FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on the HMPC assessment of thyme medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder timian, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with these thyme medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder timian, herunder passende forholdsregler, der skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This summary is not intended to provide practical advice on how to use medicines containing thyme.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder timian, skal anvendes.
English: Thyme preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af timian findes desuden kombineret med andre droger i visse plantelægemidler.
English: A clinical study involving 60 adults with productive cough treated either with a thyme preparation or bromhexine, an established treatment for productive coughs.
Danish: En klinisk undersøgelse af 60 voksne med hoste med slim, blev behandlet enten med en tilberedning af timian eller med bromhexin, som er en etableret behandling af hoste med slim.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of thyme.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af timian.
English: Herbal medicines containing these thyme preparations are usually available as herbal tea to be drunk or in liquid or solid forms to be taken by mouth.
Danish: Plantelægemidler med timian i disse tilberedninger fås normalt som urtete beregnet til at drikke eller i flydende eller fast form til anvendelse gennem munden.
English: What are the risks associated with thyme medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder timian?
English: Extracts are obtained by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Danish: Ekstrakterne fremstilles ved at udtrække stoffer fra plantematerialet i et opløsningsmiddel (f.eks. ethanol).
English: Therefore, the HMPC conclusions on the use of these thyme medicines are based on their longstanding use.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med timian er derfor baseret på den mangeårige traditionelle anvendelse.
English: What evidence supports the use of thyme medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af timian?
English: For more information about treatment with thyme medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder timian, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC concluded that, on the basis of its long-standing use, these thyme preparations can be used for productive (chesty) coughs associated with colds.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at timian i disse tilberedninger kan anvendes mod hoste med slim i forbindelse med forkølelser.
English: For practical information about using thyme medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med timian, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The solvent is then partially or completely evaporated to obtain a soft or dry extract.
Danish: Ved fremstilling af tørekstrakt/blødt ekstrakt fordampes opløsningsmidlet herefter (delvist) for at opnå det tørre/bløde ekstrakt.
English: The HMPC conclusions only cover thyme preparations which are obtained by drying and comminuting (reducing into tiny pieces) the leaves and flowers, by expressing the juice of the leaves and flowers or as dry, liquid and soft extracts.
Danish: Timian er fællesnavnet for blade og blomster af planterne Thymus vulgaris L. og Thymus zygis L. HMPC's konklusioner omfatter kun tilberedninger af timian, som fremstilles ved tørring og findeling af blade og blomster, ved presning af saften af blade og blomster eller som tørre, flydende og bløde ekstrakter.
English: The HMPC conclusions on the use of these thyme medicines for productive coughs are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med timian mod hoste med slim er baseret på lægemidlernes "traditionelle anvendelse" mod hoste med slim.
English: It is presented in glass bottle.
Danish: Den leveres i en glasflaske.
English: Children and Teenagers This medicine must not be given to children or teenagers.
Danish: Brug til børn og teenagere Denne medicin må ikke gives til børn og teenagere.
English: Always ask if you are not sure why you are getting a dose of medicine.
Danish: Spørg altid, hvis du er i tvivl om, hvorfor du får en dosis medicin.
English: • Your doctor will decide on how much Tavanic you should have
Danish: • Din læge vil afgøre, hvor megen Tavanic du skal have
English: These findings were more marked in young animals.
Danish: Disse fund var mest udtalte hos unge dyr.
English: It is unlikely that you will not be given the medicine as it has been prescribed.
Danish: Det er usandsynligt, at du ikke får medicinen som ordineret.
English: Interference with laboratory test
Danish: Interferens med laboratorieprøve
English: The time to switch from intravenous to oral treatment depends on the clinical situation but is normally 2 to 4 days.
Danish: Tidspunktet for skift fra intravenøs til oral behandling afhænger af den kliniske situation, men er normalt 2 til 4 dage.
English: Keep out of direct sunlight while having this medicine and for 2 days after you stop having it.
Danish: Undgå direkte sollys, mens du får denne medicin og i 2 dage efter, du er holdt op med medicinen.
English: Frequencies in this table are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Danish: Frekvenserne i dette skema er defineret i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Your doctor and nurse will monitor your progress, and check the medicine you are given.
Danish: Lægen og sygeplejersken vil overvåge din tilstand og kontrollere den medicin, du får.
English: If it is stopped too soon, your condition may get worse or the bacteria may become resistant to the medicine.
Danish: Hvis behandlingen standses for tidligt, kan din tilstand forværres, eller bakterierne kan blive modstandsdygtige over for medicinen.
English: This is because an unusual fast beating of the heart and a temporary lowering of blood pressure are possible side effects that have been seen during the infusion of a similar antibiotic.
Danish: Dette skyldes, at en usædvanligt hurtig hjerterytme og et midlertidigt fald i blodtrykket er mulige bivirkninger, der er blevet set under infusion af et lignende antibiotikum.
English: • The length of your treatment will depend on how serious your infection is
Danish: • Behandlingens varighed afhænger af, hvor alvorlig din infektion er.
English: Given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
Danish: Da den parenterale og orale lægemiddelform er bioækvivalente, kan samme dosering anvendes.
English: This medicine is authorised in the Member States of the EEA under the following name: Tavanic
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navn:
English: ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Danish: Ekg bør monitoreres på grund af risikoen for forlængelse af QT-intervallet.
English: If your blood pressure drops noticeably while you are being given the infusion, it will be stopped straight away.
Danish: Hvis dit blodtryk falder betydeligt, mens du får infusionen, vil den blive standset med det samme.
English: Abnormal dreams Nightmares
Danish: Unormale drømme Mareridt
English: • You are pregnant, might become pregnant or think you may be pregnant
Danish: • hvis du er gravid, planlægger at blive gravid eller har mistanke om, at du er gravid
English: Following oral and intravenous administration of levofloxacin, it is eliminated relatively slowly from the plasma (t½ : 6 - 8 h).
Danish: Efter oral og intravenøs administration elimineres levofloxacin relativt langsomt fra plasma (t½: 6-8 timer).
English: • Attacks of porphyria in people who already have porphyria (a very rare metabolic disease)
Danish: • Porfyri-anfald hos personer, der allerede har porfyri (en meget sjælden stofskiftesygdom)
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis den ikke anvendes med det samme, er brugeren ansvarlig for opbevaringstid og opbevaringsforhold under anvendelsen.
English: • Your heart rate and blood pressure should be closely monitored.
Danish: • Din hjertefrekvens (puls) og dit blodtryk vil blive nøje overvåget.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single use only
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun til engangsbrug
English: • The dose will depend on the type of infection you have and where the infection is in your body
Danish: • Dosis afhænger af, hvilken infektion du har, og hvor infektionen sidder i kroppen
English: If your doctor has prescribed a urine test, tell your doctor you are having Tavanic.
Danish: Hvis din læge ordinerer en urinprøve, skal du fortælle, at du får Tavanic.
English: • Reactions at the site of infusion
Danish: • Reaktioner på infusionsstedet
English: You may be more likely to get the side effects of ciclosporin.
Danish: Du kan have større risiko for at få bivirkninger ved ciclosporin.
English: The risk of tendinitis and tendon rupture is increased in patients aged over 60 years, inpatients receiving daily doses of 1000 mg and in patients using corticosteroids.
Danish: Risikoen for tendinitis og seneruptur er forøget hos patienter over 60 år, hos patienter, der får en daglig dosis over 1.000 mg, og hos patienter, der får kortikosteroider.
English: Psychotic reactions (with e.g. hallucination, paranoia)
Danish: Psykotiske reaktioner (med eksempelvis hallucinationer, paranoia)
English: SPECIAL STORAGE CONDITIONS Keep the bottle in the outer carton in order to protect from light
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar flasken i den ydre karton for at beskytte mod lys
English: • Tavanic solution for infusion is a medicine for use in hospitals
Danish: • Tavanic infusionsvæske er medicin til brug på hospitaler
English: Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
Danish: Levofloxacin kan hæmme væksten af Mycobacterium tuberculosis og kan derfor give falsk-negative resultater ved bakteriologisk diagnosticering af tuberkulose.
English: No protection from light is necessary during infusion.
Danish: Det er ikke nødvendigt at beskytte mod lys under infusionen.
English: EXP Should be used within 3 hours after perforation of the rubber stopper
Danish: EXP Bør anvendes inden for 3 timer efter perforation af gummiproppen
English: For the above-mentioned infections Tavanic should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Danish: Tavanic bør kun anvendes ved ovennævnte infektioner, når det er uhensigtsmæssigt at anvende de antibakterielle lægemidler, der almindeligvis anbefales til den initiale behandling af disse infektioner.
English: EUCAST clinical MIC breakpoints for levofloxacin (version 2.0, 2012-01-01):
Danish: EUCAST-kliniske MIC-grænseværdier for levofloxacin (version 2.0, 2012 -01-01):
English: This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:
Danish: Dette skyldes, at din hud vil blive mere følsom over for solen og kan blive forbrændt eller få et alvorligt blæreformet udslæt, eller du kan få en prikkende fornemmelse i huden, hvis du ikke tager følgende forholdsregler:
English: • Persistent headache with or without blurred vision (benign intracranial hypertension)
Danish: • Vedvarende hovedpine med eller uden synsforstyrrelser (benign intrakraniel hypertension)
English: See section 6.2 for incompatibilities.
Danish: 6.2 for uforligeligheder.
English: In some special situations, Tavanic solution for infusion may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax.
Danish: I særlige situationer kan Tavanic infusionsvæske anvendes til at reducere risikoen for at få en lungesygdom kaldet anthrax eller forværring af denne sygdom, hvis du har været udsat for den bakterie, der forårsager anthrax.
English: Fungal infection including Candida infection Pathogen resistance
Danish: Svampeinfektion inklusive candidainfektion Patogenresistens
English: Levofloxacin is a ‘quinolone' antibiotic.
Danish: Levofloxacin er et ”quinolon”antibiotikum.
English: Do not use this medicine if you notice that the solution is not clear, greenish-yellow solution and/or has particles in it.
Danish: Brug ikke dette lægemiddel, hvis du bemærker, at infusionsvæsken ikke er klar og grønlig-gullig, og/eller der er partikler i den.
English: Clear greenish-yellow isotonic solution with pH of 4.3 to 5.3 and osmolarity of 282 - 322 mOsm/litre.
Danish: Klar, grønlig-gullig isotonisk opløsning med pH 4,3-5,3 og en osmolaritet på 282-322 mOsm/l.
English: Stop having Tavanic and tell a doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Stop med at få Tavanic og fortæl det straks til en læge eller sygeplejerske, hvis du bemærker nogen af følgende alvorlige bivirkninger - du kan have brug for akut lægebehandling:
English: You may be more likely to have inflammation and/or rupture of your tendons.
Danish: Du kan have større risiko for at få betændelse i og/eller bristning af dine sener.
English: swelling of your lips, face, throat, or tongue.
Danish: hævede læber, ansigt, hals eller tunge
English: This is important in people with myasthenia gravis (a rare disease of the nervous system).
Danish: Personer med myasthenia gravis (en sjælden sygdom i nervesystemet) skal være opmærksom herpå.
English: After a few days treatment with the solution for infusion, your doctor may decide to switch you to the tablet form of this medicine to complete your course of treatment.
Danish: Efter et par dages behandling med infusionsvæsken, kan lægen beslutte at skifte dig over til Tavanic tabletter for at fuldføre behandlingsforløbet.
English: Should a conspicuous drop in blood pressure occur during infusion of levofloxacin, (l-isomer of ofloxacin) the infusion must be halted immediately.
Danish: Hvis der opstår et mistænkeligt blodtryksfald under infusion af levofloxacin (l-isomer af ofloxacin), skal infusionen øjeblikkeligt standses.
English: This medicine may cause “false negative” results for some tests used in laboratory to search for the bacteria causing tuberculosis.
Danish: Denne medicin kan give ”falsk negative” resultater af nogle laboratorieprøver for den bakterie, der forårsager tuberkulose.
English: There are no major differences in the pharmacokinetics of levofloxacin following intravenous and oral administration, suggesting that the oral and intravenous routes are interchangeable.
Danish: Der er ingen væsentlige forskelle på levofloxacins farmakokinetik efter intravenøs og oral indgift, hvilket antyder, at oral og intravenøs administration er substituerbare.
English: Adults and the elderly with kidney problems Your doctor may need to give you a lower dose.
Danish: Voksne og ældre patienter med nyreproblemer Lægen vil muligvis give dig en lavere dosis.
English: Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Danish: Nogle bivirkninger (f.eks. svimmelhed/vertigo, døsighed, synsforstyrrelser) kan påvirke patientens koncentrations- og reaktionsevne og kan derfor udgøre en risiko i situationer, hvor disse egenskaber er af særlig vigtighed (f.eks. når patienten fører motorkøretøj eller betjener maskiner).
English: This medicinal product must not be mixed with heparin or alkaline solutions (e.g. sodium bicarbonate).
Danish: Dette lægemiddel må ikke blandes med heparin eller basiske opløsninger (f.eks. natriumhydrogencarbonat).
English: Once the infusion bottle has been opened (rubber stopper perforated) the solution should be used immediately (within 3 hours) in order to prevent any bacterial contamination.
Danish: Når infusionsflasken er åbnet (gummiproppen er perforeret), bør opløsningen straks anvendes (inden for 3 timer) for at hindre forurening med bakterier.
English: Highlighted in grey: Applies to 500 mg (100 ml) bottle only
Danish: Fremhævet med gråt: Gælder kun for 500 mg (100 ml) flaske
English: Tavanic solution for infusion can be used to treat infections of the:
Danish: Tavanic infusionsvæske kan anvendes til at behandle infektioner i:
English: Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.
Danish: Patienter med latente eller reelle defekter i glucose-6-phoosphatdehydrogenaseaktiviteten kan have tilbøjelighed til hæmolytiske reaktioner, når de behandles med quinoloner.
English: The mean apparent total body clearance of levofloxacin following a 500 mg single dose was 175 +/-29.2 ml/min.
Danish: Den gennemsnitlige tilsyneladende totale levofloxacin-clearance efter en enkeldosis på 500 mg var 175 +/-29,2 ml/min.
English: It must only be used if the solution is clear, greenish-yellow solution, practically free from particles.
Danish: Den må kun anvendes, hvis opløsningen er en klar, grønlig-gullig opløsning og i praksis fri for partikler.
English: Do not have this medicine if any of the above applies to you.
Danish: • hvis du ammer Du må ikke få denne medicin, hvis noget af ovenstående gælder for dig.
English: Special care should be taken when taking either of these medicines with Tavanic.
Danish: Du skal være særlig forsigtig, hvis du tager et af disse lægemidler sammen med Tavanic.
English: Low-level fluoroquinolone resistance (ciprofloxacin MICs of 0.12-0.5 mg/l) may occur but there is no evidence that this resistance is of clinical importance in respiratory tract infections with H. influenzae.
Danish: Resistens ved lav fluoroquinolonkoncentration (ciprofloxacin MIC-værdier på 0,12-0,5 mg/l) kan forekomme, men der er ikke evidens for, at denne resistens er klinisk vigtig ved luftvejsinfektioner forårsaget af H. influenzae.
English: Due to the mechanism of action, there is generally no cross-resistance between levofloxacin and other classes of antibacterial agents.
Danish: På grund af virkningsmekanismen er der generelt ingen krydsresistens mellem levofloxacin og andre typer antibiotika.
English: You may get side effects after being given this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight.
Danish: Du kan få bivirkninger, efter du har fået denne medicin, inklusive svimmelhed, døsighed, en følelse af at dreje rundt (vertigo) eller ændringer i dit syn.
English: If CDAD is suspected or confirmed, levofloxacin should be stopped immediately and appropriate treatment initiated without delay.
Danish: Ved mistanke om eller verificering af CDAD skal behandling med levofloxacin øjeblikkelig stoppes og passende behandling omgående initieres.
English: Infusion Time
Danish: Infusionstid
English: Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Danish: Patienter bør rådes til øjeblikkeligt at kontakte deres læge, inden de fortsætter behandlingen, hvis der opstår reaktioner fra huden og/eller slimhinder.
English: Urine tests may show ‘false-positive' results for strong painkillers called ‘opiates' in people having Tavanic.
Danish: Urinprøver kan vise ”falsk positive” resultater for stærke smertestillende midler kaldet ”opiater” hos patienter, der får Tavanic.
English: BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER Batch
English: 1 Treatment duration includes intravenous plus oral treatment.
Danish: 8 uger 1 Behandlingsvarigheden inkluderer både intravenøs og oral behandling.
English: Levofloxacin solution for infusion must not be used:
Danish: Levofloxacin infusionsvæske må ikke anvendes:
English: Tavanic solution for infusion is compatible with the following solutions for infusion: 0.9% sodium chloride solution.
Danish: Tavanic infusionsvæske, opløsning er forligelig med følgende infusionsvæsker: 0,9 % natriumchloridinfusionsvæske.
English: Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
Danish: Forsigtighed anbefales, hvis levofloxacin anvendes til psykotiske patienter eller til patienter med en psykiatrisk anamnese.
English: Combination solutions for parenteral nutrition (amino acids, glucose, electrolytes).
Danish: Kombinerede infusionsvæsker til parenteral ernæring (aminosyrer, glucose, elektrolytter).
English: • Pain and inflammation in your tendons or ligaments which could lead to rupture.
Danish: • Smerte og inflammation (betændelse eller irritation) i dine sener eller ligamenter, som kan medføre bristning.
English: Tavanic solution for infusion is administered by slow intravenous infusion once or twice daily.
Danish: Tavanic infusionsvæske indgives ved langsom intravenøs infusion én eller to gange dagligt.
English: This is because Tavanic can affect the way some other medicines work.
Danish: Det skyldes, at Tavanic kan påvirke den måde, hvorpå anden medicin virker, og anden medicin kan påvirke den måde, hvorpå Tavanic virker.
English: Stop having Tavanic and tell a doctor or nurse straight away if you notice the following side effect:
Danish: Stop med at få Tavanic og fortæl det straks til en læge eller sygeplejerske, hvis du bemærker følgende bivirkning:
English: This medicine contains181 mg of sodium per 250 mg dose.
Danish: Denne medicin indeholder 181 mg natrium per 250 mg dosis.
English: Anaerobic bacteria Bacteroides fragilis
Danish: Anaerobe bakterier Bacteroides fragilis
English: Effect of Tavanic on other medicinal products
Danish: Tavanic virkning på andre lægemidler
English: If you have more Tavanic solution for infusion than you should It is unlikely that your doctor or nurse will give you too much medicine.
Danish: Hvis du har fået for meget Tavanic infusionsvæske Det er usandsynligt, at lægen eller sygeplejersken vil give dig for megen medicin.