FrancophonIA/ELRC3.0 huggingface dataset:
English: In the latter study, at the lowest systemic exposure where this anomaly occurred in a single animal, the estimated margin relative to the recommended daily human dose was 2 times more than the recommended daily human
Danish: I dette forsøg var den laveste plasmakoncentration, hvor denne anomali blev set hos et enkelt dyr, 2 gange større end den beregnede sikkerhedsmargin i forhold til den anbefalede dosis til mennesker (800 mg).
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Rare (≥1/10,000 to
Danish: Sjælden 1/10,000 til
English: However, in small multiple dose studies in healthy subjects with 600 mg BID celecoxib had no effect on platelet aggregation and bleeding time compared to placebo.
Danish: I mindre forsøg på raske personer havde gentagne doser af celecoxib 600 mg 2 gange dagligt dog ingen effekt på trombocytaggregation og blødningstid sammenlignet med placebo.
English: In a pharmacokinetic study of celecoxib 200 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/*1, CYP2C9*1/*3, or CYP2C9*3/*3, the median Cmax and AUC 024 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/*3 compared to other genotypes.
Danish: I et farmakokinetisk forøg med celecoxib 200 mg indgivet 1 gang dagligt til raske frivillige forsøgspersoner med genotype CYP2C9*1/*1, CYP2C9*1/*3 eller CYP2C9*3/*3 er median Cmax og AUC0-24 for celecoxib på dag 7 henholdsvis ca. firedoblet og syvdoblet hos personer med genotype CYP2C9*3/*3 sammenlignet med andre genotyper.
English: The capsules are white with ‘7767‘ and ‘200‘ marked in gold ink.
Danish: Kapslerne er hvide og mærket ”7767” og ”200” med guldblæk.
English: − The printing ink contains also shellac, propylene glycol and iron oxide E172, Brilliant Blue FCF
Danish: - Mærkningsblækket indeholder også shellac, propylenglycol og jernoxid E172, Brilliant Blue
English: Such combinations should be avoided in known CYP2C9 poor metabolisers (see sections 4.2 and 5.2).
Danish: Sådanne kombinationer bør undgås hos personer med kendt nedsat CYP2C9-metabolisering (se pkt.
English: As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1)
Danish: Da den kardiovaskulære risiko ved brug af celecoxib blev øget med en dosering på 400 mg 2 gange dagligt i APC-forsøget (se pkt 5.1), bør FAP-patienters behandlingsrespons genovervejes regelmæssigt for at undgå unødvendig eksponering hos FAP-patienter, hvor celecoxib ikke er effektivt (se pkt.
English: For any information about this medicine, please contact the local representative of the Marketing
Danish: Hvis du vil have yderligere oplysninger om Onsenal, skal du henvende dig til den lokale repræsentant:
English: Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.
Danish: Celecoxib har i kliniske forsøg vist at have samme effekt på nyrerne som det NSAID, der blev sammenlignet med.
English: The recommended oral dose is two 200 mg capsules twice per day, taken with food (see section 5.2).
Danish: Anbefalet oral dosis er 2 kapsler a 200 mg 2 gange dagligt i forbindelse med et måltid (se pkt.
English: Therefore, patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Danish: Patienter, der er i behandling med lithium, bør derfor følges omhyggeligt, når behandling med celecoxib begyndes eller
English: Among patients treated with celecoxib 200 mg BID, 48% were considered unresponsive to lisinopril at the final clinic visit (defined as either cuff diastolic blood pressure >90 mmHg or cuff diastolic blood pressure increased >10% compared to baseline), compared to 27% of patients treated with placebo; this difference was statistically significant.
Danish: Blandt de patienter, der fik celecoxib 200 mg 2 gange dagligt anses 48% ikke at respondere på lisinopril ved det afsluttende kliniske besøg (defineret enten som diastolisk blodtryk >90 mmHg eller diastolisk blodtryk steget >10% i forhold til baseline), sammenlignet med 27% af patienter behandlet med placebo.
English: Some people will need special care from their doctors when they are taking Onsenal.
Danish: Vær ekstra forsigtig med at tage Onsenal Nogle patienter har brug for særlig lægelig opmærksomhed, når de behandles med Onsenal.
English: A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical
Danish: Der ikke blevet fastslået nogen signifikant forskel i den gastrointestinale sikkerhed mellem selektive COX-2-hæmmere + acetylsalicylsyre vs. NSAID + acetylsalicylsyre i langtidsforsøg (se pkt.
English: The recommended oral dose is one 400 mg capsule twice per day, taken with food (see section 5.2).
Danish: Anbefalet oral dosis er 400 mg 2 gange dagligt i forbindelse med et måltid (se pkt.
English: Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia.
Danish: Forsigtighed bør også udvises hos patienter, som er i diuretika-behandling, eller som
English: The incidence of myocardial infarction (adjudicated) was 1.0% with (9/933 subjects) with celecoxib 400 mg once daily and 0.6% (4/628 subjects) with placebo.
Danish: Hyppigheden af myokardieinfarkt (bekræftet) er 1,0% (9/933 forsøgspersoner) med celecoxib 400 mg 1 gang dagligt og 0,6% (4/628 forsøgspersoner) med placebo.
English: In final data (adjudicated) from the APC trial in patients treated with celecoxib 800 mg daily for up to 3 years, the excess rates over placebo were 11 events per 1000 patients for myocardial infarction (common); and 5 events per 1000 patients for stroke (uncommon; types of stroke not differentiated).
Danish: De endelige data (bedømt) fra APC-forsøgene, hvor patienterne blev behandlet med celecoxib 800 mg dagligt i op til 3 år, viser en overrepræsentation i forhold til placebo af myokardieinfarkt på 11 hændelser pr. 1000 patienter (almindelig), og der ses en overrepræsentation af slagtilfælde på 5 hændelser pr. 1000 patienter (ikke almindelige; typer af slagtilfælde ikke differentieret).
English: Celecoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.
Danish: Som for andre lægemidler, der hæmmer prostaglandinsyntesen, kan celecoxib i sidste trimester af graviditeten hæmme uteruskontraktioner og give præmatur lukning af ductus arteriosus.
English: − High levels of sodium or haemoglobin and low levels of hematocrit or testosterone in blood test
Danish: højt indhold af natrium eller hæmoglobin (stoffet i de røde blodlegemer) og lav hæmatokrit eller lavt indhold af testosteron i blodet (ses ved blodprøver) nedsat hørelse ændringer i blodtallene
English: Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamide
Danish: Celecoxib påvirker ikke i klinisk relevant grad farmakokinetikken af tolbutamid (CYP2C9-substrat),
English: Hepatic impairment: In patients with moderate hepatic impairment (serum albumin of 25-35 g/l), the daily recommended dose of celecoxib should be reduced by 50% (see sections 4.3 and 5.2).
Danish: Nedsat leverfunktion: Hos patienter med moderat nedsat leverfunktion (serumalbumin 25-35 g/l) bør den daglige anbefalede celecoxibdosis reduceres med 50% (se pkt.
English: Make sure that your doctor knows before you start taking Onsenal: - if you have conditions which increase your risk of heart disease such as high blood pressure,
Danish: Tal med lægen, inden du tager Onsenal: hvis du lider af sygdomme, som øger risikoen for hjertesygdom, f.eks. forhøjet blodtryk, diabetes, forhøjet kolesterol, eller hvis du ryger.
English: In a peri-post natal study in rats, pup toxicity was observed.
Danish: I et peri-postnatalt rotteforsøg er der set toksicitet i afkommet.
English: Cerebral infarction
Danish: Myokardieinfarkt
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Onsenal bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Patients who are known or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution (see
Danish: Patienter med kendt eller formodet nedsat CYP2C9-metabolisering baseret på tidligere anamnese/erfaring med andre CYP2C9-substrater bør behandles med forsigtighed med celecoxib (se
English: As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking celecoxib.
Danish: Som for andre lægemidler, der hæmmer prostaglandinsyntesen, er der set væskeretention og ødem hos patienter, som har taget celecoxib.
English: You will usually take one 400 mg
Danish: Sædvanligvis skal du tage 1 kapsel på 400 mg 2 gange
English: CYP2C9 Poor Metabolizers: Patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution, as the risk of dose-dependent adverse effects is increased.
Danish: Personer med nedsat CYP2C9-metabolisering: Patienter med kendt eller formodet nedsat CYP2C9metabolisering baseret på genotyper eller tidligere anamnese/erfaring med andre CYP2C9-substrater bør behandles med forsigtighed med celecoxib på grund af øget risiko for dosisafhængige bivirkninger.
English: Ear infection, fungal infection (fungal infections were primarily
Danish: Infektioner og parasitære sygdomme øre infektion, svampeinfektion (svampeinfektionerne var primært ikkesystemiske)
English: The long-term cardiovascular toxicity in children exposed to celecoxib has not been evaluated and it is unknown if the long-term risk may be similar to that seen in adults exposed to celecoxib or other COX-2 selective and non-selective NSAIDs (see section 4.4; cardiovascular effects).
Danish: Det er uvist, om langtidsrisikoen kan være den samme som den, der ses hos voksne, som eksponeres for celecoxib eller andre COX-2-selektive og ikke-selektive NSAID (se pkt.
English: A.
Danish: Som
English: − The printing ink contains also shellac, propylene glycol and iron oxide E172.
Danish: - Mærkningsblækket indeholder også shellac, propylenglycol og jernoxid E172.
English: Dialysis is unlikely to be an efficient method of medicinal product removal due to high protein binding.
Danish: På grund af høj proteinbinding er dialyse sandsynligvis ikke en effektiv måde at fjerne lægemidlet på.
English: Do not store your capsules above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30°C.
English: Adverse drug reactions listed for the post-marketing population are only those that are not already listed for the arthritis trials (Table 1) or the polyp
Danish: Bivirkninger anført under post-marketing erfaring er kun de bivirkninger, som ikke allerede er anført fra forsøg på patienter med artrit (Tabel 1) eller fra forsøg
English: Symptoms may include nausea (feeling sick), diarrhoea, jaundice, yellow discolouration of the skin or eyes, dark urine, pale stools, bleeding easily, itching or chills
Danish: Symptomerne kan være kvalme, diarré, gulsot, gulfarvning af hud eller det hvide i øjnene, mørk urin, lys afføring, blødningstendens, kløe eller kuldegysninger.
English: urticaria or other allergic-type reactions after taking acetylsalicylic acid or non steroidal anti inflammatory drugs (NSAIDs) including COX-2 (cyclooxigenase-2) selective inhibitors.
Danish: angioneurotisk ødem, urticaria eller anden type af allergisk reaktion efter at have taget acetylsalicylsyre eller non-steroide antiinflammatoriske stoffer (NSAID), herunder selektive
English: In the APC trial, the relative risks compared to placebo for a composite endpoint (adjudicated) of cardiovascular death, myocardial infarction, or stroke were 3.4 (95% CI 1.4 - 8.5) with celecoxib 400 mg twice daily and 2.8 (95% CI 1.1 - 7.2) with celecoxib 200 mg twice daily.
Danish: I APC-forsøget er de relative risici sammenlignet med placebo for det sammensatte endepunkt (bekræftet) af kardiovaskulær død, myokardieinfarkt eller slagtilfælde 3,4 (95% konfidensinterval 1,48,5) med celecoxib 400 mg 2 gange dagligt og 2,8 (95% konfidensinterval 1,1-7,2) med celecoxib 200 mg 2 gange dagligt.
English: Ear and labyrinth disorders
Danish: Øre og labyrint tinnitus nedsat hørelse
English: • Breast feeding (see sections 4.6 and 5.3)
Danish: 4.5, 4.6 og 5.3).
English: Adverse reactions are listed by system organ class and ranked by frequency in Table 1, reflecting data from the following sources: - Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates greater than 0.01% and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg.
Danish: Bivirkningerne i tabel 1 er anført efter organklasse og i henhold til frekvens og afspejler information fra følgende kilder: - Bivirkninger rapporteret med hyppigheder større end 0,01% og større end for placebo hos patienter med osteoarthrosis og reumatoid artrit.
English: − if you are over 65 years of age your doctor may want to keep a regular check on you As with other non-steroidal, anti-inflammatory drugs (NSAIDs; eg, ibuprofen or diclofenac), this medicine may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood
Danish: Som for anden non-steroid anti-inflammatorisk medicin (NSAID; f.eks. ibuprofen eller diclofenac) kan denne medicin give forhøjet blodtryk.
English: The mean reduction in the number of colorectal polyps following six months of treatment was 28% (SD + 24%) for celecoxib 400 mg BID which was statistically superior to placebo (mean 5%, SD +16%).
Danish: Efter 6 måneders behandling med celecoxib 400 mg 2 gange dagligt var den gennemsnitlige reduktion i antallet af colorektale polypper på 28% (standardafvigelse + 24 %), hvilket var signifikant bedre end for placebo (middelværdi 5%, standardafvigelse + 16 %).
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for Onsenal, fordi det drejer sig om en sjælden sygdom.
English: Common side effects which may affect more than 1 person in 100, are listed below - Fluid build up with swollen ankles, legs and/or hands - Urinary infections - Sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny nose, sore throat, coughs, colds, flu-like symptoms - Dizziness, difficulty sleeping - stomach ache, diarrhoea, indigestion, wind - Rash, itching
Danish: Almindelige bivirkninger, som forekommer hos mere end 1 person ud af 100, er væskeophobning i kroppen, som kan få ankler, ben og/eller hænder til at hæve urinvejsinfektioner bihulebetændelse (stoppede eller smertende bihuler), stoppet eller løbende næse, ondt i halsen, hoste, forkølelse, influenzalignende symptomer svimmelhed, søvnbesvær mavesmerter, diarré, fordøjelsesbesvær, luft i maven hududslæt, kløe muskelstivhed forværring af eksisterende allergi
English: diabetes, high cholesterol or if you smoke you should discuss with your doctor whether Onsenal is suitable for you - if you have had a stomach or duodenal (intestinal) ulcer or bleeding in the stomach or intestines - if your heart, liver, or kidneys are not working well, your doctor may want to keep a regular
Danish: Tal med lægen om, hvorvidt Onsenal er passende behandling for dig hvis du har haft mavesår eller sår i tolvfingertarmen (duodenalsår), eller blødning i maven hvis dit hjerte, lever- eller nyre ikke fungerer normalt.
English: 2 In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes.
Danish: 2 En samlet analyse af 20 placebokontrollerede forsøg af varigheder på mere end 2 uger og op til 1 år hos patienter med osteoarthrosis og reumatoid artrit viser en overrepræsentation af myokardieinfarkt hos patienter behandlet med 200 eller 400 mg daglig på 0,7 hændelse pr. 1000 patienter (sjælden) i forhold til placebo.
English: • In pregnancy and in women who can become pregnant unless using an effective method of contraception (see sections 4.5, 4.6 and 5.3)
Danish: • Under graviditet og hos kvinder, der har mulighed for at blive gravide, medmindre der anvendes effektiv antikonception (se pkt.
English: Each capsule contains 200 mg celecoxib
Danish: Hver kapsel indeholder 200 mg celecoxib.
English: Each capsule contains 400 mg celecoxib
Danish: Hver kapsel indeholder 400 mg celecoxib.
English: Ecchymosis, bullous eruption, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema Arthralgia, myositis
Danish: forhøjede leverenzymer hepatitis, leversvigt, icterus alopeci, fotosensitivitet ekkymose, bulløs erruption, exfoliativ dermatitis, erythema multiforme, StevensJohnsons syndrom, toksisk epidermal nekrolyse, angioødem artralgi, myositis serumcarbamid akut nyresvigt, interstitial nefritis, hyponatriæmi menstruationsforstyrrelser brystsmerter
English: Uncommon side effects which may affect more than 1 person in a 1000, are listed below:
Danish: Ikke almindelige bivirkninger, som forekommer hos mere end 1 person ud af 1000:
English: In the PreSAP trial, the relative risk compared to placebo for this same composite endpoint (adjudicated) was 1.2 (95% CI 0.6 - 2.4) with celecoxib 400 mg once daily compared to placebo.
Danish: I PreSAP-forsøget er den relative risiko sammenlignet med placebo for det samme sammensatte endepunkt (bekræftet) 1,2 (95% konfidensinterval 0,6-2,4) med celecoxib 400 mg 1 gang dagligt.
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib (see section 4.8).
Danish: I forbindelse med brugen af celecoxib er der meget sjældent indberettet alvorlige hudreaktioner, nogle fatale, inklusive dermatitis exfoliativa, Stevens-Johnsons syndrom, og toksisk epidermal nekrolyse (se pkt.
English: Renal impairment: Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution (see sections 4.3, 4.4 and 5.2).
Danish: Nedsat nyrefunktion: Erfaring med celecoxib hos patienter med let til moderat nedsat nyrefunktion er begrænset, hvorfor sådanne patienter bør behandles med forsigtighed (se pkt.
English: The relative risk compared to placebo for a similar composite endpoint (CV death, MI, stroke) was 1.14 (95% CI 0.61 - 2.12) with celecoxib 200 mg twice daily.
Danish: Den relative risiko sammenlignet med placebo for lignende sammensatte endepunkter (kardiovaskulær død, myokardieinfarkt, slagtilfælde) er 1,14% (95% konfidensinterval 0,61-2,12) med celecoxib 200 mg 2 gange dagligt.
English: Onsenal contains lactose (a type of sugar).
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Onsenal Onsenal indeholder lactose (en sukkerart).
English: Bleeding events in association with increases in prothrombin time have been reported in arthritis patients (mainly elderly) receiving celecoxib concurrently with warfarin, some of them fatal (see section 4.4).
Danish: Hos gigtpatienter (især ældre) i samtidig behandling med celecoxib og warfarin er der rapporteret blødninger i forbindelse med stigning i prothrombintiden.Nogle af disse var med dødelig udgang (se pkt.
English: - Neuroleptics (used to treat some mental disorders) - Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia) - Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression) - Barbiturates ( used to treat epilepsy/seizures and some sleep disorders)
Danish: - medicin mod bakterielle infektioner (rifampicin) - medicin, som forhindrer blodpropper (warfarin) eller anden blodfortyndende medicin - anden medicin mod depression, søvnforstyrrelser, forhøjet blodtryk eller uregelmæssig puls - medicin mod visse psykiske lidelser (neuroleptika) - medicin mod leddegigt, alvorlig psoriasis og blodkræft (methotrexat) - medicin mod epilepsi/kramper eller visse typer smerter og depression (carbamazepin) - medicin mod epilepsi/kramper eller visse typer søvnforstyrrelser (barbiturater)
English: Excipients: Lactose Monohydrate 99.6 mg For a full list of excipients, see section 6.1.
Danish: Hjælpestoffer: lactosemonohydrat 99,6 mg. Alle hjælpestoffer er anført under pkt.
English: Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
Danish: I et peri-post natalt forsøg med rotter, som inkluderede behandling i den organdannende periode, blev diafragmabrok også set.
English: Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be
Danish: Ældre har hyppigere nedsat nyre- og leverfunktion og især nedsat hjertefunktion, og patienterne bør derfor kontrolleres løbende.
English: In individuals who are CYP2C9 poor metabolisers and demonstrate increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors (eg.
Danish: Hos personer, som har nedsat CYP2C9-metabolisering, og som viser øget systemisk eksponering for celecoxib, kan samtidig behandling med CYP2C9-hæmmere (f.eks. fluconazol, amiodaron) føre til yderligere stigning i eksponering for celecoxib.
English: Onsenal works by inhibiting COX-2, to which such dividing cells are sensitive.
Danish: Onsenal virker ved at hæmme COX-2, og dette påvirker betændte og unormalt voksende celler.
English: The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated.
Danish: Eksempler på lægemidler, som metaboliseres af CYP2D6, er antidepressiva (tricykliske og SSRI-præparater), neuroleptika, antiarrytmika osv. Doseringen af individuelt dosistitrerede CYP2D6-substrater bør måske nedsættes, når samtidig behandling med celecoxib initieres, eller øges, hvis behandling med celecoxib afsluttes.
English: If you take more ONSENAL than you should If you accidentally take too many capsules, tell your doctor or pharmacist as soon as possible.
Danish: Kontakt straks læge eller apotek, hvis du ved et uheld kommer til at tage for mange kapsler.
English: Celecoxib exhibits dose- and time-independent pharmacokinetics in the therapeutic dose range.
Danish: Inden for det terapeutiske dosisområde har celecoxib dosis- og tidsuafhængig farmakokinetik.
English: Cardiovascular Safety - Long-Term Studies Involving Subjects With Sporadic Adenomatous Polyps: Two studies involving subjects with sporadic adenomatous polyps were conducted with celecoxib i.e., the APC trial (Adenoma Prevention with Celecoxib) and the PreSAP trial (Prevention of Spontaneous Adenomatous Polyps).
Danish: APC-forsøget (Adenoma Prevention with Celecoxib) og PreSAP-forsøget (Prevention of Spontaneous Adenomatous Polyps).
English: Excipients: Lactose Monohydrate 49.8 mg For a full list of excipients, see section 6.1.
Danish: Hjælpestoffer: lactosemonohydrat 49,8 mg. Alle hjælpestoffer er anført under pkt.
English: Medicinal product subject to medical prescription.
Danish: Dette gælder også medicin, som ikke er købt på recept.