natgillin/translations-raw huggingface dataset:
Der er utilstrækkelig erfaring i brugen af topotecan til patienter med stærkt nedsat leverfunktion (serum- bilirubin ≥10 mg/ dl).
There is insufficient experience of the use of topotecan in patients with severely impaired hepatic function (serum bilirubin ≥ 10 mg/ dl).
Topotecan er ikke rekommanderet til anvendelse i disse patientgrupper.
Topotecan is not recommended to be used in these patients.
Diaré inkl. alvorlig diaré, der kræver hospitalsindlæggelse, er set ved behandling med oral topotecan.
Diarrhoea, including severe diarrhoea requiring hospitalization, has been reported during treatment with oral topotecan.
Diaré, der relateres til oral topotecan, kan forekomme på samme tid som lægemiddel- relateret neutropeni og dets følger.
Diarrhoea related to oral topotecan can occur at the same time as drug-related neutropenia and its sequelae.
Kommunikation med patienterne vedrørende disse bivirkninger og om proaktiv behandling af tidlige, samt alle tegn og symptomer på diaré er vigtig før administration af lægemidlet.
Communication with patients prior to drug administration regarding these side effects and proactive management of early and all signs and symptoms of diarrhoea is important.
Diaré pga. cancerbehandling forbindes med signifikant mobiditet og kan være livstruende.
Cancer treatment-induced diarrhoea (CTID) is associated with significant morbidity and may be life-threatening.
I tilfælde af diaré efter behandling med oral topotecan, anbefales det at lægerne behandler diaréen aggressivt.
Should diarrhoea occur during treatment with oral topotecan, physicians are advised to aggressively manage diarrhoea.
Kliniske vejledninger af aggressiv behandling af diaré pga. cancerbehandling omfatter særlige rekommandationer om patientkommunikation, opmærksomhed og erkendelse af de tidlige tegn, anvendelse af midler mod diaré og antibiotika, ændringer i væskeindtag og diæt samt behov for hospitalsindlæggelse.
Clinical guidelines describing the aggressive management of CTID includes specific recommendations on patient communication and awareness, recognition of early warning signs, use of anti-diarrhoeals and antibiotics, changes in fluid intake and diet, and need for hospitalization.
Intravenøs topotecan skal overvejes i følgende kliniske situationer: ukontrolleret emesis, synke - forstyrrelser, ukontrolleret diaré, kliniske tilstande og medicinering, som kan ændre den gastro - intestinale motilitet og lægemiddelabsorption.
Intravenous topotecan should be considered in the following clinical situations: uncontrolled emesis, swallowing disorders, uncontrolled diarrhoea, clinical conditions and medication that may alter gastrointestinal motility and drug absorption.
5. 2).
Topotecan does not inhibit human P450 enzymes (see section 5.2).
I et intravenøst populationsforsøg på - vistes ved samtidig administration af granisetron, ondansetron, morfin eller kortikosteroider ingen signifikant påvirkning af farmakokinetikken af total topotecan (aktiv eller inaktiv form).
In an intravenous population study, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
Topotecan er et substrat for både ABCB1 (P- glycoprotein) og ABCG2 (BCRP).
Topotecan is a substrate for both ABCB1 (P-glycoprotein) and ABCG2 (BCRP).
Det er påvist, at hæm - mere af ABCB1 og ABCG2 givet sammen med oral topotecan øger eksponeringen af topotecan.
Inhibitors of ABCB1 and ABCG2 administered with oral topotecan have been shown to increase topotecan exposure.
2 til 2, 5 gange kontrolgruppen.
Cyclosporin A (an inhibitor of ABCB1, ABCC1 [MRP-1], and CYP3A4) administered with oral topotecan increased topotecan AUC to approximately 2 - 2.5-fold of control.
5. 2).
Patients should be carefully monitored for adverse reactions when oral topotecan is administered with a drug known to inhibit ABCB1 or ABCG2 (see section 5.2).
28 topotecan- doseringen.
In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal 28 product may be required to improve tolerability.
Som for andre cytostatika kan topotecan forårsage fosterskader, hvorfor kvinder i den fødedygtige alder bør rådes til at undgå graviditet, mens de er i behandling med topotecan.
As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of child bearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Topotecan er dog som andre cytostatika genotoksisk, og påvirkning af fertili - teten, inkl. den mandlige fertilitet, kan ikke udelukkes.
However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Der var ingen tegn på kumulativ hæmatologisk eller non- hæmatologisk toksicitet.
There were no signs of cumulative haematological or non-haematological toxicity.
De nævnte hyppigheder for hæmatologiske og non- hæmatologiske bivirkninger er for de bivirkninger, der anses for at have en sammenhæng eller en mulig sammenhæng med behandling med oral topotecan.
29 The frequencies associated with the haematological and non-haematological adverse events presented are for adverse events considered to be related/ possibly related to oral topotecan therapy.
Bivirkningerne er nævnt herunder opdelt efter systemorganklasse og absolut hyppighed.
Adverse reactions are listed below, by system organ class and absolute frequency.
Hyppigheden defineres som: 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) inkl. enkeltstående tilfælde og ikke kendt (kan ikke beregnes ud fra tilgængelige data).
Frequencies are defined as: 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), including isolated reports and not known (cannot be estimated from the available data).
29 Blod og lymfesystem Meget almindelig: febril neutropeni, neutropeni (se mave/ tarm- kanalen), trombocytopeni, anæmi, leukopeni Almindelig: pancytopeni
Common: pancytopenia
4. 4)
Nausea, vomiting and diarrhoea (all of which may be severe), Common: abdominal pain*, constipation, stomatitis, dyspepsia *Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Hud og subkutane væv Meget almindelig: alopeci Almindelig: pruritus
Common: pruritis
Metabolisme og ernæring Meget almindelig: anoreksi (muligvis alvorlig)
Metabolism and nutrition disorders Very common: anorexia (which may be severe).
Almene symptomer og reaktioner på administrationsstedet Meget almindelig: træthed Almindelig: asteni, pyreksi, utilpashed
Common: asthenia, pyrexia, malaise.
Immunsystemet Almindelig: overfølsomhedsreaktion inkl. udslæt Ikke kendt: anafylaktisk reaktion, angioødem, urticaria
Immune system disorders Common: hypersensitivity reaction including rash Not known: anaphylactic reaction, angioedema, urticaria.
Lever og galdeveje Ikke almindelig: hyperbilirubinæmi
Hepato-biliary disorders Uncommon: hyperbilirubinaemia.
Sikkerhedsdata præsenteres ud fra et integreret datagrundlag med 682 patienter med recidiverende lungecancer, som havde fået 2. 536 behandlingsperioder med oral topotecan monoterapi (275 patienter med recidiverende SCLC og 407 med recidiverende non- SCLC).
Safety data are presented based on an integrated data set of 682 patients with relapsed lung cancer administered 2536 courses of oral topotecan monotherapy (275 patients with relapsed SCLC and 407 with relapsed non-SCLC).
Hæmatologi Neutropeni:
30 Haematological Neutropenia:
Alvorlig neutropeni (grad 4 - neutrofiltal < 0, 5 x 109/ l) sås hos 32% af patienterne i 13% af behandlingsperioderne.
Severe neutropenia (Grade 4 - neutrophil count < 0.5 x 109/ l) occurred in 32% of patients in 13% of courses.
I 34% af behandlingsperioderne med alvorlig neutropeni var varigheden > 7 dage.
In 34% of courses with severe neutropenia, the duration was > 7 days.
Under behandlingsperiode 1 var forekomsten 20%, under behandlingsperiode 4 var forekomsten 8%.
In course 1 the incidence was 20%, by courses 4 the incidence was 8%.
17%, 2% og 4% af patienterne.
Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
Dødsfald pga. sepsis sås hos 1% af patienterne.
Death due to sepsis occurred in 1% of patients.
Der er rapporter om pancytopeni.
Pancytopenia has been reported.
4. 4).
Growth factors were administered to 19% of patients in 8% of courses.
Alvorlig trombocytopeni (grad 4 - trombocyttal mindre end 10 x 109/ l) sås hos 6% af patienterne i 2% af behandlingsperioderne.
Severe thrombocytopenia (Grade 4 - platelets less than 10 x 109/ l) occurred in 6% of patients in 2% of courses.
Mediantiden til indtræden af alvorlig trombocytopeni var dag 15 med en medianvarighed på 2, 5 dage.
Median time to onset of severe thrombocytopenia was Day 15 with a median duration of 2.5 days.
Under 18% af behandlingsperioderne med alvorlig trombocytopeni var varigheden > 7 dage.
In 18% of courses with severe thrombocytopenia the duration was > 7 days.
30 og 50, 0 x 109/ l) sås hos 29% af patienterne i 14% af behandlingsperioderne.
Moderate thrombocytopenia (Grade 3 - platelets between 10.0 and 50.0 x 109/ l) occurred in 29% of patients in 14% of courses.
Der blev givet trombocyttransfusioner til 10% af patienterne i 4% af behandlingsperioderne.
Platelet transfusions were given to 10% of patients in 4% of courses.
Der er kun sjældne rapporter om signifikante følger af trombocytopeni inkl. fatal tumorblødning.
Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Moderat til alvorlig anæmi (grad 3 og 4 - Hb ≤ 8, 0 g/ dl) sås hos 25% af patienterne (12% af behandlingsperioderne).
Moderate to severe anaemia (Grade 3 and 4 – Hb ≤ 8.0 g/ dl) occurred in 25% of patients (12% of courses).
I 46% af behandlingsperioderne med moderat til alvorlig anæmi var varigheden > 7 dage.
In 46% of courses with moderate to severe anaemia, the duration was > 7 days.
Der blev givet transfusioner af røde blodlegemer til 30% af patienterne (13% af behandlingsperioderne).
Red blood cell transfusions were given in 30% of patients (13% of courses).
Erytropoietin blev givet til 10% af patienterne i 8% af behandlingsperioderne.
Erythropoietin was administered to 10% of patients in 8% of courses.
Non- hæmatologisk De mest almindeligt rapporterede ikke- hæmatologiske virkninger, uanset deres årsagssammenhæng, var kvalme (37%), diaré (29%), træthed (26%), opkastning (24%), alopecia (21%) og anoreksi (18%).
All cases were irrespective of associated causality.
4. 4), træthed 4%, opkastning 3%, kvalme 3% og anoreksi 2%.
For severe cases (CTC grade 3/ 4) reported as related / possibly related to topotecan administration the incidence was diarrhoea 5% (see section 4.4), fatigue 4%, vomiting 3%, nausea 3% and anorexia 2%.
4% af grad 3 og 0, 4% af grad 4.
The overall incidence of drug-related diarrhoea was 22%, including 4% with Grade 3 and 0.4% with Grade 4.
Lægemiddelrelateret diaré var hyppigere hos patienter ≥ 65 år (28%) sammenlignet med dem, der var yngre end 65 år (19%).
Drug-related diarrhoea was more frequent in patients ≥ 65 years of age (28%) compared to those less than 65 years of age (19%).
Total alopecia relateret/ muligvis relateret til administration af topotecan sås hos 9% af patienterne, og udtalt alopecia relateret/ muligvis relateret til administration af topotecan sås hos 11% af patienterne.
Complete alopecia related/ possibly related to topotecan administration was observed in 9% of patients and partial alopecia related/ possibly related to topotecan administration in 11% of patients.
Terapeutiske interventioner forbundet med non- hæmatologiske virkninger omfattede antiemetika, som blev givet til 47% af patienterne i 38% af behandlingsperioderne og midler mod diaré, som blev givet til 15% af patienterne i 6% af behandlingsperioderne.
Therapeutic interventions associated with non-haematological effects included anti-emetic agents, given to 47% of patients in 38% of courses and anti-diarrhoeal agents, given to 15% of patients in 6% of courses.
En 5- HT3- antagonist blev givet til 30% af patienterne i 24% af behandlingsperioderne.
A 5-HT3 antagonist was administered to 30% of patients in 24% of courses.
Loperamid blev givet til 13% af patienterne i 5% af behandlingsperioderne.
Loperamide was administered to 13% of patients in 5% of courses.
Mediantiden til indtræden af diaré af grad 2 eller værre var 9 dage.
The median time to onset of grade 2 or worse diarrhoea was 9 days.
Der er ingen kendt antidot mod overdosering med topotecan.
There is no known antidote for topotecan overdose.
De primære komplikationer forbundet med overdosis forventes at være knoglemarvssuppression og mucositis.
The primary complications of overdose are anticipated to be bone marrow suppression and mucositis.
Anti- tumor aktiviteten af topotecan involverer hæmning af topoisomerase- I, et enzym tæt involveret i DNA replikation, da den eliminerer den torsionale belastning, der opstår foran den bevægelige repli - kationsgaffel.
31 The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
Topotecan hæmmer topoisomerase- I ved at stabilisere det kovalente kompleks af enzym og strengkløvet DNA, som er et intermediært produkt af den katalytiske mekanisme.
Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Den cellulære følge af den af topotecan forårsagede hæmning af topoisomerase- I er fremkaldelse af proteinassocierede enkeltstrengsbrud på DNA.
The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks.
Recidiverende SCLC I et fase III- forsøg (forsøg 478) blev oral topotecan plus Best Supportive Care [BSC] [n = 71] sam - menlignet med BSC alene [n = 70] hos patienter, som havde tilbagefald efter førstebehandling [mediantid til progression [TTP] fra førstebehandling:
Relapsed SCLC A phase III trial (study 478) compared oral topotecan plus Best Supportive Care [BSC] [n=71] with BSC alone [n=70] in patients who had relapsed following first line therapy [median time to progression [TTP] from first-line therapy:
84 dage for oral topotecan + BSC, 90 dage for BSC, og for hvem gentagelse af behandling med i. v. kemoterapi ikke var hensigtsmæssig.
84 days for oral topotecan + BSC, 90 days for BSC] and for whom retreatment with intravenous chemotherapy was not considered appropriate.
Oral topotecan plus BSC- gruppen oplevede en statistisk signifikant forbedring i samlet overlevelse sam - menlignet med gruppen med BSC alene (log- rank p = 0, 0104).
Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p=0.0104).
31 oral topotecan plus BSC- gruppen i forhold til gruppen med BSC alene var 0, 64 (95% CI:
The unadjusted hazard ratio for oral topotecan plus BSC group relative to BSC alone group was 0.64 (95% CI:
Medianoverlevelsen for patienter behandlet med topotecan + BSC var 25, 9 uger [95% CI:
The median survival for patients treated with topotecan + BSC was 25.9 weeks [95% C. I.
18, 3; 31, 6] sammenlignet med 13, 9 uger [95% CI:
18.3, 31.6] compared to 13.9 weeks [95% C. I.
11, 1; 18, 6] for patienter, der modtog BSC alene.
11.1, 18.6] for patients receiving BSC alone.
I patienternes egne rapporteringer vha. en ublindet vurdering på en symptomskala i begge forsøg, var oral og i. v. topotecan forbundet med samme symptomlindring hos patienter med recidiverende, sensitiv SCLC.
One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy. (see Table 1) Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient self- reports on an unblinded symptom scale assessment in each of these two studies.
Oversigt over overlevelse, responsrate og tiden indtil progression hos SCLC- patienter, der er behandlet med oral HYCANTIN eller intravenøs HYCAMTIN
Summary of survival, response rate, and time to progression in SCLC patients treated with oral HYCAMTIN or intravenous HYCAMTIN
Intravenøs Oral topotecan topotecan
Intravenous Oral topotecan
(N = 54) (N = 153)
(N = 54) (N
32, 3
25.1
25, 1 33, 0
33.0
Risikoforhold (95% CI)
Hazard ratio (95% CI)
Forskel i responsrate (95% CI)
Difference in response rate (95% CI)
Mediantid indtil progresion (uger)
Median time to progression (weeks)
Pædiatriske patienter Sikkerhed og effektivitet af oral topotecan er ikke fastlagt for pædiatriske patienter.
32 Paediatrics Safety and effectiveness of oral topotecan in paediatric patients have not been established.
Farmakokinetikken af topotecan ved oral administration er vurderet hos cancerpatienter efter administration af 1, 2 - 3, 1 mg/ m2/ dag og 4 mg/ m2/ dag dagligt i 5 dage.
The pharmacokinetics of topotecan after oral administration have been evaluated in cancer patients following doses of 1.2 to 3.1 mg/ m2/ day and 4 mg/ m2/ day administered daily for 5 days.
40%.
The bioavailability of oral topotecan (total and lactone) in humans is approximately 40%.
2, 0 timer og 1, 5 timer og falder bieksponentielt med en middelterminal halveringstid på ca.
Plasma concentrations of total topotecan (i. e. lactone and carboxylate forms) and topotecan lactone (active moiety) peak at approximately 2.0 hours and 1.5 hours, respectively, and decline bi-exponentially with mean terminal half-life of approximately 3.0 to 6.0 hour.
Der er ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering, og der er ingen tegn på ændring i farmakokinetikken efter multiple doser.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Prækliniske forsøg tyder på, at topotecans plasmaproteinbinding er lav (35%) og fordelingen mellem blodceller og plasma er omtrent homogen.
Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
En vigtig elimineringsvej for topotecan er hydrolyse af laktonringen, så der dannes ringåbnet carboxylat.
A major route of clearance of topotecan is by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Ud over hydrolyse elimineres topotecan overvejende renalt som en mindre komponent, der metaboliseres til N- desmetylmetabolit (SB- 209780) og er fundet i plasma, urin og fæces.
Other than hydrolysis, topotecan is cleared predominantly renally, with a minor component metabolized to the N-desmethyl metabolite (SB-209780) identified in plasma, urine and faeces.
Overordnet genfinding af topotecan- relateret materiale efter fem daglige topotecandoser var 41- 76% (middel 57%) af den indgivne orale dosis.
Overall recovery of topotecan-related material following five daily doses of topotecan was 41 to 76% (mean 57%) of the administered oral dose.
20% blev udskilt som uomdannet topotecan og 2% blev udskilt som N- desmetyltopotecan i urinen.
Approximately 20% was excreted as total topotecan and 2% was excreted as N-desmethyl topotecan in the urine.
Fæcal eliminering af uomdannet topotecan udgjorde 33%, mens
Faecal elimination of total topotecan accounted for 33% while faecal elimination of N-desmethyl topotecan was 1.5%.
Samlet set bidrog N- desmetylmetabolitten i gennemsnit mindre end 6% (interval 4 – 8%) til det lægemiddelstofrelatteret materiale i urin og fæces, som der kunne redegøres for.
Overall, the N-desmethyl metabolite contributed a mean of less than 6% (range 4-8%) of the total topotecan related material accounted for in the urine and faeces.
O- glucuronider af både topotecan og N- desmetyltopotecan er fundet i urinen.
O-glucuronides of both topotecan and N- desmethyl topotecan have been identified in the urine.
Middelmetabolit: det oprindelige plasma- AUC- forhold var mindre end 10% for både totalt topotecan og topotecanlaktone.
The mean metabolite: parent plasma AUC ratio was less than 10% for both total topotecan and topotecan lactone.
In vitro hæmmede topotecan hverken de menneskelige P450- enzymer CYP1A2, CYP2A6, CYP2C8/ 9, CYP2C19, CYP2D6, CYP2E, CYP3A eller CYP4A eller de menneskelige cytosoliske enzymer dihy - dropyrimidin eller xanthinoxidase.
In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/ 9, CYP2C19, CYP2D6, CYP2E, CYP3A, or CYP4A nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
4. 5).
Following coadministration of the ABCB1 (P-gp) and ABCG2 (BCRP) inhibitor, elacridar (GF120918) at 100 to 1,000 mg with oral topotecan, the AUC0- ∞ of topotecan lactone and total topotecan increased approximately 2.5-fold (see section 4.5 for guidance).
4. 5).
Administration of oral cyclosporine A (15 mg/ kg), an inhibitor of transporters ABCB1 (P-gp) and ABCC1 (MRP-1) as well as the metabolising enzyme CYP3A4, within 4 hours of oral topotecan increased the dose normalised AUC0-24h of topotecan lactone and total topotecan approximately 2.0- and 2.5-fold, respectively (see section 4.5).
Omfanget af eksponering var den samme efter et måltid med højt fedtindhold og faste, mens tmax blev øget fra 1, 5 til 3 timer (topotecanlaktone) og fra 3 til 4 timer (totalt topotecan).
The extent of exposure was similar following a high fat meal and fasted state while tmax was delayed from 1.5 to 3 hours (topotecan lactone) and from 3 to 4 hours (total topotecan).
4. 2 og 4. 4).
The pharmacokinetics of oral topotecan has not been studied in patients with renal or hepatic impairment (see section 4.2 and 4.4).
En krydsanalyse med 217 patienter med fremskredne solide tumorer tyder på, at kønsforskelle ikke påvirkede farmakokinetikken af HYCAMTIN kapsler i et klinisk relevant omfang.
A cross-study analysis in 217 patients with advanced solid tumours indicated that gender did not affect the pharmacokinetics of HYCAMTIN capsules to a clinically relevant extent.
Der er utilstrækkelige data til at kunne afgøre om farmakokinetikken for forskellige racer påvirkes ved oral topotecan.
There are insufficient data to determine an effect of race on pharmacokinetics of oral topotecan.
Topotecan har også vist sig at forårsage embryo - og fosterdødelighed, når det gives til rotter og kaniner.
Topotecan was also 33 shown to cause embryo-foetal lethality when given to rats and rabbits.
Karcinogeniciteten ved topotecan er ikke undersøgt.
The carcinogenic potential of topotecan has not been studied.
Indhold i kapslen:
Capsule contents:
Hydrogeneret vegetabilsk olie Glycerolmonostearat
Hydrogenated vegetable oil Glyceryl monostearate
Gelatine Titandioxid (E171)
Gelatin Titanium dioxide (E171)
Sort jernoxid (E172) Shellak Ethanol, vandfri – For yderligere information se indlægssedlen Propylenglykol Isopropylalkohol Butanol Ammoniakopløsning, koncentreret Kaliumhydroxid
Black ink comprising: black iron oxide (E172) shellac anhydrous ethanol – see leaflet for further information propylene glycol isopropyl alcohol butanol concentrated ammonia solution potassium hydroxide
Opbevares i køleskab (2 °C – 8 °C)
Store in a refrigerator (2ºC - 8ºC).
Hvid polyvinylchlorid / polychlorotrifluoroethylen- blisterkort forseglet med en aluminiumsfolie.
White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding.
Et blisterkort indeholder 10 kapsler.
34 Each blister card contains 10 capsules.
12/ 11/ 1996 Dato for seneste fornyelse:
12/ 11/ 1996 Date of latest renewal: