natgillin/translations-raw huggingface dataset:
Følgende ændringer, observeret hos rotter og makakaber, der fik en kombination af irbesartan/ hydrochlorthiazid på 10/ 10 og 90/ 90 mg/ kg/ dag, blev også set ved anvendelse af de individuelle stoffer og/ eller var sekundære til blodtryksnedsættelse (der blev ikke observeret signifikante toksikologiske interaktioner): nyreforandringer karakteriseret ved let øgning af serum- urea og kreatinin samt hyperplasi/ hypertrofi af det juxtaglomerulære apparat, hvilket er en direkte konsekvens af interaktion mellem irbesartan og renin- angiotensin- systemet; let fald i erytrocytparametre (erytrocytter, hæmoglobin, hæmatokrit); i et 6 måneders toksicitetsstudie med irbesartan 90 mg/ kg/ dag, hydrochlorthiazid 90 mg/ kg/ dag, og irbesartan/ hydrochlorthiazid 10/ 10 mg/ kg/ dag blev der observeret misfarvning, sår og fokal nekrose af ventrikelslimhinden hos rotter.
The following changes, observed in rats and macaques receiving the irbesartan/ hydrochlorothiazide combination at 10/ 10 and 90/ 90 mg/ kg/ day, were also seen with one of the two medicinal products alone and/ or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed): kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/ hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system; slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit); stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/ kg/ day, hydrochlorothiazide 90 mg/ kg/ day, and irbesartan/ hydrochlorothiazide 10/ 10 mg/ kg/ day.
Disse læsioner blev ikke observeret hos makakaber; et fald i serum- kalium på grund af hydrochlorthiazid og delvis forebyggelse, når hydrochlorthiazid blev givet i kombination med irbesartan.
These lesions were not observed in macaques; decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
De optræder også med angiotensin- konverterende enzymhæmmere.
Most of the above mentioned effects appear to be due to the pharmacological activity of irbesartan (blockade of angiotensin-II-induced inhibition of renin release, with stimulation of the renin-producing cells) and occur also with angiotensin converting enzyme inhibitors.
Disse fund synes ikke at have relevans ved anvendelse af terapeutiske doser af irbesartan/ hydrochlorthiazid til mennesker.
These findings appear to have no relevance to the use of therapeutic doses of irbesartan/ hydrochlorothiazide in humans.
Effekten af irbesartan/ hydrochlorthiazid på fertilitet er ikke evalueret i dyrestudier, da der ikke har været tegn på skadelig effekt på fertiliteten hos dyr eller mennesker med de individuelle stoffer.
The effects of the irbesartan/ hydrochlorothiazide combination on fertility have not been evaluated in animal studies, as there is no evidence of adverse effect on fertility in animals or humans with either irbesartan or hydrochlorothiazide when administered alone.
Derimod har en anden angiotensin- II antagonist påvirket fertilitetsparametre i dyrestudier, når denne blev givet alene.
However, another angiotensin-II antagonist affected fertility parameters in animal studies when given alone.
Disse fund er også observeret ved lavere doser af denne anden angiotensin- II antagonist, når den blev givet i kombination med hydrochlorthiazid.
These findings were also observed with lower doses of this other angiotensin-II antagonist when given in combination with hydrochlorothiazide.
Der var ingen tegn på mutagenicitet eller clastogenicitet med irbesartan/ hydrochlorthiazid - kombinationen.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/ hydrochlorothiazide combination.
Der var ikke tegn på abnorm systemisk eller målorgan- toksicitet ved klinisk relevante doser.
Irbesartan: there was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
I prækliniske sikkerhedsstudier medførte store doser irbesartan (≥ 250 mg/ kg/ dag hos rotter og ≥ 100 mg/ kg/ dag hos makakaber) en reduktion i røde blodlegemeparametre (erytrocytter, hæmoglobin, hæmatokrit).
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Effekten anses for at være sekundær til den hypotensive effekt af lægemidlet, som medfører nedsat renal perfusion.
At very high doses (≥ 500 mg/ kg/ day) degenerative changes in the kidneys (such as interstitial nephritis, tubular distention, 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.
Derudover inducerede irbesartan hyperplasi/ hypertrofi af de juxtaglomerulære celler (hos rotter ved ≥ 90 mg/ kg/ dag, hos makakaber ved ≥ 10 mg/ kg/ dag).
Furthermore, irbesartan induced hyperplasia/ hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/ kg/ day, in macaques at ≥ 10 mg/ kg/ day).
Ved terapeutiske doser af irbesartan til mennesker, synes hyperplasi/ hypertrofi af de renale juxtaglomerulære celler ikke at have nogen relevans.
For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Denne toksiske effekt forsvandt efter fødslen.
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Selvom der er fundet modstridende resultater vedrørende genotoksisk eller karcinogen effekt, har det, på trods af et stort humant materiale, ikke været muligt at påvise en sammenhæng mellem anvendelse af hydrochlorthiazid og en stigning i antallet af neoplasmer.
12 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Mikrokrystallinsk cellulose Croscarmellosenatrium Lactosemonohydrat Magnesiumstearat Kolloid silica Prægelatineret majsstivelse Rød og gul jernoxid (E172).
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Red and yellow ferric oxides (E172)
Kartoner med 14 tabletter; 1 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere Kartoner med 28 tabletter; 2 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere Kartoner med 56 tabletter; 4 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere Kartoner med 98 tabletter; 7 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere Kartoner med 56 x 1 tablet; 7 blisterkort med 8 x 1 tablet i PVC/ PVDC/ perforerede aluminiumblistere med enkeltdosis.
Cartons of 56 x 1 tablets; 7 blister cards of 8 x 1 tablets each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
15. oktober 1998 Dato for seneste genregistrering:
15 October 1998 Date of last renewal:
CoAprovel 300 mg/ 12, 5 mg tabletter
CoAprovel 300 mg/ 12.5 mg tablets.
Hver tablet indeholder 300 mg irbesartan og 12, 5 mg hydrochlorthiazid.
Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Hver tablet indeholder 65, 8 mg lactose (som lactosemonohydrat).
Each tablet contains 65.8 mg of lactose (as lactose monohydrate).
Dosisjustering af CoAprovel til ældre patienter er ikke nødvendig.
15 Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.
16 Der kan forekomme hyperurikæmi, eller regulær urinsyregigt kan blive fremskyndet, hos visse patienter i thiazidbehandling.
16 Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Dette lægemiddel indeholder lactose.
17 Lactose: this medicinal product contains lactose.
18 Antidiabetiske lægemidler (orale stoffer og insuliner):
18 Alcohol: potentiation of orthostatic hypotension may occur;
5. 3).
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
4. 3 og 4. 4).
(see section 5.3).
19 Thiazider passerer placentabarrieren og findes i navlesnorsblod.
19 Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
20 Det reproduktive system og mammae:
Reproductive system and breast Uncommon: disorders:
21 4. 9 Overdosering
21 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
Kombinationen af hydrochlorthiazid og irbesartan giver en dosisrelateret additiv reduktion af blodtrykket over hele det terapeutiske dosisinterval for de enkelte lægemidler.
22 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Det gennemsnitlige blodtryk ved baseline var ca.
23 the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
24 5. 3 Prækliniske sikkerhedsdata
24 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Irbesartan/ hydrochlorthiazid:
5.3 Preclinical safety data
Selvom der er fundet modstridende resultater vedrørende genotoksisk eller karcinogen effekt, har det, på trods af et stort humant materiale, ikke været muligt at påvise en sammenhæng mellem anvendelse af hydrochlorthiazid og en stigning i antallet af neoplasmer.
25 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
CoAprovel 150 mg/ 12, 5 mg filmovertrukne tabletter.
CoAprovel 150 mg/ 12.5 mg film-coated tablets.
Hver filmovertrukken tablet indeholder 150 mg irbesartan og 12, 5 mg hydrochlorthiazid.
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Hver filmovertrukken tablet indeholder 38, 5 mg lactose (som laktosemonohydrat).
Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
CoAprovel 300 mg/ 25 mg kan gives til patienter, der er utilstrækkeligt regulerede med CoAprovel 300 mg / 12, 5 mg.
CoAprovel 300 mg/ 25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/ 12.5 mg.
Højere doser end 300 mg irbesartan/ 25 mg hydrochlorthiazid, 1 gang dagligt frarådes.
Doses higher than 300 mg irbesartan/ 25 mg hydrochlorothiazide once daily are not recommended.
Dosisjustering af CoAprovel til ældre patienter er ikke nødvendig.
28 Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.
4. 6) Alvorlig nyrefunktionsnedsættelse (kreatininclearance < 30 ml/ min) Refraktær hypokaliæmi, hypercalcæmi Alvorlig leverfunktionsnedsættelse, biliær cirrhose og cholestase
Hypersensitivity to the active substances, to any of the excipients (see section 6.1), or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimester of pregnancy (see sections 4.4 and 4.6) Lactation (see section 4.6) Severe renal impairment (creatinine clearance < 30 ml/ min) Refractory hypokalaemia, hypercalcaemia Severe hepatic impairment, biliary cirrhosis and cholestasis
Der er øget risiko for alvorlig hypotension og nyreinsufficiens, hvis patienter med bilateral nyrearteriestenose eller stenose af arterien til den eneste fungerende nyre behandles med angiotensin- konverterende enzymhæmmere eller angiotensin- II receptor- antagonister.
Renal artery stenosis - Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists.
Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion, hvis kreatininclearanceer ≥ 30 ml/ min.
No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥ 30 ml/ min.
Dog skal denne faste dosis- kombination gives med forsigtighed til patienter med mildt til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/ min, men < 60 ml/ min).
However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/ min but < 60 ml/ min) this fixed dose combination should be administered with caution.
Thiazidbehandling er associeret med forhøjede kolesterol - og triglycerid- niveauer, Der er dog rapporteret minimal eller ingen effekt ved en dosis på 12, 5 mg som findes i CoAprovel.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in CoAprovel, minimal or no effects were reported.
29 Der kan forekomme hyperurikæmi, eller regulær urinsyregigt kan blive fremskyndet, hos visse patienter i thiazidbehandling.
29 Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Indholdet af hydrochlorthiazid i dette lægemiddel kan medføre et positivt fund ved en Doping- test.
Anti-doping test: hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Hvis det er nødvendigt at genoptage diuretika- behandlingen, anbefales det at beskytte udsatte områder mod for sol og kunstige UVA- stråler.
If a re- administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Dette lægemiddel indeholder lactose.
30 Lactose: this medicinal product contains lactose.
Det anbefales at måle serum- kalium periodisk, når CoAprovel administreres sammen med lægemidler, der påvirkes af serum- kaliumforstyrrelser (fx digitalis glykosider, antiarytmika).
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when CoAprovel is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
31 Antidiabetiske lægemidler (orale stoffer og insuliner):
31 Alcohol: potentiation of orthostatic hypotension may occur;
Det kan være nødvendigt at justere dosis af lægemidler mod urinsyregigt, da hydrochlorthiazid kan øge niveauet af urinsyre i serum.
Antigout medicinal products: dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Thiaziddiuretika kan øge serum- calcium niveauet på grund af nedsat udskillelse.
Calcium salts: thiazide diuretics may increase serum calcium levels due to decreased excretion.
Hvis der gives calciumsupplement eller calciumsparende lægemiddel (fx D- vitamin), skal serum- calcium niveauet måles, og calcium- dosis justeres herefter;
If calcium supplements or calcium sparing medicinal products (e. g. vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly;
Den hyperglykæmiske effekt af beta- blokkere og diazoxid forstærkes af thiazider.
Other interactions: the hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Thiazider kan reducere nyreudskillelsen af cytotoksiske stoffer (f. x cyklofosfamid, methotrexat) og forstærke deres myelosuppresive effekt.
Thiazides may reduce the renal excretion of cytotoxic medicinal products (e. g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
32 Thiazider passerer placentabarrieren og findes i navlesnorsblod.
32 Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
CoAprovel er kontraindiceret under amning
CoAprovel is contraindicated during breast-feeding.
Meget almindelig (≥ 1/ 10); almindelig (≥ 1/ 100 til < 1/ 10); ikke almindelig (≥ 1/ 1. 000 til < 1/ 100); sjælden (≥ 1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
Synkope, hypotension, takykardi, ødem Svimmelhed Ortostatisk svimmelhed Hovedpine
syncope, hypotension, tachycardia, oedema dizziness orthostatic dizziness headache
Tinnitus Hoste
tinnitus cough
Kvalme/ opkastning Diarré Dyspepsi, smagsforstyrrelse
nausea/ vomiting diarrhoea dyspepsia, dysgeusia
Vaskulære sygdomme:
Metabolism and nutrition disorders:
Ikke almindelig:
Not known:
Hævelse af ekstremiteter artralgi, myalgi Hyperkalæmi Rødme Træthed
swelling extremity arthralgia, myalgia hyperkalaemia
Immunsystemet:
Vascular disorders:
Ikke kendt:
Uncommon:
Sjældne tilfælde af
flushing
33 overfølsomhedsreaktioner som fx angioødem, udslæt og urticaria
33
Det reproduktive system og Ikke mammae:
Reproductive system and breast disorders:
Ikke kendt: almindelig:
Uncommon:
Hepatitis, abnorm leverfunktion Seksuel dysfunktion, ændret libido
hepatitis, abnormal liver function sexual dysfunction, libido changes
Bivirkninger rapporteret ved anvendelse af irbesartan alene Almene symptomer og reaktioner på administrationsstedet:
Adverse reactions reported with the use of irbesartan alone General disorders and administration site conditions:
Bivirkninger (uden hensyn til forbindelse med lægemidlet) rapporteret ved anvendelse af hydrochlorthiazid alene Undersøgelser:
Adverse reactions (regardless of relationship to medicinal product) reported with the use of hydrochlorothiazide alone Investigations:
Gulsot (intrahepatisk kolestatisk gulsot) Depression, søvnforstyrrelser
jaundice (intrahepatic cholestatic jaundice) depression, sleep disturbances
34 4. 9 Overdosering
34 4.9 Overdose
Den selektive antagonisme mod angiotensin- II (AT1) receptorerne resulterer i en forhøjelse af plasma- renin - og angiotensin- II - niveauerne og i nedsat aldosteron i plasma.
The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Serum- kalium påvirkes ikke nævneværdigt, når irbesartan administreres alene ved de anbefalede doser til patienter, uden udvikling af elektrolytforstyrrelser (se pkt.
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses in patients without risk of electrolyte imbalance (see sections 4.4 and 4.5).
Tillæg af 12, 5 mg hydrochlorthiazid til 300 mg irbesartan 1 gang dagligt hos patienter, der ikke er adækvat behandlede med 300 mg irbesartan alene, medførte yderligere placebo- korrigeret diastolisk blodtryksreduktion ved
The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of
35 laveste måling (24 timer efter dosis) på 6, 1 mmHg.
35 6.1 mm Hg.
Begrænsede kliniske data (7 patienter ud af 22) tyder på, at patienter, som ikke er tilstrækkeligt regulerede med 300 mg/ 12, 5 mg- kombinationen, kan respondere ved dosisøgning til 300/ 25 mg.
Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/ 12.5 mg combination may respond when uptitrated to 300 mg/ 25 mg.
Forholdet mellem den laveste og den maksimale effekt af CoAprovel 150 mg / 12, 5 mg var 100%, når blodtrykket blev monitoreret ambulant.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of CoAprovel 150 mg/ 12.5 mg were 100%.
47, 2% af patienterne i kombinationsbehandling nåede et dal- SeDBT < 90 mmHg sammenlignet med 33, 2% af patienterne behandlet med irbesartan
Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
Typen og forekomsten af de bivirkninger, der er indberettet hos patienter, som har modtaget behandling med kombinationen, svarede til bivirkningsprofilen for patienter i enkeltstofbehandling.
36 The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
37 5. 3 Prækliniske sikkerhedsdata
37 5.3 Preclinical safety data
Følgende ændringer, observeret hos rotter og makakaber, der fik en kombination af irbesartan/ hydrochlorthiazid på 10/ 10 og 90/ 90 mg/ kg/ dag, blev også set ved anvendelse af de individuelle stoffer og/ eller var sekundære til blodtryksnedsættelse (der blev ikke observeret signifikante toksikologiske interaktioner): nyreforandringer karakteriseret ved let øgning af serum- urea og kreatinin samt hyperplasi/ hypertrofi af det juxtaglomerulære apparat, hvilket er en direkte konsekvens af interaktion mellem irbesartan og renin angiotensin systemet; let fald i erytrocytparametre (erytrocytter, hæmoglobin, hæmatokrit); i et 6 måneders toksicitetsstudie med irbesartan 90 mg/ kg/ dag, hydrochlorthiazid 90 mg/ kg/ dag, og irbesartan/ hydrochlorthiazid 10/ 10 mg/ kg/ dag blev der observeret misfarvning, sår og fokal nekrose af ventrikelslimhinden hos rotter.
The following changes, observed in rats and macaques receiving the irbesartan/ hydrochlorothiazide combination at 10/ 10 and 90/ 90 mg/ kg/ day, were also seen with one of the two medicinal products alone and/ or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed): kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/ hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system; slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit); stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/ kg/ day, hydrochlorothiazide 90 mg/ kg/ day, and irbesartan/ hydrochlorothiazide 10/ 10 mg/ kg/ day.
Selvom der er fundet modstridende resultater vedrørende genotoksisk eller karcinogen effekt, har det, på trods af et stort humant materiale, ikke været muligt at påvise en sammenhæng mellem anvendelse af hydrochlorthiazid og en stigning i antallet af neoplasmer.
Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Hypromellose Silikondioxid Magnesiumstearat
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate
Lactosemonohydrat Hypromellose Titandioxid Macrogol 3000 Rød og gul jernoxid Carnaubavoks.
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3000 Red and yellow ferric oxides Carnauba wax