FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, both partners may feel slight numbness for a short while and should take care not to injure themselves, particularly during sexual activity.
Danish: Begge partnere kan derfor kortvarigt have let nedsat følsomhed og skal derfor passe på ikke at få læsioner, navnlig under seksuel aktivitet.
English: EXP Discard 12 weeks after first use.
Danish: EXP Kasseres 12 uger efter første anvendelse.
English: Care should be taken not to allow Fortacin to come in contact with the eye, as it may cause eye irritation.
Danish: Forsigtighed bør udvises for at undgå, at Fortacin kommer i kontakt med øjet, da det kan medføre øjenirritation.
English: The medicinal product has a rapid onset of action and is effective within 5 minutes of application.
Danish: Lægemidlet har hurtigt indsættende virkning og er effektivt inden for fem minutter efter påføringen.
English: The efficacy of Fortacin was demonstrated in two multi-centre, multinational, randomised, double-blind, placebo controlled studies, both followed by an open-label phase.
Danish: Virkningen af Fortacin blev påvist i to multinationale, randomiserede, dobbeltblindede, placebokontrollerede multicenterundersøgelser, begge efterfulgt af en åben fase.
English: Both IELT and IPE scores continued to increase slightly more throughout the remainder of the double-blind phase.
Danish: Både IELT- og IPE-score steg fortsat let gennem hele den tilbageværende del af den dobbeltblindede fase.
English: Uncommon Vaginal candidiasis
Danish: Vaginal candidiasis
English: It should not be punctured, broken or burnt, even when apparently empty.
Danish: Det må ikke gennemhulles, brydes eller brændes, selv om den tilsyneladende er tom.
English: A study in rats showed that Fortacin caused a reduction in sperm motility.
Danish: En undersøgelse hos rotter viste, at Fortacin medførte nedsat motilitet af sædceller.
English: Ask your pharmacist if you are unsure.
Danish: Spørg på apoteket, hvis du ikke er sikker.
English: Fortacin has no or negligible influence on the ability to drive and use machines.
Danish: Fortacin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Danish: Dyreforsøg tyder ikke på reproduktionstoksicitet (se pkt.
English: The systemic clearance is 18 - 64 mL/min/kg.
Danish: Den systemiske clearance er 18-64 ml/min/kg.
English: Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive medicinal products.
Danish: Svære neurologiske symptomer (kramper, CNS-depression) skal behandles symptomatisk med respiratorisk støtte og administration af antikonvulsiva.
English: • local irritation of the throat (if inhaled)
Danish: • lokal irritation i halsen (hvis lægemidlet indåndes)
English: In serious cases of overdose, symptoms may include fits, low blood pressure, slowed breathing, stopped breathing and altered heart beat.
Danish: Ved svær overdosering kan symptomerne bestå i krampeanfald, lavt blodtryk, langsom vejrtrækning, vejrtrækningsstop og ændret hjerterytme.
English: However this study did not reproduce the circumstances of clinical use, as the concentration of Fortacin in direct contact with the sperm would be many fold lower.
Danish: Denne undersøgelse svarede imidlertid ikke til forholdene under klinisk anvendelse, da koncentrationen af Fortacin i direkte kontakt med sæd vil være mange gange lavere.
English: Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylthioninium chloride.
Danish: Klinisk betydningsfuld methæmoglobinæmi bør behandles ved langsom intravenøs injektion af methylthioniniumchlorid.
English: • a high temperature
Danish: • temperaturforhøjelse
English: The PEP scores followed a similar pattern of improvement to the IELT and IPE scores.
Danish: PEP-score fulgte et mønster med tilsvarende bedring som IELT- og IPE-score.
English: Fortacin is a combination of two medicines: lidocaine and prilocaine.
Danish: Fortacin er en kombination af to lægemidler: lidocain og prilocain.
English: • Ringing in the ears
Danish: • ringen for ørerne
English: Prilocaine crosses the blood-brain barrier and also crosses the placenta.
Danish: Prilocain passerer blod-hjernebarrieren og passerer også placenta.
English: You must throw away the container 12 weeks after you first use it.
Danish: Du skal kassere beholderen 12 uger efter at du har brugt den første gang.
English: Do not puncture, break or burn it even when apparently empty.
Danish: Du må ikke gennemhulle, bryde eller brænde den, selv om den tilsyneladende er tom.
English: Women of childbearing potential / contraception in male and females
Danish: Kvinder i den fødedygtige alder/antikonception til mænd og kvinder
English: Human exposure from Fortacin is 20-30 fold less than the minimum dose that did not result in tumours and 200 fold less than the minimum dose that did result in tumours.
Danish: Den humane eksponering med Fortacin er 20-30 gange under den mindste dosis, der ikke medførte tumorer, og 200 gange under den mindste dosis, der medførte tumorer.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg lægen eller apoteket til råds, før du tager nogen form for medicin.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing incidence.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet i rækkefølge efter aftagende forekomst.
English: During sexual intercourse, a small amount of this medicine may be transferred e.g. to the vagina or the anus.
Danish: Under samleje kan der overføres en lille smule af dette lægemiddel til f.eks. skeden eller anus.
English: Frequency of the adverse reactions is defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til < 1/1 000), meget sjælden
English: The steady-state volume of distribution is 1.1 to 2.1 L/kg after intravenous administration.
Danish: Steady state-fordelingsvolumenet er 1,1 til 2,1 l/kg efter intravenøs administration.
English: The elimination half-life of prilocaine following intravenous administration is approximately 10 - 150 minutes.
Danish: Eliminationshalveringstiden af prilocain efter intravenøs administration er ca. 10-150 minutter.
English: You may also be more likely to have reduced feeling in and around the penis.
Danish: Du vil også lettere kunne få nedsat følsomhed i og omkring penis.
English: • medicines reducing your stomach acid (cimetidine)
Danish: • lægemidler, der nedsætter syreindholdet i maven (cimetidin)
English: This medicinal product may reduce the possibility of pregnancy, but should not be used as a contraceptive.
Danish: Dette lægemiddel kan nedsætte muligheden for graviditet, men bør ikke anvendes som antikonceptivum.
English: Adjusted mean change scores (Fortacin vs. placebo) at Month 3 were 8.2 vs. 2.2 for the ejaculatory control score, 7.2 vs. 1.9 for the sexual satisfaction score, and 3.7 vs. 1.1 for the distress score.
Danish: Den justerede gennemsnitsscore (Fortacin versus placebo) i måned 3 var 8,2 mod 2,2 for ejakulationskontrol-score, 7,2 mod 1,9 for seksuel tilfredshedsscore og 3,7 mod 1,1 for score for frustration.
English: Following intravenous administration, the steady state volume of distribution of prilocaine is 0.7 to 4.4 L/kg.
Danish: Efter intravenøs administration er steady state-fordelingsvolumenet af prilocain 0,7-4,4 l/kg.
English: Note, this dose did result in tumours.
Danish: Det bemærkes, at denne dosis ikke medførte tumorer.
English: Prilocaine is also distributed in breast milk.
Danish: Prilocain udskilles i modermælk.
English: Medicinal products that reduce the clearance of lidocaine (e.g. cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine is given intravenously in repeated high doses over a long time period (30 hours).
Danish: Lægemidler der nedsætter clearance af lidocain (f.eks. cimetidin eller betablokkere) kan forårsage potentielt toksiske plasmakoncentrationer, navnlig når lidocain gives intravenøst i gentagne høje doser i længere tidsrum (30 timer).
English: Fortacin is not indicated for use by women.
Danish: Fortacin er ikke bestemt til anvendelse hos kvinder.
English: Do not use this medicine after the expiry date which is stated on the spray container label and the carton after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på spraybeholderens etiket og på kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The risk of additional systemic toxicity should be considered when large doses of Fortacin are applied to patients already using other local anaesthetics or structurally related medicinal products, e.g. class I anti-arrhythmics such as mexiletine.
Danish: Risikoen for øget systemisk toksicitet bør tages i betragtning ved administration af store doser af Fortacin til patienter, der i forvejen bruger andre lokalanæstetika eller strukturelt beslægtede lægemidler, f.eks. klasse I-antiarytmika såsom mexiletin.
English: Check the material that your contraceptive or your partner's contraceptive is made of.
Danish: Kontroller, hvilket materiale, dit eller din partners præventionsmiddel er fremstillet af.
English: During the 3 months of the double-blind treatment phase, the geometric mean IELT increased from 0.58 to 3.17 minutes in the Fortacin group and from 0.56 to 0.94 minutes in the placebo group.
Danish: I de første tre måneder af den dobbeltblindede behandlingsfase steg den geometriske middelværdi af IELT fra 0,58 til 3,17 minutter i grupperne på Fortacin og fra 0,56 til 0,94 minutter i placebogruppen.
English: Lidocaine
Danish: Lidocain
English: Any barrier contraceptives (e.g. male or female condom), which are made from polyurethane-based material cannot be guaranteed to protect against disease or pregnancy when you are also using Fortacin.
Danish: Præventionsmidler af barrieretypen (f.eks. kondomer eller femidomer) fremstillet af polyuretanbaseret materiale kan ikke garanteres at give beskyttelse mod sygdomme eller graviditet, når du også bruger Fortacin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF MARKEDSFØRINGSTILLADELSEN
English: The active substances lidocaine and prilocaine block the transmission of nerve impulses in the glans penis, reducing the sensitivity of the glans penis.
Danish: De aktive stoffer lidocain og prilocain blokerer transmissionen af nerveimpulser i glans penis og nedsætter derved dannes følsomhed.
English: Lidocaine is largely metabolised in the liver by cytochrome P450 (CYP 3A4) and probably to a minor extent in the skin.
Danish: Lidocain metaboliseres hovedsagelig i leveren af cytokrom P450 (CYP 3A4) og antagelig i mindre omfang i huden.
English: Prilocaine was not genotoxic and the carcinogenic potential of prilocaine has not been studied.
Danish: Prilocain var ikke genotoksisk, og det carcinogene potentiale af prilocain er ikke undersøgt.
English: • Chloroquine, pamaquine, primaquine, quinine - used to treat malaria
Danish: • chloroquin, pamaquin, primaquin, kinin - anvendes til behandling af malaria
English: The risk of methaemoglobinaemia can also be increased by the use of certain dyes (aniline dyes), or the pesticide naphthalene, so let your doctor know if you work with any dyes or chemical pesticides.
Danish: Risikoen for methæmoglobinæmi kan desuden øges ved anvendelse af visse farvestoffer (anilinfarver) eller pesticidet naphthalen; sig det derfor til lægen, hvis du arbejder med farlige stoffer eller kemiske pesticider.
English: Retract any foreskin from the head of the penis.
Danish: Træk eventuel forhud tilbage fra hovedet af penis.
English: If contact with the eye occurs, immediately rinse the eye with water or sodium chloride solution and protect it until sensation returns.
Danish: Ved kontakt med øjet skal øjet straks skylles med vand eller natriumchloridopløsning og beskyttes, indtil følsomheden vender tilbage.
English: Lidocaine and prilocaine are excreted in human milk, but at therapeutic doses of Fortacin no effects on the breastfed newborns/infants are anticipated due to active substance transfer from the male patient to his female partner.
Danish: Lidocain og prilocain udskilles i human mælk, men ved terapeutiske doser forventes ingen påvirkning af den ammede nyfødte/spædbarnet ved overførsel af aktivt stof fra den mandlige patient til dennes kvindelige partner.
English: The clinically significant increases in IELT were paralleled by significant differences in the IPE scores (p <0.0001).
Danish: Den kliniske betydningsfulde stigning i IELT var ledsaget af signifikante forskelle i IPE-score (p <0,0001).
English: This is translated into a delaying of the ejaculatory latency time without adversely affecting the sensation of ejaculation.
Danish: Dette medfører forlængelse af latenstiden for ejakulation uden negativ påvirkning af følelsen af ejakulation.
English: As this medicine is applied to the surface of the head of the penis the risk of overdose is low.
Danish: Da dette lægemiddel påføres på overfladen af hovedet af penis, er risikoen for overdosis lille.
English: The most frequent adverse reactions reported with the use of this medicinal product in female partners were vulvovaginal burning sensation (3.9%), and genital hypoaesthesia (1.0%).
Danish: De hyppigste bivirkninger, der er indberettet ved anvendelse af dette lægemiddel hos kvindelige partnere, er vulvovaginal brænden (3,9 % og genital hypæstesi (1,0 %).
English: • discomfort in the anus and rectum
Danish: • ubehag i anus og endetarmen
English: The terminal elimination half-life of lidocaine from the plasma following intravenous administration is approximately 65 - 150 minutes and the systemic clearance is 10 - 20 mL/min/kg.
Danish: Den terminale eliminationshalveringstid af lidocain i plasma efter intravenøs administration er ca. 65-150 minutter, og den systemiske clearance er 10-20 ml/min/kg.
English: The most frequent adverse reactions reported with the use of this medicinal product in male patients were local effects of genital hypoaesthesia (4.5%) and erectile dysfunction (4.4%).
Danish: De hyppigste bivirkninger, der er indberettet ved anvendelse af dette lægemiddel hos mandlige patienter, var lokale virkninger i form af genital hypæstesi (4.5 %) og erektil dysfunktion (4.4 %).
English: Lidocaine was not genotoxic and the carcinogenic potential of lidocaine has not been studied.
Danish: Lidocain var ikke genotoksisk, og det carcinogene potentiale af lidocain er ikke undersøgt.
English: Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression.
Danish: Toksisk virkning af lokalanæstetika viser sig ved symptomer på ekscitation af nervesystemet og i svære tilfælde depression af centralnervesystemet og det kardiovaskulære system.
English: • Tingling of the skin around the mouth and numbness of the tongue
Danish: • prikken rundt om munden og følelsesløshed af tungen
English: When you use this medicine, particularly during priming of the container, aim the container away from the face to avoid accidental contact with ears, eyes, nose and mouth.
Danish: Når du bruger dette lægemiddel, navnlig når du gør beholderen klar til brug, skal du vende den bort fra ansigtet for at undgå, at lægemidlet kommer i kontakt med ører, øjne, næse eller mund.
English: The prilocaine metabolite o-toluidine has genotoxic potential in vitro.
Danish: Prilocainmetabolitten o-toluidin har genotoksisk potentiale in vitro.
English: • failure to ejaculate during sexual intercourse
Danish: • manglende evne til at opnå sædafgang under samleje
English: Aim the container away from faces to avoid contact with eyes, nose, mouth and ears.
Danish: Ret beholderen væk fra dit og partnerens ansigt for at undgå kontakt med øjne, næse, mund og ører.
English: Pharmacotherapeutic group: Anaesthetics, amides, ATC code: N01BB20
Danish: Farmakoterapeutisk klassifikation: Lokalanæstetika, amider, kombinationer, ATC-kode: N01BB20.
English: Fortacin may also come into contact with other mucous membranes such as your, or your partner's, mouth, nose and throat, causing them to feel slightly numb for a short while.
Danish: Fortacin kan også komme i kontakt med andre slimhinder såsom din eller din partners mund, næse og hals, der derved kortvarigt vil have nedsat følsomhed.
English: For all of the three monthly assessments completed by the subjects, there was a significant difference between Fortacin and placebo (p < 0.0001).
Danish: For alle deltagernes tre månedlige vurderinger var der signifikant forskel mellem Fortacin og placebo (p < 0,0001).
English: The following side effects have been reported with Fortacin in male patients:
Danish: Følgende bivirkninger med Fortacin er indberettet hos mandlige patienter:
English: The plasma levels of lidocaine and prilocaine in male and female subjects were below the level associated with toxicity (5,000 ng/ml).
Danish: Plasmaniveauet af lidocain og prilocain hos de mandlige og kvindelige deltagere var under det niveau, der er forbundet med toksicitet (5.000 ng/ml).
English: The risk of a disorder reducing the amount of oxygen in the blood (methaemoglobinaemia) may be increased if you are already taking medicines known to cause the condition, such as those listed below:
Danish: Risikoen for en sygdom, der giver nedsat iltindhold i blodet (methæmoglobinæmi) kan øges, hvis du i forvejen tager lægemidler, der vides at medføre denne tilstand, såsom følgende:
English: The following side effects have been reported with Fortacin in female partners:
Danish: Følgende bivirkninger med Fortacin er indberettet hos kvindelige partnere:
English: If you or your sexual partner get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du eller din seksualpartner oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: The recommended dose of Fortacin is 3 sprays (3 sprays = 1 dose) on the head of the penis before sexual intercourse.
Danish: Den anbefalede dosis af Fortacin er 3 sprayaktiveringer (3 sprayaktiveringer = 1 dosis) på hovedet af penis før samleje.
English: Prilocaine is reported to be 55% bound to plasma proteins, including alpha-1-acid glycoprotein.
Danish: Prilocain angives at være 55 % bundet til plasmaproteiner, herunder alpha-1-acid glycoprotein.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: In carcinogenicity studies of o-toluidine in rats, mice and hamsters, tumours were observed in several organs.
Danish: I karcinogenicitetsundersøgelserne af o-toluidin hos rotter, mus og hamstere iagttoges tumorer i flere organer.
English: In a study of pregnant rats receiving a combination of lidocaine and prilocaine during organogenesis, no effects on embryonic/foetal development were observed.
Danish: Hos drægtige rotter, der fik en kombination af lidocain og prilocain under organogenesen, iagttoges ingen virkninger på den embryonale/føtale udvikling.
English: Lidocaine is reported to be 66% bound by plasma proteins, including alpha-1-acid glycoprotein.
Danish: Lidocain angives at være 66 % bundet til plasmaproteiner, herunder alfa-1-acid glycoprotein.
English: Prilocaine
Danish: Prilocain
English: Any foreskin should be retracted from the glans penis.
Danish: Eventuel forhud skal trækkes tilbage fra glans penis.
English: The positive changes in IELT and IPE domain scores were maintained during the open-label treatment phase.
Danish: Den positive ændring i score for IELT og IPE holdt sig gennem hele den åbne behandlingsfase.
English: The effectiveness of the medicinal product has been demonstrated to persist on repeat use over time.
Danish: Ved gentagen anvendelse over tid er lægemidlets effektivitet påvist at vedvare.
English: Vulvovaginal discomfort or burning sensation caused discontinuation of treatment in 0.3% of subjects.
Danish: Ubehag eller brænden i vulva og vagina medførte seponering hos 0,3 % af deltagerne.
English: Medicinal products subject to medical prescription.
Danish: Lægemidlet er receptpligtigt.
English: As Fortacin is applied topically to the glans penis the risk of overdose is low.
Danish: Da Fortacin påføres topikalt på glans penis, er risikoen for overdosering lav.
English: • Phenobarbital, phenytoin - used to treat epilepsy
Danish: • phenobarbital, phenytoin - anvendes til behandling af epilepsi
English: Fortacin should not come into contact with a damaged ear drum.
Danish: Fortacin må ikke komme i kontakt med en trommehinde, der er beskadiget.
English: The lidocaine metabolite 2,6-xylidine has genotoxic potential in vitro.
Danish: Lidocainmetabolitten 2,6-xylidin har genotoksisk potentiale in vitro.
English: Breast-feeding This medicine may be used while your partner is breast-feeding.
Danish: Amning Du kan godt bruge dette lægemiddel, selv om din partner ammer.
English: 66.2% of Fortacin-treated subjects and 18.8% of placebo-treated subjects achieved a mean IELT > 2 minutes.
Danish: 66,2 % af de deltagere, der blev behandlet med Fortacin, og 18,8 % af placebogruppen opnåede en gennemsnitlig IELT på over 2 minutter.
English: Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Fortacin should be used with caution in patients with a history (or partner with a history) of sensitivities to medicinal products, especially if the aetiologic medicinal product is uncertain.
Danish: Patienter, der er allergiske over for derivater af paraaminobenzoesyre (procain, tetracain, benzocain osv.) har ikke udvist krydsfølsomhed over for lidocain og/eller prilocain; Fortacin bør imidlertid anvendes med forsigtighed ved kendt tidligere lægemiddeloverfølsomhed hos patienten (eller dennes partner), navnlig hvis det ætiologiske lægemiddel ikke kendes med sikkerhed.
English: It works by decreasing the sensitivity of the head of the penis to increase time before ejaculation.
Danish: Det virker ved at nedsætte følsomheden i hovedet af penis, så tiden til sædafgang forlænges.
English: Patients with severe hepatic impairment
Danish: Patienter med svært nedsat leverfunktion
English: Plasma levels of these metabolites detected after administration of Fortacin in clinical trials were low in both male and female subjects, even after doses of it many times in excess of the clinical dose were applied.
Danish: I de kliniske undersøgelser var niveauet af disse metabolitter efter administration af Fortacin lavt hos både mandlige og kvindelige deltagere, også efter doser mange gange over den kliniske dosis.
English: If you use Fortacin with condoms, you may be more likely to be unable to develop or maintain an erection.
Danish: Hvis du bruger Fortacin sammen med kondom, at der større mulighed for, at du for vanskeligt ved at opnå eller opretholde rejsning.
English: Norflurane
Danish: Norfluran
English: Prilocaine in high doses may cause an increase in the methaemoglobin level particularly in conjunction with methaemoglobin-inducing agents (e.g. sulphonamides).
Danish: Prilocain kan i høje doser medføre stigning i methæmoglobin, navnlig i forbindelse med methæmoglobin-inducerende midler (f.eks. sulfonamider).
English: Prilocaine is excreted in the urine mainly as its metabolites, with only a small proportion excreted unchanged.
Danish: Prilocain udskilles i urinen hovedsagelig som metabolitter, og kun en lille andel udskilles uændret.