natgillin/translations-raw huggingface dataset:
Et 24-ugers studie evaluerede virkningen af fast-dosiskombinationen af vildagliptin og metformin (gradvist titreret til en dosis på 50 mg/500 mg to gange daglig eller 50 mg/1.000 mg to gange daglig) som initialbehandling hos lægemiddel-naive patienter.
In a 24-week trial the efficacy of the fixed dose combination of vildagliptin and metformin (gradually titrated to a dose of 50 mg/500 mg twice daily or 50 mg/1000 mg twice daily) as initial therapy in drug-naïve patients was evaluated.
I et klinisk forsøg af 2 års varighed blev vildagliptin (50 mg to gange daglig) sammenlignet med glimepirid (op til 6 mg daglig - gennemsnitlig dosis ved 2 år: 4,6 mg) hos patienter behandlet med metformin (gennemsnitlig daglig dosis: 1894 mg).
In a clinical trial of 2 years' duration, vildagliptin (50 mg twice daily) was compared to glimepiride (up to 6 mg/day - mean dose at 2 years: 4.6 mg) in patients treated with metformin (mean daily dose: 1894 mg).
4.4) - Akut eller kronisk sygdom, der kan medføre vævshypoksi, f.eks. hjerte- eller åndedrætsinsufficiens nyligt myokardieinfarkt chok - Nedsat leverfunktion (se pkt.
Acute or chronic disease which may cause tissue hypoxia, such as: cardiac or respiratory failure, recent myocardial infarction, shock.
Filmovertrukne tabletter
Film-coated tablet
I kliniske forsøg ændrede vægten sig ikke fra baseline, når vildagliptin 100 mg daglig blev administreret som monoterapi (-0,3 kg og -1,3 kg for henholdsvis vildagliptin og placebo).
In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Ændringer i kropsvægt med vildagliptin var -0,2 kg mod +1,6 kg med glimepirid.
Body weight change with vildagliptin was -0.2 kg vs +1.6 kg with glimepiride.
- Zomarist er indiceret som trippelbehandling med insulin som supplement til diæt og motion for at forbedre den glykæmiske kontrol hos voksne patienter, der ikke opnår tilstrækkelig glykæmisk kontrol med en stabil dosis insulin og metformin alene.
- Zomarist is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Den gennemsnitlige placebokorrigerede reduktion i HbA1c i forhold til middel-baseline på 8,8 % var -0,76 %.
The placebo-adjusted mean reduction from a mean baseline HbA1c of 8.8% was -0.76%.
Behandling med Zomarist kan påbegyndes med én tablet på enten 50 mg/850 mg eller 50 mg/1000 mg to gange daglig, givet som en tablet om morgenen og en tablet om aftenen.
Zomarist may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Multipakning: 360 (6 pakninger a 60) filmovertrukne tabletter.
Multipack: 360 (6 packs of 60) film-coated tablets.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
Cationic active substances
I kontrollerede kliniske studier med vildagliptin 50 mg to gange dagligt i kombination med insulin, med eller uden samtidig administration af metformin, var den samlede seponeringshyppighed grundet bivirkninger 0,3 % i vildagliptin-gruppen og 0 i placebo-gruppen.
In controlled clinical trials using vildagliptin 50 mg twice daily in combination with insulin, with or without concomitant metformin, the overall incidence of withdrawals due to adverse reactions was 0.3% in the vildagliptin treatment group and there were no withdrawals in the placebo group.
Tabel 3 Bivirkninger, der blev rapporteret hos patienter, der fik vildagliptin 100 mg dagligt i kombination med insulin (med eller uden metformin) i dobbeltblindede studier (N=371)
Table 3 Adverse reactions reported in patients who received vildagliptin 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Et 24-ugers randomiseret, dobbeltblindet, placebo-kontrolleret studie med 318 patienter evaluerede virkningen og sikkerheden af vildagliptin (50 mg to gange dagligt) i kombination med metformin (≥1500 mg dagligt) og glimepirid (≥4 mg dagligt).
A 24-week randomised, double-blind, placebo-controlled trial was conducted in 318 patients to evaluate the efficacy and safety of vildagliptin (50 mg twice daily) in combination with metformin (≥1500 mg daily) and glimepiride (≥4 mg daily).
• Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer): ledsmerter, træthed, Forstoppelse, hævede hænder, ankler eller fødder (ødem).
• Uncommon (may affect up to 1 in 100 people): joint pain, tiredness, constipation, swollen hands, ankle or feet (oedema).
Tabel 2 Bivirkninger, der blev rapporteret hos patienter, der fik vildagliptin 50 mg to gange dagligt i kombination med metformin og et sulfonylurinstof (N=157)
Table 2 Adverse reactions reported in patients who received vildagliptin 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Multipakning: 120 (2 pakninger a 60) filmovertrukne tabletter.
Multipack: 120 (2 packs of 60) film-coated tablets.
Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Hyppigheden af hypoglykæmi var lavere i vildagliptin-gruppen end i placebo-gruppen (22,9 % versus
The incidence of hypoglycaemia was lower in the vildagliptin group than in the placebo group (22.9% vs. 29.6%).
Der blev observeret en øget incidens af bølgede ribben hos rotter i forbindelse med reducerede maternelle legemsvægtparametre med en NOEL på 75 mg/kg (10 gange human eksponering).
An increased incidence of wavy ribs was observed in rats in association with reduced maternal body weight parameters, with a no-effect dose of 75 mg/kg (10-fold human exposure).
Zomarist 50 mg/1000 mg filmovertrukne tabletter er mørkegule, ovale tabletter med ”NVR” på den ene side og ”FLO” på den anden.
Zomarist 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Tabel 1 Bivirkninger, der blev rapporteret hos patienter, der fik vildagliptin 100 mg daglig som tillægsbehandling til metformin, sammenlignet med placebo plus metformin i dobbeltblindede studier (N=208)
Table 1 Adverse reactions reported in patients who received vildagliptin 100 mg daily as add-on therapy to metformin compared to placebo plus metformin in double-blind studies (N=208)
Multipakning: 180 (3 pakninger a 60) filmovertrukne tabletter.
Multipack: 180 (3 packs of 60) film-coated tablets.
Hudsygdomme
Skin disorders
I den samlede population var den gennemsnitlige placebo-korrigerede reduktion i HbA1c i forhold til middel-baseline på 8,8 % -0,72 %.
In the overall population, the placebo-adjusted mean reduction from a mean baseline HbA1c 8.8% was -0.72%.
Symptomerne på laktatacidose omfatter: opkastning mavesmerter muskelkramper almen utilpashed med udpræget træthed vejrtrækningsbesvær nedsat kropstemperatur og langsommere puls
Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat
Svimmelhed, tremor
Diarrhoea, flatulence
Hvis der er mistanke om pankreatitis, bør vildagliptin seponeres.
If pancreatitis is suspected, vildagliptin should be discontinued if acute pancreatitis is confirmed, vildagliptin should not be restarted.
Tal med din læge, hvis du har spørgsmål til, hvor længe du skal tage medicinen.
If you have any questions about how long to take this medicine, talk to your doctor.
Hud og subkutane væv Almindelig
Dizziness, tremor Skin and subcutaneous tissue disorders Common
I et 24-ugers forsøg blev vildagliptin (50 mg to gange daglig) sammenlignet med pioglitazon (30 mg én gang daglig) hos patienter, der var utilstrækkeligt kontrolleret med metformin (gennemsnitlig daglig dosis: 2020 mg).
In a 24-week trial, vildagliptin (50 mg twice daily) was compared to pioglitazone (30 mg once daily) in patients inadequately controlled with metformin (mean daily dose: 2020 mg).
Zomarist fås i pakninger med 10, 30, 60, 120, 180 eller 360 filmovertrukne tabletter og i multipakninger med 120 (2x60), 180 (3x60) eller 360 (6x60) filmovertrukne tabletter.
Zomarist is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Hud og subkutane væv Ikke kendt
Myalgia Skin and subcutaneous tissue disorders Not known
Zomarist bør gives som 50 mg vildagliptin to gange dagligt (i alt 100 mg dagligt) sammen med en dosis metformin svarende til den dosis, der allerede administreres.
The dose of Zomarist should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
”EXP”(Udløbsdato).
“EXP”.
Det sammensatte endepunkt for bekræftede alvorlige kardiovaskulære bivirkninger [Major Adverse Cardiovascular Events (MACE)], herunder akut myokardieinfarkt, slagtilfælde eller kardiovaskulær død var sammenligneligt for vildagliptin versus kombinerede aktive og placebokomparatorer [Mantel-Haenszel risiko-ratio (M-H RR) 0,82 (95% CI 0,61-1,11)].-MACE forekom hos 83 ud af 9.599 (0,86%) patienter behandlet med vildagliptin og hos 85 ud af 7.102 (1,20%) patienter behandlet med komparatorer.
The composite endpoint of adjudicated major adverse cardiovascular events (MACE) including acute myocardial infarction, stroke or cardiovascular death was similar for vildagliptin versus combined active and placebo comparators [Mantel-Haenszel risk ratio (M-H RR) 0.82 (95% CI 0.61-1.11)].
• Ikke almindelige: diare, luftafgang fra tarmen.
• Uncommon: diarrhoea, flatulence.
Dosisjustering ikke nødvendig.
No dose adjustment.
Vildagliptin forbedrer alfacellernes følsomhed over for glucose ved at øge de endogene GLP-1niveauer, og det resulterer i mere glucosepassende glucagonsekretion.
By increasing endogenous GLP-1 levels, vildagliptin also enhances the sensitivity of alpha cells to glucose, resulting in more glucose-appropriate glucagon secretion.
I et 52-ugers studie blev vildagliptin (50 mg to gange daglig) sammenlignet med gliclazid (gennemsnitlig daglig dosis 229,5 mg) hos patienter, som var utilstrækkeligt kontrolleret med metformin (metformin-baseline-dosis 1.928 mg/daglig).
In a 52-week trial, vildagliptin (50 mg twice daily) was compared to gliclazide (mean daily dose: 229.5 mg) in patients inadequately controlled with metformin (metformin dose at baseline 1928 mg/day).
Zomarist 50 mg/850 mg filmovertrukne tabletter er gule, ovale tabletter med ”NVR” på den ene side og ”SEH” på den anden.
What Zomarist looks like and contents of the pack Zomarist 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Når nyrefunktionen er svækket, reduceres den renale clearance i forhold til kreatinins, og således forlænges elimineringstiden, hvilket medfører forøgede metforminniveauer i plasma.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Kombination med ACE-hæmmere
Combination with ACE inhibitors
Polychlorotrifluoroethylen (PCTFE)/PVC/Alu blister Fås i pakninger med 10, 30, 60, 120, 180 eller 360 filmovertrukne tabletter og i multipakninger indeholdende 120 (2 pakninger med 60), 180 (3 pakninger med 60) eller 360 (6 pakninger med 60) filmovertrukne tabletter.
Polychlorotrifluoroethylene (PCTFE)/PVC/Alu blister Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Din læge kan ordinere en lavere dosis, hvis du har nedsat nyrefunktion.
If you have reduced kidney function, your doctor may prescribe a lower dose.
Gul, oval, filmovertrukket tablet med skrå kant, præget med ”NVR” på den ene side og ”SEH” på den anden side.
Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “SEH” on the other side.
Behandling med metformin skal afbrydes forud for eller på tidspunktet for billeddiagnostiske procedurer og først genoptages mindst 48 timer herefter, forudsat at nyrefunktionen er blevet vurderet og fundet stabil, se pkt.
Metformin should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and
Dyreforsøg har ikke påvist reproduktionstoksicitet for metformin.
For metformin, studies in animals have not shown reproductive toxicity.
Aluminium/Aluminium-blister (PA/Alu/PVC/Alu) Fås i pakninger med 10, 30, 60, 120, 180 eller 360 filmovertrukne tabletter og i multipakninger indeholdende 120 (2 pakninger med 60), 180 (3 pakninger med 60) eller 360 (6 pakninger med 60) filmovertrukne tabletter.
Aluminium/Aluminium (PA/Alu/PVC/Alu) blister Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Derfor skal der udføres nøje overvågning af glykæmisk kontrol, dosisjustering inden for den anbefalede dosering og ændringer i diabetesbehandlingen.
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see section 4.4).
Efter en oral dosis metformin nås den maksimale plasmakoncentration Cmax efter ca. 2,5 time.
After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h.. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Tabel 4 Bivirkninger rapporteret hos patienter, der fik vildagliptin 100 mg som monoterapi i dobbeltblindede studier (N=1855)
Table 4 Adverse reactions reported in patients who received vildagliptin 100 mg daily as monotherapy in double-blind studies (N=1855)
For at nedsætte risikoen for hypoglykæmi bør en lavere dosis sulfonylurinstof overvejes.
Therefore, a lower dose of sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Patienter med nedsat leverfunktion bør ikke behandles med Zomarist, inklusive dem der før behandlingstidspunktet har ALAT eller ASAT > 3x ULN (se pkt.
Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Zomarist (see sections 4.2, 4.3 and 4.8).
Siden denne medicin er blevet markedsført er følgende bivirkninger blevet rapporteret: - Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data):kløende udslæt, betændelse i bugspytkirtlen, områder med afskalning af huden eller blærer i huden, muskelsmerter.
• Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain.
Meget almindelig Kvalme, opkastning, diare, mavesmerter og appetitløshed Lever og galdeveje
Gastrointestinal disorders Very common Nausea, vomiting, diarrhoea, abdominal pain and loss of appetite Hepatobiliary disorders Very rare
- Patienter, der skifter fra samtidig administration af vildagliptin og metformin som separate tabletter:
- For patients switching from co-administration of vildagliptin and metformin as separate tablets: Zomarist should be initiated at the dose of vildagliptin and metformin already being taken.
Zomarist 50 mg/1000 mg filmovertrukne tabletter
Zomarist 50 mg/1000 mg film-coated tablets
Du skal straks kontakte en læge eller apoteket, hvis du har taget for mange Zomarist-tabletter, eller hvis en anden tager dine tabletter.
If you take too many Zomarist tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Metabolisme og ernæring Meget sjælden Reduktion af vitamin B12-absorption og laktatacidose* Nervesystemet Almindelig
Decrease of vitamin B12 absorption and lactic acidosis*
Derfor forventes den metaboliske clearance for vildagliptin ikke at blive påvirket af samtidig administration af præparater, der er CYP 450-hæmmere og/eller -induktorer.
Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent, and accordingly the metabolic clearance of vildagliptin is not anticipated to be affected by comedications that are CYP 450 inhibitors and/or inducers.
Mørkegul, oval, filmovertrukket tablet med skrå kant, præget med ”NVR” på den ene side og ”FLO” på den anden side.
Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side.
Zomarist 50 mg/850 mg filmovertrukne tabletter
Zomarist 50 mg/850 mg film-coated tablets
KARTON FOR ENHEDSPAKNING
FOLDING BOX FOR UNIT PACK
Zomarist 50 mg/850 mg filmovertrukne tabletter Zomarist 50 mg/1000 mg filmovertrukne tabletter
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets
For at undgå at du får lavt blodsukker [hypoglykæmi], vil din læge måske nedsætte din dosis af sulfonylurinstoffet, når du tager det sammen med Zomarist.
Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Zomarist in order to avoid low blood glucose (hypoglycaemia).
Er du i tvivl, så spørg lægen eller på apotekspersonalet.
- If you have any further questions, ask your doctor, pharmacist or nurse.
Zomarist 50 mg/1000 mg filmovertrukne tabletter vildagliptin/metforminhydrochlorid
Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
- Enhver type af akut metabolisk acidose (såsom laktatacidose, diabetisk ketoacidose) - Diabetisk præ-koma - Svær nyreinsufficiens (GFR < 30 ml/min) (se pkt.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) Diabetic pre-coma Severe renal failure (GFR < 30 ml/min) (see section 4.4) Acute conditions with the potential to alter renal function, such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).
- Hver Zomarist 50 mg/850 mg filmovertrukket tablet indeholder 50 mg vildagliptin og 850 mg metforminhydrochlorid (svarende til 660 mg metformin).
- Each Zomarist 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Zomarist bør ikke anvendes til børn og unge under 18 år.
Zomarist is not recommended for use in children and adolescents (< 18 years).
- Øvrige indholdsstoffer: Hydroxypropylcellulose, magnesiumstearat, hypromellose, titandioxid
- The other ingredients are: Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc.
- Hver Zomarist 50 mg/1000 mg filmovertrukket tablet indeholder 50 mg vildagliptin og 1000 mg metforminhydrochlorid (svarende til 780 mg metformin).
- Each Zomarist 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Mave-tarm-kanalen Ikke kendt
Hepatobiliary disorders Not known
Laktatacidose er kendetegnet ved acidotisk dyspnø, mavesmerter, muskelkramper, asteni og hypotermi efterfulgt af koma.
Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
Zomarist 50 mg/850 mg filmovertrukne tabletter vildagliptin/metforminhydrochlorid
Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Zomarist 50 mg/850 mg filmovertrukne tabletter Zomarist 50 mg/1000 mg filmovertrukne tabletter vildagliptin/metforminhydrochlorid
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Sådan skal du tage Zomarist
How to take Zomarist
Knogler, led, muskler og bindevæv Ikke kendt
Musculoskeletal and connective tissue disorders Not known
Hver tablet indeholder 50 mg vildagliptin og 850 mg metforminhydrochlorid (svarende til 660 mg metformin).
Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Hver tablet indeholder 50 mg vildagliptin og 1000 mg metforminhydrochlorid (svarende til 780 mg metformin).
Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Kvalme, gastroøsofageal reflukssygdom Ikke almindelig Diarré, flatulens
Nausea, gastro-oesophageal reflux disease
Hver filmovertrukket tablet indeholder 50 mg vildagliptin og 1000 mg metforminhydrochlorid (svarende til 780 mg af metformin).
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).
Hver filmovertrukket tablet indeholder 50 mg vildagliptin og 850 mg metforminhydrochlorid (svarende til 660 mg af metformin).
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
Tag pakningen og denne indlægsseddel med, hvis det er nødvendigt at gå til lægen eller på hospitalet.
If you have to go to a doctor or hospital, take the pack and this leaflet with you.
EU/1/08/483/007 10 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/008 30 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/009 60 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/010 120 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/011 180 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/012 360 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/025 10 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/026 30 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/027 60 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/028 120 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/029 180 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/030 360 filmovertrukne tabletter (PCTFE/PVC/Alu)
EU/1/08/483/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/030 360 film-coated tablets (PCTFE/PVC/Alu)
Lever og galdeveje Ikke kendt
Gastrointestinal disorders Not known