FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivemend have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ivemend.
English: _ _ 1 Whole virion non-adjuvanted influenza vaccine, inactivated, containing antigen of *: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms hemagglutinin
Danish: _ _ 1 Hel virion, ikke-adjuveret influenzavaccine, inaktiveret, indeholder antigen af *: A/Vietnam/1203/2004 (H5N1) 7,5 mikrogram** pr. 0,5 ml dosis * dyrket i vero-celler (kontinuerlig cellelinje fra pattedyr) ** udtrykt i mikrogram hæmagglutinin
English: MA (EU) Number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn
English: Immediate Packaging Content (concentration)
Danish: Indhold (Koncentration)
English: 20 vials
Danish: 20 hætteglas
English: Single-dose prefilled syringe (glass) without needle
Danish: 1 enkeltdosis fyldt injektionssprøjte (glas) uden nål
English: 1 syringe
Danish: 1 injektionssprøjte
English: Route of Administration
Danish: Paknings-størrelse
English: Pack size multi-dose vial (glass)
Danish: Multidosis hætteglas
English: This overview was last updated in 05-2019.
Danish: Denne oversigt blev sidst ajourført i 05-2019.
English: Telzir received a marketing authorisation valid throughout the EU on 12 July 2004.
Danish: Telzir fik en markedsføringstilladelse med gyldighed i hele EU den 12. juli 2004.
English: A similar benefit was also seen in one main study including 57 children aged between 2 and 18 years.
Danish: En lignende fordel blev også påvist i et hovedstudie, der omfattede 57 børn på mellem 2 og 18 år.
English: Further information on Telzir can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Telzir.
Danish: Yderligere information om Telzir findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Telzir.
English: Other information about Telzir:
Danish: Andre oplysninger om Telzir:
English: However, there were too few patients aged below 6 years to support the use of Telzir in this age group.
Danish: Der var dog for få patienter i alderen under 6 år til at støtte brugen af Telzir i denne aldersgruppe.
English: Telzir has been studied in three main studies involving 1,862 adults.
Danish: Telzir var genstand for tre hovedstudier, der omfattede 1 862 voksne.
English: It contains the active substance fosamprenavir.
Danish: Det indeholder det aktive stof fosamprenavir.
English: As for all medicines, data on the use of Telzir are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Telzir løbende overvåget.
English: Telzir is available as tablets (700 mg) and as an oral suspension (50 mg/ml) to be taken by mouth.
Danish: Telzir fås som tabletter (700 mg) og som oral suspension (50 mg/ml) til indtagelse gennem munden.
English: Similar side effects are seen in younger patients.
Danish: Hos yngre patienter ses lignende bivirkninger.
English: In adults, each dose of Telzir must be given with 100 mg ritonavir, twice a day.
Danish: Hos voksne skal hver dosis Telzir gives sammen med 100 mg ritonavir to gange dagligt.
English: What measures are being taken to ensure the safe and effective use of Telzir?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Telzir?
English: There is no recommended dose for patients below 18 years who weigh less than 25 kg.
Danish: Der er ikke nogen anbefalet dosis til patienter under 18 år, som vejer under 25 kg.
English: An overview of Telzir and why it is authorised in the EU
Danish: En oversigt over Telzir, og hvorfor det er godkendt i EU
English: Treatment with Telzir should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandlingen med Telzir bør indledes af en læge med erfaring i behandling af hivinfektion.
English: Why is Telzir authorised in the EU?
Danish: Hvorfor er Telzir godkendt i EU?
English: Telzir does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Telzir kurerer ikke hivinfektion eller aids, men sinker den skade på immunsystemet og udviklingen af infektioner og sygdomme, der er forbundet med aids.
English: Adults with liver problems should take a reduced dose of Telzir and be closely monitored for side effects and their response to treatment.
Danish: Voksne med leverproblemer bør tage en nedsat dosis af Telzir og overvåges nøje med henblik på bivirkninger og deres reaktion på behandlingen.
English: The active substance in Telzir, fosamprenavir, is a ‘prodrug' of the protease inhibitor amprenavir, which means that it is converted into amprenavir in the body.
Danish: Det aktive stof i Telzir, fosamprenavir, er et "prodrug" til proteasehæmmeren amprenavir, hvilket betyder, at det omdannes til amprenavir i kroppen.
English: Side effects reported with Telzir are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Telzir vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: It slows down the rate at which amprenavir is broken down, helping to increase levels of amprenavir in the blood.
Danish: Den mindsker den hastighed, hvormed amprenavir nedbrydes, hvorved mængden af amprenavir i blodet øges.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Danish: Når enzymet blokeres, formerer virusset sig ikke normalt, og infektionen spredes langsommere.
English: What is Telzir and what is it used for?
Danish: Hvad er Telzir, og hvad anvendes det til?
English: Telzir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Telzir tages i kombination med andre antivirale lægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
English: For more information about using Telzir, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Telzir, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The oral suspension should be taken without food in adults, but in younger patients it should be taken with food in order to hide the taste and help them stick to treatment.
Danish: Voksne skal tage den orale suspension mellem måltider, men yngre patienter skal tage den sammen med et måltid for at skjule smagen og hjælpe dem med at overholde behandlingen.
English: Ritonavir, another protease inhibitor, is used with Telzir as a ‘booster'.
Danish: Ritonavir, en anden proteasehæmmer, anvendes sammen med Telzir som "booster".
English: What are the risks associated with Telzir?
Danish: Hvilke risici er der forbundet med Telzir?
English: In patients aged between 6 and 18 years who weigh between 25 and 39 kg, the dose depends on body weight.
Danish: Til patienter på mellem 6 og 18 år, der vejer mellem 25 og 39 kg, afhænger dosis af legemsvægten.
English: As Telzir is converted into amprenavir in the body, it must not be given at the same time as other medicines containing amprenavir.
Danish: Da Telzir omdannes til amprenavir i kroppen, må det ikke anvendes sammen med andre lægemidler, der indeholder amprenavir.
English: The recommended dose for adults (aged 18 years or over) and for patients aged between 6 and 18 years who weigh more than 39 kg is 700 mg twice a day.
Danish: Den anbefalede dosis til voksne (18 år eller derover) og til patienter mellem 6 og 18 år, der vejer over 39 kg, er 700 mg to gange dagligt.
English: Telzir must not be used in patients who are taking lurasidone (for schizophrenia and bipolar disorder), paritaprevir (for hepatitis C), simvastatin or lovastatin (for lowering blood cholesterol), rifampicin (for tuberculosis), St John's wort (a herbal preparation for depression and anxiety), or certain medicines that are broken down in the same way as Telzir or ritonavir as Telzir may affect their blood levels.
Danish: Telzir må ikke anvendes hos patienter, som får lurasidon (mod skizofreni og bipolar lidelse), paritaprevir (mod hepatitis C), simvastatin eller lovastatin (til sænkning af kolesterolindholdet i blodet), rifampicin (mod tuberkulose), perikum (et urtepræparat mod depression og angst) eller lægemidler, der nedbrydes i kroppen på samme måde som Telzir eller ritonavir, da Telzir kan påvirke patienternes blod.
English: The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of cholesterol (a type of fat) in the blood.
Danish: De hyppigste bivirkninger ved Telzir hos voksne (som optræder hos mere end 1 ud af 10 patienter) er diarré og en stigning i blodets indhold af kolesterol (en type fedtstoffer).
English: Patients in these three adult studies also took two reverse-transcriptase inhibitors (another type of antiviral medicine) in addition to Telzir or the medicine Telzir was being compared with.
Danish: Patienterne i disse tre studier blandt voksne fik også to reverse transkriptasehæmmere (en anden type antiviralt lægemiddel) ud over Telzir eller det lægemiddel, Telzir blev sammenlignet med.
English: Two of the studies in previously untreated patients showed that Telzir in combination with other antiviral medicines was as effective as comparator medicines.
Danish: To af studierne, der omfattede tidligere ubehandlede patienter, viste, at Telzir i kombination med andre antivirale lægemidler var lige så effektivt som sammenligningslægemidlerne.
English: The European Medicines Agency concluded that Telzir, which contains a prodrug of amprenavir, is as effective as comparator medicines in reducing viral load.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Telzir, der indeholder et prodrug til amprenavir, er lige så effektivt som sammenligningslægemidler til at mindske virusindholdet.
English: In one study, after 48 weeks of treatment, 69% of previously untreated adults taking ritonavir-boosted Telzir (221 out of 322) and 68% of those taking nelfinavir (221 out of 327) had viral loads below 400 copies/ml (considered a low viral load).
Danish: I et studie havde 69 % (221 ud af 322) af de tidligere ubehandlede voksne, der fik Telzir boostet med ritonavir, og 68 % (221 ud af 327) af dem, der fik nelfinavir, et virusindhold under 400 kopier/ml efter 48 uger (betragtes som lav virusmængde i blodet).
English: In a third study in patients who had been treated before, Telzir was less effective than the comparator medicine lopinavir, with patients taking lopinavir having larger reductions in viral loads over the first 48 weeks.
Danish: I et tredje studie, som omfattede tidligere behandlede patienter, var Telzir mindre effektivt end sammenligningslægemidlet lopinavir, idet der hos de patienter, som fik lopinavir, sås større fald i virusindholdet i løbet af de første 48 uger.
English: In younger patients, the dose of ritonavir depends on body weight.
Danish: Ritonavirdosen hos yngre patienter afhænger af deres kropsvægt.
English: For patients who have taken medicines to treat their HIV infection before and did not respond to that treatment, doctors should only prescribe Telzir once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus's response to any new antiviral medicines that might be prescribed.
Danish: Til patienter, der tidligere har fået forskellige lægemidler mod hivinfektion, men ikke reagerede på denne behandling, skal lægen, inden der ordineres Telzir, gennemgå de antivirale lægemidler, patienten tidligere har fået, og vurdere sandsynligheden for, at virusset reagerer på nye antivirale lægemidler, der måtte ordineres.
English: Telzir is used in combination with ritonavir and other HIV medicines.
Danish: Telzir anvendes sammen med ritonavir og andre hiv-lægemidler.
English: Similar results were seen in the other study comparing ritonavir-boosted Telzir with ritonavir-boosted lopinavir, with around three-quarters of both groups of previously untreated patients having viral loads below 400 copies/ml.
Danish: Tilsvarende resultater sås i det andet studie, hvor ritonavir-boostet Telzir blev sammenlignet med ritonavir-boostet lopinavir, idet ca. tre fjerdedele af de tidligere ubehandlede patienter i begge grupper havde et virusindhold på mindre end 400 kopier/ml.
English: Telzir should not be used in people who are hypersensitive (allergic) to fosamprenavir, amprenavir, any of the other ingredients, or ritonavir.
Danish: Telzir bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for fosamprenavir, amprenavir, eller andre af indholdsstofferne eller ritonavir.
English: Telzir is an antiviral medicine for treating patients aged 6 years or above who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Telzir er et antiviralt lægemiddel til behandling af patienter på seks år og derover, som er smittet med humant immundefektvirus type 1 (hiv-1).
English: For the full list of side effects of Telzir, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Telzir fremgår af indlægssedlen.
English: What benefits of Telzir have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Telzir?
English: How does Telzir work?
Danish: Hvordan virker Telzir?
English: How is Telzir used?
Danish: Hvordan anvendes Telzir?
English: Telzir tablets can be taken with or without food.
Danish: Telzirtabletter kan tages sammen med et måltid eller mellem måltider.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Telzir have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Telzir.
English: blocks an enzyme that is involved in the reproduction of HIV.
Danish: Amprenavir, som tidligere var tilgængeligt i EU, blokerer et enzym, der medvirker ved formeringen af hiv.
English: Although the Agency noted that the use of ritonavir-boosted Telzir had not been studied sufficiently in heavily pretreated patients and that studies carried out in children did not compare Telzir with a comparator medicine, it decided that Telzir's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet bemærkede, at brugen af ritonavir-forstærket Telzir ikke er tilstrækkeligt undersøgt hos patienter, der tidligere har fået omfattende behandling, og at studier gennemført hos børn ikke sammenlignede Telzir med et sammenligningslægemiddel.
English: Packaging Content Package size
Danish: Indgivelsesvej Emballage Indhold Pakning sstørrel se
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Dyrearte r, som lægemid let er beregnet til
English: EU (MA) number Invented name
Danish: EU-nummer
English: EU/1/03/249/016 Vivanza 10 mg Orodispersible tablet blister (alu/alu) 4 x 1 tablets (unit dose)
Danish: 10 mg Smeltetablet blister (alu/alu)
English: Strength Pharmaceutical form Route of administration
Danish: MF (EU)-nummer Særnavn Styrke Lægemiddelform Administration Emballage
English: EU Number
Danish: MF (EU)nummer
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage
English: The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 17 April 2007.
Danish: CVMP vedtog sin udtalelse den 17. januar 2007, og Kommissionen vedtog den efterfølgende beslutning den 17. april 2007.
English: In addition, a more robust test for potency should be applied to the product in the future.
Danish: Desuden bør der i fremtiden anvendes en mere robust styrketest.
English: However, it was important to ensure that the pass limits of the potency test do not drift from the original.
Danish: Det er imidlertid vigtigt at sikre, at godkendelsesgrænserne for styrkeprøven ikke afviger fra de oprindelige.
English: The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product.
Danish: CVMP konkluderede, at der på grundlag af de foreliggende oplysninger ingen anledning var til betænkeligheder med hensyn til lægemidlets sikkerhed eller virkning.
English: France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/82/EC, as amended, in relation to Suvaxyn Parvo/E.
Danish: Den 11. juli 2006 underrettede Frankrig EMEA om en sag indbragt i henhold til artikel 40 i Rådets direktiv 2001/82/EF, med senere ændringer, vedrørende Suvaxyn Parvo/E.
English: Suvaxyn Parvo/E is indicated for the active immunisation of pigs (gilts and sows) to prevent reproductive disorders caused by porcine parvovirus and to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1.
Danish: Suvaxyn Parvo/E er indiceret til aktiv immunisering af svin (gylte og søer) med henblik på at forebygge mod reproduktive forstyrrelser forårsaget af svineparvovirus og reducere kliniske symptomer forårsaget af Erysipelothrix rhusiopathiae- infektioner (serotype 1 og 2).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) started the referral procedure on 19 July 2006.
Danish: Udvalget for Veterinærlægemidler (CVMP) påbegyndte proceduren for indbragte sager den 19. juli
English: OPINION FOLLOWING AN ARTICLE 40 REFERRAL FOR SUVAXYN PARVO/E
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 40 VEDRØRENDE SUVAXYN PARVO/E
English: The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
Danish: Den indbragte sag beror på, at Frankrig er af den opfattelse, at der for disse 2 batcher ikke er blevet påvist ækvivalens mellem referencevaccinebatchen i batchstyrketesten for erysipelas, som er godkendt i det oprindelige dossier, og den nye referencevaccinebatch, og at CVMP derfor må overveje, om markedsføringstilladelsen skal ændres, suspenderes eller inddrages.
English: The CVMP, therefore, recommended that the Marketing Authorisation should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
Danish: CVMP anbefalede derfor, at markedsføringstilladelsen skulle ændres med henblik på passende foranstaltninger, så forskellene ved den serologiske styrketest i mus blev mindsket.
English: Three definitions of Cmin were discussed:
Danish: Der blev redegjort for tre definitioner af Cmin:
English: • The risk-benefit balance is therefore not positive.
Danish: • Derfor er risk/benefit-forholdet ikke positivt.
English: Member State EU/EEA Applicant
Danish: Medlemsstat EU/EØS
English: • Bioequivalence issues
Danish: • Bioækvivalensproblemer
English: In addition, tmax was in the same range for both products.
Danish: Desuden lå tmax i det samme interval for begge lægemidler.
English: Scientific conclusions and grounds for refusal
Danish: Videnskabelige konklusioner og begrundelser for afslag
English: Overall summary of the scientific evaluation of Galantamine STADA and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Galantamin STADA og relaterede navne (se bilag I)
English: Grounds for refusal
Danish: Begrundelser for afslag
English: It is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
Danish: Det er indiceret til symptomatisk behandling af mild til moderat alvorlig demens af Alzheimer-typen.
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Danish: Liste over lægemidlets navne, lægemiddelformer, styrker, indgivelsesvej og ansøgere i medlemsstaterne
English: However none of the 90%CI for this parameter fit into the standard bioequivalence limits.
Danish: Der er dog ingen af 90 %-CI'erne for dette parameter, som passer ind i standardkriterierne for bioækvivalens.
English: The active substance galantamine, a tertiary alkaloid, is a selective, competitive and reversible inhibitor of acetylcholinesterase (AChE).
Danish: Det aktive stof galantamin er en tertiær alkaloid, som er en selektiv, kompetitiv og reversibel acetylcholinesterasehæmmer (AChE).
English: • Bioequivalence in the multiple dose study has not been sufficiently demonstrated.
Danish: • Der er ikke i tilstrækkelig grad blevet påvist bioækvivalens i flerdosisundersøgelsen.
English: The high CV may therefore just reflect a sufficiently large difference between the performance of the compared products.
Danish: Den høje variationskoefficient kan således bare afspejle en tilstrækkeligt stor forskel mellem de sammenlignede lægemidlers ydeevne.
English: This procedure concerns a hybrid application (submitted under Art 10(3) of Directive 2001/83/EC as amended) of galantamine containing prolonged release tablets.
Danish: Denne procedure vedrører en hybridansøgning (indgivet i henhold til artikel 10, stk. 3, i direktiv 2001/83/EF med senere ændringer) for depottabletter, som indeholder galantamin.
English: It was also noted that the IS-CV was not as high for the 8mg and 16mg strengths (18% and 25%).
Danish: Det blev ligeledes bemærket, at IS-CV ikke var lige så høj for 8 mg- og 16 mgstyrkerne (18 % og 25 %).
English: All bioequivalence criteria were fulfilled in this study, except for Cmin, which the Applicant originally calculated as the minimum value recorded during 24 hours at steady-state.
Danish: Alle bioækvivalenskriterier blev opfyldt i denne undersøgelse, undtagen for Cmin, som ansøgeren oprindeligt beregnede som den minimumsværdi, der blev registreret i 24 timer ved steady state.
English: the CHMP has recommended the refusal of the granting of the marketing authorisation for Galantamine and associated names (see Annex I).
Danish: anbefalede CHMP afslag på ansøgningen om markedsføringstilladelse for Galantamin og relaterede navne (se bilag I).
English: In addition the CHMP agreed that the method of analysis should have been clearly indicated in the protocol, and that post-hoc calculations of Cpd and Ctrough were therefore not acceptable.
Danish: CHMP var ligeledes enig i, at analysemetoden skulle have været klart angivet i protokollen, og at post hoc-beregningerne af Cpd og Ctrough derfor ikke var acceptable.
English: In the case of prolonged release formulations, Cmin is usually lower than Ctrough.
Danish: Såfremt der er tale om depotformuleringer, er Cmin sædvanligvis lavere end Ctrough.
English: It was also noted by the CHMP that descriptive Cmin data had already been reported initially.
Danish: CHMP bemærkede ligeledes, at beskrivende Cmin-data allerede var blevet indberettet i starten.
English: A study at steady state with the highest strength (24 mg) after gradual dose increase (8 mg and
Danish: En steady state-undersøgelse med den højeste styrke (24 mg) efter en gradvis dosisøgning (8
English: The two other ways of calculations (Cpd and Ctrough) were conducted post hoc after it became apparent that prespecified Cminss data did not result in acceptable 90%CI.
Danish: De to andre beregningsmåder (Cpd og Ctrough) blev anvendt efterfølgende, da det viste sig, at de præspeficerede Cminss-data ikke resulterede i en acceptabel 90 %-CI.
English: 16 mg for 4 days each with dosing after a light meal).
Danish: mg og 16 mg i 4 dage hver med indgivelse efter et let måltid).