FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration every 48 hours is recommended based on modelling of single-dose pharmacokinetic data for emtricitabine and tenofovir disoproxil in non-HIV infected subjects with varying degrees of renal impairment (see section 4.4).
Danish: Ud fra modellering af farmakokinetiske data for enkeltdosis af emtricitabin og tenofovirdisoproxil hos ikke-hiv-inficerede forsøgspersoner med varierende grader af nedsat nyrefunktion anbefales det at administrere hver 48. time (se pkt.
English: should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: bør ikke initieres hos pædiatriske patienter med nedsat nyrefunktion, og Emtricitabine/Tenofovir disoproxil Krka d.d.
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of emtricitabine/tenofovir disoproxil use.
Danish: Hvis nyreabnormiteter mistænkes eller påvises, bør der tages kontakt til en nefrolog med henblik på at overveje, om brugen af Emtricitabine/Tenofovir disoproxil Krka d.d.
English: + Ritonavir (100 mg q.d.)
Danish: + Ritonavir (100 mg
English: Tablet core: pregelatinized starch, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, stearic acid.
Danish: Tabletkerne: stivelse; pregelatineret, croscarmellosenatrium, lactosemonohydrat,
English: should be taken with food.
Danish: skal så vidt muligt tages sammen med mad.
English: therapy - The importance of regular monitoring of renal function during Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: -behandling påbegyndes (nyrefunktion ved baseline) - Vigtigheden af regelmæssig monitorering af nyrefunktionen under Emtricitabine/Tenofovir disoproxil Krka d.d.
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvis nyreabnormiteter mistænkes eller påvises, bør der tages kontakt til en nefrolog med henblik på at overveje at afbryde behandlingen - At Emtricitabine/Tenofovir disoproxil Krka d.d.
English: → Do not stop taking Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: → Hold ikke op med at tage Emtricitabine/Tenofovir disoproxil Krka d.d.
English: is taken with food.
Danish: helst tages sammen med mad.
English: If you have kidney problems, your doctor may advise you to stop taking Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvis De har nyreproblemer, vil Deres læge muligvis råde Dem til at holde op med at tage Emtricitabine/Tenofovir disoproxil Krka d.d., eller, hvis De er inficeret med hiv, til at tage Emtricitabine/Tenofovir disoproxil Krka d.d.
English: AUC: ↓ 53% (↓ 61 to ↓ 43) Cmax: ↓ 47% (↓ 57 to ↓ 36) Cmin: ↓ 57% (↓ 64 to ↓ 48)
Danish: Cmax: ↓ 47% (↓ 57 til ↓ 36) Cmin: ↓ 57% (↓ 64 til ↓ 48)
English: What you need to know before you take Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Det skal De vide, før De begynder at tage Emtricitabine/Tenofovir disoproxil Krka d.d.
English: is not recommended for use in paediatric patients with renal impairment - That use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: frarådes til pædiatriske patienter med nedsat nyrefunktion - At det bør undgås at anvende Emtricitabine/Tenofovir disoproxil Krka d.d.
English: The most frequently reported adverse reactions considered possibly or probably related to emtricitabine and/or tenofovir disoproxil were nausea (12%) and diarrhoea (7%) in an open-label randomised clinical study in adults (GS-01-934, see section 5.1).
Danish: 5.1) var de hyppigst indberettede bivirkninger, som blev anset for at have en mulig eller sandsynlig forbindelse til emtricitabin og/eller tenofovirdisoproxil, kvalme (12 %) og diarré (7 %).
English: Look out for any symptoms of infection or other symptoms such as:
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som
English: If you forget to take Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvis De glemmer at tage Emtricitabine/Tenofovir disoproxil Krka d.d.
English: The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established (see section 5.2).
Danish: Pædiatrisk population: Emtricitabin/tenofovirdisoproxils sikkerhed og virkning hos børn og unge under 12 år er ikke klarlagt (se pkt.
English: is missed within 12 hours of the time it is usually taken, Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: i 12 timer efter tidspunktet, hvor dosen normalt skulle tages, skal patienten tage Emtricitabine/Tenofovir disoproxil Krka d.d.
English: See section 2 "Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Se afsnit 2 “Emtricitabine/Tenofovir disoproxil Krka d.d.
English: In study GS-US-104-0352, 89 HIV-1 infected paediatric patients with a median age of 7 years (range
Danish: I studiet GS-US-104-0352 blev 89 HIV 1-inficerede pædiatriske patienter med en medianalder på 7 år (2-15 år) eksponeret for tenofovirdisoproxil i en median periode på 331 uger.
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14) Cmin: NC
Danish: AUC: ↑ 5% (↓ 2 til ↑ 13) Cmax: ↑ 5% (↓ 3 til ↑ 14)
English: contains lactose", "Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: indeholder lactose”, “Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Do not take Emtricitabine/Tenofovir disoproxil Krka d.d.if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Emtricitabine/Tenofovir disoproxil Krka d.d., hvis De allerede tager anden medicin som indeholder indholdsstofferne i Emtricitabine/Tenofovir disoproxil Krka d.d.
English: As Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Da Emtricitabine/Tenofovir disoproxil Krka d.d.
English: should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Danish: Patienter, som er inficeret med HBV, og som seponerer Emtricitabine/Tenofovir disoproxil Krka d.d., bør monitoreres nøje med både klinisk og laboratoriemæssig opfølgning i flere måneder, efter at behandlingen er stoppet.
English: Your doctor will prescribe Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Deres læge ordinere Emtricitabine/Tenofovir disoproxil Krka d.d.
English: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity → If you notice these or any symptoms of inflammation or infection, get medical help immediately.
Danish: Hold øje med symptomer på infektion eller andre symptomer såsom: muskelsvaghed svaghed, der begynder i hænder og fødder og bevæger sig op mod selve kroppen hjertebanken, rysten (tremor) eller hyperaktivitet
English: If you have taken Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvis De har taget Emtricitabine/Tenofovir disoproxil Krka d.d.
English: in patients with hepatic impairment (see sections 4.2 and 5.2).
Danish: 4.8 Tabel over bivirkninger og 5.1).
English: Darunavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Danish: Tenofovirdisoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: Tel: +32 (0) 487 50 73 62 (BE)
Danish: KRKA Belgium, SA. Tel: +32 (0) 487 50 73 62 (BE)
English: Although there are limited clinical data on the use of emtricitabine/tenofovir disoproxil in pregnant women, it is not usually used unless absolutely necessary.
Danish: Selvom der foreligger begrænsede kliniske data om brug af Emtricitabine/Tenofovir disoproxil Krka d.d.
English: If you stop taking Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvis De holder op med at tage Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Renal impairment: As Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Nedsat nyrefunktion: Da Emtricitabine/Tenofovir disoproxil Krka d.d.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Danish: Sikkerheden af tenofovirdisoproxilsammen med sofosbuvir/velpatasvir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
English: Prior to initiating Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Inden påbegyndelse af Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Interrupting use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Afbrydelse af brugen af med Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Increased plasma concentrations of tenofovir resulting from co administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir og lopinavir/ritonavir kan øge risikoen for bivirkninger relateret til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: in adolescent patients for the treatment of HIV-1 infection are provided with a physician educational pack containing the
Danish: til enten unge patienter til behandling af hiv 1-infektion,
English: Renal management in HIV-1 infected patients
Danish: Behandling af HIV 1-infektion hos den pædiatriske population
English: If bone abnormalities are detected or suspected during use of emtricitabine/tenofovir disoproxil in any paediatric patient, consultation with an endocrinologist and/or nephrologist should be obtained.
Danish: hos en pædiatrisk patient, bør der søges råd hos en endokrinolog og/eller en nefrolog.
English: Increased plasma concentrations of tenofovir resulting from co administration of tenofovir disoproxil, sofosbuvir/velpatasvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir og atazanavir/ritonavir kan øge risikoen for bivirkninger relateret til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Krka d.d..
Danish: Det er vigtigt, at De husker at tage alle doser Emtricitabine/Tenofovir disoproxil Krka d.d..
English: AUC: ↓ 5% (↓ 9 to ↓ 1)
Danish: Velpatasvir: AUC: ↓ 53% (↓ 61 til ↓ 43)
English: Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Danish: ANTIINFEKTIVA Antiretrovirale lægemidler Proteasehæmmere Atazanavir/Ritonavir/ Tenofovirdisoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: Discontinuation of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Seponering af Emtricitabine/Tenofovir disoproxil Krka d.d.
English: If Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvis Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Each tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to
Danish: Hver tablet indeholder 200 mg emtricitabin og 245 mg tenofovirdisoproxil (svarende til 300,7 mg tenofovirdisoproxilsuccinat eller 136 mg tenofovir).
English: Tablet core
Danish: For tabletbeholderen:
English: While taking Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Mens De tager Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Therefore the use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Samtidig administration af Emtricitabine/Tenofovir disoproxil Krka d.d.
English: without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir disoproxil Krka d.d..
Danish: Se punkt 3, ”Hvis De holder op med at tage Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Scientific conclusions and grounds for the suspension of the marketing authorisation presented by the European Medicines Agency
Danish: Videnskabelige konklusioner og begrundelse for suspendering af markedsføringstilladelsen fremlagt af Det Europæiske Lægemiddelagentur
English: Grounds for the suspension of the marketing authorisation
Danish: Begrundelse for suspenderingen af markedsføringstilladelserne
English: On 8 September 2014, Aastrom Biosciences notified the European Medicines Agency of the withdrawal by the Danish authorities of the manufacturing licence for the manufacturing site for the active substance, finished product and batch release of MACI (matrix-applied characterised autologous cultured chondrocytes): Genzyme Biosurgery ApS, Oliefabriksvej 45, DK - 2770 Kastrup, Denmark.
Danish: Den 8. september 2014 underrettede Aastrom Biosciences Det Europæiske Lægemiddelagentur om, at de danske myndigheder havde inddraget fremstillingstilladelsen for fremstillingsstedet for det aktive stof, det færdige lægemiddel og batchfrigivelse af MACI (matrix-applicerede karakteriserede dyrkede autologe chondrocytter): Genzyme Biosurgery ApS, Oliefabriksvej 45, DK - 2770 Kastrup, Danmark.
English: In view of the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 10 September 2014, requesting the Agency to give its opinion on whether the marketing authorisation for MACI should be suspended or revoked in accordance with Article 118 of
Danish: På denne baggrund indledte Europa-Kommissionen den 10. september 2014 en procedure i medfør af artikel 20 i forordning (EF) nr. 726/2004, idet agenturet blev anmodet om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelsen for MACI burde suspenderes eller inddrages i medfør af artikel 118 i direktiv 2001/83/EF.
English: The CHMP considered that this information does not impact the safety and efficacy profile of MACI but that in the absence of an authorised manufacturing site, the requirements laid down in Article 41 of Directive 2001/83/EC are no longer met.
Danish: CHMP fandt, at denne oplysning er uden betydning for sikkerheds- og virkningsprofilen af MACI, men at kravene i artikel 41 i direktiv 2001/83/EF ikke længere er opfyldt i mangel af et godkendt fremstillingssted.
English: For the suspension of the marketing authorisation to be lifted, the MAH shall register a site for manufacture of the active substance, finished product and batch release.
Danish: For at suspenderingen af markedsføringstilladelsen kan ophæves, skal indehaveren af markedsføringstilladelsen registrere et fremstillingssted for det aktive stof, det færdige lægemiddel og batchfrigivelse.
English: For the suspension to be lifted, the MAH shall register a manufacturing site for the active substance, finished product and batch release (see Annex II).
Danish: For at suspenderingen kan ophæves, skal indehaveren af markedsføringstilladelsen registrere et fremstillingssted for det aktive stof, det færdige lægemiddel og batchfrigivelse (se bilag II).
English: • The Committee concluded that in view of the absence of an authorised manufacturing site for the active substance, finished product and batch release, the requirements laid down in Article 41 of
Danish: • udvalget konkluderede, at kravene i artikel 41 i direktiv 2001/83/EF ikke længere er opfyldt i fravær af et godkendt fremstillingssted for det aktive stof, det færdige lægemiddel og batchfrigivelse anbefaler CHMP suspendering af markedsføringstilladelsen for MACI i medfør af artikel 118 i direktiv 2001/83/EF.
English: • The Committee considered the notification under Article 20 of Regulation (EC) No 726/2004 for
Danish: • udvalget behandlede den procedure, som var indledt i henhold til artikel 20 i forordning (EF) nr. 726/2004 for MACI og udkastet til CHMP's beslutning, der var udarbejdet af Udvalget for Avancerede Terapier (CAT)
English: ATC vet code: QI07AB01.
Danish: ATCvet-kode: QI07AB01.
English: No data are available on the safety of an overdose.
Danish: Der foreligger ingen oplysninger om sikkerhed ved overdosering.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/171/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/14/171/001
English: Pharmacotherapeutic group: Immunologicals for canidae, inactivated bacterial vaccines.
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til canidae - inaktiverede bakterievacciner.
English: Overdose (symptoms, emergency procedures, antidotes): No data are available on the safety of an overdose.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift): Der foreligger ingen oplysninger om sikkerhed ved en overdosis.
English: Type I glass vial containing 1 ml closed with a chlorobutyl rubber stopper and aluminium cap.
Danish: Hætteglas type I der indeholder 1 ml, lukket med en gummiprop af chlorobutyl og et aluminiumlåg.
English: Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus L4.
Danish: Varighed af immunitet: Mindst et år efter basisvaccination for alle komponenter i Versican Plus L4.
English: 50 x 1 dose
Danish: 50 x 1dosis
English: Onset of immunity: 4 weeks after the completion of primary course.
Danish: Indtræden af immunitet: 4 uger efter afsluttet basisvaccination.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versican Plus DHPPi and Versican Plus Pi. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre veterinærlægemidler til dyr bortset fra Versican Plus DHPPi og Versican Plus Pi. En eventuel beslutning om at anvende vaccinen umiddelbart før eller efter brug af et andet veterinærlægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: Primary vaccination scheme: Two doses of Versican Plus L4 3-4 weeks apart from 6 weeks of age.
Danish: Basisvaccination: To doser af Versican Plus L4 med 3 til 4 ugers mellemrum fra 6-ugers alderen.
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injections
Danish: Kaliumdihydrogenphosphat Dinatriumphosphatdodecahydrat Vand til injektionsvæsker
English: 10 DATE OF REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Danish: Vaccinen er beregnet til aktiv immunisering af raske hvalpe og hunde mod sygdomme forårsaget af Leptospira interrogans serogruppe Australis serovar Bratislava, Leptospira interrogans serogruppe Canicola servar Canicola, Leptospira kirschneri serogruppe Grippotyphosa serovar Grippotyphosa og Leptospira interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products other than those mentioned in section 8.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette veterinærlægemiddel ikke blandes med andre veterinærlægemidler end dem, der er anført i pkt.
English: Appearance: whitish liquid with fine sediment.
Danish: Udseende: Hvidlig væske med fint bundfald.
English: * Antibody micro agglutination-lytic reaction.
Danish: 1,8 - 2,2 mg. * Antistof mikroagglutinationsreaktion - lytisk reaktion (antibody micro agglutination-lytic reaction).
English: PACKAGE SIZE 25 x 1 dose
Danish: 25 x 1 dosis
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus L4 for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus L4 til hund
English: Plastic box containing 50 vials (1 ml).
Danish: Plastikæske indeholdende 50 hætteglas (1 ml).
English: A transient swelling (up to 5 cm) may commonly be observed at the injection site following subcutaneous administration in dogs.
Danish: Efter subkutan indgift hos hunde kan der på injektionsstedet udvikles en forbigående hævelse (op til 5
English: Plastic box containing 25 vials (1 ml).
Danish: Plastikæske indeholdende 25 hætteglas (1 ml).
English: Re-vaccination scheme: A single dose of Versican Plus L4 to be given annually.
Danish: Revaccinationsprogram: Der anbefales en årlig vaccination med Versican Plus L4.
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Almindelige (flere end 1, men færre end 10 dyr i 100 behandlede dyr) Ikke almindelige (flere end 1, men færre end 10 dyr i 1.000 behandlede dyr) Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: If protection against DHPPi or Pi is required, dogs can be vaccinated with two doses of Versican Plus DHPPi or Versican Plus Pi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus DHPPi or Versican Plus Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Danish: Vaccination mod distemper-, adeno-, parvo- og parainfluenza-virus (DHPPi): Hvis der ønskes beskyttelse mod DHPPi eller Pi, kan hunde vaccineres med to doser Versican Plus DHPPi eller Versican Plus Pi blandet med Versican Plus L4 med 3 til 4 ugers mellemrum fra 6-ugers alderen:
English: Once broached, use immediately.
Danish: Anvendes straks efter anbrud.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus L4 suspension for injection for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus L4 injektionsvæske, suspension til hund
English: PACKAGE LEAFLET: Versican Plus L4 suspension for injection for dogs
Danish: INDLÆGSSEDDEL Versican Plus L4 injektionsvæske, suspension til hund
English: − to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and
Danish: − for at forebygge kliniske symptomer og udskillelse i urinen og reducere infektion forårsaget af L. interrogans serogruppe Canicola serovar Canicola og L. interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae og
English: ADVICE ON CORRECT ADMINISTRATION Shake well and administer immediately the entire contents (1 ml) of the product.
Danish: Indgiv straks al indholdet (1 ml).
English: Dose and route of administration: Shake well and administer immediately the entire contents (1 ml) of the product.
Danish: Indgiv straks al indholdet (1 ml) af produkt i hætteglasset.
English: 10 July 2015
Danish: Den 10. juli 2015
English: Moreover, the intended use does not require medical supervision.
Danish: Desuden kræver den påtænkte anvendelse ikke lægeligt opsyn.
English: If symptoms last longer than two weeks during treatment, a doctor or a qualified healthcare practitioner should be consulted.
Danish: Hvis symptomer varer længere end to uger i behandling, bør en læge eller en anden kvalificeret sundhedsmedarbejder kontaktes.
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: Dette betyder, at selv om der ikke er tilstrækkelig dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og der er beviser for, at de uden risiko har været anvendt på denne måde i mindst 30 år (herunder mindst 15 år inden for EU).
English: Mouse-ear hawkweed should only be used in adults.
Danish: Håret gøgeurt bør kun anvendes til voksne.