FrancophonIA/ELRC3.0 huggingface dataset:
English: One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.
Danish: Et hætteglas med injektionsvæske, opløsning indeholder 0,9 ml opløsning, svarende til 6,75 mg atosiban.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Atosiban SUN 37.5 mg/5 ml sterile concentrate atosiban
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Atosiban SUN 37,5 mg/5 ml koncentrat, sterilt atosiban
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Atosiban SUN 6.75 mg/0.9 ml injection atosiban
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Atosiban SUN 6,75 mg/0,9 ml injektionsvæske atosiban
English: NAME OF THE MEDICINAL PRODUCT Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion atosiban
Danish: LÆGEMIDLETS NAVN Atosiban SUN 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning
English: Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion atosiban
Danish: Atosiban SUN 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning atosiban
English: NAME OF THE MEDICINAL PRODUCT Atosiban SUN 6.75 mg/0.9 ml solution for injection
Danish: LÆGEMIDLETS NAVN Atosiban SUN 6,75 mg/0,9 ml injektionsvæske, opløsning
English: In women in pre-term labour receiving atosiban by infusion (300 micrograms/min for 6 to 12 hours), steady state plasma concentrations were reached within one hour following the start of the infusion (mean 442 ± 73 ng/ml, range 298 to 533 ng/ml).
Danish: Hos kvinder i for tidlig fødsel, der modtog atosiban ved infusion (300 mikrogram/min i 6 til 12 timer), blev steady state plasmakoncentrationer nået inden for en time efter infusionens start (middelværdi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 0.9 ml solution contains 6.75 mg of atosiban (as acetate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 0,9 ml opløsning indeholder 6,75 mg atosiban (som acetat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 5 ml solution contains 37.5 mg of atosiban (as acetate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 5 ml opløsning indeholder 37,5 mg atosiban (som acetat).
English: Atosiban SUN contains atosiban.
Danish: Virkning og anvendelse Atosiban SUN indeholder atosiban.
English: - Fast heart beat.
Danish: - en normal føtal hjertefrekvens.
English: Rambla de Catalunya 53-55 08007 Barcelona España tel. +34 93 342 78 90
Danish: Rambla de Catalunya 53-55
English: What Atosiban SUN looks like and contents of the pack Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles.
Danish: Atosiban SUN 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning er en klar, farveløs opløsning uden partikler.
English: Atosiban SUN 6.75 mg/0.9 ml solution for injection atosiban
Danish: Atosiban SUN 6,75 mg/0,9 ml injektionsvæske, opløsning atosiban
English: Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Atosiban SUN Fortæl det altid til lægen, jordemoderen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
Danish: Hvert hætteglas med 0,9 ml opløsning indeholder 6,75 mg atosiban (som acetat).
English: Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with: - regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes - a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50% - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate
Danish: 30 minutter - en cervikal dilatation på 1 til 3 cm (0-3 hos nullipara) og en udslettelse på ≥50 %
English: - Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to
Danish: - Derefter gives der yderligere en uafbrudt infusion (drop) med en dosis på 6 mg/time i op til 45 timer, eller indtil sammentrækningerne af livmoderen er stilnet af.
English: Ranbaxy Italia S.p.A. Viale Giulio Richard, 1 20143 Milano Italia tel. +39 02 33 49 07 93
Danish: Italia tel. +39 02 33 49 07 93
English: Not applicable
Danish: Intravenøs anvendelse
English: - If you have any further questions, ask your doctor, midwife or pharmacist.
Danish: - Spørg lægen, apotekspersonalet eller jordemoderen, hvis der er mere, du vil vide.
English: - If you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions).
Danish: Alvorlig svangerskabsforgiftning er en tilstand med forhøjet blodtryk, væskeophobning og/eller protein i urinen - hvis du har fødekramper (eklampsi), der svarer til "alvorlig svangerskabsforgiftning", men desuden ledsaget af kramper.
English: The full EPAR for the reference medicines can also be found on the Agency's website.
Danish: Den fuldstændige EPAR for referencelægemidlerne findes også på agenturets websted.
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Danish: Det kaldes et »atypisk« antipsykotisk lægemiddel, fordi det adskiller sig fra de ældre antipsykotiske lægemidler, der har været på markedet siden 1950'erne.
English: It is available as orodispersible tablets (5, 10, 15 and 20 mg).
Danish: Det fås som smeltetabletter (5, 10, 15 og 20 mg).
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Danish: Skizofreni er en psykisk sygdom med en række symptomer, herunder desorganiseret tankegang og tale, hallucinationer (opfattelsen af at høre eller se ting, som ikke er der), mistænksomhed og vrangforestillinger (forestillinger, der er ude af trit med virkeligheden).
English: The full EPAR for Olanzapine Glenmark Europe can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Olanzapine Glenmark Europe findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended starting dose of Olanzapine Glenmark Europe depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Danish: Den anbefalede startdosis af Olanzapine Glenmark Europe afhænger af, hvilken sygdom der behandles: Der anvendes 10 mg om dagen til skizofreni og forebyggelse af maniske episoder og 15 mg om dagen til behandling af maniske episoder, medmindre det anvendes sammen med andre lægemidler.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Danish: Derved afbrydes de signaler, som hjernecellerne sender til hinanden ved hjælp af »neurotransmittere«, dvs. kemiske stoffer, som nervecellerne bruger til at kommunikere indbyrdes.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Olanzapine Glenmark Europe.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Olanzapine Glenmark Europe skal anvendes.
English: For more information about treatment with Olanzapine Glenmark Europe, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Olanzapine Glenmark Europe, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment.
Danish: Det kan endvidere anvendes til at forebygge tilbagefald af sådanne episoder ved bipolar sygdom (en psykisk lidelse, hvor patienten svinger mellem højt humør og depression) hos voksne, der har reageret på det første behandlingsforløb.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Glenmark Europe on 3 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Olanzapine Glenmark Europe den 3. december 2009.
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Glenmark Europe.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Olanzapine Glenmark Europe.
English: Olanzapine Glenmark Europe is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Danish: Olanzapine Glenmark Europe anvendes ligeledes til at behandle moderate til svære maniske episoder (ekstremt højt humør) hos voksne.
English: Olanzapine Glenmark Europe is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Danish: Olanzapine Glenmark Europe er også effektivt til at fastholde den kliniske bedring ved fortsat behandling af patienter, der har reageret på det første behandlingsforløb.
English: This means that Olanzapine Glenmark Europe is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotabs.
Danish: Det betyder, at Olanzapine Glenmark Europe er identisk med »referencelægemidler«, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zyprexa og Zyprexa Velotab.
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Glenmark Europe has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Olanzapin Glenmark Europe er af sammenlignelig kvalitet og er bioækvivalent/sammenlignelig med Zyprexa og Zyprexa Velotab.
English: Olanzapine Glenmark Europe is used to treat adults with schizophrenia.
Danish: Olanzapine Glenmark Europe anvendes til behandling af voksne med skizofreni.
English: The active substance in Olanzapine Glenmark Europe, olanzapine, is an antipsychotic medicine.
Danish: Det aktive stof i Olanzapine Glenmark Europe, olanzapin, er et antipsykotisk lægemiddel.
English: Because Olanzapine Glenmark Europe is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicines.
Danish: Da Olanzapine Glenmark Europe er et generisk lægemiddel, som er bioækvivalent med referencelægemidlerne, anses benefit/risk-forholdet for at være det samme som for referencelægemidlerne.
English: Olanzapine Glenmark Europe is a medicine containing the active substance olanzapine.
Danish: Olanzapine Glenmark Europe er et lægemiddel, som indeholder det aktive stof olanzapin.
English: Olanzapine Glenmark Europe is a ‘generic medicine'.
Danish: Olanzapine Glenmark Europe er et »generisk lægemiddel«.
English: Because Olanzapine Glenmark Europe is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab.
Danish: Da Olanzapine Glenmark Europe er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlerne Zyprexa og Zyprexa Velotab.
English: Other information about Olanzapine Glenmark Europe
Danish: Andre oplysninger om Olanzapine Glenmark Europe
English: The Committee recommended that Olanzapine Glenmark Europe be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Olanzapine Glenmark Europe.
English: What are the benefits and risks of Olanzapine Glenmark Europe?
Danish: Hvilken fordel og risiko er der forbundet med Olanzapine Glenmark Europe?
English: Why has Olanzapine Glenmark Europe been approved?
Danish: Hvorfor blev Olanzapine Glenmark Europe godkendt?
English: What is Olanzapine Glenmark Europe?
Danish: Hvad er Olanzapine Glenmark Europe?
English: How has Olanzapine Glenmark Europe been studied?
Danish: Hvordan blev Olanzapine Glenmark Europe undersøgt?
English: What is Olanzapine Glenmark Europe used for?
Danish: Hvad anvendes Olanzapine Glenmark Europe til?
English: How is Olanzapine Glenmark Europe used?
Danish: Hvordan anvendes Olanzapine Glenmark Europe?
English: How does Olanzapine Glenmark Europe work?
Danish: Hvordan virker Olanzapine Glenmark Europe?
English: The overall conclusion is that proposed plan presented by Baxter is acceptable.
Danish: Den samlede konklusion er, at den foreslåede plan, som Baxter har fremlagt, er acceptabel.
English: The issue was resolved from a chemical-pharmaceutical point of view.
Danish: Spørgsmålet blev løst ud fra et kemisk-farmaceutisk synspunkt.
English: Both issues were considered potential serious risks to public health and were the basis for triggering the referral.
Danish: Begge spørgsmål blev anset for at udgøre potentielle alvorlige risici for den offentlige sundhed og var årsag til indbringelsen.
English: Patient demand being unfulfilled is unacceptable.
Danish: Det er uacceptabelt, hvis patientefterspørgslen ikke bliver dækket.
English: 16494 Kista Sweden
Danish: 16494 Kista Sverige
English: In addition the new SLP-HS method will be implemented by the end of December 2009.
Danish: Desuden vil den nye SLP-HS-metode blive taget i brug inden udgangen af december 2009.
English: Previously this limit was not part of the finished product specification.
Danish: Tidligere var denne grænse ikke en del af produktspecifikationen for det færdige lægemiddel.
English: It corresponds to the limit of quantitation of the current SLP test.
Danish: Den svarer til kvantificeringsgrænsen i den nuværende SLP-test.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF EXTRANEAL
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF EXTRANEAL
English: Piazzale dell'Industria 20 00144 Roma Italy
Danish: Piazzale dell'Industria 20 00144 Roma Italien
English: The applicant gave a Letter of Undertaking and committed to resolve it as a Follow-up Measure after the opinion, within an agreed timeframe.
Danish: Ansøgeren fremsendte et tilsagnsbrev og forpligtede sig til at løse spørgsmålet som en opfølgningsforanstaltning efter udtalelsen inden for en aftalt tidsramme.
English: The applicant was asked therefore to set acceptable limits for PG with the improved method.
Danish: Ansøgeren blev derfor bedt om at fastlægge acceptable grænser for PG med den forbedrede metode.
English: 46394 Ribarroja del Turia (Valencia) Spain
Danish: 46394 Ribarroja del Turia (Valencia) Spanien
English: In view of the circumstances, the proposed limit for peptidoglycans in the aactive substance was considered acceptable until the end of the year.
Danish: Omstændighederne taget i betragtning blev den foreslåede grænse for peptidoglycaner i det aktive stof anset for at være acceptabel indtil årets udgang.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions relating to quality aspects are fulfilled by the Marketing Authorisation Holders within the specified time frame:
Danish: De kompetente nationale myndigheder, som koordineres af referencemedlemsstaten, skal sikre, at indehaverne af markedsføringstilladelse opfylder følgende betingelser vedrørende kvalitetsaspekter inden for den fastlagte tidsfrist:
English: At the time of the CHMP opinion, there were minor unresolved quality issues, which have no impact on the Benefit/Risk ratio of the product.
Danish: På det tidspunkt, hvor CHMP afgav sin udtalelse, var der mindre uløste kvalitetsspørgsmål, som ikke har nogen indflydelse på lægemidlets risk/benefit-forhold.
English: It is presented as a sterile solution in 1.5, 2.0 and 2.5 liter bags and it is intended for peritoneal dialysis.
Danish: Det fås som en steril opløsning i poser på 1,5, 2,0 og 2,5 liter, og det er beregnet til peritonealdialyse.
English: 15233 Halandri Athens Greece
Danish: 15233 Halandri Athens Grækenland
English: Extraneal is an isotonic solution of 7.5% icodextrin.
Danish: Extraneal er en isotonisk opløsning, der indeholder 7,5 % icodextrin.
English: All batches used icodextrin material supplied by the same manufacturer.
Danish: I alle batcher var der brugt icodextrinmateriale, som var leveret af den samme fremstiller.
English: It should allow on peptidoglycan limit for the drug product which is considered to be sufficiently low from a chemicalpharmaceutical and toxicological point of view.
Danish: Det burde give en peptidoglycangrænse for lægemidlet, som kan anses for at være tilstrækkeligt lav set ud fra et kemisk-farmaceutisk og toksikologisk synspunkt.
English: 85716 Unterschleissheim Germany
Danish: 85716 Unterschleissheim Tyskland
English: Boulevard R. Branquart 80 7680 Lessines Belgium
Danish: Boulevard R. Branquart 80 7680 Lessines Belgien
English: Moreover since it has not been possible to improve in short term manufacturing process of the active substance in one of currently approved manufacturing sites, this site will be removed by the end of the year for the European market and globally by the end of next year.
Danish: Eftersom det i løbet af kort tid ikke var muligt at forbedre fremstillingsprocessen for det aktive stof på et af de nuværende godkendte produktionssteder, vil dette produktionssted ikke længere fremstille til det europæiske marked fra årets udgang og til det globale marked fra udgangen af 2010.
English: It is expected that the peptidoglycan levels in the drug product are indirectly controlled as well as the active substance currently appears to be the only source of this contamination.
Danish: Det forventes, at peptidoglycanniveauerne i lægemidlet kontrolleres indirekte, og det lader i øjeblikket til, at det aktive stof er den eneste kilde til denne kontaminering.
English: The product also contains as active ingredients sodium lactate, sodium chloride, calcium chloride and magnesium chloride.
Danish: Andre aktive stoffer i lægemidlet er natriumlaktat, natriumchlorid, calciumchlorid og magnesiumchlorid.
English: It was concluded that the method of analysis was not able to detect the PG level precisely, accurately and consistently and hence does not support the proposed limit in the finished product.
Danish: Konklusionen var, at analysemetoden ikke var i stand til at vise PG-niveauet på en nøjagtig, korrekt og konsekvent måde og derfor ikke underbygger den foreslåede grænse i det færdige lægemiddel.
English: As no agreement was reached by NL on 9 July 2009 on the draft decision of the RMS, the procedure was referred to the CHMP according to Article 6(12) and the Referral procedure was initiated on 23 July 2009 with the adoption of a CHMP List of Questions to be addressed by the MAHs.
Danish: Eftersom Nederlandene ikke nåede til enighed den 9. juli 2009 om referencemedlemsstatens forslag til afgørelse, blev sagen indbragt for CHMP i henhold til artikel 6, stk. 12, og indbringelsesproceduren blev indledt den 23. juli 2009 med vedtagelsen af en liste over spørgsmål fra CHMP, som indehaverne af markedsføringstilladelsen skulle besvare.
English: Baxter A/S Gydevang 43 3450 Allerød Denmark
Danish: Baxter A/S Gydevang 43 3450 Allerød Danmark
English: Baxter S.A.S 6 av. Louis Pasteur 78310 Maurepas France
Danish: Baxter S.A.S 6 av. Louis Pasteur 78310 Maurepas Frankrig
English: This method is able to detect lower amounts of PG (i.e. 0.5 ng/ml) in the finished product.
Danish: Med denne metode er man i stand til at spore lavere mængder PG (dvs. 0,5 ng/ml) i det færdige lægemiddel.
English: - Variations to add the new SLP-HS method and limits to the active substance (API) and finished product specifications will be submitted no later than the end of December 2009;
Danish: - Ændringer vedrørende tilføjelsen af den nye SLP-HS-metode og grænseværdierne i specifikationerne for det aktive stof (API) og den endelige produktbeskrívelse indsendes senest ved udgangen af december 2009;
English: Nevertheless, in order to rule out contamination with PG from sources other than the API, peptidoglycan levels should be controlled at the lowest possible level in the drug product as well.
Danish: For at udelukke kontaminering med PG fra andre kilder end det aktive stof bør peptidoglycanniveauerne dog ligeledes kontrolleres på det lavest mulige niveau i lægemidlet.
English: - The Roquette Frères manufacturing site for the active substance will be removed from EU licences via appropriate variation procedure by February 2010.
Danish: - Produktionsstedet, Roquette Frères, for det aktive stof fratages licens via passende ændringsprocedure senest i februar 2010.
English: Extraneal is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on CAPD therapy in such patients.
Danish: Extraneal anbefales som en erstatning én gang om dagen af et enkelt glukoseskift som et led i en kontinuerlig ambulant peritonealdialyse (CAPD) eller automatiseret peritonealdialyse (APD) til behandling af kronisk nyresvigt, navnlig til patienter, for hvilke ultrafiltrering med glukoseopløsninger er opgivet, eftersom Extraneal kan forlænge tiden med CAPD-behandling hos sådanne patienter.
English: Historically the cause of PG induced peritonitis has always been linked with contaminated active substance.
Danish: Historisk set er årsagen til PG-fremkaldt peritonitis altid blevet sat i forbindelse med et kontamineret aktivt stof.
English: Following occurrence of increased reported cases of Aseptic Peritonitis (AP) in 2002 and then in 2007, Baxter committed to the Reference Member State (UK) to vary the marketing authorisation in order to include a peptidoglycan test to the drug product specification.
Danish: Efter forekomsten af et øget antal rapporterede tilfælde af aseptisk peritonitis (AP) i 2002 og herefter i 2007 lovede Baxter referencemedlemsstaten (Det Forenede Kongerige) at ændre markedsføringstilladelsen med henblik på at medtage en peptidoglycantest i lægemidlets produktspecifikation.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Controls over the active substance were therefore likely to limit the occurrence of peritonitis and ensure better control the finished product.
Danish: Derfor var det sandsynligt, at kontroller af det aktive stof ville begrænse forekomsten af peritonitis og sikre en bedre kontrol af det færdige lægemiddel.
English: Baxter agreed setting tighter specification limit for PG in the finished product together with a lower limit for PG in the active substance, to allow patients adequate safety margins.
Danish: Baxter sagde ja til at sætte en fastere specifikationsgrænse for PG i det færdige lægemiddel samt en lavere grænse for PG i det aktive stof for at give patienterne en passende sikkerhedsmargin.