natgillin/translations-raw huggingface dataset:
Resolors virkning blev påvist i tre randomiserede, dobbeltblindede, placebokontrollerede multicenterstudier af 12 ugers varighed hos studiepersoner med kronisk obstipation (n = 1.279 på Resolor; 1.124 kvinder og 155 mænd). 
The efficacy of Resolor was established in three multicentre, randomised, double-blind, 12-week placebo-controlled studies in subjects with chronic constipation (n=1,279 on Resolor, 1,124 females, 155 males).
Forekomsten af patienter med mindst 1 bivirkning, der var opstået som følge af behandlingen (treatment-emergent adverse event, TEAE), var ens i Resolor-gruppen (69,8 %) og placebogruppen (60,7 %). 
The incidence of subjects with at least 1 treatment-emergent adverse event (TEAE) was similar between the Resolor treatment group (69.8%) and the placebo treatment group (60.7%).
Sammenlignet med studiepersoner med normal nyrefunktion var plasmakoncentrationerne af prucaloprid efter en enkelt 2 mg-dosis i gennemsnit henholdsvis 25 % og 51 % højere hos studiepersoner med let nedsat (ClCR 50-79 ml/min) og moderat nedsat (ClCR 25-49 ml/min) nyrefunktion. 
Compared to subjects with normal renal function, plasma concentrations of prucalopride after a single 2 mg dose were on average 25% and 51% higher in subjects with mild (ClCR 50-79 ml/min) and moderate (ClCR 25-49 ml/min) renal impairment, respectively.
Resolor indeholder: 
What Resolor contains
Hos hunde ændrer prucaloprid tarmmotilitetsmønstrene via stimulering af 5-HT4-receptoren: Det stimulerer proksimal tarmmotilitet, forstærker gastroduodenal motilitet og accelererer forsinket gastrisk tømning. 
In dogs, prucalopride alters colonic motility patterns via serotonin 5-HT4 receptor stimulation: it stimulates proximal colonic motility, enhances gastroduodenal motility and accelerates delayed gastric emptying.
- hvis du er i dialyse - hvis du lider af perforation eller tillukning af tarmvæggen eller svær betændelse i tarmkanalen såsom Crohns sygdom, ulcerøs colitis (sårdannelse og betændelse i tyktarmen) eller toksisk megakolon/megarektum (kraftig udvidelse af tyktarmen/endetarmen). 
- if you are on renal dialysis, - if you suffer from perforation or obstruction of the gut wall, severe inflammation of the intestinal tract, such as Crohn's disease, ulcerative colitis or toxic megacolon/megarectum.
Patienter med nedsat nyrefunktion: Til patienter med svært nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2) er dosis 1 mg én gang dagligt (se pkt. 
Patients with renal impairment: The dose for patients with severe renal impairment (GFR <30 ml/min/1.73 m2) is 1 mg once daily (see sections 4.3 and 5.2).
Hvis du er over 65 år, eller hvis du har en alvorlig leversygdom, er startdosis én 1 mg-tablet én gang dagligt. 
If you are older than 65 years or have severe liver disease, the starting dose is one 1 mg tablet once a day, which your doctor may increase to 2 mg once a day if needed.
Efter første behandlingsdag blev de hyppigste bivirkninger rapporteret med samme hyppighed for både Resolor og placebo (højst 1 % forskel mellem prucaloprid og placebo i incidens), bortset fra kvalme og diarré, der stadig optrådte hyppigere under Resolor-behandling, men mindre udtalt (forskellene i incidens mellem Resolor og placebo var på henholdsvis 1,3 % (kvalme) og 3,4 % diarré)). 
After the first day of treatment, the most common adverse reactions were reported in similar frequencies (incidence no more than 1% different between prucalopride and placebo) during Resolor therapy as during placebo, with the exception of nausea and diarrhoea that still occurred more frequently during Resolor therapy, but less pronounced (differences in incidence between Resolor and placebo of 1.3% and 3.4%, respectively).
Ved doser over 5 mg/kg in vivo hos rotter (svarende til 30-70 gange højere eller mere end den kliniske eksponering) inducerede prucaloprid hyperprolaktinæmi som følge af en antagonistisk handling ved D2-receptoren. 
In rats, prucalopride in vivo, at doses above 5 mg/kg (at and above 30-70 times the clinical exposure), induced hyperprolactinaemia caused by an antagonistic action at the D2 receptor.
Studiets primære endepunkt blev opfyldt: En statistisk signifikant højere andel af patienterne i Resolor-gruppen (37,9 %) havde gennemsnitligt ≥ 3 SCBM'er/uge sammenholdt med patienterne i placebo-gruppen (17,7 %) (p < 0,0001) i den dobbeltblindede behandlingsperiode på 12 uger. 
The primary endpoint of the study was met: a statistically significantly higher percentage of subjects in the Resolor group (37.9%) had an average of ≥3 SCBMs/week compared with subjects in the placebo treatment group (17.7%) (p<0.0001) over the 12-week double-blind treatment period.
Ved behandling én gang dagligt med 2 mg prucaloprid fluktuerede steady state-plasmakoncentrationerne mellem 2,5 ng/ml og 7 ng/ml som henholdsvis laveste og højeste værdi. 
On once daily treatment with 2 mg prucalopride, steady-state plasma concentrations fluctuate between trough and peak values of 2.5 and 7 ng/ml, respectively.
Palpitationer blev rapporteret hos 0,7 % af de placebo-behandlede patienter, hos 0,9 % af de patienter, der blev behandlet med 1 mg prucaloprid, hos 0,9 % af de patienter, der blev behandlet med 2 mg prucaloprid, og hos 1,9 % af de patienter, der blev behandlet med 4 mg prucaloprid. 
Palpitations were reported in 0.7% of the placebo patients, 0.9% of the 1 mg prucalopride patients, 0.9% of the 2 mg prucalopride patients and 1.9% of the 4 mg prucalopride patients.
Undtagelsen herfra var en beskeden stigning i hjerterytme og blodtryk observeret hos bedøvede svin efter intravenøs administration og en stigning i blodtryk hos hunde ved bevidsthed efter intravenøs administration af en bolus-dosis, hvilket ikke sås hverken hos bedøvede hunde eller efter oral administration hos hunde, der nåede lignende plasmaniveauer. 
An extended series of safety pharmacology studies with special emphasis on cardiovascular parameters showed no relevant changes in haemodynamic and ECG derived parameters (QTc) with the exception of a modest increase in heart rate and blood pressure observed in anaesthetised pigs after intravenous administration, and an increase in blood pressure in conscious dogs after bolus intravenous administration, which was not observed either in anaesthetised dogs or after oral administration in dogs reaching similar plasma levels.
Patienter med nedsat leverfunktion: Patienter med svært nedsat leverfunktion (Child-Pugh klasse C) skal starte med 1 mg én gang dagligt, som om nødvendigt kan øges til 2 mg for at forbedre virkningen, hvis 1 mg dosis er veltolereret (se pkt. 
Patients with hepatic impairment: Patients with severe hepatic impairment (Child-Pugh class C) start with 1 mg once daily which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated (see sections 4.4 and 5.2).
Resolor er indiceret til symptomatisk behandling af kronisk obstipation hos voksne, der ikke opnår tilstrækkelig lindring med laksantia. 
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Efter dosering med 1 mg én gang dagligt var maksimumplasmakoncentrationen af og AUC for prucaloprid 26 % til 28 % højere hos ældre personer end hos unge voksne. 
After once daily dosing of 1 mg, peak plasma concentrations and AUC of prucalopride in older people were 26% to 28% higher than in young adults.
Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion. 
No dose adjustment is required for patients with mild to moderate renal impairment.
Følgende meget almindelige bivirkninger er blevet indberettet (kan forekomme hos flere end 1 ud af 10 personer): hovedpine, kvalme, diarré og mavesmerter. 
The following side effects have been reported very commonly (may affect more than 1 in 10 people): headache, feeling sick, diarrhoea and abdominal pain.
Resolors virkning og sikkerhed hos pædiatriske patienter (i alderen 6 måneder til 18 år) med funktionel obstipation blev undersøgt i et 8 ugers, dobbeltblindt, placebokontrolleret studie (N = 213) efterfulgt af et 16-ugers åbent komparatorkontrolleret (polyethylenglycol 4000) studie på op til 24 uger (N = 197). 
The efficacy and safety of Resolor in paediatric patients (aged 6 months to 18 years) with functional constipation, were evaluated in an 8-week double-blind, placebo-controlled trial (N=213), followed by a 16 week open-label comparator-controlled (Polyethylene glycol 4000) study of up to 24 weeks (N=197).
Ydermere inducerer prucaloprid kæmpestore migrerende kontraktioner. 
Furthermore, giant migrating contractions are induced by prucalopride.
Aluminium/aluminium perforerede enkeltdosisblistere (kalendermærket) indeholdende 7 tabletter. 
Aluminium/aluminium perforated unit dose blisters (calendar marked) containing 7 tablets.
Den væsentligste elimination af prucaloprid sker ikke ved metabolisme. 
Metabolism is not the major route of elimination of prucalopride.
Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig. 
Other medicines and Resolor Tell your doctor if you are taking, or have recently taken, or might take any other medicines.
De hyppigst rapporterede bivirkninger ved behandling med 2 mg Resolor var hovedpine (17,8 %) og symptomer i mave-tarm-kanalen (abdominale smerter (13,7 %), kvalme (13,7 %) og diarré (12,0 %)). 
The most frequently reported adverse reactions associated with Resolor 2 mg therapy are headache (17.8%) and gastrointestinal symptoms (abdominal pain (13.7%), nausea (13.7%) and diarrhoea (12.0%)).
Hos studiepersoner med svært nedsat nyrefunktion (ClCR ≤ 24 ml/min) var plasmakoncentrationerne 2,3 gange niveauet hos raske studiepersoner (se pkt. 
In subjects with severe renal impairment (ClCR ≤24 ml/min), plasma concentrations were 2.3 times the levels in healthy subjects (see section 4.2 and 4.4).
Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 156,75 mg lactose (som monohydrat). 
Excipients with known effect: Each film-coated tablet contains 156.75 mg lactose (as monohydrate).
Ved uge 4 var andelen af patienter med en forbedring på ≥1 vs. baseline i delskalaerne for Patient Assessment of Constipation-Quality of Life-tilfredshed (PACQOL) 47,7 % hos patienter i behandling med 2 mg Resolor, sammenlignet med 20,2 % hos patienter på placebo. 
At Week 4, the proportion of patients with an improvement of ≥1 versus baseline in the Patient Assessment of Constipation-Quality of Life satisfaction subscale (PAC-QOL) was 47.7% in patients treated with Resolor 2 mg compared with 20.2% in patients on placebo.
Lactosemonohydrat Mikrokrystallinsk cellulose Kolloid silica 
Lactose monohydrate Microcrystalline cellulose Colloidal silicon dioxide Magnesium stearate
Følgende ikke almindelige bivirkninger er også set (kan forekomme hos op til 1 ud af 100 personer): rystelser, hjertebanken, blødning fra endetarmen, hyppig vandladning (pollakisuri), feber og utilpashed. 
The following uncommon side effects have also been seen (may affect up to 1 in 100 people): tremors, pounding heart, rectal bleeding, increase in frequency of passing urine (pollakiuria), fever and feeling unwell.
Prucaloprid én gang dagligt har under forlænget behandling udvist tidsuafhængig kinetik. 
Prucalopride o.d. displays time-independent kinetics during prolonged treatment.
Tabletovertræk: Hypromellose Lactosemonohydrat Triacetin 
Tablet coating Hypromellose Lactose monohydrate Triacetin
2 mg-tabletten indeholder også rødt jernoxid (E 172), gult jernoxid (E 172) og indigocarmin aluminium lake (E132). 
The 2 mg tablet also contains iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Derudover blev Resolors virkning, sikkerhed og tolerabilitet hos mandlige patienter med kronisk obstipation vurderet i et randomiseret, dobbeltblindet, placebokontrolleret 12-ugers multicenterstudie (N = 370). 
In addition, the efficacy, safety and tolerability of Resolor in male patients with chronic constipation were evaluated in a 12-week, multi-centre, randomised, double-blind, placebo-controlled study (N=370).
Der er i in vitro-studier kun fundet affinitet for andre receptorer ved koncentrationer, der var mere end 150 gange højere end dets 5-HT4-receptoraffinitet. 
In vitro, only at concentrations exceeding its 5-HT4 receptor affinity by at least 150-fold, affinity for other receptors was detected.
Tabel 1: Bivirkninger ved Resolor 
Table 1: Adverse Drug Reactions (ADRs) Associated with Resolor
En dosis på 1 mg anbefales hos patienter med svært nedsat nyrefunktion (se pkt. 
A dose of 1 mg is recommended in subjects with severe renal impairment (see section 4.2).
Andelen af patienter med gennemsnitligt ≥3 spontane, fuldstændige afføringer (SCBM) om ugen (dvs. respondenter) i den 24-ugers dobbeltblindede behandlingsfase var ikke statistisk forskellig (p=0,367) mellem Resolor-gruppen (25,1 %) og placebogruppen (20,7 %). 
The proportion of patients with an average weekly frequency of ≥3 Spontaneous Complete Bowel Movements (SCBMs) per week (i.e., responders) over the 24-week double-blind treatment phase was not statistically different (p=0.367) between the Resolor (25.1%) and placebo (20.7%) treatment groups.
Et toksicitetsstudie med subkutan administration hos nyfødte/unge rotter med en alder på 7-55 dage medførte et NOAEL (no observed adverse effect level) på 10 mg/kg/dag. 
A subcutaneous neonatal/juvenile toxicity study performed in rats 7-55 days of age resulted in a NOAEL of 10 mg/kg/day.
En klinisk relevant forbedring på ≥ 1 SCBM pr. uge, det vigtigste sekundære endepunkt, blev opnået hos 51,0 % (uge 4) og 44,2 % (uge 12) af patienterne behandlet med 2 mg Resolor vs. 21,7 % (uge 4) og 22,6 % (uge 12) af placebopatienterne. 
A clinically meaningful improvement of ≥1 SCBM per week, the most important secondary efficacy endpoint, was achieved in 51.0% (week 4) and 44.2% (week 12) treated with 2 mg Resolor versus 21.7% (week 4) and 22.6% (week 12) of placebo patients.
Lactosemonohydrat Triacetin 
Lactose monohydrate Triacetin
Følgende almindelige bivirkninger er blevet rapporteret (kan forekomme hos op til 1 ud af 10 personer): nedsat appetit, svimmelhed, opkastning, fordøjelsesforstyrrelser (dyspepsi), luft i maven, unormale tarmlyde, træthed. 
The following side effects have been reported commonly (may affect up to 1 in 10 people): decreased appetite, dizziness, vomiting, disturbed digestion (dyspepsia), windiness, abnormal bowel sounds, tiredness.
mavebesvær, smerter og kramper), afføringsrelaterede (ufuldstændige afføringer, falsk alarm, forcering, for hårde, for små) og rektale symptomer (smertefulde afføringer, brændende fornemmelse, blødning/fissurer), vurderet i uge 4 og 12. 
In all three studies, treatment with Resolor also resulted in significant improvements in a validated and disease specific set of symptom measures (PAC-SYM), including abdominal (bloating, discomfort, pain and cramps), stool (incomplete bowel movements, false alarm, straining, too hard, too small) and rectal symptoms (painful bowel movements, burning, bleeding/tearing), determined at week 4 and week 12.
Jernoxid, rød (E172) Jernoxid, gul (E172) Indigocarmin aluminium lake (E 132) 
Iron oxide red (E172) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132)
Resolors virkning og sikkerhed hos patienter (i alderen ≥18) med kronisk forstoppelse blev undersøgt i et 24-ugers randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie (N=361). 
The efficacy and safety of Resolor in patients (aged ≥18 or older) with chronic constipation, were evaluated in a 24 week multicentre, randomised, double-blind, placebo controlled study (N=361).
Tilsvarende resultater blev observeret ved uge 12: 46,9 % hos patienter i behandling med 2 mg Resolor vs. 19,0 % hos patienter på placebo (p<0,001 vs. placebo). 
Similar results were observed at Week 12: 46.9% in 2 mg Resolor patients versus 19.0% in placebo patients (p<0.001 vs placebo).
Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 142,5 mg lactose (som monohydrat). 
Excipients with known effect: Each film-coated tablet contains 142.5 mg lactose (as monohydrate).
Resolor fås i aluminium/aluminium perforerede enkeltdosisblisterkort (mærket med ugedagene) indeholdende 7 tabletter. 
Resolor is provided in aluminium/aluminium perforated unit dose blister (calendar marked) containing 7 tablets.
Administration Oral anvendelse. 
Method of administration Oral use
Hvis du har taget for mange Resolor 
If you take more Resolor than you should
Tabletterne indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption. 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Aktivt stof: prucaloprid. 
The active substance is prucalopride.
Lyserøde, runde, bikonvekse tabletter mærket med 'PRU 2' på den ene side. 
Pink, round, biconvex tablets marked “PRU 2” on one side.
Resolor 2 mg filmovertrukne tabletter er lyserøde, runde tabletter mærket med 'PRU 2' på den ene side. 
Resolor 2 mg film-coated tablets are pink round shaped tablets marked “PRU 2” on one side.
Hvis du får kraftig hjertebanken, skal du sige det til din læge. 
If pounding heart occurs, please tell your doctor.
Ved uge 12 havde 68,3 % af patienterne i behandling med 2 mg prucaloprid en gennemsnitlig stigning på ≥1 SBM/uge vs. 37,0 % af placebopatienterne (p<0,001 vs. placebo). 
At week 12, 68.3% of patients treated with 2 mg prucalopride had an average increase of ≥1 SBM/week versus 37.0% of placebo patients (p<0.001 vs placebo).
Tilsvarende resultater blev observeret ved uge 12: hhv. 43,4 %, 42,9 % og 31,7 % hos patienter i behandling med 2 mg Resolor vs. hhv. 26,9 %, 27,2 % og 23,4 % hos patienter på placebo (p<0,001 vs. placebo). 
Similar results were observed at Week 12: 43.4%, 42.9%, and 31.7% respectively in 2 mg Resolor patients versus 26.9%, 27.2%, and 23.4% in placebo patients (p<0.001 vs placebo).
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Eliminationen af prucaloprid sker hovedsagligt gennem renal udskillelse (se pkt. 
Renal excretion is the main route of elimination of prucalopride (see section 5.2).
Ældre personer (> 65 år): Start med 1 mg én gang dagligt (se pkt. 
Older people (>65 years): Start with 1 mg once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily.
Andelen af kvindelige patienter, hvor laksantia ikke giver tilstrækkelig lindring, som opnåede i gennemsnit ≥ 3 SCBM pr. uge, var 31,0 % (uge 4) og 24,7 % (uge 12) ved behandling med den anbefalede dosis på 2 mg Resolor (n=458) vs. 8,6 % (uge 4) og 9,2 % (uge 12) i placebogruppen. 
The proportion of female patients in whom laxatives fail to provide adequate relief treated with the recommended dose of 2 mg Resolor (n=458) that reached an average of ≥3 SCBM per week was 31.0% (week 4) and 24.7% (week 12), versus 8.6% (week 4) and 9.2% (week 12) on placebo.
Ved uge 12 havde 68,3 % af patienterne i behandling med 2 mg Resolor en gennemsnitlig stigning på ≥1 SBM/uge vs. 37,0 % af placebopatienterne (p<0,001 vs. placebo). 
At week 12, 68.3% of patients treated with 2 mg Resolor had an average increase of ≥1 SBM/week versus 37.0% of placebo patients (p<0.001 vs placebo).
Ved uge 4 var andelen af patienter med en forbedring på ≥1 vs. baseline i PAC-SYM-delskalaerne for abdominal-, afførings- og rektalsymptomer hhv. 41,3 %, 41,6 % og 31,3 % hos patienter i behandling med 2 mg Resolor, sammenlignet med hhv. 26,9 %, 24,4 % og 22,9 % hos patienter på placebo. 
At week 4, the proportion of patients with an improvement of ≥1 versus baseline in the PAC-SYM abdominal, stool, and rectal symptom subscales was 41.3%, 41.6%, and 31.3% respectively in patients treated with Resolor 2 mg compared with 26.9%, 24.4% and 22.9% in patients on placebo.
Dette stemmer ikke overens med de 5 andre 12-ugers randomiserede, dobbeltblindede, placebokontrollerede multicenterstudier, der påviste effekt på dette tidspunkt hos voksne patienter. 
The difference between treatment groups in the average weekly frequency of ≥3 SCBMs per week was not statistically significant over Weeks 1-12 which is inconsistent with the 5 other multicentre, randomised, double-blind, 12-week placebo controlled studies demonstrating efficacy at this timepoint in adult patients.
Hvide til råhvide, runde, bikonvekse tabletter mærket med 'PRU 1' på den ene side. 
White to off-white, round, biconvex tablets marked “PRU 1” on one side.
Opkastning, dyspepsi, flatulens, unormale tarmlyde 
Vomiting, dyspepsia, flatulence, gastrointestinal sounds abnormal
Resolor 1 mg filmovertrukne tabletter Resolor 2 mg filmovertrukne tabletter prucaloprid 
Resolor 1 mg film-coated tablets Resolor 2 mg film-coated tablets prucalopride
Prucaloprid kan udskilles i mælken ved amning. 
When breast-feeding, prucalopride can pass into breast milk.
Nedsat nyrefunktion 
Rectal haemorrhage
Én filmovertrukken tablet Resolor 2 mg indeholder 2 mg prucaloprid (som succinat). 
One film-coated tablet of Resolor 2 mg contains 2 mg prucalopride (as succinate).
Én filmovertrukken tablet Resolor 1 mg indeholder 1 mg prucaloprid (som succinat). 
One film-coated tablet of Resolor 1 mg contains 1 mg prucalopride (as succinate).
Tabletovertræk: 
Tablet coating
Resolor 2 mg filmovertrukne tabletter 
Resolor 2 mg film-coated tablets
Resolor 1 mg filmovertrukne tabletter er hvide til råhvide, runde tabletter mærket med 'PRU 1' på den ene side. 
What Resolor looks like and contents of the pack Resolor 1 mg film-coated tablets are white to off-white round shaped tablets marked “PRU 1” on one side.
Der forventes ingen påvirkning af nyfødte børn/spædbørn ammet af kvinder, der har taget terapeutiske doser af Resolor. 
At therapeutic doses of Resolor, no effects on breast-fed newborns/infants are anticipated.
Resolor 2 mg tabletter prucaloprid 
Resolor 2 mg tablets prucalopride
Resolor 1 mg tabletter prucaloprid 
Resolor 1 mg tablets prucalopride
Bivirkning 
Incidence Category
Resolor 1 mg filmovertrukne tabletter 
Resolor 1 mg film-coated tablets.
Det skal du vide, før du begynder at tage Resolor Sådan skal du tage Resolor Bivirkninger 
What Resolor is and what it is used for What you need to know before you take Resolor How to take Resolor
Hver filmovertrukken tablet indeholder 2 mg prucaloprid (som succinat). 
Each film-coated tablet contains 2 mg prucalopride (as succinate).
Hver filmovertrukken tablet indeholder 1 mg prucaloprid (som succinat). 
Each film-coated tablet contains 1 mg prucalopride (as succinate).
Resolor 2 mg filmovertrukne tabletter prucaloprid 
Resolor 2 mg film-coated tablets prucalopride
Resolor 1 mg filmovertrukne tabletter prucaloprid 
Resolor 1 mg film-coated tablets prucalopride
EU/1/09/581/004 (7 tabletter) EU/1/09/581/006 (14 tabletter) EU/1/09/581/002 (28 (tabletter) EU/1/09/581/008 (84 tabletter) 
EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/002 (28 tablets) EU/1/09/581/008 (84 tablets)
EU/1/09/581/001 (28 tabletter) EU/1/09/581/003 (7 tabletter) EU/1/09/581/005 (14 tabletter) EU/1/09/581/007 (84 tabletter) 
EU/1/09/581/001 (28 tablets) EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/007 (84 tablets)
EU/1/09/581/002 (28 tabletter) EU/1/09/581/004 (7 tabletter) EU/1/09/581/006 (14 tabletter) EU/1/09/581/008 (84 tabletter) 
EU/1/09/581/002 (28 tablets) EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/008 (84 tablets)
EU/1/09/581/001 (7 tabletter) EU/1/09/581/003 (14 tabletter) EU/1/09/581/001 (28 tabletter) EU/1/09/581/007 (84 tabletter) 
EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/001 (28 tablets) EU/1/09/581/007 (84 tablets)
Iffeza 50 Mikrogramm/5 Mikrogramm pro Sprühstoß 
Iffeza 50 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation
Iffeza 125 Mikrogramm/5 Mikrogramm pro Sprühstoß 
Iffeza 125 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation
10 hætteglas 0 dage 
10 bottles Zero days
10 flasker 
10 glass vials