FrancophonIA/ELRC3.0 huggingface dataset:
English: Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis),and severe allergic reactions (anaphylactic shock).
Danish: Bivirkninger, hvor hyppigheden ikke er kendt, er: følelse af, at omgivelserne kører rundt, hovedpine, smagsforstyrrelser, ringen for ørerne, muskelkramper, led- og muskelsmerter, nedsat antal blodplader, unormal leverfunktion, forhøjet mængde af kalium i blodet, nedsat nyrefunktion, betændelseslignende tilstand i de små blodkar, der primært påvirker huden (en tilstand der kaldes leukocytoklastisk vaskulitis) samt alvorlige allergiske reaktioner (anafylaktisk shock).
English: Warning and precautions Talk to your doctor before taking Aprovel and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Aprovel for diabetic kidney disease.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Aprovel, hvis noget af det følgende gælder for dig:  hvis du får hyppig opkastning eller diarré  hvis du lider af nyreproblemer hvis du lider af hjerteproblemer hvis du får Aprovel for diabetisk nyresygdom.
English: Warnings and precautions Talk to your doctor before taking Aprovel and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Aprovel for diabetic kidney disease.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Aprovel, hvis noget af det følgende gælder for dig:  hvis du får hyppig opkastning eller diarré  hvis du lider af nyreproblemer hvis du lider af hjerteproblemer hvis du får Aprovel for diabetisk nyresygdom.
English: Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Danish: Kaliumtilskud og kalium-besparende diuretika: Erfaringer med brug af andre lægemidler, der indvirker på renin-angiotensinsystemet, viser, at samtidig brug af kalium-besparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller andre lægemidler, som kan øge serumkaliumniveauet (fx heparin), kan medføre øget serum-kalium.
English: Each tablet contains: irbesartan 300 mg
Danish: Hver tablet indeholder: irbesartan 300 mg
English: leukocytoclastic vasculitis Musculoskeletal and connective tissue disorders Common:
Danish: Leukocytoklastisk vaskulitis Knogler, led, muskler og bindevæv Almindelig:
English: At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Danish: Ved meget høje doser (≥ 500 mg/kg/dag) inducerede irbesartan degenerative ændringer i nyren hos rotter og marekatte (så som interstitiel nefritis, tubulær udvidelse, basofile tubuli, øget plasmakoncentration af urinstof og kreatinin).
English: In particular, they appeared less favourable in women and non-white subjects (see section 5.1).
Danish: Specielt hos kvinder og patienter, der ikke var af europæisk afstamning, sås der en mindre effekt (se pkt.
English: Each tablet contains: irbesartan 150 mg
Danish: Hver tablet indeholder: irbesartan 150 mg
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Hypromellose Silikondioxid
English: In patients insufficiently controlled with 150 mg once daily, the dose of Aprovel can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Hos patienter som ikke er tilstrækkeligt kontrolleret på 150 mg, 1 gang dagligt, kan dosis af Aprovel øges til 300 mg, eller andre antihypertensiva kan tilføjes (se pkt.
English: Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.
Danish: Der fås også enkeltdosisblisterpakninger med 56 x 1 tablet til hospitalsbrug.
English: The study of the “Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Danish: IRMA 2-studiet (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2diabetes Mellitus) viste, at irbesartan 300 mg forsinker progression til klinisk proteinuri hos patienter med mikroalbuminuri.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets.
Danish: LÆGEMIDLETS NAVN Aprovel 75 mg tabletter.
English: The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.
Danish: Dosis kan senere øges til 300 mg 1 gang dagligt (fire tabletter dagligt) afhængig af blodtryksmålingerne.
English: vertigo, headache Ear and labyrinth disorder Not known:
Danish: Øre og labyrint Ikke kendt:
English: While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Danish: Der var dog færre patienter i irbesartan der fik 300 mg (5,2%) som nåede endepunktet, klinisk proteinuri, sammenlignet med placebo-gruppen (14,9%) og irbesartangruppen der fik 150 mg (9,7%), hvilket viste en relativ risikoreduktion på 70% versus placebo (p= 0,0004) ved den højere dosis.
English: The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.
Danish: Dosis kan senere øges til 300 mg 1 gang dagligt (to tabletter dagligt) afhængig af blodtryksmålingerne.
English:  Keep this leaflet.
Danish: Gem indlægssedlen.
English: Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Danish: 6.1 Graviditet i 2. og 3. trimester (se pkt.
English: Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.
Danish: Der fås også enkeltdosisblisterpakninger med 56 x 1 filmovertrukken tablet til hospitalsbrug.
English: Aprovel 150 mg film-coated tablets irbesartan
Danish: Aprovel 150 mg filmovertrukne tabletter irbesartan
English: Side effects reported in clinical studies for patients treated with Aprovel were: Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 patienter): hvis du har højt blodtryk og type 2 diabetes med nyresygdom, kan blodprøver vise, at du har for meget kalium i blodet.
English: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Lactosemonohydrat Magnesiumstearat Kolloid silica
English: Aprovel 300 mg film-coated tablets irbesartan
Danish: Aprovel 300 mg filmovertrukne tabletter irbesartan
English: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let/moderat leverfunktionsnedsættelse.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets.
Danish: LÆGEMIDLETS NAVN Aprovel 300 mg tabletter.
English: In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Danish: Der er set fald i hæmoglobin, som ikke var klinisk signifikant, hos 1,7% (dvs almindelig) af de hypertensive patienter med fremskreden diabetisk nyresygdom behandlet med irbesartan.
English: Sanofi S.p.A. Tel: 800.536389
Danish: Tel: 800.536389
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Aprovel 75 mg tabletter irbesartan NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis groupe UDLØBSDATO
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Aprovel 75 mg filmovertrukne tabletter.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Aprovel 300 mg tabletter irbesartan NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis groupe UDLØBSDATO
English: NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets.
Danish: LÆGEMIDLETS NAVN Aprovel 150 mg tabletter.
English: In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/3-6 mm Hg (systolic/diastolic).
Danish: Hos patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende med irbesartan alene, kan irbesartan suppleres med en lille dosis hydrochlorthiazid (12,5 mg), 1 gang dagligt.
English: Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie
Danish: Indehaveren af markedsføringstilladelsen: sanofi-aventis groupe
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Aprovel has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Danish: På trods af dette er Aprovel uden risiko blevet administreret sammen med andre antihypertensive lægemidler som beta-blokkere, langtidsvirkende calcium-antagonister samt diuretika af thiazidtypen.
English: No dosage adjustment is necessary in patients with impaired renal function.
Danish: Det er ikke nødvendigt, at dosisjustere patienter med nedsat nyrefunktion.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg of irbesartan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 75 mg irbesartan.
English:  The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
Danish: Hver filmovertrukken Aprovel-tablet 300 mg indeholder 300 mg irbesartan  Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, hypromellose, silicondioxid, magnesiumstearat, titandioxid (E171), macrogol 3000, carnaubavoks.
English: Hepatobiliary disorders: Uncommon: jaundice Not known:
Danish: Lever og galdeveje Ikke almindelig: Gulsot Ikke kendt:
English: The demonstration of renal benefit of Aprovel in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Dokumentationen for forbedring af nyresygdom ved brug af Aprovel hos hypertensive type 2-diabetikere er baseret på studier, hvor irbesartan blev brugt efter behov med tillæg af andre antihypertensive lægemidler, for at nå det ønskede blodtryk (se pkt.
English: Package leaflet: Information for the user Aprovel 75 mg tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Aprovel 75 mg tabletter irbesartan
English: Excipient with known effect: 61.50 mg of lactose monohydrate per tablet.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 61,50 mg lactosemonohydrat.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Aprovel 300 mg filmovertrukne tabletter.
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Danish: Patienter med højt blodtryk og type 2-diabetes med nyresygom Hos patienter med højt blodtryk og type 2 diabetes er 300 mg 1 gang dagligt den foretrukne vedligeholdelsesdosis til behandling af ledsagende nyresygdom.
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Danish: Patienter med højt blodtryk og type 2-diabetes med nyresygom Hos patienter med højt blodtryk og type 2 diabetes er 300 mg 1 gang dagligt (fire tabletter dagligt) den foretrukne vedligeholdelsesdosis til behandling af ledsagende nyresygdom.
English: Excipient with known effect: 30.75 mg of lactose monohydrate per tablet.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 30,75 mg lactosemonohydrat.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Aprovel 150 mg filmovertrukne tabletter.
English: Aprovel 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Danish: Aprovel 75 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of irbesartan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 300 mg irbesartan.
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Danish: Patienter med højt blodtryk og type 2-diabetes med nyresygom Hos patienter med højt blodtryk og type 2 diabetes er 300 mg 1 gang dagligt (to tabletter dagligt) den foretrukne vedligeholdelsesdosis til behandling af ledsagende nyresygdom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 75 mg irbesartan.
English: Aprovel 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Danish: Aprovel 150 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter.
English: Package leaflet: Information for the user Aprovel 300 mg tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Aprovel 300 mg tabletter irbesartan
English: Aprovel 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Danish: Aprovel 300 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter.
English: Excipient with known effect: 15.37 mg of lactose monohydrate per tablet.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 15,37 mg lactosemonohydrat.
English: Package leaflet: Information for the user Aprovel 150 mg tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Aprovel 150 mg tabletter irbesartan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 150 mg irbesartan.
English: Cartons of 56 x 1 tablet in PVC/PVDC/Aluminium perforated unit dose blisters.
Danish: Æsker med 56 x 1 tabletter i perforerede PVC/PVDC/aluminiumblistere med éngangsdoser.
English: France sanofi-aventis France Tél: 0 800 222 555
Danish: Tél: 0 800 222 555
English: In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
Danish: Almindelig (påvirker op til 1 ud af 10 patienter): svimmelhed, kvalme/opkastning, træthed og blodprøver, der viser en forhøjet mængde af et enzym, der måler muskel- og hjertefunktionen (kreatinin-kinase-enzym).Der er hos patienter med forhøjet blodtryk og type 2-diabetes med nyresygdom også indberettet svimmelhed, når man rejser sig op fra liggende eller siddende stilling, lavt blodtryk når man rejser sig op fra liggende eller siddende stilling, led- og muskelsmerter og en nedsat mængde protein i de røde blodlegemer (hæmoglobin).
English: Excipient with known effect: 25.50 mg of lactose monohydrate per film-coated tablet.
Danish: Hver tablet indeholder 25,50 mg lactosemonohydrat.
English: Package leaflet: Information for the user Aprovel 75 mg film-coated tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Aprovel 75 mg filmovertrukne tabletter irbesartan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 300 mg irbesartan.
English: Cartons of 56 x 1 film-coated tablet in PVC/PVDC/Aluminium perforated unit dose blisters.
Danish: Æsker med 56 x 1 filmovertrukne tabletter i perforerede PVC/PVDC/aluminiumblistere med éngangsdoser.
English: What Aprovel looks like and contents of the pack Aprovel 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Danish: Aprovel 75 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2771 på den anden side.
English: Do not take Aprovel  if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)  if you are more than 3 months pregnant.
Danish: Tag ikke Aprovel: hvis du er overfølsom (allergisk) over for irbesartan eller et af de øvrige indholdsstoffer i Aprovel(angivet i punkt 6).
English: Cartons of 56 tablets in PVC/PVDC/Aluminium blisters.
Danish: Æsker med 56 tabletter i PVC/PVDC/aluminiumblistere.
English: Aprovel 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Danish: Aprovel 150 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
English: Use in children and adolescents
Danish: Børn og unge må ikke få Aprovel
English: Aprovel 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Danish: Aprovel 75 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
English: Hepatic impairment
Danish: Hyperkaliæmi
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 150 mg irbesartan.
English: Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Danish: Aprovel 300 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
English: Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
Danish: Æsker med 14 tabletter i PVC/PVDC/aluminiumblistere.
English: Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Danish: Almindelig (kan påvirke op til 1 ud af 10 patienter): svimmelhed, kvalme/opkastning, træthed og blodprøver, der viser en forhøjet mængde af et enzym, der måler muskel- og hjertefunktionen (kreatinin-kinase-enzym).Der er hos patienter med forhøjet blodtryk og type 2-diabetes med nyresygdom også indberettet svimmelhed, når man rejser sig op fra liggende eller siddende stilling, lavt blodtryk når man rejser sig op fra liggende eller siddende stilling, led- og muskelsmerter og en nedsat mængde protein i de røde blodlegemer (hæmoglobin).
English: Package leaflet: Information for the user Aprovel 150 mg film-coated tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Aprovel 150 mg filmovertrukne tabletter irbesartan
English: What Aprovel looks like and contents of the pack Aprovel 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Danish: Aprovel 75 mg filmovertrukne tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2871 på den anden side.
English: Fri
Danish: Hjerte
English: In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you are going to have an operation (surgery) or be given anaesthetics if you are taking any of the following medicines used to treat high blood pressure:
Danish: I dette tilfælde kan lægen tage regelmæssige blodprøver med særlig henblik på at måle kaliumniveauet i blodet, hvis nyrefunktionen er nedsat.
English: Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Danish: Æsker med 28 tabletter i PVC/PVDC/aluminiumblistere.
English: Cartons of 30 film-coated tablets in PVC/PVDC/Aluminium blisters.
Danish: Æsker med 30 filmovertrukne tabletter i PVC/PVDC/aluminiumblistere.
English: Package leaflet: Information for the user Aprovel 300 mg film-coated tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Aprovel 300 mg filmovertrukne tabletter irbesartan
English: Cartons of 56 film-coated tablets in PVC/PVDC/Aluminium blisters.
Danish: Æsker med 56 filmovertrukne tabletter i PVC/PVDC/aluminiumblistere.
English: Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Danish: Æsker med 98 tabletter i PVC/PVDC/aluminiumblistere.
English: What Aprovel looks like and contents of the pack Aprovel 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Danish: Aprovel 150 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2772 på den anden side.
English: What Aprovel looks like and contents of the pack Aprovel 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Danish: Aprovel 300 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2773 på den anden side.
English: Cartons of 84 film-coated tablets in PVC/PVDC/Aluminium blisters.
Danish: Æsker med 84 filmovertrukne tabletter i PVC/PVDC/aluminiumblistere.
English: Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Danish: Æsker med 90 filmovertrukne tabletter i PVC/PVDC/aluminiumblistere.
English: What Aprovel looks like and contents of the pack Aprovel 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Danish: Aprovel 150 mg filmovertrukne tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2872 på den anden side.
English: EU/1/97/046/011 - 14 tablets EU/1/97/046/004 - 28 tablets EU/1/97/046/005 - 56 tablets EU/1/97/046/014 - 56 x 1 tablets EU/1/97/046/006 - 98 tablets
Danish: EU/1/97/046/011 - 14 tabletter EU/1/97/046/004 - 28 tabletter EU/1/97/046/005 - 56 tabletter EU/1/97/046/014 - 56 x 1 tabletter EU/1/97/046/006 - 98 tabletter