natgillin/translations-raw huggingface dataset:
Nogle af disse tyder på neural toksicitet: Vejrtrækning med åben mund, spytafsondring, hvid skummende opkastning, ataksi, skælven, nedsat aktivitet og/eller krum stilling.
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately
Der blev ikke observeret bivirkninger i fertiliteten hos han- og hunrotter, der blev behandlet med sitagliptin før og under parringsperioden.
No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Gennemsnitlig baseline HbA1c (%)
Mean baseline HbA1c (%)
Ikke almindelige: Svimmelhed, forstoppelse, kløe.
Uncommon: dizziness, constipation, itching
• en PPAR-agonist og metformin, når anvendelse af en PPAR-agonist er hensigtsmæssig, og når diæt og motion plus dual behandling med disse lægemidler ikke giver tilstrækkelig glykæmisk kontrol.
• a PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
HbA1c (%) i 18. uge
HbA1c (%) at week 18.
Efter 54 uger var den gennemsnitlige reduktion i forhold til baseline i HbA1c -0,76% med sitagliptin og -0,64% med glipizid (Per Protocol Analysis).
After 54 weeks, the mean reduction from baseline in HbA1c was -0.76 % with sitagliptin and -0.64 % with glipizide (Per-Protocol Analysis).
Prækliniske undersøgelser har ikke vist, at sitagliptin er genotoksisk.
Sitagliptin has not been demonstrated to be genotoxic in preclinical studies.
De må ikke tage en dobbeltdosis som erstatning for den glemte dosis af lægemidlet.
Do not take a double dose of this medicine.
Til patienter med moderat nyreinsufficiens (GFR ≥30 til <45 ml/min) er dosis 50 mg Ristaben en gang dagligt.
For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Ristaben is 50 mg once daily.
Alle tilfælde af apopleksi (letale og ikke-letale)
All stroke (fatal and non-fatal)
Det primære kardiovaskulære endepunkt var sammensat af første forekomst af kardiovaskulær død, ikke-letalt myokardieinfarkt, ikke-letal apopleksi eller hospitalsindlæggelse på grund af ustabil angina.
The primary cardiovascular endpoint was a composite of the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.
Mikrokrystallinsk cellulose (E460) Calciumhydrogenphosphat, vandfrit (E341) Croscarmellosenatrium (E468) Magnesiumstearat (E470b) Natriumstearylfumarat
Tablet core: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Bivirkningsfrekvens
Frequency of adverse reaction
I denne undersøgelse var virkningsog sikkerhedsprofilen for sitagliptin 25 eller 50 mg en gang dagligt generelt den samme som i andre monoterapiundersøgelser hos patienter med normal nyrefunktion.
In this study, the efficacy and safety profile of sitagliptin at 25 or 50 mg once daily was generally similar to that observed in other monotherapy studies in patients with normal renal function.
Derudover var osteoartritis og ekstremitetssmerter medtaget under de bivirkninger, som blev rapporteret uden hensyntagen til årsagssammenhæng med lægemidlet og som forekom hyppigere hos patienter i behandling med sitagliptin (som ikke nåede niveauet på 5%, men som forekom med en incidens, der var > 0,5% højere med sitagliptin i forhold til incidensen i kontrolgruppen).
Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5 % level, but occurring with an incidence of > 0.5 % higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
I disse undersøgelser var incidensen af hypoglykæmi den samme, som blev rapporteret for patienter, der var blevet behandlet med sitagliptin eller placebo.
In these studies there was a similar incidence of hypoglycaemia reported for patients treated with sitagliptin or placebo.
Patienter, der blev behandlet med sitagliptin havde en moderat vægtøgning sammenlignet med de patienter, der fik placebo.
Patients treated with sitagliptin had a modest increase in body weight compared to those given placebo.
I undersøgelserne blev kropsvægten ikke øget fra baseline ved behandling med sitagliptin, mens der sås en lille vægtreduktion hos patienter, der fik placebo.
Body weight did not increase from baseline with sitagliptin therapy in either study, compared to a small reduction in patients given placebo.
HbA1c (%) i 26. uge
HbA1c (%) at week 26.
Til patienter med let nyreinsufficiens (glomerulær filtrationsrate [GFR] 60 til <90 ml/min) er dosisjustering ikke nødvendig.
For patients with mild renal impairment (glomerular filtration rate [GFR]  60 to < 90 ml/min), no dose adjustment is required.
Ændringen i kropsvægt i forhold til baseline var den samme for patienter, der blev behandlet med sitagliptin i forhold til placebo.
Change from baseline in body weight was similar for patients treated with sitagliptin relative to placebo.
Til patienter med moderat nyreinsufficiens (GFR 45 til <60 ml/min) er dosisjustering ikke nødvendig.
For patients with moderate renal impairment (GFR  45 to < 60 mL/min), no dosage adjustment is required.
Fortæl Deres læge, om De har eller har haft: - En sygdom i bugspytkirtlen (f.eks. pankreatitis).
Tell your doctor if you have or have had: - a disease of the pancreas (such as pancreatitis) - gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Tilsvarende forandringer var ikke til stede ved en eksponering, der var 6 gange højere end den kliniske eksponering.
A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
HbA1c (%) i 24. uge
HbA1c (%) at week 24.
Letal og ikke-letal hæmoragisk og nekrotiserende pankreatitis
Frequency not known fatal and non-fatal haemorrhagic and necrotizing pancreatitis
Behandling med sitagliptin 100 mg en gang dagligt som monoterapi gav signifikante forbedringer i HbA1c, i faste-plasma-glucose (FPG) og i 2-timers postprandial glucose (2-timers PPG), når det blev sammenlignet med placebo i to undersøgelser, hvoraf den ene var af 18 ugers varighed og den anden af 24 ugers varighed.
Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.
Den observerede incidens af hypoglykæmi hos de patienter, der blev behandlet med sitagliptin, var den samme som for placebo.
The observed incidence of hypoglycaemia in patients treated with sitagliptin was similar to placebo.
Reduktionen i HbA1c hos de patienter, der blev behandlet med sitagliptin og insulin (med eller uden metformin), var -1,31% sammenlignet med -0,87% hos de patienter, der blev behandlet med placebo og insulin (med eller uden metformin), en forskel på -0,45% [95% konfidensinterval: -0,60; -0,29].
The reduction in HbA1c in patients treated with sitagliptin and insulin (with or without metformin) was -1.31 % compared to -0.87 % in patients treated with placebo and insulin (with or without metformin), a difference of -0.45 % [95 % CI: -0.60, -0.29].
Gennemsnitlig ændring fra baseline HbA1c (%)
Mean change from baseline HbA1c (%)
Den almindelige anbefalede dosis er: - En 100 mg filmovertrukken tablet.
The usual recommended dose is: one 100mg film-coated tablet once a day by mouth
Sitagliptin som supplement til pioglitazon og metformin forbedrede de glykæmiske parametre signifikant.
The addition of sitagliptin to pioglitazone and metformin provided significant improvements in glycaemic parameters.
Hypoglykæmi i kombination med andre anti-hyperglykæmiske lægemidler Der er foretaget kliniske undersøgelser af Ristaben som monoterapi og som del af kombinationsbehandling med lægemidler, der ikke er kendt for at medføre hypoglykæmi (dvs. metformin og/eller en PPAR-agonist).
Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Ristaben as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Nogle patienter har oplevet følgende bivirkninger, når de har taget sitagliptin sammen med pioglitazon og metformin:
Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Overfølsomhedsreaktioner herunder anafylaktiske reaktioner
Immune system disorders hypersensitivity reactions including anaphylactic responses
En 24-ugers placebokontrolleret undersøgelse blev designet til at evaluere effekt og sikkerhed af sitagliptin (100 mg en gang dagligt) som supplement til insulin (ved en stabil dosis i mindst 10 uger) med eller uden metformin (mindst 1.500 mg).
A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
Nogle patienter har oplevet følgende bivirkninger, når de har taget sitagliptin sammen med et sulfonylurinstof og metformin:
Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin:
• et sulfonylurinstof og metformin, når diæt og motion plus dual behandling med disse lægemidler ikke giver tilstrækkelig glykæmisk kontrol.
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
En 24-ugers placebokontrolleret undersøgelse med 660 patienter blev designet til at vurdere den insulinbesparende effekt og sikkerheden af sitagliptin (100 mg en gang dagligt) som supplement til insulin glargin med eller uden metformin (mindst 1.500 mg) under optrapning af insulinbehandling.
A 24-week placebo-controlled study involving 660 patients was designed to evaluate the insulin-sparing efficacy and safety of sitagliptin (100 mg once daily) added to insulin glargine with or without metformin (at least 1,500 mg) during intensification of insulin therapy.
Reduktionen i kropsvægt med kombinationen af sitagliptin og metformin var den samme som den, der blev observeret med metformin alene eller placebo.
The decrease in body weight with the combination of sitagliptin and metformin was similar to that observed with metformin alone or placebo; there was no change from baseline for patients on sitagliptin alone.
Sekundært sammensat endepunkt (Kardiovaskulær død, ikke-letalt myokardieinfarkt, ikke-letal apopleksi)
Secondary Composite Endpoint (Cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke)
Brug af anden medicin sammen med Ristaben Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Primært sammensat endepunkt (Kardiovaskulær død, ikke-letalt myokardieinfarkt, ikke-letal apopleksi eller hospitalsindlæggelse pga. ustabil angina)
Primary Composite Endpoint (Cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina)
Initialbehandling (to gange dagligt) Sitagliptin 50 mg + metformin 1000 mg (N=178)
Initial therapy (twice daily) Sitagliptin 50 mg + metformin 1,000 mg (N=178)
Det gennemsnitlige fordelingsvolumen ved steady state efter en enkelt intravenøs dosis på 100 mg sitagliptin til raske personer er ca. 198 l. Den fraktion af sitagliptin, som er reversibelt bundet til plasmaproteiner, er lav (38%).
The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 litres.
Et 26-ugers placebokontrolleret studie blev designet til at evaluere sitagliptins effekt og sikkerhed (100 mg en gang dagligt) som supplement til kombinationen pioglitazon plus metformin.
A 26-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to the combination of pioglitazone and metformin.
Sitagliptin 100 mg en gang dagligt (N=229)
Sitagliptin 100 mg once daily (N= 193) Sitagliptin 100 mg once daily (N= 229)
Ristaben indeholder det aktive stof sitagliptin, som tilhører en klasse af lægemidler, som kaldes DPP4-hæmmere (dipeptylpeptidase-4-hæmmere).
Ristaben contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Minimale forlængelser af QTc-intervallet blev observeret i et studie med en 800 mg dosis sitagliptin, men blev ikke anset for at være klinisk relevante.
Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
Initialbehandling (to gange dagligt) Sitagliptin 50 mg + metformin 500 mg (N=183)
Initial therapy (twice daily) Sitagliptin 50 mg + metformin 500 mg (N=183)
Sådan skal De tage Ristaben
How to take Ristaben
Rund, beige, filmovertrukken tablet mærket med ”277” på den ene side.
Round, beige film-coated tablet with “277” on one side.
For at opnå den samme plasmakoncentration for sitagliptin som hos patienter med normal nyrefunktion bør patienter med GFR <45 ml/min have lavere doser (se pkt.
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min (see section 4.2).
Derfor bør en lavere dosis af sulfonylurinstof eller insulin overvejes for at reducere risikoen for hypoglykæmi (se pkt.
Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea or insulin may be considered (see section 4.2).
En 24-ugers placebokontrolleret undersøgelse blev designet til at evaluere effekten samt sikkerheden af sitagliptin (100 mg en gang dagligt) som supplement til glimepirid alene eller glimepirid i kombination med metformin.
A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride alone or glimepiride in combination with metformin.
I intention to treat-populationen var incidensen af svær hypoglykæmi blandt patienter, som fik insulin og/eller et sulfonylurinstof ved baseline, 2,7% hos patienter i sitagliptin-armen og 2,5% hos patienter i placebo-armen.
In the intention-to-treat population, among patients who were using insulin and/or a sulfonylurea at baseline, the incidence of severe hypoglycaemia was 2.7 % in sitagliptin-treated patients and 2.5 % in placebo-treated patients; among patients who were not using insulin and/or a sulfonylurea at baseline, the incidence of severe hypoglycaemia was 1.0 % in sitagliptin-treated patients and 0.7 % in placebo-treated patients.
Indehaver af markedsføringstilladelsen Merck Sharp & Dohme B.V.
Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 39
Den samlede incidens af alvorlige bivirkninger hos patienter i sitagliptin-armen var den samme som hos patienter i placeboarmen.
The overall incidence of serious adverse events in patients receiving sitagliptin was similar to that in patients receiving placebo.
Sitagliptin 100 mg en gang dagligt som supplement til insulin (+/- metformin) behandling (N=305)
Sitagliptin 100 mg once daily added to ongoing insulin (+/- metformin) therapy (N=305)
Sitagliptin 100 mg en gang dagligt som supplement til glimepirid + metforminbehandling (N=115)
Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy (N=115)
Peakplasmakoncentrationer (median Tmax) forekom 1-4 timer efter dosering, gennemsnitlig plasma-AUC for sitagliptin var 8,52 µM•hr, Cmax var 950 nM. Sitagliptins absolutte biotilgængelighed er ca. 87%.
Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 M•hr, Cmax was 950 nM.
Andre patientkarakteristika
Other patient characteristics
Rund, lyserød, filmovertrukken tablet mærket med ”221” på den ene side.
Round, pink film-coated tablet with “221” on one side.
Sitagliptin 100 mg en gang dagligt som supplement til glimepiridbehandling (N=102)
Sitagliptin 100 mg once daily added to ongoing glimepiride therapy (N=102)
Patienterne fik sitagliptin (7.332) 100 mg dagligt (eller 50 mg dagligt, hvis eGFR ved baseline var ≥ 30 og < 50 ml/min/1,73 m2) eller placebo (7.339) som supplement til standardbehandling målrettet de regionale standarder for HbA1c og kardiovaskulære risikofaktorer.
The TECOS was a randomised in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0 % with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
Nogle patienter har oplevet følgende bivirkninger efter at sitagliptin er blevet føjet til metformin: Almindelige (kan berøre op til 1 ud af 10): Lavt blodsukker, kvalme, øget luftafgang fra tarmen, opkastning.
Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness.
I kliniske undersøgelser ændrede sitagliptin ikke farmakokinetikken for metformin, glyburid, simvastatin, rosiglitazon, warfarin eller orale kontraceptiva signifikant.
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
Sitagliptin 100 mg en gang dagligt som supplement til pioglitazonbehandling (N=163)
Sitagliptin 100 mg once daily added to ongoing pioglitazone therapy (N=163)
- Komplikation til diabetes med forhøjet blodsukker, hurtigt vægttab, kvalme eller opkastning
- type 1 diabetes - diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
Incidensen af hypoglykæmi var også den samme hos sitagliptinbehandlede og placebobehandlede patienter.
The incidence of hypoglycaemia was also similar in patients treated with sitagliptin or placebo.
Hos hunde er der ved et eksponeringsniveau på over 23 gange den kliniske eksponering observeret forbigående behandlingsrelaterede fysiske tegn.
23 times the clinical exposure level.
Rund, lys beige, filmovertrukken tablet mærket med ”112” på den ene side.
Round, light beige film-coated tablet with “112” on one side.
Er De i tvivl, så spørg lægen eller apotekspersonalet.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
For at opnå den samme plasmakoncentration for sitagliptin som hos patienter med normal nyrefunktion bør patienter med GFR <45 ml/min samt ESRD-patienter med behov for hæmodialyse eller peritonealdialyse have lavere doser (se pkt.
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis (see section 4.2 and 5.2).
Ristaben er indiceret til at forbedre den glykæmiske kontrol:
For adult patients with type 2 diabetes mellitus, Ristaben is indicated to improve glycaemic control:
Udseende og pakningsstørrelser
What Ristaben looks like and contents of the pack
Ristaben 100 mg tabletter sitagliptin
Ristaben 100 mg tablets Sitagliptin
Talcum (E553b) Titandioxid (E171) Rød jernoxid (E172) Gul jernoxid (E172)
Film coating: poly(vinyl alcohol) macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
Ristaben 25 mg tabletter sitagliptin
Ristaben 25 mg tablets Sitagliptin
Der er hos patienter med moderat til svær nyreinsufficiens udført en undersøgelse, hvor sitagliptin 25 eller 50 mg dagligt blev sammenlignet med glipizid 2,5 mg til 20 mg/dag.
A study comparing sitagliptin at 25 or 50 mg once daily to glipizide at 2.5 to 20 mg/day was conducted in patients with moderate to severe renal impairment.
Det skal De vide, før De begynder at tage Ristaben Sådan skal De tage Ristaben Bivirkninger
What Ristaben is and what it is used for What you need to know before you take Ristaben How to take Ristaben
Sitagliptin viste ingen bivirkninger i en præ- og postnatal udviklingsundersøgelse udført med rotter.
In a pre-/postnatal development study performed in rats sitagliptin showed no adverse effects.
Dosisjustering af Ristaben er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (Child-Pugh score ≤9).
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score > 9).
Abnormiteter af fortænderne observeredes hos rotter ved en eksponering, der var 67 gange højere end det kliniske eksponeringsniveau.
Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no-effect level for this finding was 58-fold based on the 14-week rat study.
(diabetisk ketoacidose).
(pancreatitis).
Ristaben 50 mg tabletter sitagliptin
Ristaben 50 mg tablets Sitagliptin
Kombinationsterapiundersøgelser Sitagliptin 100 mg en gang dagligt som supplement til metforminbehandling (N=453)
Sitagliptin 100 mg once daily added to ongoing metformin therapy (N=453)
Ristaben 100 mg filmovertrukne tabletter
Ristaben 100 mg film-coated tablets
EU/1/10/621/013 14 filmovertrukne tabletter EU/1/10/621/014 28 filmovertrukne tabletter EU/1/10/621/023 30 filmovertrukne tabletter EU/1/10/621/015 56 filmovertrukne tabletter EU/1/10/621/016 84 filmovertrukne tabletter EU/1/10/621/024 90 filmovertrukne tabletter EU/1/10/621/017 98 filmovertrukne tabletter EU/1/10/621/018 50 x 1 filmovertrukne tabletter
EU/1/10/621/013 14 film-coated tablets EU/1/10/621/014 28 film-coated tablets EU/1/10/621/023 30 film-coated tablets EU/1/10/621/015 56 film-coated tablets EU/1/10/621/016 84 film-coated tablets EU/1/10/621/024 90 film-coated tablets EU/1/10/621/017 98 film-coated tablets EU/1/10/621/018 50 x 1 film-coated tablets
EU/1/10/621/001 14 filmovertrukne tabletter EU/1/10/621/002 28 filmovertrukne tabletter EU/1/10/621/019 30 filmovertrukne tabletter EU/1/10/621/003 56 filmovertrukne tabletter EU/1/10/621/004 84 filmovertrukne tabletter EU/1/10/621/020 90 filmovertrukne tabletter EU/1/10/621/005 98 filmovertrukne tabletter EU/1/10/621/006 50 x 1 filmovertrukne tabletter
EU/1/10/621/001 14 film-coated tablets EU/1/10/621/002 28 film-coated tablets EU/1/10/621/019 30 film-coated tablets EU/1/10/621/003 56 film-coated tablets EU/1/10/621/004 84 film-coated tablets EU/1/10/621/020 90 film-coated tablets EU/1/10/621/005 98 film-coated tablets EU/1/10/621/006 50 x 1 film-coated tablets
Ristaben 25 mg filmovertrukne tabletter
Ristaben 25 mg film-coated tablets
EU/1/10/621/007 14 filmovertrukne tabletter EU/1/10/621/008 28 filmovertrukne tabletter EU/1/10/621/021 30 filmovertrukne tabletter EU/1/10/621/009 56 filmovertrukne tabletter EU/1/10/621/010 84 filmovertrukne tabletter EU/1/10/621/022 90 filmovertrukne tabletter EU/1/10/621/011 98 filmovertrukne tabletter EU/1/10/621/012 50 x 1 filmovertrukne tabletter
EU/1/10/621/007 14 film-coated tablets EU/1/10/621/008 28 film-coated tablets EU/1/10/621/021 30 film-coated tablets EU/1/10/621/009 56 film-coated tablets EU/1/10/621/010 84 film-coated tablets EU/1/10/621/022 90 film-coated tablets EU/1/10/621/011 98 film-coated tablets EU/1/10/621/012 50 x 1 film-coated tablets