natgillin/translations-raw huggingface dataset:
Østrogener, orale antikonceptiva og clofibrat (og muligvis andre lipidsænkende stoffer), øger den hepatiske kolesterolsekretion, og fremmer dannelse af kolesterolgaldesten og modvirker derved virkningen af cholsyre.
Oestrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering substances) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of cholic acid.
Ciclosporin ændrer cholsyres farmakokinetik ved at hæmme den hepatiske optagelse og hepatobiliære sekretion af galdesyrer og ændrer desuden dens farmakodynamik ved at hæmme kolesterol7α-hydroxylase.
Ciclosporin alters the pharmacokinetics of cholic acid by inhibition of the hepatic uptake and hepatobiliary secretion of bile acids, as well as via its pharmacodynamics by inhibiting cholesterol 7α-hydroxylase.
Samtidig med, at de atypiske galdesyremetabolitter forsvinder, ses en tilsvarende reduktion og normalisering af leverenzymværdierne i serum.
Concurrent with the disappearance of atypical bile acid metabolites, there is a consistent reduction and normalization in serum liver enzymes.
Den konjugerede cholsyre udskilles i galden og føres til tyndtarmen, hvor den sammen med de øvrige komponenter i galden varetager sin hovedfunktion i fordøjelsen.
Conjugated cholic acid is secreted into bile and will pass into the small intestine where, in association with other components of bile, it will perform its principal digestive function.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Irland
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Ireland
Cellulose, mikrokrystallinsk, silicificeret Magnesiumstearat
Silicified microcrystalline cellulose
Patienter med nydiagnosticeret eller familiær hypertriglyceridæmi må forventes at absorbere cholsyre dårligt fra tarmen.
Patients with newly diagnosed or a family history of familial hypertriglyceridaemia are expected to poorly absorb cholic acid from the intestine.
I perioder med hurtig vækst, sygdom eller graviditet foretages supplerende eller hyppigere undersøgelser til monitorering af behandlingen (se pkt.
Additional or more frequent investigations should be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Hos patienter med CTX (n=3) var niveauet af galdesyrer i urinen ved baseline normalt hos 1 patient og forhøjet hos 2 patienter, forhøjet for alle patienter i analysen med dårligste værdi efter behandling og normalt i den bedste vurdering efter baseline hos alle 3 patienter.
In patients with CTX (N=3), urinary bile acids at baseline were normal for 1 patient and elevated for 2 patients, elevated for all patients in the worst post-treatment analysis, and normal in the best postbaseline assessment for all 3 patients.
Af de 52 ovennævnte patienter, der indgik i den 17 år lange undersøgelse CAC-91-10-10, afgik de 6 ved døden, 3 viste ingen tegn på behandlingen, 4 udgik af undersøgelsen, 10 blev tabt for opfølgning, og for 1 lykkedes det ikke at skaffe oplysninger.
Of the 52 patients described above that were included in Study CAC-91-10-10 during the 17-year study period, 6 died, 3 had no evidence of treatment, 4 terminated the study, 10 were lost to follow-up, and for 1, data retrieval was unsuccessful.
Oralt administreret cholsyre absorberes ved passiv diffusion fra hele mave-tarmkanalen.
Orally administered cholic acid is absorbed by passive diffusion along the length of the gastrointestinal tract.
I undersøgelse CAC-91-10-10 viste analysen af virkning, at cholsyre medførte væsentlig bedring (i form af nedsat) galdesyreudskillelse i urinen hos patienter med enkeltenzymdefekter.
In Study CAC-91-10-10 the efficacy analysis showed that treatment with cholic acid significantly improved (i.e., decreased) urinary bile acid excretion in patients with single enzyme defects.
4.5) på omtrent samme klokkeslæt hver dag, morgen og/eller aften.
It is recommended that cholic acid is taken with food (see section 4.5) at approximately the same time each day, in the morning and/or evening.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE Kolbam
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOLBAM
Til spædbørn og børn, der ikke kan synke kapsler, skal du åbne kapslen ved at vride den forsigtigt og hælde indholdet i modermælkserstatning, udmalket modermælk eller frugtmos i en ren skål.
For babies and children who cannot swallow capsules, open the capsule by gently twisting it and add the contents to infant formula, expressed breast milk or fruit puree in a suitable clean container.
Phenobarbital kan standse virkningen af cholsyre.
Phenobarbital may stop cholic acid from working.
Anvendelse af cholsyre under graviditet kan overvejes, hvis lægen skønner, at fordelene for patienten overstiger den mulige risiko.
The use of cholic acid may be considered during pregnancy if the doctor considers that the benefits to the patient outweigh the possible risk.
Til spædbørn kan indholdet blandes med modermælkserstatning, udmalket modermælk eller frugtmos, og til børn under seks år blandes i f.eks. kartoffelmos eller æblemos.
For young infants the contents may be mixed with infant formula, expressed breast milk or fruit puree and for infants and children under 6 years, mixed with soft food such as mashed potatoes or apple puree.
Behandlingen med eksogen cholsyre har til formål at erstatte den fysiologiske galdesyre ved medfødte fejl i galdesyresyntesen.
Treatment with exogenous cholic acid is intended to replace physiological bile acid in cases of inborn errors of bile acid synthesis.
Phenobarbital er derfor kontraindiceret ved behandling med cholsyre (se pkt.
Therefore use of phenobarbital in patients treated with cholic acid is contraindicated (see section 4.3).
Af de 41 ovennævnte patienter, der blev behandlet i undersøgelse CAC-002-01 seponerede 13 patienter behandlingen, 8 som følge af bivirkninger, 1 som følge af manglende virkning/tab af virkning, 1 var tabt for opfølgning og 3 trak deres samtykke tilbage.
Of the 41 patients described above that were treated in Study CAC-002-01, 13 patients discontinued: 8 due to AEs, 1 for lack/loss of efficacy, 1 was lost to follow-up, and 3 withdrew consent.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Irland
MARKETING AUTHORISATION HOLDER Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Ireland
Til spædbørn kan indholdet blandes med modermælkserstatning, udmalket modermælk eller frugtmos, og til børn under seks år straks blandes i f.eks. kartoffelmos eller æblemos.
For young infants the contents may be mixed with infant formula, expressed breast milk or fruit puree and for infants and children under 6 years, mixed with soft food such as mashed potatoes or apple puree.immediately.
Rationalet for behandling med cholsyre er at forbedre galdeflow og fedtabsorption og genoprette den fysiologiske feedbackhæmning af galdesyresyntesen og således sænke produktionen af toksiske galdesyreprækursorer.
The rationale for cholic acid therapy is improvement of bile flow and fat absorption and restoration of a physiologic feedback inhibition on bile acid synthesis, lowering the production of toxic bile acid precursors.
Titaniumdioxid (E171) Printerblæk
Titanium dioxide (E171)
Efter administration af cholsyre nedreguleres galdesyresyntesen, og de abnorme galdesyrer bliver stærkt reduceret eller forsvinder næsten helt.
After administration of cholic acid a down-regulation of bile acid synthesis occurs and there is a strong decrease or almost complete disappearance of abnormal bile acids.
Patienter, der er i behandling med cholsyre og har nedsat leverfunktion, bør overvåges tæt (se pkt.
Patients with hepatic impairment who are treated with cholic acid should be monitored closely (see section 4.4).
Til spædbørn og børn, som ikke kan synke kapsler, kan kapslerne åbnes, og indholdet opblandes i modermælkserstatning eller juice.
For infants and children who cannot swallow capsules, the capsules may be opened and the content added to infant formula or juice.
• stikken og prikken (let perifer neuropati)
• feeling of pins and needles (mild peripheral neuropathy)
Serumtransaminaser var under ULN hos 1 patient, og forhøjet (≥2 gange ULN) hos 2 patienter ved baseline, forhøjet hos 2 patienter i analysen med dårligste værdi efter baseline, men under ULN hos alle 3 patienter i analysen med bedste værdi efter behandling.
Serum transaminases were below the ULN for 1 patient and elevated (≥2 times the ULN) for 2 patients at baseline, were elevated for 2 patients in the worst post baseline analysis but were below the ULN for all 3 patients in the best post-treatment analysis.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Kapsler, hårde.
PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
MARKEDSFØRINGSTILLADELSESNUMMER EU/1/13/895/002
MARKETING AUTHORISATION NUMBER EU/1/13/895/002
Familiær hypertriglyceridæmi
Familial hypertriglyceridaemia
Den konjugerede cholsyre absorberes fra ileum via transportproteiner, føres tilbage til leveren og gennemløber en ny cyklus i det enterohepatiske kredsløb.
Conjugated cholic acid is absorbed in the ileum via transporters , passed back to the liver and enters another cycle of enterohepatic circulation.
Kolesterolsænkende lægemidler såsom colestyramin, colestipol eller colesevelam kan påvirke optagelsen af cholsyre, hvilket ligeledes gælder visse aluminiumholdige syreneutraliserende midler (f.eks. midler mod fordøjelsesbesvær).
Medicines for lowering cholesterol levels in the blood, such as cholestyramine, colestipol or colesevelam, and certain antacids which contain aluminium (e.g. indigestion relief products) may affect the absorption of cholic acid.
Printerblæk
Printing ink
Kolbam indeholder det aktive stof cholsyre.
Kolbam contains a substance called cholic acid.
Patienter med familiær hypertriglyceridæmi
Patients with familial hypertriglyceridaemia
Diarré vides at forekomme ved overdosering med cholsyre.
Diarrhoea is also known to occur in cases of excessive dosing with cholic acid.
Kolbam indeholder: Det aktive stof er cholsyre.
CONTENTS OF THE PACK AND OTHER INFORMATION What Kolbam contains - The active substance is cholic acid.
• gulfarvning af huden (ikterus)
• yellowing of the skin (jaundice)
Det kan overvejes at anvende cholsyre under amning, hvis lægen finder, at fordelene for patienten overstiger den mulige risiko.
Cholic acid can be used during breastfeeding if the doctor considers that the benefits to the patient outweigh the possible risk.
50 mg kapslerne er orange (sort aftryk "ASK001" og "50 mg").
The 50 mg capsules are orange (black imprint “ASK001” and “50mg”).
Heraf var 22 (42 %) behandlingsnaive, dvs. de fik deres første dosis cholsyre i undersøgelse CAC-002-01.
A total of 53 patients took part in the clinical study and received at least one dose of cholic acid; 22 (42%) were treatment naive, i.e., received their first dose of cholic acid during study CAC002-01.
Hvis du har taget for meget Kolbam
If you take more Kolbam than you should
<{DD måned ÅÅÅÅ}>
DD month YYYY
Tabellen indeholder desuden bivirkninger, der beskrives i litteraturen, og hvis hyppighed ikke er kendt:
The adverse reactions reported in the literature with an unknown frequency are also reported in the following table.
Kolbam anvendes til behandling af disse medfødte fejl i galdesyresyntesen.
Kolbam is used to treat these ‘inborn errors of bile acid synthesis'.
Titaniumdioxid (E171) Jernoxid, rød (E172)
Titanium dioxide (E171) Red iron oxide (E172)
MARKEDSFØRINGSTILLADELSESNUMMER) EU/1/13/895/001
MARKETING AUTHORISATION NUMBER EU/1/13/895/001
Til patienter med familiær hypertriglyceridæmi skal dosis af cholsyre fastlægges og om nødvendigt tilpasses, idet dosisforhøjelse kan være nødvendig for at undertrykke galdesyrer i urinen (se pkt.
The cholic acid dose for patients with familial hypertriglyceridaemia will have to be established and adjusted as necessary: an elevated dose may be required in order to suppress urinary bile acids (see section 4.4).
Patienter med nydiagnosticeret hypertriglyceridæmi eller med familiær hypertriglyceridæmi kan have nedsat cholsyreabsorption fra tarmen.
Patients with newly diagnosed, or a family history of, familial hypertriglyceridaemia may have poor absorption of cholic acid from the intestine.
• østrogen
• oestrogen,
- Hvis du får bivirkninger, skal du sige det til lægen eller på apoteket eller til sundhedspersonalet.
- If you get any side effects, talk to your doctor, pharmacist or nurse.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder 250 mg cholsyre.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg of cholic acid.
Hvis administration af ciclosporin anses for nødvendig, bør galdesyreindholdet overvåges tæt, og dosis af cholsyre justeres i henhold hertil.
If administration of ciclosporin is considered necessary, serum and urinary bile acid levels should be closely monitored and the cholic acid dose adjusted accordingly.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder 50 mg cholsyre.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of cholic acid.
Denne indlægsseddel blev senest revideret DDmÅÅÅÅ.
This leaflet was last revised in DDmonthYYYY.
Indehaver af markedsføringstilladelsen Retrophin Europe Limited Palmerston House, Fenian Street Dublin 2
Marketing Authorisation Holder Retrophin Europe Limited Palmerston House Fenian Street
Kolbam, 250 mg: Hver kapsel indeholder 250 mg cholsyre.
Kolbam 250 mg: Each capsule contains 250 mg of cholic acid.
Registret skal overvåge akkumulerende data om sikkerheden og virkningen til behandling af medfødte fejl i galdesyresyntesen hos spædbørn, børn, unge og voksne som følge af sterol 27-hydroxylase (manifesteret som cerebrotendinøs xanthomatose, CTX), 2- (eller α-) methylacyl-CoA racemase (AMACR) og kolesterol 7α-hydroxylase (CYP7A1) mangel.
The registry will monitor accumulating data on efficacy and safety in the treatment of inborn errors in primary bile acid synthesis in infants, children, adolescents and adults due to Sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis,
Eksogen cholsyre vil efter absorption indgå i kroppens pool af galdesyrer og gennemløbe en række cyklusser i det enterohepatiske kredsløb.
Once absorbed, exogenous cholic acid will enter into the body's bile acid pool and will undergo multiple cycles of enterohepatic circulation.
Kolbam, 50 mg: Hver kapsel indeholder 50 mg cholsyre.
Kolbam 50 mg: Each capsule contains 50 mg of cholic acid.
250 mg kapslerne er hvide (sort aftryk "ASK002" og "250 mg").
The 250 mg capsules are white (black imprint “ASK002” and “250mg”).
Propylenglycol (E1520) Salmiakspiritus (E527) Kaliumhydroxid (E525) Sort jernoxid (E172)
Propylene Glycol (E1520) Strong Ammonia Solution (E527) Potassium Hydroxide (E525) Black Iron Oxide (E172)
Ved familiær hypertriglyceridæmi skal dosis af cholsyre fastlægges og tilpasses efter behov (se pkt.
The cholic acid dose for patients with familial triglyceridaemia will have to be established and adjusted as necessary (see section 4.2).
Niveauet af galdesyrer i urinen var normalt hos alle patienter (100 %) ved baseline og ved dårligste vurderinger efter baseline, og hos de fleste patienter (88 %) ved den bedste vurdering efter baseline.
Urinary bile acids were normal for all patients (100%) at baseline and worst post-baseline assessments, and for most patients (88%) at the best post-baseline assessment; 1 patient (12%) had a slight elevation of urinary bile acids at best post-baseline assessment.
Undersøgelsen var åben og urandomiseret og havde én forsøgsarm.
The study was an open-label, single arm, non-randomized design.
• hudforandringer
• skin lesions
• let kvalme
Hepatic impairment
Pædiatrisk population cholsyre sikkerhed og virkning hos nyfødte børn (under 1 måned) er ikke klarlagt.
The safety and efficacy of cholic acid in neonates less than one month of age has not been established.
Hvis du er gravid, kan det overvejes at anvende cholsyre, hvis lægen finder, at fordelene for dig overstiger den mulige risiko.
The use of cholic acid may be considered during pregnancy if your doctor considers that the benefits to you outweigh any possible risk.
Kolbam, hårde kapsler, 50 mg Kolbam, hårde kapsler, 250 mg cholsyre
Kolbam 50 mg hard capsules Kolbam 250 mg hard capsules cholic acid
250 mg kapsel
250 mg Capsule shell Gelatin
Patienter med sygdomme med medfødte fejl i galdesyntesen kan ikke danne cholsyre og galde på normal måde.
Patients with certain types of conditions known as inborn errors of bile synthesis cannot produce cholic acid and bile normally, which leads to the production and build-up of abnormal substances that are potentially damaging to the liver.
250 mg kapsel: Kapselstørrelse 0 med hvid overdel og hvid underdel (sort aftryk "ASK002" og "250 mg").
250 mg capsule: Size number 0 capsule with a white cap (black imprint “ASK002”) and white body (black imprint “250mg”).
• halsbrand (ved tilbageløb fra mavesækken)
• heartburn (gastric reflux)
LÆGEMIDLETS NAVN Kolbam, hårde kapsler, 250 mg.
NAME OF THE MEDICINAL PRODUCT Kolbam 250 mg hard capsules.
Behandling med cholsyre medfører sædvanligvis kun lette til moderate bivirkninger hos både voksne og børn; nedenstående tabel angiver de vigtigste iagttagne bivirkninger.
Adverse reactions in patients (both adults and children) receiving cholic acid are generally mild to moderate in severity; the main reactions observed are given in the table below.
LÆGEMIDLETS NAVN Kolbam, hårde kapsler, 50 mg.
NAME OF THE MEDICINAL PRODUCT Kolbam 50 mg hard capsules.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 250 mg cholsyre
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 250 mg cholic acid
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 50 mg cholsyre
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 50 mg cholic acid
50 mg kapsel: Kapselstørrelse 2 med orange overdel og underdel (sort aftryk "ASK001" og "50 mg").
50 mg capsule: Size number 2 capsule with a Swedish orange cap (black imprint “ASK001”) and body (black imprint “50mg”).
Printerblæk - Shellac (E904) - Propylenglycol (E1520) - Salmiakspiritus (E527) - Kaliumhydroxid (E525) - Sort jernoxid (E172)
Printing ink Shellac (E904) Propylene Glycol (E1520) Strong Ammonia Solution (E527) Potassium Hydroxide (E525) Black Iron Oxide (E172) What Kolbam looks like and contents of the pack Kolbam is provided as hard capsules.
Ved klare tegn på svært leversvigt bør behandlingen seponeres tidligere.
Treatment should be stopped earlier if there are clear indicators of severe hepatic failure.
Cholsyre har sædvanligvis kun lette til moderate bivirkninger hos både voksne og børn, som det fremgår af følgende tabel, der bygger på de kliniske undersøgelser.
Based on clinical trial data, adverse reactions in patients (both adults and children) receiving cholic acid are generally mild to moderate in severity and are provided in the following table.
- Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
You should check with your doctor or pharmacist if you are unsure.
Hyppighed
Malaise
Kolbam, hårde kapsler, 50 mg cholsyre
NAME OF THE MEDICINAL PRODUCT Kolbam 50 mg hard capsules cholic acid
Kolbam, hårde kapsler, 250 mg cholsyre
NAME OF THE MEDICINAL PRODUCT Kolbam 250 mg hard capsules cholic acid
Dosering
Breastfeeding
Emballage Indhold Pakningsstør relse
Packaging Content (concentration)
Indgivelse svej
Route of administration
Denne dosis må ikke øges.
This dose should not be increased.
Dato for første markedsføringstilladelse: 4. marts 2011 Dato for seneste fornyelse: 19. november 2015
Date of first authorisation: 04 March 2011 Date of latest renewal: 19 November 2015
Prøv at tage medicinen på nogenlunde samme tidspunkt hver dag.
Try to take your daily dose at about the same time each day.
Ifirmacombi bør tages mindst en time før eller fire timer efter disse lægemidler.
Ifirmacombi should be taken at least one hour before or four hours after these medications;
Primær aldosteronisme:
Primary aldosteronism:
Ikke kendt: tinnitus
Not known: tinnitus
og 5.1).
and 5.1)
Se også information under overskriften ”Tag ikke Ifirmacombi”.
See also information under the heading “Do not take Ifirmacombi”.
Den maksimale blodtrykssænkende virkning nås 6-8 uger efter behandlingen er påbegyndt.
The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
Børn og unge Ifirmacombi må ikke gives til børn og unge (under 18 år).
Children and adolescents Ifirmacombi should not be given to children and adolescents (under 18 years).
Yderligere information om interaktioner med irbesartan:
Additional information on irbesartan interactions:
Nogle af bivirkningerne kan dog være alvorlige og kræve behandling.
Some of these effects may be serious and may require medical attention.
Selvom dette ikke er dokumenteret for Ifirmacombi, kan der forventes en lignende virkning.
While this is not documented with Ifirmacombi, a similar effect should be anticipated.
Efter enten oral eller intravenøs administration af
After either oral or intravenous administration of
Du kan tage Ifirmacombi med eller uden mad.
You can take Ifirmacombi with or without food.
Non-steroide antiinflammatoriske lægemidler:
Non-steroidal anti-inflammatory drugs:
Det er vigtigt, at du fortsætter med at tage Ifirmacombi, indtil lægen siger, du kan stoppe.
It is important that you continue to take Ifirmacombi until your doctor tells you otherwise.
Chloridmangel er generelt beskeden og kræver normalt ingen behandling.
Chloride deficit is generally mild and usually does not require treatment.
Ikke kendt: feber
Not known: fever
I langvarige opfølgningsstudier blev virkningen af irbesartan/hydrochlorthiazid opretholdt i mere end 1 år.
In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained for over one year.
Hvis det er klinisk hensigtsmæssigt, kan direkte skift fra monoterapi til de faste kombinationer overvejes:
When clinically appropriate direct change from monotherapy to the fixed combinations may be considered:
Ikke kendt: postural hypotension
Not known: postural hypotension
Brug af Ifirmacombi sammen med mad, drikke og alkohol Ifirmacombi kan tages med eller uden mad.
Ifirmacombi with food, drink and alcohol Ifirmacombi can be taken with or without food.
De almindelige tegn og symptomer på overdosering er kvalme og døsighed.
The most common signs and symptoms of overdose are nausea and somnolence.
Ifirmacombi frarådes til behandling af børn og unge, da sikkerhed og virkning ikke er klarlagt.
Ifirmacombi is not recommended for use in children and adolescents because the safety and efficacy have not been established.
Se punkt 2 ”Ifirmacombi indeholder natrium”.
See section 2 "Ifirmacombi contains sodium".
Det primære formål med forsøget var at sammenligne andelen af patienter, hvis SeDBT var kontrolleret (SeDBT < 90 mmHg) efter 5 ugers behandling.
The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
Irbesartans plasma-proteinbinding er ca. 96%, med en ubetydelig binding til cellulære blodkomponenter.
Plasma protein binding of irbesartan is approximately 96%, with negligible binding to cellular blood components.
Hvis Ifirmacombi anvendes i ammeperioden, bør dosis være så lav som muligt.
If Ifirmacombi is used during breast feeding, doses should be kept as low as possible.
Hyppigheden af bivirkninger anført nedenfor defineres i henhold til følgende konventioner: 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) ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
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) - Not known (cannot be estimated from the available data)
Metabolisk og endokrin virkning:
Metabolic and endocrine effects: