360 tabletter (4 pakninger af 90 x 1 tabletter) - med Blue Box - 80 mg/10 mg
English: −24.7/−20.2 mmHg (40 mg/10 mg) and −26.4/−20.1 mmHg (80 mg/10 mg).
Danish: 40 mg/10 mg, 80 mg/10 mg over for -7,4/-6,5 mmHg med amlodipin 10 mg).
English: - Amlodipine belongs to a group of substances called “calcium channel blockers”.
Danish: - Amlodipin er en calciumantagonist.
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets telmisartan/amlodipine
Danish: LÆGEMIDLETS NAVN Onduarp 80 mg /5 mg tabletter telmisartan/amlodipin
English: 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
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Inder pakning til multipakning med 360 tabletter (4 pakninger af 90 x 1 tabletter) - uden Blue Box - 80 mg/5 mg
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Danish: Tablet Blå og hvide ovale tolagstabletter præget med produktkoden A1 og firmalogo på den anden side.
English: Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side.
Danish: Tablet Blå og hvide ovale tolagstabletter præget med produktkoden A3 og firmalogo på den anden side.
English: 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
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre pakning til bundtet multipakning med 360 tabletter (4 pakninger af 90 x tabletter) - uden Blue Box - 80 mg/10 mg
English: Hepatic function abnormal, liver disorder2 Skin and subcutaneous tissue disorders Uncommon: Rare:
Danish: Knogler, led, muskler og bindevæv Sjælden:
English: Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side.
Danish: Tablet Blå og hvide ovale tolagstabletter præget med produktkoden A4 og firmalogo på den anden side.
English: Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side.
Danish: Tablet Blå og hvide ovale tolagstabletter præget med produktkoden A2 og firmalogo på den anden side.
English: The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
Danish: Brug af telmisartan sammen med aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/005 (28 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/729/005 (28 tabletter)
English: What Onduarp is and what it is used for What you need to know before you take Onduarp How to take Onduarp
Danish: Det skal du vide, før du begynder at tage Onduarp Sådan skal du tage Onduarp Bivirkninger
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/003 (28 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/729/003 (28 tabletter)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/001 (28 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/729/001 (28 tabletter)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/002 (28 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/729/002 (28 tabletter)
English: This study did not raise any concern in terms of safety.
Danish: Undersøgelsen gav ikke anledning til bekymring med hensyn til sikkerheden.
English: This study population is considered representative of the patients in the EU.
Danish: Undersøgelsespopulationen anses for at være repræsentativ for patienterne i EU.
English: Overall summary of the scientific evaluation of Prevora
Danish: Samlet resumé af den videnskabelige vurdering af Prevora
English: Benefit-risk assessment
Danish: Benefit/risk-vurdering
English: The study population consisted of 983 adults ranging in age from 18 and 80 years and with a mean age of 43 years.
Danish: Undersøgelsespopulationen bestod af 983 voksne i alderen fra 18 til 80 år og med en gennemsnitsalder på 43 år.
English: The following indication was agreed by the CHMP:
Danish: CHMP blev enige om følgende indikation:
English: To be used in dental offices only by dental professionals.'
Danish: Må kun anvendes af fagfolk i tandklinikker."
English: 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.
Danish: Det er beregnet til at blive påført overfladen af blivende tænder i fire ugentlige påførelser i den første behandlingsmåned efterfulgt af en enkelt påførelse ved måned seks.
English: The two clinical studies initially submitted by the MAH to support the proposed indication were:
Danish: De to kliniske undersøgelser, som indehaveren af markedsføringstilladelsen oprindeligt indsendte til støtte for den foreslåede indikation, var:
English: Dental caries is a bacterial based chronic disease.
Danish: Caries i tænderne er en bakteriefremkaldt kronisk sygdom.
English: 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.
Danish: Det blev konkluderet, at indikationen hos patienter i højrisikogruppen skulle opretholdes, og at det resultat, der ses med kroneoverfladerne, også skulle afspejles.
English: The pivotal study included a total of 79 subjects on active.
Danish: Den pivotale undersøgelse omfattede i alt 79 personer, der blev behandlet med det aktive stof.
English: Therefore, these results do not provide robust evidence of efficacy.
Danish: Derfor giver disse resultater ikke nogen pålidelig dokumentation for virkningen.
English: 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.
Danish: De positive resultater, der ses i undersøgelsen, vedrører kun undergruppen kvinder, som ikke var baseret på en på forhånd defineret undergruppeanalyse, men en post hoc-analyse.
English: 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.
Danish: Selv om resultaterne måske ikke er statistisk signifikante, var der ingen tegn på en interaktion, og der er således tilstrækkelig statistisk evidens for at tillade en indikation for alle overflader i højrisikopopulationen og ikke blot rodoverfladerne.
English: The significance of this preventive effect increases for high risk participants, for both all tooth surfaces and for coronal surfaces.
Danish: Betydningen af denne præventive effekt vokser for højrisikodeltagere både for alle tandoverflader og for kronens overflader.
English: 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.
Danish: Sammen med de tidligere fremsendte data foreligger der derfor nu tilstrækkelig dokumentation til at kunne konkludere, at benefit/risk-forholdet er positivt for den foreslåede indikation.
English: The objecting Member State was of the view that the evidence provided was not considered compelling enough even in the high-risk adult population.
Danish: Den medlemsstat, der havde gjort indsigelse, mente, at den fremlagte dokumentation ikke var overbevisende nok, selv i gruppen af voksne med høj risiko.
English: • 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
Danish: • den videnskabelige drøftelse i udvalget anbefalede CHMP, at der udstedes markedsføringstilladelse, for hvilken produktresuméet og indlægssedlen fremgår af bilag III for Prevora.
English: Subsequent applications being based upon clinical judgment of caries risk by the dental professional.
Danish: Efterfølgende påførelser baseres på tandlægens kliniske bedømmelse af cariesrisikoen.
English: 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.
Danish: Det består af en klorhexidin belægningsopløsning (fase 1) og en inaktiv forseglende belægning (fase 2), der påføres efter klorhexidinopløsningen.
English: 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.
Danish: Indehaveren af markedsføringstilladelsen, CHX Technologies Europe Ltd, fremlagde resultaterne af en anden undersøgelse af forebyggelse af caries hos voksne ("Prevention of Adult Caries Study") for CHMP for at bekræfte de hidtidige resultater.
English: Clinical Study #002 (Dundee Adolescent Study)
Danish: Klinisk undersøgelse #002 (Dundee-undersøgelse af unge)
English: 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.
Danish: Der er ingen tegn på en forskel i punktestimatet for kronens overflader og alle overflader, der tyder på, at resultaterne for rodoverfladerne skulle være af en tilsvarende størrelsesorden.
English: Clinical Study #001 (Adult Xerostomia Study)
Danish: Klinisk undersøgelse #001 (Xerostomi-undersøgelse af voksne)