FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean decrease from baseline at Week 24 in the number of days/week on parenteral nutrition, based on subject diary data, was -1.34 (±2.24) days/week corresponding to a percentage decrease of -21.33% (±34.09).
Danish: Den gennemsnitlige reduktion fra baseline ved uge 24 i antallet af dage/uger med parenteral ernæring baseret på forsøgspersonernes dagbogsdata var -1,34 (±2,24) dage/uge svarende til en procentvis reduktion på -21,33 % (±34,09).
English: In case of recurrent intestinal obstructions, the need for continued Revestive treatment should be reassessed.
Danish: I tilfælde af gentagne intestinale obstruktioner, skal behovet for fortsat behandling med Revestive revurderes.
English: The mean decrease from baseline at Week 12 in the number of days/week on parenteral nutrition, in the ITT population based on physician-prescribed data, was -1.36 (±2.37) days/week corresponding to a percentage decrease of -24.49% (±42.46).
Danish: Det gennemsnitlige fald fra baseline til uge 12 i antallet af dage/uge med parenteral ernæring hos ITT-populationen, baseret på data fra lægeordinationer, var -1,36 (±2,37) dage/uge svarende til et procentvist fald på -24,49 % (±42,46).
English: Common (may affect up to 1 in 10 people): - Flu (influenza) or flu-like symptoms - Decreased appetite - Swelling of hands and/or feet - Problems sleeping, anxiety - Cough, shortness of breath - Polyps (small abnormal growths) in your child's large bowel - Passing gas (flatulence) - Narrowing or blockage of your child's pancreatic duct, which may cause inflammation of the pancreas - Inflammation of the gallbladder
Danish: Almindelige (forekommer hos op til 1 ud af 10 personer): - Influenza eller influenzalignende symptomer - Appetitløshed - Hævede hænder og/eller fødder - Søvnproblemer, angst - Hoste, åndenød - Polypper (små, unormale vækster) i dit barns tyktarm - Luftafgang fra tarmen (flatulens) - Forsnævring eller blokering af passager i dit barns bugspytkirtel, hvilken kan føre til betændelse i bugspytkirtlen - Betændelse i galdeblæren
English: An individual assessment whether increased frequency of surveillance is necessary should be performed based on the patient characteristics (e.g., age, underlying disease).
Danish: Dette skal baseres på patientkarakteristika (f.eks. alder og underliggende sygdom).
English: 1.1 Take the pre-filled syringe with the solvent and flip off the top part of the white plastic cap on the pre-filled syringe so that it is ready for the reconstitution needle to be attached.
Danish: 1.1 Tag den fyldte injektionssprøjte med solvens og bræk toppen af det hvide plastiklåg på den fyldte injektionssprøjte, så den er klar til, at kanylen til rekonstitution sættes på.
English: Contact the doctor or the emergency unit if your child experiences yellowing of the skin and the whites in the eyes, itching, dark urine and light-coloured stools or pain in the upper right side or middle of the stomach area
Danish: Kontakt lægen eller skadestuen, hvis dit barn får gulfarvning af huden og det hvide i øjnene, kløe, mørkfarvet urin og lys afføring eller smerter i den øvre side eller på midten af maven
English: Very common (may affect more than 1 in 10 people): - Respiratory tract infection (any infection of the sinuses, throat, airways or lungs) - Headache - Stomach pain, bloated stomach, feeling sick (nausea), swelling of stoma (an artificial opening for waste removal), vomiting - Reddening, pain or swelling at the site of the injection
Danish: Meget almindelige (forekommer hos flere end 1 ud af 10 personer): - Luftvejsinfektioner (infektion af bihuler, hals, luftveje eller lunger) - Hovedpine - Mavesmerter, oppustethed, utilpashed (kvalme), hævelse ved stomi (kunstig åbning til afføring),
English: 2.2 Uncap the reconstitution needle on the assembled pre-filled syringe with solvent without touching the tip of the needle.
Danish: 2.2 Fjern hætten fra rekonstitutionskanylen på den fyldte injektionssprøjte med solvens uden at røre ved spidsen af kanylen.
English: 4.2 Clean the intended site of injection on your skin with an alcohol swab, using a circular motion, working outwards.
Danish: 4.2 Rens huden på det valgte injektionssted med en afspritningsserviet, idet du arbejder dig udad i cirkelbevægelser.
English: Contact your doctor or the emergency unit if you experience yellowing of the skin and the whites in the eyes, itching, dark urine and light-coloured stools or pain in the upper right side or middle of the stomach area
Danish: Kontakt lægen eller skadestuen, hvis du får gulfarvning af huden og det hvide i øjnene, kløe, mørkfarvet urin og lys afføring eller smerter i den øvre side eller på midten af maven
English: - if your child has other severe diseases that are not well controlled.
Danish: hvis dit barn lider af andre alvorlige sygdomme, som ikke er velkontrollerede, vil lægen tage hensyn hertil før ordination af denne medicin.
English: However, chemical and physical stability has been demonstrated for 24 hours at 25°C.
Danish: Der er dog påvist kemisk og fysisk stabilitet i 24 timer ved 25 °C.
English: Pharmacokinetics in subpopulations
Danish: Farmakokinetik i særlige patientgrupper
English: At Week 12, there was a -35.11% (±53.04) mean change from baseline in parenteral nutrition calorie consumption in the ITT population based on physician-prescribed data.
Danish: Reduktion i kalorieindtagelsen ved parenteral ernæring Ved uge 12 var der en gennemsnitlig ændring på -35,11 % (±53,04) fra baseline i kalorieindtagelsen fra parenteral ernæring hos ITT-populationen, baseret på data fra lægeordinationer.
English: Your doctor will consider this when prescribing this medicine.
Danish: Din læge vil tage hensyn til dette før ordination af Revestive.
English: Sodium phosphate monohydrate Disodium phosphate heptahydrate Sodium hydroxide (pH adjustment) Hydrochloric acid (pH adjustment)
Danish: Natriumphosphatmonohydrat Dinatriumphosphatheptahydrat Natriumhydroxid (pH-justering) Saltsyre (pH-justering)
English: The recommended dose of Revestive is 0.05 mg/kg body weight once daily.
Danish: Den anbefalede dosis er 0,05 mg Revestive/kg kropsvægt 1 gang daglig.
English: Table 2
Danish: Dublin 2
English: Gastrointestinal neoplasia including hepatobiliary tract In the rat carcinogenicity study, benign tumours were found in the small bowel and the extrahepatic bile ducts.
Danish: I et karcinogenicitetsstudie med rotter blev der fundet benigne tumorer i tyndtarmen og i de ekstrahepatiske galdegange.
English: The reactions included injection site haematoma, injection site erythema, injection site pain, injection site swelling and injection site haemorrhage (see also section 5.3).
Danish: Reaktionerne inkluderede hæmatom, erytem, smerte, hævelse og blødning på injektionsstedet (se også pkt.
English: The solution must not be used if it is cloudy or contains particulate matter.
Danish: Injektionsvæsken må ikke bruges, hvis den er uklar eller indeholder partikler.
English: Teduglutide increases villus height and crypt depth of the intestinal epithelium.
Danish: Teduglutid øger højden af tarmtrævler (villus) og kryptdybde i tarmvæggen.
English: Includes the following preferred terms: Injection site haematoma, Injection site erythema, Injection site pain, Injection site swelling and Injection site haemorrhage.
Danish: Omfatter følgende foretrukne termer: Hæmatom, erytem, smerte, hævelse og blødning ved injektionsstedet.
English: Revestive should not be used if a cancer is detected during your colonoscopy.
Danish: Dit barn må ikke få Revestive, hvis der påvises kræft ved koloskopien.
English: However, chemical and physical stability has been demonstrated for 3 hours at 25°C.
Danish: Der er dog påvist kemisk og fysisk stabilitet i 3 timer ved 25 °C.
English: Patients with a history of malignancies in the gastrointestinal tract, including the hepatobiliary system and pancreas within the last five years.
Danish: Patienter, der inden for de seneste fem år har haft malign sygdom i mave-tarm-kanalen inklusive lever og galdeveje og pancreas.
English: Revestive is a powder and solvent for solution for injection (5 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Danish: Revestive er pulver og solvens til injektionsvæske, opløsning (5 mg teduglutid i hætteglas, 0,5 ml solvens i en fyldt injektionssprøjte).
English: Powder and solvent for solution for injection 28 vials of powder containing 1,25 mg teduglutide 28 pre-filled syringes containing 0.5 ml of solvent
Danish: Pulver og solvens til injektionsvæske, opløsning 28 hætteglas med pulver, der indeholder 1,25 teduglutid 28 fyldte injektionssprøjter, der indeholder 0,5 ml solvens
English: Always use this medicine exactly as the doctor has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens anvisning.
English: The pre-filled syringe must be assembled with a reconstitution needle.
Danish: Den fyldte injektionssprøjte skal monteres med en kanyle til rekonstitution.
English: Adverse reactions were retrieved from 2 placebo-controlled clinical studies with teduglutide in 109 adult patients with SBS treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day for up to 24 weeks.
Danish: Bivirkninger blev opsamlet fra 2 placebo-kontrollerede kliniske studier med teduglutid hos 109 voksne patienter med korttarmssyndrom, der blev behandlet med 0,05 mg/kg/dag og 0,10 mg/kg/dag i op til 24 uger.
English: Uncommon (may affect up to 1 in 100 people) - Polyps (small abnormal growths) in your small bowel
Danish: Ikke almindelige (forekommer hos op til 1 ud af 100 personer): - Polypper (små, unormale vækster) i tyndtarmen
English: Revestive has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Revestive er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (se pkt.
English: Adverse reactions were retrieved from 2 placebo-controlled clinical studies with teduglutide in 109 patients with SBS treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day for up to 24 weeks.
Danish: Bivirkninger blev opsamlet fra 2 placebo-kontrollerede kliniske studier med teduglutid hos 109 patienter med korttarmssyndrom, der blev behandlet med 0,05 mg/kg/dag og 0,10 mg/kg/dag i op til 24 uger.
English: Common (may affect up to 1 in 10 people): - Flu (influenza) or flu-like symptoms - Decreased appetite - Swelling of hands and/or feet - Problems sleeping, anxiety - Cough, shortness of breath - Polyps (small abnormal growths) in your large bowel - Passing gas (flatulence) - Narrowing or blockage of your pancreatic duct, which may cause inflammation of the pancreas - Inflammation of the gallbladder
Danish: Almindelige (forekommer hos op til 1 ud af 10 personer): - Influenza eller influenzalignende symptomer - Appetitløshed - Hævede hænder og/eller fødder - Søvnproblemer, angst - Hoste, åndenød - Polypper (små, unormale vækster) i tyktarmen - Luftafgang fra tarmen (flatulens) - Forsnævring eller blokering af passager i bugspytkirtlen, hvilken kan føre til betændelse i bugspytkirtlen - Betændelse i galdeblæren
English: Revestive is a powder and solvent for solution for injection (1.25 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Danish: Revestive er pulver og solvens til injektionsvæske, opløsning (1,25 mg teduglutid i hætteglas, 0,5 ml solvens i en fyldt injektionssprøjte).
English: Seek immediate medical attention if any of the following side effects occur:
Danish: Hvis du oplever en af følgende bivirkninger, skal du straks søge lægehjælp:
English: If you are not sure, ask the doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet.
English: Decreased appetite Fluid overload
Danish: Appetitløshed Væskeophobning
English: EU/1/12/787/003 28 vials
Danish: EU/1/12/787/003 28 hætteglas
English: Check with your child's doctor, pharmacist or nurse if you are not sure.
Danish: Spørg dit barns læge, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: EU/1/12/787/002 1 vial EU/1/12/787/001 28 vials
Danish: EU/1/12/787/002 1 hætteglas EU/1/12/787/001 28 hætteglas
English: Contact the doctor if your child experiences tiredness, shortness of breath or swelling of ankles or legs - Inflammation of the pancreas (pancreatitis).
Danish: Kontakt lægen, hvis dit barn oplever træthed, åndenød eller hævede ankler eller ben - Betændelse i bugspytkirtlen (pankreatitis).
English: Solvent Pre-filled syringe (glass) with plungers (bromobutyl) containing 0.5 ml of solvent.
Danish: Solvens Fyldt injektionssprøjte (glas) med stempel (brombutyl), der indeholder 0,5 ml solvens.
English: A colonoscopy with removal of polyps should be performed at the time of starting treatment with Revestive.
Danish: Ved behandlingsstart med Revestive bør der foretages koloskopi med fjernelse af polypper.
English: Dose linearity
Danish: Dosislinearitet
English: *Includes the following preferred terms: Nasopharyngitis, Influenza, Upper respiratory tract infection, and Lower respiratory tract infection.
Danish: Komplikationer med gastrointestinal stomi *Omfatter følgende foretrukne termer: Nasofaryngitis, influenza, infektion i øvre luftveje og infektion i nedre luftveje Omfatter følgende foretrukne termer: Pancreatitis, akut pancreatitis og kronisk pancreatitis.
English: The doctor will consider this when prescribing this medicine.
Danish: Lægen vil tage hensyn til dette før ordination af Revestive.
English: Complete weaning
Danish: Fuldstændig afvænning
English: Contact your doctor if you experience tiredness, shortness of breath or swelling of ankles or legs - Inflammation of the pancreas (pancreatitis).
Danish: Kontakt lægen, hvis du oplever træthed, åndenød eller hævede ankler eller ben - Betændelse i bugspytkirtlen (pankreatitis).
English: Contact your doctor or the emergency unit if you experience severe stomach ache, vomiting and constipation - Reduced flow of bile from the gallbladder and/or inflammation of the gallbladder.
Danish: Kontakt din læge eller skadestuen, hvis du får stærke mavesmerter, opkastning og forstoppelse - Nedsat mængde galde fra galdeblæren og/eller betændelse i galdeblæren.
English: - if your child is allergic to teduglutide or any of the other ingredients of this medicine (listed in section 6) or trace residues of tetracycline.
Danish: - hvis dit barn er allergisk over for teduglutid eller et af de øvrige indholdsstoffer i Revestive
English: Revestive is used to treat children and adolescents (aged 1 year and above) with Short Bowel Syndrome.
Danish: Revestive bruges til behandling af børn og unge (i alderen 1 år og derover) med korttarmssyndrom.
English: How to use Revestive
Danish: Sådan skal du bruge Revestive
English: Your doctor will perform further colonoscopies if you continue treatment with Revestive.
Danish: Lægen vil udføre en koloskopi hvert år, så længe du er i behandling med Revestive.
English: Fluid overload has been observed in clinical trials.
Danish: Der er blevet observeret væskeophobning i kliniske studier.
English: Two (2) patients on the recommended teduglutide dose were weaned off parenteral nutrition by Week 24.
Danish: Ved uge 24 kunne 2 patienter, som fik den anbefalede teduglutid-dosis, undvære parenteral ernæring.
English: Respiratory tract infection*
Danish: Luftvejs-infektion* Influenzalignende sygdom
English: 3.4 Remove the injection syringe from reconstitution needle leaving the needle in the vial.
Danish: 3.4 Fjern injektionssprøjten fra rekonstitutionskanylen og lad kanylen blive siddende i hætteglasset.
English: Revestive comes in pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Danish: Revestive fås i pakningsstørrelser med 1 hætteglas med pulver med 1 fyldt sprøjte eller 28 hætteglas med pulver med 28 fyldte sprøjter.
English: Revestive 1.25 mg powder and solvent for solution for injection Teduglutide For children and adolescents
Danish: Revestive 1,25 mg pulver og solvens til injektionsvæske, opløsning Teduglutid Til børn og unge
English: Contact the doctor or the emergency unit if your child experiences severe stomach ache and fever - Intestinal obstruction (blockage of the bowel).
Danish: Kontakt lægen eller skadestuen, hvis dit barn får stærke mavesmerter og får feber - Tarmobstruktion (tarmblokade).
English: Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
Danish: Pulver: L-histidin, mannitol, natriumphosphatmonohydrat, dinatriumphosphatheptahydrat, natriumhydroxid (pH-justering), saltsyre (pH-justering).
English: In addition to the need for a colonoscopy with removal of polyps by the time of the initiation of the treatment (see section 4.4.
Danish: Ved behandlingsstart bør der, ud over en gennemført koloskopi med fjernelse af polypper (se pkt.
English: Two doses of teduglutide were studied: 0.025 mg/kg/day (n=24) and 0.05 mg/kg/day (n=26); 9 subjects were enrolled in a standard of care (SOC) arm. Randomisation was stratified by age across dose groups.
Danish: To doser af teduglutid blev undersøgt: 0,025 mg/kg/dag (n=24) og 0,05 mg/kg/dag (n=26).
English: - Do not use Revestive if you notice that the solution is cloudy or contains particulate matter.
Danish: Brug ikke Revestive, hvis injektionsvæsken er uklar eller indeholder partikler.
English: Reconstituted product Chemical and physical stability has been demonstrated for 3 hours at 25°C.
Danish: Rekonstitueret præparat Der er påvist kemisk og fysisk stabilitet i 3 timer ved 25 °C.
English: Revestive comes in pack sizes of 28 vials of powder with 28 pre-filled syringes.
Danish: Revestive fås i pakningsstørrelser på 28 hætteglas med pulver med 28 fyldte sprøjter.
English: One vial of powder contains 1.25 mg of teduglutide*.
Danish: Et hætteglas med pulver indeholder 1,25 mg teduglutid*.
English: - The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
Danish: - Øvrige indholdsstoffer: L-histidin, mannitol, natriumphosphatmonohydrat, dinatriumphosphatheptahydrat, natriumhydroxid (til pH-justering), saltsyre (til pH-justering).
English: One vial of powder contains 1.25 mg of teduglutide.
Danish: Et hætteglas med pulver indeholder 1,25 mg teduglutid.
English: In case of gallbladder or bile duct-related symptoms, the need for continued Revestive treatment should be reassessed.
Danish: I tilfælde af galdeblære- eller galdevejssymptomer skal den fortsatte behandling med Revestive revurderes.
English: Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
Danish: Pulver: L-histidin, mannitol, natriumphosphatmonohydrat, dinatriumphosphatheptahydrat.
English: Pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Danish: Pakningerne indeholder 1 hætteglas med pulver med 1 fyldt injektionssprøjte eller 28 hætteglas med pulver med 28 fyldte injektionssprøjter.
English: Reconstituted product Chemical and physical in-use stablility has been demonstrated for 24 hours up to 25°C.
Danish: Rekonstitueret præparat Der er påvist kemisk og fysisk stabilitet under brug i 24 timer ved temperaturer på op til 25 °C.
English: Colo-rectal polyps
Danish: Kolorektale polypper
English: - The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
Danish: - Øvrige indholdsstoffer: L-histidin, mannitol, natriumphosphatmonohydrat, dinatriumphosphatheptahydrat.
English: One vial of powder contains 5 mg of teduglutide*.
Danish: Et hætteglas med pulver indeholder 5 mg teduglutid*.
English: One vial of powder contains 5 mg of teduglutide.
Danish: Et hætteglas med pulver indeholder 5 mg teduglutid.
English: Revestive 1.25 mg powder and solvent for solution for injection
Danish: Revestive 1,25 mg pulver og solvens til injektionsvæske, opløsning
English: The solution must be injected subcutaneously into a cleaned area on the abdomen, or if this is not possible, on the thigh (see section 4.2 Method of administration) using a thin needle for subcutaneous injection.
Danish: Injektionsvæsken skal injiceres subkutant på et afsprittet område på abdomen, eller hvis dette ikke er muligt på låret (se pkt.
English: In case of pancreatic adverse events, the need for continued Revestive treatment should be reassessed.
Danish: I tilfælde af pancreasbivirkninger skal den fortsatte behandling med Revestive revurderes.
English: Pack size of 28 vials of powder with 28 pre-filled syringes.
Danish: Pakningen indeholder 28 hætteglas med pulver med 28 fyldte injektionssprøjter.
English: - If you have any further questions, ask your child's doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg dit barns læge, apotekspersonalet eller sundhedspersonalet.
English: If you use more Revestive than you should
Danish: Hvis du har taget for meget Revestive
English: Revestive 1.25 mg powder for solution for injection teduglutide
Danish: Revestive 1,25 mg pulver til injektionsvæske, opløsning teduglutid
English: Contact your doctor or the emergency unit if you experience severe stomach ache and fever - Intestinal obstruction (blockage of the bowel).
Danish: Kontakt lægen eller skadestuen, hvis du får stærke mavesmerter og får feber - Tarmobstruktion (tarmblokade).
English: - After reconstitution, from a microbiological point of view, the solution should be used immediately.
Danish: - Ud fra et mikrobiologisk perspektiv skal injektionsvæsken anvendes straks efter rekonstitution.
English: If your child is pregnant or breast-feeding, the use of Revestive is not recommended.
Danish: Dit barn må ikke bruge Revestive, hvis hun er gravid eller ammer.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or trace residues of tetracycline.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Dispose of all needles and syringes in a sharps disposal container.
Danish: Smid alle brugte kanyler og sprøjter i en affaldsbeholder til skarpe genstande.
English: - Dispose of all needles and syringes in a sharps disposal container.
Danish: - Kasser alle brugte kanyler og sprøjter i en affaldsbeholder til skarpe genstande.
English: Revestive 1.25 mg powder and solvent for solution for injection teduglutide
Danish: Revestive 1,25 mg pulver og solvens til injektionsvæske, opløsning teduglutid
English: The mean change in parenteral nutrition volume from baseline at Week 24, based on subject diary data, was -23.30 (±17.50) mL/kg/day, corresponding to -41.57% (±28.90); the mean change in the SOC arm was -6.03 (±4.5) mL/kg/day (corresponding to a -10.21% [±13.59]).
Danish: Den gennemsnitlige ændring i parenteralt ernæringsvolumen fra baseline til uge 24 baseret på personernes dagbogsdata var -23,30 (±17,50) ml/kg/dag svarende til -41,57 % (±28,90).
English: The solution must be injected subcutaneously into a cleaned area on the abdomen, or if this is not possible, on the thigh (see section 4.2 Method of administration) using a thin needle for subcutaneous injection suitable for paediatric use.
Danish: 4.2 Dosering og administration) ved at bruge en tynd kanyle til subkutan injektion, der er egnet til pædiatrisk anvendelse.
English: What Revestive is and what it is used for What you need to know before you use Revestive How to use Revestive
Danish: Det skal du vide, før du begynder at bruge Revestive Sådan skal du bruge Revestive Bivirkninger
English: Revestive 5 mg powder and solvent for solution for injection
Danish: Revestive 5 mg pulver og solvens til injektionsvæske, opløsning
English: Hyperplasia in the gall bladder, hepatic biliary ducts, and pancreatic ducts were observed in subchronic and chronic toxicology studies.
Danish: I studier af subkronisk og kronisk toksikologi er observeret hyperplasi i galdeblære, de hepatiske galdegange og i bugspytkirtlens udførselsgange.
English: What Revestive looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Materials provided in the pack: - 28 vials with 1.25 mg teduglutide as a powder - 28 pre-filled syringes with solvent
Danish: 28 hætteglas med 1,25 mg teduglutid som pulver 28 fyldte injektionssprøjter med solvens