FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinically relevant toxicity that was reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Danish: Klinisk relevant toksicitet, som blev rapporteret hos < 1 % af de patienter, som blev randomiseret til at få cisplatin og pemetrexed, omfattede: forhøjet GGT, brystsmerter, arytmier og motorisk neuropati.
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Danish: Den passende mængde rekonstitueret pemetrexedopløsning skal fortyndes yderligere til 100 ml med 0,9% natriumchloridinjektionsvæske, uden konserveringsmiddel, og indgives som langsom intravenøs infusion over 10 minutter.
English: For patients with NSCLC other than predominantly squamous cell histology (n = 430, independently reviewed population) median PFS was 4.4 months for the ALIMTA arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p = 0.00001).
Danish: For patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 430), uafhængig overvåget population) var middel PFS 4,4 måneder for ALIMTA-delen og 1,8 måneder for placebodelen, hazard ratio = 0,47, 95% CI = 0,37-0,60; p=0,00001.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Danish: De klinisk relevante CTC-toksiciteter af enhver grad, der blev rapporteret hos ≥1% og ≤5% af de patienter, som var randomiseret til pemetrexed, omfatter: febril neutropeni, infektion, nedsat antal blodplader, diarré, forstoppelse, alopeci, kløe, feber (uden neutropeni), sygdom i øjets overflade (inklusive konjunktivitis), øget tåreflåd, svimmelhed og motorisk neuropati.
English: ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion
Danish: ALIMTA 100 mg pulver til koncentrat til infusionsvæske, opløsning ALIMTA 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Squamous cell (N=473)
Danish: Pladeepitelceller (N=473)
English: Pemetrexed/cisplatin
Danish: Hyppighed Bivirkning* Pemetrexed/cisplatin
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Danish: Den passende mængde rekonstituerede pemetrexedopløsning skal fortyndes yderligere til 100 ml med 0,9 %-natriumchloridinjektionsvæske, uden konserveringsmiddel, og indgives som langsom intravenøs infusion over 10 minutter.
English: ALIMTA 100 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 100 mg of pemetrexed.
Danish: ALIMTA 100 mg pulver til koncentrat til infusionsvæske, opløsning Hætteglas af type I med gummiprop, der indeholder 100 mg pemetrexed.
English: For Precautions to be taken before handling or administering ALIMTA, see section 6.6.
Danish: For information om sikkerhedsforanstaltninger, der skal tages før håndtering og administration af ALIMTA, se pkt.
English: ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section
Danish: ALIMTA er indiceret som 2. linjes monoterapi til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: ALIMTA 500 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 500 mg of pemetrexed.
Danish: ALIMTA 500 mg pulver til koncentrat til infusionsvæske, opløsning Hætteglas af type I med gummiprop, der indeholder 500 mg pemetrexed.
English: Patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/or after receiving cisplatin (see also cisplatin Summary of Product Characteristics for specific dosing advice).
Danish: Patienten skal have modtaget passende antiemetisk behandling og relevant hydrering inden og/eller efter indgift af cisplatin.
English: Interstitial pneumonitis (scarring of the air sacs of the lung)
Danish: Interstitiel lungebetændelse (lungebetændelse med talrige små udbredte infektionsområder mellem alveolerne).
English: Conjunctivitis (inflamed eye)
Danish: Bindehindebetændelse (øjenbetændelse) Mavegener
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Danish: Klinisk relevant toksicitet, som blev rapporteret hos ≥ 1 % og ≤ 5 % af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: forhøjet AST, forhøjet ALT, infektion, febril neutropeni, nyresvigt, pyreksi, dehydrering, konjunktivitis og nedsat kreatininclearance.
English: Neuropathysensory
Danish: Sensorisk neuropati
English: Breast-feeding must be discontinued during ALIMTA treatment.
Danish: Amningen skal afbrydes under behandling med ALIMTA.
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Danish: De klinisk relevante CTC-toksiciteter, som blev rapporteret hos ≥ 1 % og < 5 % af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: nyresvigt, infektion, pyreksi, febril neutropeni, forhøjet ASAT, ALAT og GGT, nældefeber og brystsmerter.
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the ALIMTA arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Danish: Ved at inkludere induktionsfasen blev middel OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller 18,6 måneder for ALIMTA-delen og 13,6 måneder for placebodelen (hazard ratio=0,71, 95% CI = 0,56 - 0,88, p=0,002).
English: Common Constipation
Danish: Almindelig Konjunctivitis
English: ALIMTA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: ALIMTA er indiceret til behandling sammen med cisplatin, som 1. linje-behandling til patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: Extravasation should be managed by local standard practice as with other non-vesicants.
Danish: Som med andre ikkeblæretrækkende stoffer skal eventuel ekstravasation håndteres i henhold til lokal standardpraksis.
English: As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Danish: Forsigtighedsregler i forbindelse med forberedelse og administration Som med et hvilket som helst andet potentielt toksisk lægemiddel til behandling af kræft skal der udvises forsigtighed ved håndtering og forberedelse af infusionsopløsninger af pemetrexed.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the ALIMTA arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Danish: Den gennemsnitlige OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 481) var 15,5 måneder for ALIMTA-delen og 10,3 måneder for placeboarmen (hazard ratio = 0,70, 95% CI = 0,56 - 0,88, p = 0,002).
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 800 patients randomly assigned to receive single agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
Danish: Bivirkningerne blev rapporteret hos > 5 % af de 800 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed, og de 402 patienter, som var randomiseret til placebo i studiet med pemetrexed vedligeholdelsesbehandling (JMEN: N=663) og studiet med pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling (PARAMOUNT: N=539).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatrium).
English: ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: ALIMTA 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed
Danish: ALIMTA 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of ALIMTA versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR = 0.78; 95% CI = 0 .61-1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n = 172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95% CI = 1.08-2.26, p = 0.018).
Danish: versus 8,0 måneder, justeret HR= 0,78; 95 % CI= 0,61-1,00; p= 0,047) og til fordel for docetaxel for carcinom af pladeepitelceller (n= 172; 6,2 versus 7,4 måneder, justeret HR = 1,56; 95 % CI= 1,082,26; p= 0,0018).
English: What ALIMTA contains
Danish: ALIMTA indeholder:
English: 100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity In the event of neurotoxicity, the recommended dose adjustment for ALIMTA and cisplatin is documented in Table 3.
Danish: 100 % af tidligere dosis a National Cancer Institute Common Toxicity Criteria (CTC v 2.0; NCI 1998) b Undtagen neurotoksicitet
English: ALIMTA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Danish: ALIMTA 100 mg: Hvert hætteglas indeholder 100 milligram pemetrexed (som pemetrexeddinatrium) ALIMTA 500 mg: Hvert hætteglas indeholder 500 milligram pemetrexed (som pemetrexeddinatrium)
English: 8.3 months for patients treated with ALIMTA (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288).
Danish: Et åbent, randomiseret fase 3-multicenterstudie med ALIMTA versus docetaxel til patienter med lokalt fremskreden eller metastatisk NSCLC (ikke-småcellet lungekræft), der tidligere var behandlet med kemoterapi, har vist en median-overlevelsestid på 8,3 måneder for patienter, som blev behandlet med ALIMTA (intent-to-treat-population n = 283), og 7,9 måneder for patienter, som blev behandlet med docetaxel (ITT n = 288).
English: Common Dyspepsia/ Heartburn
Danish: Almindelig Dyspepsi/ halsbrand
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatrium).
English: Each vial contains approximately 11 mg sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hvert hætteglas indeholder ca. 11 mg natrium.
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with ALIMTA/ radiation therapy.
Danish: Betændelse i spiserørets overflade er forekommet med ALIMTA i kombination med strålebehandling.
English: Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
Danish: Amning skal ophøre under behandling med pemetrexed se pkt.
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of ALIMTA plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the ALIMTA arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95% CI = 0.47-0.74).
Danish: Investigatorernes mediane PFS-vurdering for de randomiserede patienter var 6,9 måneder for ALIMTA-armen og 5,6 måneder for placebo-armen (hazard ratio = 0,59; 95% CI = 0,47-0,74) målt fra start af ALIMTA og cisplatin førstelinje-induktionsbehandling.
English: Loss of sensation
Danish: Hudirritation og -kløe
English: QUALITATIVE AND QUANTITATIVE COMPOSITION ALIMTA 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Danish: ALIMTA 100 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatrium).
English: For the purpose of this table a cut off of 5 % was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Danish: Til denne tabel blev der anvendt en afskæringsværdi på 5 % til inkludering af alle hændelser, hvor indberetteren anså, at bivirkningen muligvis var forbundet med pemetrexed og cisplatin.
English: Renal and urinary disorders
Danish: Nyrer og urinveje Almindelig Nyresygdomme**
English: Stomatitis/
Danish: Mavesmerter
English: Table 1 - Dose modification table for ALIMTA (as single agent or in combination) and cisplatin - Haematologic toxicities Nadir ANC < 500 /mm3 and nadir platelets ≥ 50,000 /mm3
Danish: ANC-nadir < 500 /mm3 og nadir for trombocytter ≥ 50.000 /mm3
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hvert hætteglas med 100 mg rekonstitueres med 4,2 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hvert hætteglas med 500 mg rekonstitueres med 20 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Haemoglobin decreased
Danish: Nedsat trombocytter
English: NAME OF THE MEDICINAL PRODUCT ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ALIMTA 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Hemoglobin decreased Neutrophils/ Granulocytes decreased Leukocytes Decreased Platelets Decreased
Danish: Nedsat hæmoglobin Almindelig Nedsat leukocytttal Nedsat neutrofilocyttal
English: Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hætteglas med 100 mg rekonstitueres med 4,2 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hætteglas med 500 mg rekonstitueres med 20 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: NAME OF THE MEDICINAL PRODUCT ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ALIMTA 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: For the purpose of this table a cut off of 5 % was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed.
Danish: Til denne tabel blev der anvendt en afskæringsværdi på 5 % til inkludering af alle hændelser, hvor indberetteren anså, at bivirkningen muligvis var forbundet med pemetrexed.
English: Each vial contains approximately 54 mg sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hvert hætteglas indeholder ca. 54 mg natrium.
English: What ALIMTA is and what it is used for What you need to know before you use ALIMTA How to use ALIMTA
Danish: Det skal De vide, før De begynder at bruge ALIMTA Sådan skal De bruge ALIMTA Bivirkninger
English: Upset stomach
Danish: Brystsmerter
English: VIAL LABEL
Danish: Udslæt/ hudafskalning
English: Blood clots in the lung blood vessels (pulmonary embolism)
Danish: Smerter i arme og ben, lav temperatur og misfarvning er indberettet Blodpropper i lungernes blodårer (lungeemboli)
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Danish: 6.6) indeholder hvert hætteglas 25 mg/ml pemetrexed.
English: Skin and subcutaneous tissue disorders Common
Danish: Nedsat hæmoglobin Almindelig Nedsat trombocytter
English: Grade 34 toxicity
Danish: Toksicitet i grad 3-4
English: Loss of appetite
Danish: Nyrer og urinveje
English: Hop strobile EMA/304459/2016
Danish: september 2016 EMA/304459/2016
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: Det betyder, at selvom der ikke foreligger tilstrækkelig dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og at der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (herunder mindst 15 år i EU).
English: Hop strobile medicines should only be used in adults and adolescents over the age of 12 years.
Danish: Lægemidler med humlekopper bør kun anvendes til voksne og børn over 12 år.
English: If symptoms last more than two weeks or worsen during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Danish: Hvis symptomerne varer længere end to uger eller forværres under brug af lægemidlet, bør der søges råd hos en læge eller en kvalificeret sundhedsperson.
English: Hop strobile
Danish: Humlekopper
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/304459/2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: Hop strobile preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af humlekopper findes desuden kombineret med andre droger i visse plantelægemidler.
English: Any applications for the licensing of medicines containing hop strobile have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder humlekopper, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: What is hop strobile?
Danish: Hvad er humlekopper?
English: Information on the use and licensing of hop strobile medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder humlekopper, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of hop strobile.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af humlekopper.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing hop strobile.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder humlekopper.
English: Further information on the HMPC assessment of hop strobile medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder humlekopper, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: "ema.europa.eu/Find medicine/Herbal medicines for human use".
English: Extracts are obtained by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Danish: Ekstrakterne fremstilles ved at udtrække stoffer fra plantematerialet i et opløsningsmiddel (f.eks. ethanol) e. Herved fås et flydende ekstrakt.
English: Other information about hop strobile medicines
Danish: Andre oplysninger om lægemidler, der indeholder humlekopper
English: Detailed instructions on how to take hop strobile medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med humlekopper bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Further information on the risks associated with these hop strobile medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder humlekopper, herunder passende forholdsregler, der skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: "ema.europa.eu/Find medicine/Herbal medicines for human use".
English: This summary is not intended to provide practical advice on how to use medicines containing hop strobile.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder humlekopper, skal anvendes.
English: The HMPC also considered clinical studies but since these studies used combinations of hop strobile and valerian root preparations to aid sleep, firm conclusions on the effects of hop strobile could not be drawn.
Danish: HMPC har også taget hensyn til kliniske undersøgelser, men da disse undersøgelser anvendte kombinationer af humlekopper og baldrianrod til at gøre det lettere at falde i søvn, kan der ikke drages endelige konklusioner om virkningen af humlekopper.
English: Therefore, the HMPC conclusions on the use of these hop strobile medicines are based on their long-standing use.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med humlekopper er derfor baseret på den mangeårige traditionelle anvendelse.