FrancophonIA/ELRC3.0 huggingface dataset:
English: In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with mild to severe hepatic insufficiency (Child Pugh Class A, B and C), the Cmax, AUC and t1/2 of telithromycin were similar compared to those obtained in age- and sex-matched healthy subjects.
Danish: I et enkelt dosis forsøg (800 mg) med 12 patienter og et fler dosis forsøg (800 mg) med 13 patienter med mild til alvorlig nedsat leverfunktion (Child Pugh Class A, B og C), var Cmax, AUC og t½ af telithromycin tilsvarende det, som blev opnået hos alders- og kønssammenlignelige raske personer.
English: If you forget to take Levviax
Danish: Hvis De glemmer at tage Levviax
English: Levviax should not be used during and 2 weeks after treatment with CYP3A4 inducers.
Danish: Levviax bør ikke anvendes under og 2 uger efter behandling med CYP3A4 inducere.
English: Therefore, concomitant administration of CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort) is likely to result in subtherapeutic levels of telithromycin and loss of effect.
Danish: Derfor vil samtidig administration af CYP3A4 inducere ( fx rifampicin, phenytoin, carbamazepin, phenobarbital, St Johns wort) sandsynligvis resultere i subterapeutiske koncentrationer af telithromycin og tab af effekt.
English: Due to limited experience in patients with decreased metabolic capacity of the liver, Levviax should be used with caution in patients with hepatic impairment (see also section 4.4).
Danish: På grund af begrænset erfaring med patienter med nedsat metabolisk kapacitet i leveren, bør Levviax anvendes med forsigtighed til patienter med nedsat leverfunktion (seogså pkt.
English: In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in Cmax,ss, and a 2-fold increase in AUC (0-24)ss at 800 mg multiple doses in the severe renally impaired group (CLCR < 30 mL/min) compared to healthy volunteers were observed and a reduced dosage of Levviax is recommended (See Section 4.2.).
Danish: I en multi dosis undersøgelse med36 patienter med forskellige grader af nedsat nyrefunktion, blev en 1,4-fold stigning i Cmax,ss, og en 2-fold stigning i AUC (0-24)ss ved 800 mg multiple doser i gruppen med alvorlig nedsat nyrefunktion (CLCR < 30 mL/min) observeret sammenlignet med raske frivillige og en nedsat dosis Levviax anbefales (se pkt.
English: There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose triphasic oral contraceptives in healthy subjects.
Danish: Der er ikke set farmakodynamiske eller klinisk relevant farmakokinetisk interaktion med lavdosis trifasiske perorale kontraceptiva hos raske forsøgspersoner.
English: Caution is warranted when Levviax is administered to patients taking other medicinal products with the potential to prolong QT interval (see section 4.4).
Danish: Forsigtigheden bør skærpes når Levviax administreres til der får anden medicin med potentiale til at forlænge QT intervallet (se pkt.
English: There were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical program and no subgroups at risk were identified.
Danish: Ingen patienter i nogen af grupperne viste en ΔQTc> 60 msec. Der var ingen rapporter på TdP eller andre alvorlige ventriculære arytmier eller relateret syncope i det kliniske program, og der blev ikke fundet risiko subgrupper
English: Concomitant administration of Levviax and any of the following substances is contraindicated: cisapride, ergot alkaloid derivatives (such as ergotamine and dihydroergotamine), pimozide, astemizole and terfenadine (see section 4.5).
Danish: Samtidig administration af Levviax og et eller flere af følgende stoffer er kontraindiceret: cisaprid, sekalealkaloider ( såsom ergotamin og dihydroergotamin ), pimozid, astemizol , ogterfenadin (se pkt.
English: Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
Danish: Telithromycin er CYP3A4-hæmmer og i en svag CYP2D6-hæmmer.
English: Levviax should not be used concomitantly with simvastatin, atorvastastin and lovastatin.
Danish: Levviax må ikke anvende samtidig med simvastatin, atorvastatin og lovastatin.
English: Oral Candida infection, stomatitis anorexia, constipation, ,
Danish: Peroral Candida infektion, stomatitis, anoreksi, obstipation
English: Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 and 2E1.
Danish: Hoved CYP450 enzymet involveret i telithromycin metaboliseringen er CYP3A4Telithromycin er CYP3A4 og CYP2D6 hæmmer men har ingen ellerbegrænset effekt på CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 og 2E1.
English: Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Levviax and alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities.
Danish: Ved ekstrapolering fra erythromycin A og josamycin kan samtidig medicinering med Levviax og sekalealkaloidderivater føre til alvorlig vasokonstriktion (”ergotisme”) med mulig nekrose i ekstremiteterne.
English: If you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking the next dose.
Danish: Hvis De på grund af bivirkninger føler, at De er nødt til at stoppe med at tage Levviax , bør De spørge Deres læge til råds inden De tager næste dosis.
English: Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY France
Danish: Aventis Pharma S:A 20, Avenue Raymond Aron F-92160 ANTONY Frankrig
English: In patients of 12 to 18 years old, the treatment regimen will be: - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Danish: Patienter 12-18 år gamle er behandlingen som følger Tonsilitis/Pharyngitis forårsaget af Streptococcus pyogenes 800 mg én gang daglig i 5 dage.
English: When prescribing Levviax, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).
Danish: Når Levviax ordineres skal generelle retningslinjer vedrørende rationel brug af antibiotika følges samt lokal forekomst af resistens (se også pkt.
English: Increase in liver enzymes (AST, ALT, alkaline phosphatase)
Danish: Forhøjede leverenzymer (ASAT, ALAT, basisk fosfatase)
English: The recommended dose is 800 mg once a day i.e. two 400 mg tablets once a day.
Danish: Anbefalet dosis 800 mg én gang daglig, dvs. 2 tabletter à 400 mg én gang daglig.
English: Aerobic Gram- negative bacteria Haemophilus influenzae$*
Danish: Aerobe Gram-negative bakterier Haemophilus influenzae*
English: - The active substance is telithromycin - The other ingredients are microcrystalline cellulose, povidone K25, croscarmellose sodium, magnesium stearate in the tablet core as well as talc, macrogol 8000 , hypromellose 6 cp, titanium dioxide E171, yellow iron oxide E172, red iron oxide E172 in the film-coating.
Danish: - De øvrige indholdsstoffer er: Mikrokrystallinsk cellulose, povidon K25, croscarmellosenatrium, magnesiumstearat, i tabletkernen og talkum, macrogol 8000, hypromellose 6 cp, titandioxid (E171), gul jernoxid (E172) og rød jernoxid (E172) i filmovertrækket.
English: Dizziness, headache, disturbance of taste
Danish: Svimmelhed, hovedpine, smagsforstyrrelser
English: Benzodiazepins
Danish: Benzodiazepiner
English: 20 Avenue Raymond Aron F-92160 ANTONY
Danish: Avenue Raymond Aron F-92160 ANTONY Frankrig
English: Aventis Pharma S.p.A. Strada Statale No 17, km22 67019 Scoppito (L'Aquila) Italy
Danish: Strada Statale No 17, km22 67019 Scoppito (L'Aquila) Italien
English: Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/l (range 0.027.6 mg/l) and 0.2±0.2 mg/l (range 0.010 to 1.29 mg/l), during a therapeutic 800 mg once-daily dose regimen.
Danish: Genemsnitlige maksimum og minimum plasmakoncentrationer ved steady state hos patienter var 2,9±1,6 mg/l (interval 0,02-7,6 mg/ml) og 0,2±0,2 mg/l( interval 0,010-1,29 mg/l) under et terapeutisk 800 mg daglig dosis regime.
English: So, if any of the following happens, stop taking Levviax and tell your doctor immediately: - Allergic or skin reactions such as face swelling, general allergic reactions including allergic shock, or serious skin conditions associated with red spots, blisters.
Danish: Hvis De oplever en af følgende tilstande, skal De holde op med at tage Levviax, og omgående kontakte lægen: - Overfølsomheds- og hudreaktioner som fx ansigtshævelse, generelle allergiske reaktioner,
English: Cardiovascular disorders
Danish: Hjertekarsygdomme
English: - if you experience visual disturbances (blurred vision, difficulty in focusing, double vision) - if you experience transient loss of consciousness (fainting).
Danish: - Hvis De oplever synsforstyrrelser (sløret syn, besvær med at se skarpt, dobbeltsyn).
English: Taking Levviax tablets may cause side effects such as visual disturbances, which may reduce the capacity to carry out certain tasks.
Danish: Indtaglse af Levviax tabletter kan give bivirkninger, så som synsforstyrrelser som kan nedsætte evnen til at udføre forskellige opgaver.
English: The maximum total tissue concentration in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 14.9±11.4 mg/l, 318.1±231 mg/l, 3.88±1.87 mg/kg, 3.95±0.53 mg/kg and 6.96±1.58 mg/kg, respectively.
Danish: De maksimale totale vævskoncentrationer i epitelomkranset væske, alveolære makrofager, bronchial mucosa, ,tonsiller og sinusvæv var henholdsvis 14,9 ± 11,4 mg/l, 318,1 ± 231 mg/l, 3,88 ± 1,87 mg/kg, 3,95 ± 0,53 mg/kg og 6,96 ± 1,58 mg/kg.
English: Constipation, anorexia (loss of appetite), stomatitis (inflammation in themouth), oral Candida infection (fungal infection), hepatitis, rash, urticaria (hives), pruritus (itching), eczema, somnolence, insomnia, nervousness, vertigo, paraesthesia (tingling of the hands or feet), , visual disturbances (blurred vision, difficulty in focusing, double vision), , flushes, transient loss of consciousness (fainting), arrhythmia, bradycardia or palpitations (changes in heart rate or in ECG), hypotension (low blood pressure), eosinophilia (increase of certain white blood cells, detected by blood test).
Danish: Usædvanlige eller sjældne bivirkninger (fra 1 ud af 10.000 til mindre end 1 ud af 100 patienter) som forekommer med Levviax er: - Forstoppelse, anoreksi (tab af appetit), stomatitis (betændelse i munden), oral Candida infektion (svampeinfektion), hepatitis, udslæt, urticaria (nældefeber), pruritus (kløe), eksem, somnolens, søvnløshed, nervøsitet, , paræstesi (snurren i hænder og fødder), synsforstyrrelser (sløret syn, svært ved at fokusere, dobbeltsyn), blussen, forbigående bevidsthedstab (besvimelse), arytmi, bradykardi eller palpitationer (ændringer i hjertefrekvensen eller i EKG), hypotension (lavt blodtryk), eosinofili (forøgelse af visse hvide blodlegemer, påvist ved blodprøve).
English: Additional side effects which may occur with Levviax are: abnormality of electrocardiogram (ECG) called prolongation of QT interval and inflamed pancreas (pancreatitis).
Danish: Unormalt elektrokardiogram (EKG) også kaldet forlængelse af QT intervallet og betændt bugspytkirtel (pankreatitis).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Aventis Pharma S.A.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Aventis Pharma S.A.
English: There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome (see sections 4.7 and 4.8).
Danish: Der har været rapporteret post-marketing bivirkninger af forbigående tab af bevidsthed inklusive nogle tilfælde associeret med vagus syndrom (se pkt.
English: Uncommon or rare side effects (1 out of 10,000 to less than 1 out of 100 patients) which may occur with Levviax are:
Danish: Meget sjældne bivirkninger (mindre end 1 ud af 10.000 patienter) som kan forekommer med Levviax er:
English: There is no clinically relevant pharmacokinetic interaction of Levviax and theophylline administered as extended release formulation.
Danish: Der er ikke nogen klinisk relevante farmakokinetiske interaktioner mellem Levviax og teofyllin, når dette gives som retardformulering.
English: If possible take the tablets before going to bed, to reduce the potential impact of visual disturbances and loss of consciousness.
Danish: Hvis det er muligt, bør De tage tabletterne umiddelbart inden sengetid for at mindske de mulige følgevirkninger såsom synsforstyrrelser samt tab af bevidsthed.
English: Due to limited experience, Levviax should be used with caution in patients with liver impairment (see section 5.2).
Danish: Levviax bør grundet begrænset erfaring anvendes med forsigtighed til patienter med nedsat lerverfunktion (se pkt.
English: Microcrystalline cellulose Povidone K25
Danish: Mikrokrystallinsk cellulose
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of telithromycin
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 400 mg telithromycin
English: NAME OF THE MEDICINAL PRODUCT Levviax 400 mg film-coated tablets Telithromycin
Danish: LÆGEMIDLETS NAVN Levviax 400 mg filmovertrukne tabletter Telithromycin
English: In patients of 18 years and older, according to the indication, the treatment regimen will be: - Community-acquired pneumonia: 800 mg once a day for 7 to 10 days, - Acute exacerbation of chronic bronchitis: 800 mg once a day for 5 days, - Acute sinusitis: 800 mg once a day for 5 days, - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Danish: Patienter på 18 år og opefteralt efter indikation er behandlingen som følger: Pneumoni: 800 mg én gang daglig i 7-10 dage Akutte eksacerbationer af kronisk bronkitis: 800 mg én gang daglig i 5 dage.
English: The total tissue concentration 24 h after dose in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 0.84±0.65 mg/l, 162±96 mg/l, 0.78±0.39 mg/kg, 0.72±0.29 mg/kg and 1.58±1.68 mg/kg, respectively.
Danish: De totale vævskoncentrationerne 24 timer efter dosis i epitelomkranset væske, alveolære makrofager, bronchial mucosa, tonsiller, og sinusvæv var henholdsvis 0,84 ± 0,65 mg/l, 162 ± 96 mg/l, 0,78 ± 0,39 mg/kg, 0,72 ± 0,29 mg/kg og 1,58 ± 1,68 mg/kg.
English: Pseudomembranous colitis
Danish: Pseufomembr anøs colitis
English: Hence, Levviax should not be used during treatment with medicinal products that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or adverse events can be closely monitored.
Danish: Hæmningsgraden af forskellige CYP3A4 substrater er vanskelig at forudsige, Levviax bør derfor ikke anvendes under behandling med andre midler, der er CYP3A4 substrater, med mindre at plasmakoncentrationerne af CYP3A4 substrat, effekten eller bivirkninger nøje kan monitoreres.
English: Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness.
Danish: Det bør overvejes at give Levviax ved sengetid for at reducere den potentielle følgevirkning synsforstyrrelser og tab af bevidsthed.
English: - If you have further questions, ask your doctor or your pharmacist.
Danish: Spørg Deres læge eller apotek, hvis De har yderligere spørgsmål.
English: The total clearance (mean ±SD) is approximately 58±5 l/h after an intravenous administration with renal clearance accounting for about 22 % of this.
Danish: Den non-renale clearance m nedsættes når dosis forøges.Total clearance er ca. 58±5 L/time efter intravenøs hvoraf den renale clearance er på 22 %.
English: Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the excipients.
Danish: Overfølsomhed overfor det aktive stof, overfor en eller flere makrolidantibiotika eller overfor nogen af indholdsstofferne i Levviax.
English: The manufacturer of Levviax is: Aventis Pharma S.p.A.
Danish: Levviax fremstilles af: Aventis Pharma S.p.A.
English: Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness (see section 4.4).
Danish: Det bør overvejes at give Levviax ved sengetid for at reducere den potentielle følgevirkning synsforstyrrelser og tab af bevidsthed (se pkt.
English: How to take Levviax.
Danish: HVORDAN DE TAGER LEVVIAX
English: • a medicine called protease inhibitor (HIV treatment) Refer also to section “Taking other medicines”.
Danish: • medicin, som kaldes en protease hæmmer (HIV behandling)
English: The recommended dose of Levviax for adults and children of 12 years and older is two tablets of 400 mg once daily (800 mg once daily).
Danish: Den anbefalede dosis af Levviax til voksne og børn på 12 eller derover er 800 mg en gang daglig, dvs. 2 tabletter á 400 mg en gang daglig.
English: Chlamydophila pneumoniae* Chlamydia psittaci Mycoplasma pneumoniae*
Danish: Chlamydophila pneumoniae*
English: However, the co-administration of both medicinal products should be separated by one hour in order to avoid possible digestive side effects such as nausea and vomiting.
Danish: Hvis begge lægemidler skal anvendes samtidig, skal de indtages med 1 times interval for at undgå mulige bivirkninger fra mavetarmkanalen fx kvalme og opkastning.
English: If patients experience visual disorders or loss of consciousness while taking Levviax patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities (see sections 4.4 and 4.8).
Danish: Hvis patienterne oplever sysnforstyrrelser eller tab af bevidsthed under behandling med Levviax, bør de ikke køre bil, betjene tunge maskiner eller påtage sig andre risikobetonede aktiviteter (se pkt.
English: sanofi-aventis Oy Puh/Tel: +358 (0) 201 200 300
Danish: Suomi/Finland sanofi-aventis Oy Puh/Tel: +358 (0) 201 200 300
English: The in vitro protein binding is approximately 60 % to 70 %.
Danish: In-vitro proteinbindingen er ca. 60% til 70%.Telithromycin fordeles bredt i hele kroppen.
English: - if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
Danish: De bør ikke anvende Levviax: - Hvis De lider af myasthenia gravis, en sjælden sygdom, som giver muskelsvaghed.
English: Opaque PVC/Aluminium perforated unit dose blisters.
Danish: Uigennemsigtig PVC/aluminiumsblisterpakning, som perforeret ”Unit dose” pakning Muligvis vil ikke alle pakninger blive markedsført
English: Gastro-intestinal disorders
Danish: Gastrointestinale sygdomme
English: HOW TO STORE LEVVIAX
Danish: HVORDAN DE OPBEVARER LEVVIAX
English: The rate and extent of absorption is unaffected by food intake, and thus Levviax tablets can be given without regard to food.
Danish: Den absolutte biotilgængelighed er ca.57% efter en enkelt dosis på 800 mg. Absorptionsraten og -udbredelsen påvirkes ikke af fødeindtagelse, hvorfor Levviax tabletter kan gives uden hensyn til fødeindtagelse.
English: Hence, Levviax should be used with caution (see also section 4.4 and 5.2).
Danish: Som følge heraf bør Levviax anvendes med forsigtighed (se også pkt.
English: Studies in rats and rabbits were inconclusive with respect to potential for teratogenicity, there was equivocal evidence of adverse effects on foetal development at high doses.
Danish: Forsøg på rotter og kaniner var inklusiv med hensyn til potentiale for teratogenicitet.
English: Telithromycin is metabolized both by CYP450 isoenzymes and non-CYP enzymes.
Danish: isoenzymer og non-Cyp enzymer.
English: Due to the potential for the prolongation of the QT interval and increased risk of arrhythmia, ECG monitoring must take place
Danish: Blodelektrolytter (specielt kalium) skal kontrolleres og grundet risikoen for forlængelse af Qtinterval og øget risiko for arytmier skal EKG måling finde sted.
English: Tablet coating:
Danish: Tabletkerne:
English: Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose.Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Danish: Forværring af myasthenia gravis er rapporteret hos patienter behandlet med telithromycin og denne forværring er nogle gange indtruffet indenfor få timer efter første dosis.
English: Legionella pneumophila Moraxella catarrhalis* Other
Danish: Moraxella catarrhalis*
English: Nausea, vomiting, abdominal pain, flatulence (excess wind), dizziness, headaches, disturbance of taste, vaginal Candida infection (fungal infection associated with local itching, burning and white discharge), increase in liver enzymes (detected by blood test).
Danish: Øvrige bivirkninger som forekommer hyppigt (1 til 10 ud af 100 patienter) med Levviax er: - Kvalme, opkastning, mavesmerter, flatulens (luft i maven), svimmelhed, hovedpine, smagsforstyrrelser, vaginal Candida infektion (svampeinfektion ledsaget af lokal kløe, brænden og hvidt udflåd), forhøjede leverenzymer (kan afsløres ved blodprøve).
English: Treatment with these agents should be interrupted during Levviax treatment (see section 4.5).
Danish: Behanndling med disse stoffer bør afbrydes under behandling med Levviax (se pkt.
English: Levviax should not be used by breast-feeding women.
Danish: Levviax bør ikke anvendes under amning.
English: Haemophilus parainfluenzae$ Inherantly resistant organisms Aerobic Gram- negative bacteria Acinetobacter
Danish: Arveligt betingede resistente organismer Aerobe Gram-negative bakterier Acinetobacter
English: The marketing authorisation holder of Levviax is: Aventis Pharma S.A.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen for Levviax er: Aventis Pharma S.A.
English: Aerobic Gram-positive bacteria
Danish: Aerobe Gram-negative bakterier Legionella pneumophila
English: Rare cases of transient loss of consciousness (fainting), which may be preceded by vagal symptoms (malaise, gastrointestinal distress), have been reported.
Danish: Der er rapporteret sjældne tilfælde af forbigående bevidsthedstab (besvimelse), hvilke kan forudgås af vagus symptomer (utilpashed, mavegener) Disse symptomer kan forekomme så tidligt som efter den første dosis af Levviax.
English: NAME OF THE MEDICINAL PRODUCT Levviax 400 mg film-coated tablets.
Danish: Levviax 400 mg filmovertrukne tabletter.
English: Opaque PVC/Aluminium blisters
Danish: Uigennemsigtig PVC/aluminiumsblisterpakning Pakning på 5 x 2 tabletter
English: Lancefield group C and G ( ß haemolytic ) streptococci Streptococcus agalactiae
Danish: Aerobe Gram-positive bakterier Staphylococcus aureus methicillin følsomme (MSSA)* Lancefield gruppe C og G streptococci (β hæmolytisk) Streptococcus agalactiae
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Hvis en bivirkning bliver alvorlig, eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter recept.
English: Reproductive system disorders
Danish: Lidelser i det reproduktive system og brystsygdomme
English: What Levviax is and what it is used for Before you take Levviax.
Danish: Hvad Levviax er, og hvad det anvendes til Hvad De skal gøre, før De begynder at anvende Levviax Hvordan De anvender Levviax Hvilke mulige bivirkninger Levviax har Hvordan De opbevarer Levviax Yderligere oplysninger