FrancophonIA/ELRC3.0 huggingface dataset:
English: Temsirolimus 175/75 (temsirolimus 175 mg weekly for 3 weeks followed by 75 mg weekly) led to an improvement in PFS compared with investigator's choice in patients with relapsed and/or refractory MCL that was statistically significant (hazard ratio = 0.44; p-value = 0.0009).
Danish: Temsirolimus 175/75 (175 mg temsirolimus om ugen i 3 uger efterfulgt af 75 mg om ugen) gav en statistisk signifikant forbedring af den progressionsfrie overlevelse sammenlignet med investigators valg hos patienter med recidiverende og/eller refraktært MCL (risikoforhold = 0,44; p-værdi = 0,0009).
English: • Inject the 1.8 ml of solvent into the vial of Torisel 30 mg concentrate.
Danish: • Sprøjt de 1,8 ml solvens ind i hætteglasset med Torisel 30 mg koncentrat
English: In the RCC clinical trial, a Phase 3 clinical trial for RCC, 26% of patients reported hyperglycaemia as an adverse event.
Danish: I RCC-studiet, et fase 3 klinisk studie vedrørende RCC, rapporterede 26 % af patienterne hyperglykæmi som bivirkning.
English: Summary of efficacy results in temsirolimus MCL clinical trial
Danish: Resumé af effektresultater i temsirolimus RCC-klinisk studie 1
English: Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
Danish: Indehaver af markedsføringstilladelsen Pfizer Europe MA EEIG Boulevard de la Plaine 17
English: Subjects were randomly assigned in a 1:1:1 ratio to receive intravenous temsirolimus 175 mg (3 successive weekly doses) followed by 75 mg weekly (n = 54), intravenous temsirolimus 175 mg (3 successive weekly doses) followed by 25 mg weekly (n = 54), or the investigator's choice of single-agent treatment (as specified in the protocol; n = 54).
Danish: Forsøgspersonerne fik ved randomisering i forholdet 1:1:1 enten 175 mg intravenøs temsirolimus (3 på hinanden følgende ugentlige doser) efterfulgt af 75 mg om ugen (n = 54), 175 mg intravenøs temsirolimus (3 på hinanden følgende ugentlige doser) efterfulgt af 25 mg om ugen (n = 54) eller investigators valg af monoterapi (som angivet i protokollen; n = 54).
English: In 23 healthy subjects the concentration of desipramine, a CYP2D6 substrate, was unaffected when 25 mg of temsirolimus was co-administered.
Danish: Hos 23 raske frivillige forblev koncentrationen af desipramin, et CYP2D6-substrat, uændret efter samtidig administration af 25 mg temsirolimus.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to or even lower than clinical exposure levels and with possible relevance to clinical use, were as follows: pancreatic islet cell vacuolation (rat), testicular tubular degeneration (mouse, rat and monkey), lymphoid atrophy (mouse, rat and monkey), mixed cell inflammation of the colon/caecum (monkey), and pulmonary phospholipidosis (rat).
Danish: Bivirkninger, der ikke blev observeret i kliniske studier, men som blev set i dyr ved ekspopsitionsniveauer svarende til eller lavere end kliniske ekspositionsniveauer og med mulig relevans ved klinisk brug, var som følger: øcellevakuolisering i pancreas (rotte), tubulær degeneration i testis (mus, rotte og abe), lymfoid atrofi (mus, rotte og abe), blandet celleinflammation i colon/coecum (abe) og pulmonal fosfolipidose (rotte).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic: handle with caution.
Danish: Cytotoksisk: Skal håndteres med forsigtighed.
English: In RCC clinical trial 1, temsirolimus 25 mg was associated with a statistically significant advantage over IFN-α in the primary endpoint of OS at the 2nd pre-specified interim analysis (n = 446 events,
Danish: I RCC-klinisk studie 1, var 25 mg temsirolimus forbundet med en statistisk signifikant fordel frem for IFN- i det primære endemål for OS, ved den 2. forud specificerede foreløbige analyse (n = 446 hændelser, p = 0,0078).
English: Torisel may elevate triglycerides and/or cholesterol, and this may require treatment with lipid-lowering agents (medicines used to reduce cholesterol in the blood).
Danish: Dette kan kræve behandling med lipidsænkende medicin (medicin, der bruges til at sænke kolesterol i blodet).
English: Polyvinyl chloride (PVC) bags and medical devices must not be used for the administration of preparations containing polysorbate 80, because polysorbate 80 leaches di-2-ethylhexylphthalate (DEHP) from PVC.
Danish: Polivinylchlorid (PVC) poser og medicinsk udstyr bør ikke bruges til at administrere opløsninger indeholdende polysorbat 80, da polysorbat 80 lækker di-2-etylhexylphtalat (DEHP) fra PVC.
English: Continuing dosea 75 mg
Danish: Efterfølgende dosis 75 mg
English: No dose adjustment is recommended in patients with renal impairment.
Danish: Der anbefales ikke dosisjustering hos patienter med nyreinsufficiens.
English: Do not throw away any medicines via wastewater.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet.
English: Overall survival Months (95% CI)
Danish: Median samlet overlevelse Måneder (95% CI)
English: Angioneurotic oedema-type reactions have been reported in some patients who received temsirolimus and ACE-inhibitors concomitantly.
Danish: Angioødem-lignende reaktioner er blevet rapporteret hos nogle patienter, som fik temsirolimus og ACE-hæmmere samtidigt.
English: After first dilution of the concentrate with 1.8 ml of the supplied solvent, the mixture may be stored for up to 24 hours below 25°C and protected from light prior to further dilution.
Danish: Efter fortyndning af koncentratet med 1,8 ml af den medfølgende solvens kan blandingen opbevares ved temperaturer under 25 °C i op til 24 timer og beskyttet mod lys inden yderligere fortynding.
English: RCC clinical trial 2
Danish: RCC-klinisk studie 2
English: The solvent contains polysorbate 80 (E 433), macrogol 400 and anhydrous ethanol (see section “Torisel contains ethanol [alcohol]”).
Danish: Solvensen indeholder polysorbat 80 (E 433), macrogol 400 og vandfri ethanol (se afsnittet “Torisel indeholder ethanol (alkohol)”).
English: Agents inducing CYP3A metabolism
Danish: Stoffer, der inducerer CYP3A-metabolismen
English: After further dilution of the concentrate-solvent mixture with sodium chloride 9 mg/ml (0.9%) solution for injection, the solution may be stored for up to 6 hours below 25°C and protected from light.
Danish: Efter yderligere fortynding af koncentrat-solvensopløsningen med natriumchlorid 9 mg/ml (0,9%) injektionsvæske kan opløsningen opbevares ved temperaturer under 25 °C i op til 6 timer, beskyttet mod lys.
English: Interstitial lung disease
Danish: Interstitiel lungesygdom
English: It is important that the recommendations in sections 4.2 and 6.6 in the SmPC be followed closely.
Danish: 4.2. og 6.6 i produktresuméet følges nøje.
English: Nail disorder Ecchymosis*** Petechiae***
Danish: Neglesygdomme Ekkymose*** Petekkier***
English: In Part 2, 45 patients aged from 1 to 17 years with recurrent/relapsed rhabdomyosarcoma, neuroblastoma, or high grade glioma were administered temsirolimus at a weekly dose of 75 mg/m2.
Danish: I del 2 fik 45 patienter i alderen fra 1 til 17 år med tilbagevendende/recidiverende rabdomyosarkom, neuroblastom eller høj-grads gliom temsirolimus i en ugentlig dosis på 75 mg/m².
English: In Part 1, 14 patients aged from 1 to 17 years with advanced recurrent/refractory solid tumours received temsirolimus at doses ranging from 10 mg/m2 to
Danish: I del 1 fik 14 patienter i alderen fra 1 til 17 år med avancerede tilbagevendende/refraktære solide tumorer temsirolimus i doser fra 10 mg/m² til 150 mg/m².
English: RCC clinical trial 1
Danish: RCC-klinisk studie 1
English: Because of the potential for adverse reactions in breast-fed infants from temsirolimus, breast-feeding should be discontinued during therapy.
Danish: På grund af risikoen for bivirkninger af temsirolimus hos ammende nyfødte, skal amning ophøre under behandlingen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: In reproduction toxicity studies in animals, decreased fertility and partly reversible reductions in sperm counts were reported in male rats.
Danish: I reproduktionstoksicitetsstudier på dyr blev der hos hanrotter rapporteret om nedsat fertilitet og delvist reversible reduktioner i spermietallet.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: • Withdraw the required amount of concentrate-solvent mixture (containing temsirolimus 10 mg/ml) from the vial; i.e., 2.5 ml for a temsirolimus dose of 25 mg.
Danish: • Træk den ønskede mængde af koncentrat-solvens-blandingen (indeholdende 10 mg/ml temsirolimus) op af hætteglasset, d.v.s. 2,5 ml til en temsirolimus-dosis på 25 mg.
English: Patients administered the higher dose of 175 mg of temsirolimus for the initial treatment of MCL may receive up to 4.85 g of ethanol (equivalent to 123 ml beer or 51 ml wine per dose).
Danish: Patienter, der får den høje dosis på 175 mg temsirolimus til den initiale behandling af MCL, kan få op til 4,85 g ethanol (svarende til 123 ml øl eller 51 ml vin).
English: Serious adverse reactions observed in clinical trials of temsirolimus for MCL, but not in clinical trials of temsirolimus for advanced RCC include: thrombocytopenia, and neutropenia (including febrile neutropenia).
Danish: Alvorlige bivirkninger, set i kliniske studier af temsirolimus til MCL, men ikke i kliniske studier af temsirolimus til fremskredent RCC, omfatter: trombocytopeni og neutropeni (herunder febril neutropeni).
English: In the RCC clinical trial 1, hyperlipaemia was reported as an adverse event in 27% of patients.
Danish: I RCC-klinisk studie 1 blev hyperlipæmi rapporteret som bivirkning hos 27 % af patienterne.
English: The occurrence of undesirable effects following the dose of 175 mg temsirolimus/week for MCL, e.g. Grade 3 or 4 infections or thrombocytopenia, is associated with a higher incidence than that observed with either 75 mg temsirolimus/week or conventional chemotherapy.
Danish: Forekomsten af bivirkninger efter dosering på 175 mg temsirolimus/uge til MCL f.eks. grad 3 eller 4 infektioner eller trombocytopeni er højere end den forekomst, der ses ved 75 mg temsirolimus/uge eller konventionel kemoterapi.
English: Conjunctivitis (including conjunctivitis, lacrimal disorder) Uncommon Eye haemorrhage*** Cardiac disorders Uncommon Pericardial effusion Vascular disorders Common
Danish: Almindelig Conjunctivitis (herunder conjunctivitis, unormal tåresekretion) Ikke almindelig Øjenblødning***
English: if you are allergic to temsirolimus, to polysorbate 80 or to any of the other ingredients listed in section 6. if you are allergic to sirolimus (used to prevent the body from rejecting transplanted kidneys) since sirolimus is released from temsirolimus in the body.
Danish: - hvis du er allergisk over for sirolimus (bruges til at forebygge, at kroppen afstøder transplanterede nyrer), da sirolimus frigives fra temsirolimus i kroppen.
English: Depression Anxiety
Danish: Almindelig Depression Angst
English: Sími: +354 540 8000
Danish: Simi:+354 540 8000
English: Patients receiving the higher dose of 175 mg of Torisel for the initial treatment of mantle cell lymphoma may receive a dose of ethanol equivalent to up to 123 ml beer or 51 ml wine per dose.
Danish: Patienter, der får den høje dosis på 175 mg Torisel til den initiale behandling af mantlecellelymfom, kan få en alkoholdosis, der svarer til 123 ml øl eller 51 ml vin per dosis.
English: Torisel is a concentrate and solvent for solution for infusion.
Danish: Torisel er et koncentrat og solvens til infusionsvæske, opløsning.
English: Temsirolimus should not be used in patients with MCL and moderate or severe hepatic impairment (see section 4.3).
Danish: Temsirolimus bør ikke anvendes hos patienter med MCL og moderat eller svær leverinsufficiens (se pkt.
English: Temsirolimus is a selective inhibitor of the enzyme mTOR (mammalian target of rapamycin) that blocks tumour cell growth and division.
Danish: Temsirolimus er en selektiv hæmmer af enzymet mTOR (mål for rapamycin hos pattedyr), som blokerer vækst og deling af kræftceller.
English: Previously treated mantle cell lymphoma, a type of cancer affecting the lymph nodes.
Danish: - fremskreden nyrekræft - tidligere behandlet mantlecellelymfom, en form for kræft som påvirker lymfekirtlerne
English: No dose adjustment is recommended for patients with advanced -RCC and mild to moderate hepatic impairment.
Danish: Der anbefales ingen dosisjustering hos patienter med fremskreden RCC og let til moderat leverinsufficiens.
English: The possible development of lymphoma and other malignancies, particularly of the skin, may result from immunosuppression.
Danish: Immunosuppression kan potentielt medføre udvikling af lymfomer og andre maligniteter, især i huden.
English: Age does not appear to affect temsirolimus and sirolimus pharmacokinetics significantly.
Danish: Tilsyneladende påvirker alder ikke kinetikken signifikant for temsirolimus og sirolimus.
English: Renal failure (including fatal outcomes) has been observed in patients receiving temsirolimus for advanced RCC and/or with pre-existing renal insufficiency (see section 4.8).
Danish: Der er set nyresvigt (herunder letale tilfælde) hos patienter, der har fået temsirolimus mod fremskreden RCC og/eller patienter med præeksisterende nyreinsufficiens (se pkt.
English: Very common Bacterial and viral infections (including infection, viral infection, cellulitis, herpes zoster, oral herpes, influenza, herpes simplex, herpes zoster ophthalmic, herpes virus infection, bacterial infection, bronchitis*, abscess, wound infection, post-operative wound infections) Pneumoniaa (including interstitial pneumonia)
Danish: Bakterie- og virusinfektioner (herunder infektion, virusinfektion, cellulitis, herpes zoster, influenza, herpes simplex, herpes ophthalmicus, herpesvirusinfektion, bakterieinfektion, bronkitis*, absces, sårinfektion, postoperative sårinfektioner
English: protease inhibitors used in the treatment of Human Immunodeficiency Virus (HIV) antibiotics (including rifampicin) or antifungal medicines (including itraconazole, ketoconazole and voriconazole) used to treat infections nefazodone or selective serotonin re-uptake inhibitors used to treat depression anti-epileptic medicines, including carbamazepine, phenytoin and phenobarbital rifabutin used to treat infection in people with HIV and other diseases herbal medicines or natural remedies containing St. John's wort (Hypericum perforatum) used to treat mild depression angiotensin converting enzyme (ACE) inhibitors (such as enalapril, ramipril, lisinopril) or a calcium channel blocker (such as amlodipine) used to treat high blood pressure or other cardiovascular problems amphiphilic medicines used to treat heart arrhythmias (such as amiodarone), or statins used to treat high cholesterol sunitinib used to treat cancer of the kidney medicines which are P-gp substrates (such as digoxin, vincristine, colchicine, dabigatran, lenalidomide, paclitaxel)
Danish: - proteasehæmmere, der anvendes til behandling af hiv (human immundefekt virus) - antibiotika (herunder rifampin) eller svampedræbende medicin (herunder itraconazol, ketoconazol og voriconazol), der anvendes til behandling af infektioner - nefazodon eller selektive serotonin re-uptake-hæmmere, der anvendes til behandling af depression - medicin mod epilepsi herunder carbamazepin, phenytoin og phenobarbital - rifabutin, der anvendes til at behandle infektion hos patienter med HIV og andre sygdomme - naturlægemidler indeholdende perikon (Hypericum perforatum), der anvendes til behandling af nedtrykthed - angiotensin-konverterende enzymhæmmere (ACE-hæmmere) (såsom enalapril, ramipril, lisinopril) eller en calciumantagonist (såsom amlodipin), der anvendes til at behandle forhøjet blodtryk eller andre hjertekarsygdomme - amfifile lægemidler, der anvendes til at behandle uregelmæssig hjerterytme (som f.eks. amiodaron) eller statiner, der anvendes til at behandle højt kolesterol i blodet - sunitinib, der anvendes til behandling af nyrekræft - medicin, som kaldes P-gp-substrater (f.eks digoxin, vincristin, colchicin, dabigatran, lenalidomid, paclitaxel).
English: Cytotoxic
Danish: Cytotoksisk
English: After first dilution of Torisel 30 mg concentrate with 1.8 ml of the supplied solvent 24 hours when stored below 25°C and protected from light.
Danish: Efter første fortynding af Torisel 30 mg koncentrat med 1,8 ml af den medfølgende solvens: 24 timer ved opbevaring ved temperaturer under 25 °C og beskyttet mod lys.
English: Median overall survival, Months (95% CI) Median progression-free survival by independent assessment
Danish: Median progressionsfri overlevelse ved uafhængig vurdering Måneder (95% CI) Median progressionsfri overlevelse efter investigatorens vurdering
English: Based on a whole blood mean Cmax concentration of 2.6 μM for temsirolimus in MCL patients receiving the 175 mg dose there is a potential for interactions with concomitantly administered medicinal products that are substrates of CYP3A4/5 in patients treated with the 175 mg dose of temsirolimus (see section 4.5).
Danish: Baseret på middel Cmax-temsirolimus-koncentrationer i helblod på 2,6 µM hos MCL-patienter, som fik en dosis på 175 mg, er der en risiko for interaktioner med samtidigt indgivne lægemidler, som er substrater for CYP3A4/5 hos patienter behandlet med en temsirolimusdosis på 175 mg (se pkt.
English: You should seek medical advice immediately if you have acute abdominal pain, high fever, nausea and vomiting, or blood in the stools.
Danish: Kontakt straks læge, hvis du får akutte mavesmerter, høj feber, kvalme og opkastning eller blod i afføringen.
English: Concomitant treatment with moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, clarithromycin, erythromycin, aprepitant, amiodarone) should only be administered with caution in patients receiving 25 mg and should be avoided in patients receiving temsirolimus doses higher than 25 mg.
Danish: Samtidig behandling med moderate CYP3A4-hæmmere (f.eks. diltiazem, verapamil, chlarithromycin, erythromycin, aprepitant, amiodaron) bør gennemføres med forsigtighed hos patienter, som får 25 mg, og bør undgås hos patienter, som får højere doser temsirolimus end 25 mg.
English: If you experience any of these during the administration of Torisel, the doctor or nurse will stop the infusion.
Danish: Hvis du får nogle af disse symptomer, vil lægen eller sygeplejersken afbryde behandlingen.
English: Increased alanine aminotransferase a: One fatal case b: One pleural effusion fatal event occurred in the low-dose (175/25 mg) arm of the MCL study *Most NCI-CTC Grade 3 and above reactions observed in clinical trials of temsirolimus for MCL ** Most NCI-CTC all grades reactions observed in clinical trials of temsirolimus for MCL *** All NCI-CTC Grade 1 and 2 reactions observed in clinical trials of temsirolimus for MCL ****Interstitial lung disease is defined by a cluster of related Preferred Terms: interstitial lung disease (n = 6), pneumonitisa (n = 7), alveolitis (n = 1), alveolitis allergic (n = 1), pulmonary fibrosis (n = 1)
Danish: Almindelig Øget aspartataminotransferase Almindelig Øget alaninaminotransferase a: 1 dødeligt tilfælde b: 1 dødeligt tilfælde af pleural effusion forekom i MCL-forsøgets lavdosis-arm (175/25 mg) * Flest NCI-CTC grad 3 bivirkninger og derover set i kliniske studier med temsirolimus til MCL ** Flest NCI-CTC bivirkninger af alle grader set i kliniske studier med temsirolimus til MCL *** Alle NCI-CTC grad 1 og 2 bivirkninger set i kliniske studier med temsirolimus til MCL
English: In male rats, decreased fertility and partly reversible reductions in sperm counts were reported (see section 5.3).
Danish: Hos hanrotter er der rapporteret om nedsat fertilitet og delvist reversibel reduktion i spermtallene (se pkt.
English: For patients with severe hepatic impairment, a reduction of the temsirolimus dose to 10 mg is recommended to provide temsirolimus plus sirolimus exposures in blood (mean AUCsum approximately 6510 ng·h/ml; n=7), which approximate to those following the 25 mg dose (mean AUCsum approximately 6580 ng·h/ml; n=6) in patients with normal liver function (see sections 4.2 and 4.4).
Danish: Til patienter med svær leverinsufficiens anbefales reduktion af temsirolimusdosis til10 mg for at opnå eksponering af temsirolimus plus sirolimus (middel-AUCsum cirka 6.510 ng•h/ml; n=7) i blodet, som nærmer sig niveauerne efter en dosis på 25 mg (middel-AUCsum 6.580 ng•h/ml; n=6) hos patienter med normal leverfunktion (se pkt.
English: Men with partners of childbearing potential should use medically acceptable contraception while receiving Torisel (see section 5.3).
Danish: Mænd, der har en partner i den fertile alder, bør anvende sikker kontraception, mens de får Torisel (se pkt.
English: Agents such as protease inhibitors (nelfinavir, ritonavir), antifungals (e.g. itraconazole, ketoconazole, voriconazole), and nefazodone are strong CYP3A4 inhibitors and may increase blood concentrations of the active drug substances, temsirolimus and its metabolite, sirolimus.
Danish: Stoffer såsom proteasehæmmere (nelfinavir, ritonavir), antimykotika, (som f.eks. itraconazol, ketoconazol, voriconazol) og nefazodon er stærke CYP3A4-hæmmere og kan øge blodkoncentrationerne af de aktive lægemiddelstoffer, temsirolimus og dets metabolit sirolimus.
English: Following a single 25 mg intravenous dose of temsirolimus, temsirolimus mean ± SD systemic clearance from whole blood was 11.4 ± 2.4 l/h.
Danish: Efter en enkelt intravenøs dosis på 25 mg temsirolimus, var middel  SD systemisk clearance for temsirolimus fra helblod 11,4  2,4 l/t.
English: 25 mg a In the MCL clinical trial, up to two dose level reductions were allowed per patient.
Danish: I MCL-studiet var det tilladt at reducere dosisniveauet op til to gange hos hver patient.
English: These symptoms might be caused by a bleeding in the brain.
Danish: Disse symptomer kan skyldes en blodprop i lungen.
English: The recommended dose of temsirolimus for advanced RCC is 25 mg administered by intravenous infusion over a 30- to 60-minute period once a week.
Danish: Den anbefalede dosis af temsirolimus til fremskredent RCC er 25 mg som intravenøs infusion over 30 til 60 minutter en gang om ugen.
English: For patients with MCL, it is recommended that coadministration of CYP3A4/5 inducers should be avoided due to the higher dose of temsirolimus (see section 4.5).
Danish: Samtidig indgivelse af CYP3A4/5-induktorer til patienter med MCL bør undgås på grund af den højere dosis temsirolimus (se pkt.
English: You should also tell your doctor straight away: if you have cough, chest pain, difficulties in breathing.
Danish: Kontakt også straks lægen: - hvis du får hoste, brystsmerter, vejrtrækningsbesvær.
English: It is important that the recommendations in section 4.2 be followed closely.
Danish: Det er vigtigt, at anbefalingerne i pkt.
English: The recommended dosing regimen of temsirolimus for MCL is 175 mg, infused over a 30-60 minute period once a week for 3 weeks followed by weekly doses of 75 mg, infused over a 30-60 minute period.
Danish: Det anbefalede doseringsregime for temsirolimus mod MCL er 175 mg, der infunderes over en periode på 30-60 minutter én gang om ugen i 3 uger, efterfulgt af ugentlige doser på 75 mg, der infunderes over en periode på 30-60 minutter.
English: if you have or have had inflammation of the lungs.
Danish: - hvis du har eller har haft en betændelseslignende tilstand i lungerne.
English: • Appropriate administration materials must be used to avoid excessive loss of medicinal product and to decrease the rate of DEHP extraction.
Danish: • Hensigtsmæssige materialer til indgivelse skal anvendes for at undgå for kraftigt tab af lægemiddel og for at nedsætte ekstraktionsgraden af DEHP. Materialerne til indgivelse skal bestå af slanger med et passende filter af non-DEHP, non-PVC.
English: Anhydrous ethanol all-rac-α-Tocopherol (E 307) Propylene glycol Citric acid (E 330)
Danish: Vandfri ethanol All-rac--tocopherol (E 307) Propylenglycol Citronsyre (E 330)
English: Angioneurotic oedema-type reactions
Danish: Angioødem-lignende reaktioner