FrancophonIA/ELRC3.0 huggingface dataset:
English: <For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.>
Danish: <De bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis De ønsker yderligere oplysninger om dette veterinærlægemiddel>
English: <Store in the original <container><package>>
Danish: <Opbevares i den originale <beholder><yderpakning>.>
English: <Protect from light.>
Danish: <Beskyttes mod lys.>
English: <Shelf life after <dilution> <reconstitution> according to directions: …..>
Danish: < Opbevaringstid <efter fortynding><rekonstituering> ifølge anvisning:>
English: <Incompatibilities:>
Danish: <Uforligeligheder:>
English: <Pregnancy and lactation:>
Danish: <Drægtighed og Laktation:>
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Danish: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling)
English: <Store in a freezer {temperature range}.>
Danish: <Opbevares i dybfryser {temperaturinterval}.>
English: <This veterinary medicinal product does not require any special temperature storage conditions.>
Danish: <Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel>
English: <To be supplied only on veterinary prescription.>
Danish: <kræver recept.>
English: The words “Keep out of the sight and reach of children”
Danish: Teksten “ Opbevares utilgængeligt for børn”
English: - common (more than 1 but less than 10 animals in 100 animals treated)
Danish: - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr)
English: Withdrawal period(s)
Danish: Tilbageholdelsestid(er)
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated)
Danish: - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr)
English: {Pilsēta}, LV{Pasta indekss }>
Danish: Latvija {Nosaukums} <{Adrese} {Pilsēta}, LV{Pasta indekss }> Tel: + {Telefona numurs} <{E-mail}> United Kingdom {Name} <{Address} {Town} {Postal code} - UK> Tel: + {Telephone number} <{E-mail}>
English: - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Danish: - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr)
English: <Lactation:>
Danish: <Laktation>
English: Teл: + 359 {Телефонен номер}
Danish: Република България {Наименование} <{Адрес} BG {Град} {Пощенски код}> Teл: + 359 {Телефонен номер} <{E-mail}> Luxembourg/Luxemburg {Nom} <{Adresse} L-0000 {Localité/Stadt}> Tél/Tel: + {N° de téléphone/Telefonnummer} <{E-mail}>
English: Special warning(s)
Danish: Særlige advarsel/advarsler
English: Κύπρος
Danish: Opbevaringstid
English: Tél: + {Numéro de téléphone}
Danish: France {Nom} <{Adresse} FR-00000 {Localité}> Tél: + {Numéro de téléphone} <{E-mail}> Portugal {Nome} <{Morada} PT-0000000 {Cidade}> Tel: + {Número de telefone} <{E-mail}>
English: <Pregnancy:>
Danish: <Drægtighed: >
English: <Store in a dry place>
Danish: <Opbevares tørt.>
English: Puh/Tel: + {Puhelinnumero/Telefonnummer}
Danish: Italia {Nome} <{Indirizzo} IT-00000 {Località}> Tel: + {Numero di telefono}> <{E-mail}> Suomi/Finland {Nimi/Namn} <{Osoite/Adress} FI-00000 {Postitoimipaikka/Stad}> Puh/Tel: + {Puhelinnumero/Telefonnummer} <{E-mail}>
English: Tlf: + {Telefonnummer}
Danish: Eesti (Nimi) <(Aadress) EE - (Postiindeks) (Linn)> Tel: +(Telefoninumber) <{E-mail}> Norge {Navn} <{Adresse} N-0000 {poststed}> Tlf: + {Telefonnummer} <{E-mail}>
English: PL - 00 000{Miasto:}>
Danish: España {Nombre} <{Dirección} ES-00000 {Ciudad}> Tel: + {Teléfono} <{E-mail}> Polska {Nazwa/ Nazwisko:} <{Adres:} PL - 00 000{Miasto:}> Tel.: + {Numer telefonu:} <{E-mail}>
English: NL-0000 XX {stad}>
Danish: Deutschland {Name} <{Anschrift} DE-00000 {Stadt}> Tel: + {Telefonnummer} <{E-mail}> Nederland {Naam} <{Adres} NL-0000 XX {stad}> Tel: + {Telefoonnummer} <{E-mail}>
English: IE - {Town} {Code for Dublin}>
Danish: Ireland {Name} <{Address} IE - {Town} {Code for Dublin}> Tel: + {Telephone number} <{E-mail}> Slovenija {Ime} <{Naslov} SI-0000 {Mesto}> Tel: + {telefonska številka} <{E-mail}>
English: Tel.: + {Numer telefonu:}
Danish: Česká republika Název <Adresa CZ město> Tel: +telefonní číslo <{E-mail}> Magyarország {Név} <{Cím} HU-0000 {Város}> Tel.: + {Telefonszám} <{E-mail}>
English: {Oraş} {Cod poştal} - RO>
Danish: Hrvatska {Ime} <{Adresa} {Poštanski broj} {grad}> Tel: + {Telefonski broj} <{e-mail}> România {Nume} <{Adresă} {Oraş} {Cod poştal} - RO> Tel: + {Număr de telefon} <{E-mail}>
English: Thursday 22 January 2015
Danish: 22. januar 2015
English: PRAC recommendations on signals for update of the product information
Danish: PRAC's anbefalinger om signaler til ajourføring af produktinformationen
English: Frequency ‘not known': aggression
Danish: Hyppighed “ikke kendt”: aggression
English: Additional tests and medicines may be needed to diagnose and treat this.
Danish: Det kan være nødvendigt med ekstra prøver og lægemidler for at stille diagnosen og behandle dette.
English: In addition, routine pharmacovigilance should be performed in order to better characterise the risk.
Danish: Desuden skal der foretages rutinemæssig lægemiddelovervågning for at karakterisere risikoen bedre.
English: Pharmacovigilance Risk Assessment Committee
Danish: Udvalget for Risikovurdering inden for Lægemiddelovervågning
English: Adopted at the 6-9 January 2015 PRAC
Danish: Vedtaget den 6.-9. januar 2015, PRAC
English: Homeopathic products containing lithium are not affected by this PRAC recommendation.
Danish: Homøopatiske lægemidler indeholdende lithium er ikke omfattet af denne anbefaling fra PRAC.
English: • in neonates up to 4 weeks of age (see section 4.4).
Danish: • hos nyfødte op til 4-ugers alderen (se pkt.
English: Optimark is contraindicated
Danish: Optimark er kontraindiceret
English: The package leaflets should be updated accordingly.
Danish: Indlægssedlerne skal ajourføres tilsvarende.
English: Patients with known or suspected mitochondrial disease
Danish: Patienter med kendt eller formodet mitokondriel sygdom
English: • in patients in the perioperative liver transplantation period and
Danish: • i den perioperative periode ved levertransplantation, og
English: Footnote - cases of aggression were observed in post marketing experience Package Leaflet:
Danish: Fodnote - Tilfælde af aggression er iagttaget efter markedsføring Indlægsseddel:
English: Following the variation of the marketing authorisation for these products, the MAHs for any product with the same active substance should submit a respective variation application.
Danish: Efter ændring af markedsføringstilladelsen for disse produkter skal indehaverne af markedsføringstilladelse for alle produkter med samme aktive stof indsende en tilsvarende ansøgning om ændring.
English: POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders (see section 4.3).
Danish: Der bør testes for POLG-mutation i henhold til gældende klinisk praksis for diagnostisk vurdering af sådanne sygdomme (se pkt.
English: Valproate and related substances - Mitochondrial toxicity (EPITT no 17956)
Danish: Valproat og relaterede stoffer - Mitokondriel toksicitet (EPITT nr. 17956)
English: Paroxetine - Aggression (EPITT no 18089)
Danish: Paroxetin - Aggression (EPITT nr. 18089)
English: Side effects of unknown frequency: Muscle weakness that is constant.
Danish: Bivirkninger med ukendt hyppighed: Vedvarende muskelsvaghed.
English: Section 2.
Danish: Afsnit 2.
English: What you need to know before you <take> <use> <product name> Warnings and Precautions:
Danish: Det skal du vide, før du begynder at <tage> <bruge> <særnavn> Advarsler og forsigtighedsregler:
English: Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - Immune-mediated necrotizing myopathy (IMNM) (EPITT no 18140)
Danish: Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - Immunmedieret nekrotiserende myopati (IMNM) (EPITT nr. 18140)
English: SmPC changes for Optimark (gadoversetamide) 4.2 Posology and method of administration
Danish: Ændringer af produktresuméet for Optimark (gadoversetamid) 4.2 Dosering og administration
English: Musculoskeletal disorders:
Danish: Muskuloskeletale lidelser
English: Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Danish: Før administration af Optimark skal alle patienter screenes for renal dysfunktion ved laboratorieprøver.
English: Prior to administration of <invented name>, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Danish: Før administration af <særnavn> bør alle patienter screenes for renal dysfunktion ved laboratorieprøver.
English: POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy, cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.
Danish: POLG-relaterede sygdomme bør formodes ved familiær anamnese eller symptomer tydende på POLGrelateret sygdom, herunder, men ikke begrænset til, uforklarlig encefalopati, refraktær epilepsi (fokal, myoklonisk), status epilepticus ved undersøgelse, forsinket udvikling, psykomotorisk regression, aksonal sensomotorisk neuropati, myopati, cerebellar ataksi, oftalmoplegi eller kompliceret migræne med occipital aura.
English: In light of the data submitted by the marketing authorisation holders and the advice provided by the Pharmacogenomics Working Party, the PRAC concluded that the evidence is sufficient to support a causal association between valproate and aggravation of underlying mitochondrial diseases, including risk of hepatotoxicity occurring mainly in patients suffering from POLG (polymerase gamma) mutations.
Danish: På baggrund af data fra indehaverne af markedsføringstilladelse og rådgivning fra arbejdsgruppen vedrørende farmakogenomik konkluderede PRAC, at der er tilstrækkelig evidens for en årsagssammenhæng mellem valproat og forværring af underliggende mitokondrielle sygdomme, herunder risikoen for hepatotoksicitet, der hovedsagelig forekommer hos patienter med mutationer af POLG (polymerase gamma).
English: Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Danish: Patienter, som har fået foretaget eller undergår levertransplantation, er særligt udsat på grund af høj forekomst af akut nyresvigt i denne gruppe.
English: In light of the data available, the PRAC has agreed that the evidence is sufficient to conclude that longterm use of lithium may induce microcysts, oncocytomas and collecting duct renal carcinomas.
Danish: På baggrund af de foreliggende data har PRAC vedtaget, at der er tilstrækkelig dokumentation til at konkludere, at langvarig anvendelse af lithium kan bevirke mikrocyster, onkocytomer og karcinomer i samlerørene i nyrerne.
English: Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
Danish: Fortæl det til lægen eller på apoteket, hvis <du> <De> har vedvarende muskelsvaghed.
English: Optimark is contraindicated in these patients (see section 4.3).
Danish: Optimark er kontraindiceret hos disse patienter (se pkt.
English: Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Danish: Patienter, som får foretaget levertransplantation, er særligt udsat på grund af høj forekomst af akut nyresvigt i denne gruppe.
English: Section 4.8 - Undesirable effects:
Danish: Punkt 4.8 - Bivirkninger:
English: Section 2:
Danish: Afsnit 2:
English: Possible side effects:
Danish: Bivirkninger:
English: Gadodiamide; gadopentetic acid; gadoversetamideNephrogenic systemic fibrosis in patients with acute kidney injury (EPITT no 408)
Danish: Gadodiamid, gadopentetinsyre, gadoversetamidNefrogen systemisk fibrose hos patienter med akut nyreskade (EPITT nr. 408)
English: Valproate may trigger or worsen clinical signs of underlying mitochondrial diseases caused by mutations of mitochondrial DNA as well as the nuclear encoded POLG gene.
Danish: Valproat kan fremkalde eller forværre kliniske tegn på underliggende mitokondrielle sygdomme forårsaget af mutationer i det mitokondrielle DNA og af POLG-genet, der kodes i cellekernen.
English: IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
Danish: Klinisk er IMNM karakteriseret ved vedvarende proksimal muskelsvaghed og forhøjet serum-kreatininkinase, som begge vedvarer trods seponering af statinbehandlingen.
English: Valproate is contraindicated in patients known to have mitochondrial disorders caused by mutations in the nuclear gene encoding the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome, and in children under two years of age who are suspected of having a POLG-related disorder (see section 4.4).
Danish: Valproat er kontraindiceret hos patienter med mitokondrielle sygdomme forårsaget af mutationer i det kernegen, der koder for det mitokondrielle enzym polymerase γ (POLG), f.eks. Alpers-Huttenlocher syndrom, og hos børn under 2 år, som formodes at have en POLG-relateret sygdom (se pkt.
English: <invented name> is contraindicated in these patients (see section 4.3).
Danish: <Særnavn> er kontraindiceret hos disse patienter (se pkt.
English: SmPC changes for Omniscan (gadodiamide) and Magnevist (gadopentetic acid)
Danish: Ændring af produktinformationen for Omniscan (gadodiamid) og Magnevist (gadopentetinsyre)
English: Lithium - Solid renal tumours (EPITT no 18090)
Danish: Lithium - Renale organtumorer (EPITT nr. 18090)
English: 4.4 Special warnings and precautions for use
Danish: 4.4.Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, oncocytoma or collecting duct renal carcinoma).
Danish: Nyresvulster: Patienter med svært nedsat nyrefunktion, som har fået lithium i mere end 10 år, kan risikere at få en godartet eller ondartet nyresvulst (mikrocyster, onkocytomer eller karcinomer i nyrernes samlerør).
English: Having considered the available evidence from the literature, the PRAC has agreed that the MAHs for medicinal products containing atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin or lovastatin should submit a variation within 2 months to amend the product informations as described below (new text underlined):
Danish: Efter gennemgang af den foreliggende dokumentation fra litteraturen vedtog PRAC, at indehaverne af markedsføringstilladelse for lægemidler indeholdende atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin eller lovastatin inden 2 måneder skal indsende en ansøgning om ændring af produktinformationen som beskrevet nedenfor (ny tekst er understreget): Produktresumé:
English: Patients with iImpaired renal function
Danish: Patienter med nNedsat nyrefunktion
English: Section 4 Possible side effects:
Danish: Punkt 4 Bivirkninger:
English: Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3).
Danish: Optimark må derfor ikke anvendes hos patienter, som har fået foretaget alle undergår levertransplantation, eller hos nyfødte (se pkt.
English: Frequency not known: Immune-mediated necrotizing myopathy (see section 4.4) Package Leaflet:
Danish: Ikke kendt: Immunmedieret nekrotiserende myopati (se pkt.
English: In particular, valproateinduced acute liver failure and liver-related deaths have been reported at a higher rate in patients with hereditary neurometabolic syndromes caused by mutations in the gene for the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome.
Danish: Der er således øget hyppighed af indberetninger om valproat-induceret akut leversvigt og leverrelaterede dødsfald hos patienter med hereditære neurometaboliske syndromer som følge af mutationer i genet for det mitokondrielle enzym polymerase γ (POLG), f.eks. Alpers-Huttenlocher syndrom.
English: Therefore <invented name> must not be used in patients with severe renal impairment, in patients in the perioperative liver transplantation period and in neonates (see section 4.3).
Danish: <Særnavn> må derfor ikke anvendes hos patienter med svært nedsat nyrefunktion, hos patienter i den perioperative periode ved levertransplantation eller hos nyfødte (se pkt.
English: Renal tumours: Cases of microcysts, oncocytomas and collecting duct renal carcinoma have been reported in patients with severe renal impairment who received lithium for more than 10 years (see Section 4.8).
Danish: Nyretumorer: Der er beskrevet mikrocyster, onkocytomer og karcinom i nyrernes samlerør hos patienter med svært nedsat nyrefunktion, som har fået lithium i mere end 10 år (se pkt.
English: Therefore, the Marketing Authorisation Holders of lithium containing medicinal products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Danish: Indehaverne af markedsføringstilladelse for lægemidler indeholdende lithium skal derfor inden 2 måneder indsende en ansøgning om ændring af produktinformationen som beskrevet nedenfor (ny tekst er understreget).
English: Frequency unknown: Benign/malignant kidney tumours (microcysts, oncocytoma, or collecting duct renal carcinoma) (in long-term therapy).
Danish: Ukendt hyppighed: Godartede/ondartede svulster i nyrerne (mikrocyster, onkocytom eller karcinom i nyrernes samlerør) (ved langvarig behandling).
English: The marketing authorisation holders for valproate (and related substances) containing medicinal products should submit a variation within 2 months to amend the product information as described below (new text underlined).
Danish: Indehaverne af markedsføringstilladelse for lægemidler indeholdende valproat (og relaterede stoffer) skal inden 2 måneder indsende en ansøgning om ændring af produktinformationen som beskrevet i det følgende (ny tekst er understreget).
English: • in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury.
Danish: • ved svært nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2) og/eller akut nyreskade,
English: Frequency unknown: Microcysts, oncocytoma and collecting duct renal carcinoma (in long-term therapy) (see Section 4.4).
Danish: Ukendt hyppighed: Mikrocyster, onkocytomer og karcinomer i samlerørene i nyrerne (ved langvarig behandling) (se pkt.
English: Having considered the available evidence the PRAC has agreed that the MAH of Omniscan, Optimark and Magnevist should submit a variation within 2 months, to amend the product information as described below (new text underlined / text to be removed strikethrough).
Danish: Efter gennemgang af den foreliggende dokumentation har PRAC vedtaget, at indehaveren af markedsføringstilladelserne for Omniscan, Optimark og Magnevist inden 2 måneder skal indsende en ansøgning om ændring af produktinformationen som beskrevet i det følgende (ny tekst er understreget / tekst, som skal slettes, er gennemstreget).
English: There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen: I meget sjældne tilfælde er beskrevet immunmedieret nekrotiserende myopati (IMNM) under eller efter behandling med visse statiner.
English: Package leaflet:
Danish: Produktresumé:
English: Talk to your doctor <or> , <pharmacist> <or nurse> before <taking> <using> <product name>: You know that there is a genetic problem causing a mitochondrial disorder in your family.
Danish: Det skal <du> <De> vide, før <du> <De> begynder at <tage> <bruge> <lægemidlets navn> <Du> <De> bør ikke <tage> <bruge> <lægemidlets navn>: hvis <du> <De> har en arvelig lidelse, der medfører en mitokondriel sygdom (f.eks. AlpersHuttenlocher syndrom).
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m²) and/or acute kidney injury.
Danish: Der er beskrevet nefrogen systemisk fibrose (NSF) ved brug of Optimark og visse andre gadoliniumholdige kontrastmidler hos patienter med akut eller kronisk svær nyrefunktionsnedsættelse (GFR <30ml/min/1,73 m2) og/eller akut nyreskade.
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of <invented name> and some other gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury.
Danish: Der er beskrevet nefrogen systemisk fibrose (NSF) ved brug af <særnavn> og visse andre gadoliniumholdige kontrastmidler hos patienter med akut eller kronisk svær nyrefunktionsnedsættelse (GFR <30 ml/min/1,73 m2) og/eller akut nyreskade.
English: Taken into account all available data PRAC agreed that all MAHs for paroxetine containing products should submit a variation within 2 months to amend the product information (section 4.8 of the SmPC and package leaflet) as described below (new text underlined).
Danish: På grundlag af alle foreliggende data vedtog PRAC, at indehavere af markedsføringstilladelse for lægemidler indeholdende paroxetin inden 2 måneder skal indsende en ansøgning om ændring af produktinformationen (punkt 4.8 i produktresuméet og indlægssedlen) som beskrevet i det følgende (ny tekst er understreget).
English: Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3).
Danish: Optimark er kontraindiceret hos patienter med svært nedsat nyrefunktion (GFR <30 ml/min/1,73 m2) og/eller akut nyreskade, hos patienter, som har fået foretaget levertransplantation, eller patienter i den perioperative periode ved levertransplantation (se pkt.
English: 4.3 Contraindications <invented name> is contraindicated in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury, in patients in the perioperative liver transplantation period and in neonates up to 4 weeks of age (see section 4.4).
Danish: 4.3 Kontraindikationer <særnavn> er kontraindiceret hos patienter med svært nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2) og/eller akut nyreskade hos patienter i den perioperative periode ved levertransplantation samt hos nyfødte op til 4-ugers alderen (se pkt.
English: Renal impairment <invented name> is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury and in patients in the perioperative liver transplantation period (see section 4.3).
Danish: Nedsat nyrefunktion <særnavn> er kontraindiceret hos patienter med svært nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2) og/eller akut nyreskade samt hos patienter i den perioperative periode ved levertransplantation (se pkt.
English: Member State EU / EEA
Danish: Medlemsstat EU/EEA
English: • The medicine should be taken at the same time each day, usually in the morning.
Danish: • Medicinen skal tages på samme tidspunkt hver dag, som regel om morgenen.
English: Animal studies are insufficient.
Danish: Dyreforsøg er utilstrækkelige.
English: This especially applies to the following medicines:
Danish: Dette gælder især for følgende medicin:
English: The fourth issue was regarding the time of maximal effects.
Danish: Det fjerde spørgsmål drejede sig om tidsperioden med maksimal virkning.
English: Patients should be rehydrated before the administration.
Danish: Patienter skal rehydreres før administrationen.