FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you or your sexual partner are allergic to lidocaine or prilocaine or any of the other ingredients of this medicine (listed in section 6); - if you or your sexual partner have a history of allergy or sensitivity to other local anaesthetics with a similar structure (known as amide-type local anaesthetics).
Danish: - hvis du eller din seksualpartner er allergisk over for lidocain eller prilocain eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6) - hvis du eller din seksualpartner tidligere har været allergisk eller overfølsom over for andre lokalbedøvende midler med tilsvarende struktur (lokalbedøvende midler af amidtypen).
English: Lidocaine can cross the blood brain barrier and the placenta and is distributed in breast milk.
Danish: Lidocain kan passere blodhjernebarrieren og placenta og udskilles i modermælk.
English: As a precautionary measure, it is preferable to avoid the use of Fortacin during pregnancy unless effective male barrier contraceptive measures are taken in order to avoid potential foetal exposure.
Danish: Under graviditet må det som sikkerhedsforanstaltning foretrækkes at undgå brug af Fortacin, medmindre den mandlige partner anvender effektiv prævention af barrieretypen for at undgå risiko for eksponering af fosteret.
English: Should other symptoms of systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of local anaesthetics by other routes.
Danish: Eventuelle andre symptomer på systemisk toksicitet forventes at være af lignende art som ved administration af lokalanæstetika ad andre veje.
English: The potential for reduction of sperm motility following the clinical use of the medicinal product can not be excluded; therefore it is not possible to state whether Fortacin would prevent pregnancy.
Danish: Det kan ikke udelukkes, at Fortacin har potentiale for at nedsætte motiliteten af sædceller efter klinisk anvendelse, hvorfor det ikke kan angives, om Fortacin forhindrer graviditet.
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid Fortacin nøjagtigt efter lægens anvisning.
English: 85.2% of subjects in the Fortacin group achieved a mean IELT of > 1 minute over the course of 3 months of treatment with it, whereas 46.4% of the placebo subjects had a mean IELT of > 1 minute.
Danish: 85,2 % af personerne i gruppen på Fortacin opnåede en gennemsnitlig IELT på over 1 minut i løbet af 3 måneders behandling med Fortacin, mens 46,4 % af placebogruppen havde en gennemsnitlig IELT på under 1 minut.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Fortacin in all subsets of the paediatric population in primary premature ejaculation (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Fortacin i alle undergrupper af den pædiatriske population ved primær præmatur ejakulation (se pkt.
English: • Sulphonamides (also called sulpha medicines) e.g. sulfamethoxazole - an antibiotic used to treat urinary infections, and sulfasalazine - used to treat Crohn's disease, ulcerative colitis and rheumatoid arthritis
Danish: • sulfonamider (også kaldet sulfapræparater), f.eks. sulfamethoxazol, som er et antibiotikum til behandling af urinvejsinfektioner, og sulfasalazin, som anvendes til behandling af Crohns sygdom, ulcerøs kolitis og reumatoid artritis
English: Methaemoglobinaemia may be accentuated in patients already taking medicinal products known to induce the condition, e.g. sulphonamides, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenobarbital, phenytoin, primaquine and quinine (see section 4.4).
Danish: Methæmoglobinæmi kan forstærkes hos patienter, der i forvejen får lægemidler, der vides at fremkalde denne tilstand, f.eks. sulfonamider, acetanilid, anilinfarvestoffer, benzocain, chloroquin, dapson, metoclopramid, naphthalen, nitrater og nitritter, nitrofurantoin, nitroglycerin, nitroprussid, pamaquin, para-aminosalicylsyre, phenobarbital, phenytoin, primaquin og kinin (se pkt.
English: No teratogenic effects were observed in studies of embryonic/foetal development in rats and rabbits receiving doses during organogenesis.
Danish: Der blev ikke iagttaget teratogene virkninger i undersøgelserne af embryonal/føtal udvikling hos rotter og kaniner, som blev doseret under organogenesen.
English: Fortacin is not recommended for use whilst your partner is pregnant unless you use a male condom, as listed above, to prevent exposure of the unborn child.
Danish: Det frarådes at anvende Fortacin, hvis din partner er gravid, medmindre du bruger kondom som nævnt ovenfor for at undgå, at det ufødte barn udsættes for lægemidlet.
English: Fortacin is only indicated for application to the glans penis.
Danish: Fortacin er kun indiceret til påføring på glans penis.
English: • medicines for high blood pressure and to regulate your heart rhythm (so-called beta blockers)
Danish: • lægemidler mod højt blodtryk og lægemidler til regulering af hjerterytmen (såkaldte betablokkere)
English: Specific interaction studies with lidocaine/prilocaine and anti-arrhythmic medicinal products class III (e.g. amiodarone) have not been performed, but caution is advised (see also section 4.4).
Danish: Der er ikke udført specifikke interaktionsundersøgelser med lidocain/prilocain og antiarytmika af klasse III (f.eks. amiodaron), men forsigtighed tilrådes (se også pkt.
English: In Fortacin-treated subjects, IELT and IPE scores increased at the first measured timepoint.
Danish: Ved behandling med Fortacin steg IELT- og IPE-score ved det første måletidspunkt.
English: Although the systemic availability of prilocaine by cutaneous absorption of Fortacin is low, caution should be exercised in patients with anaemia, congenital or acquired methaemoglobinaemia or patients on concomitant therapy known to produce such conditions.
Danish: Skønt den systemiske tilgængelighed af prilocain ved kutan absorption af Fortacin er lav, bør der udvises forsigtighed ved anæmi, kongenit eller erhvervet methæmoglobinæmi eller samtidig behandling med midler, der vides at forårsage disse tilstande.
English: Lidocaine is excreted in the urine mainly as metabolites, with only a small proportion excreted unchanged.
Danish: Lidocain udskilles i urinen hovedsagelig som metabolitter, og kun en lille del udskilles uændret.
English: In a carcinogenicity study of rats exposed to 2,6-xylidine in utero, postnatally and throughout their lifetime, tumours in the nasal cavity, subcutaneous tumours and liver tumours were observed.
Danish: I karcinogenicitetsundersøgelsen hos rotter, der blev eksponeret for 2,6-xylidin in utero postnatalt og i hele deres levetid, iagttoges subkutane tumorer og levertumorer.
English: Wait 5 minutes then wipe off any excess spray prior to having sexual intercourse.
Danish: Vent fem minutter, og aftør overskydende spray før samleje.
English: • Sodium nitroprusside, isosorbide dinitrate - used to treat high blood pressure and heart failure
Danish: • natriumnitroprussid, isosorbiddinitrat - anvendes til behandling af højt blodtryk og hjertesvigt
English: Female volunteers receiving repeated doses directly to the cervix and vagina of up to five times the recommended dose for the male partner, had maximum plasma levels of lidocaine which were less than 8% of toxic levels, and prilocaine which were less than 1% of toxic levels.
Danish: Kvindelige forsøgspersoner, som gentagne gange direkte på cervix og vagina fik appliceret doser på op til fem gange den anbefalede dosis til den mandlige partner, fik et maksimalt plasmaniveau af lidocain på under 8 % af det toksiske niveau, og af prilocain på under 1 % af det toksiske niveau.
English: - The other ingredient is norflurane
Danish: - Øvrige indholdsstoffer: norfluran.
English: At each of the three monthly assessments all subjects completed a Premature Ejaculation Profile (PEP) questionnaire relating to perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty relating to ejaculation.
Danish: Ved hver af de tre månedlige vurderinger udfyldte alle deltagerne et spørgeskema vedrørende præmatur ejakulation (Premature Ejaculation Profile, PEP), hvor de angav deres opfattelse af kontrollen med ejakulation, personlig frustration vedrørende ejakulation, tilfredshed med samlejet og problemer i de personlige relationer i forbindelse med ejakulation.
English: • Dapsone - used to treat skin conditions such as leprosy and dermatitis and also to prevent malaria and pneumonia in high-risk patients
Danish: • dapson - anvendes til behandling af hudlidelser såsom spedalskhed og dermatitis og til forebyggelse hos patienter med høj risiko for malaria og lungebetændelse
English: There is no relevant use of Fortacin in the paediatric population for the indication of treatment of primary premature ejaculation in adult men.
Danish: Det er ikke relevant at anvende Fortacin hos den pædiatriske population til indikationen behandling af primær præmatur ejakulation hos voksne mænd.
English: • Para-aminosalicylic acid (PAS) - used to treat tuberculosis
Danish: • para-aminosalicylsyre (PAS) - anvendes til behandling af tuberkulose
English: The clinical relevance of tumour findings in respect of short-term/intermittent use of prilocaine in humans is unknown.
Danish: Den kliniske relevans af fundet af tumorer i forhold til kortvarig/midlertidig brug af prilocain hos mennesker er ukendt.
English: After 5 minutes any excess spray should be wiped off prior to intercourse.
Danish: Efter fem minutter aftørres overskydende spray før samleje.
English: The recommended dose is 3 actuations applied to cover the glans penis.
Danish: Den anbefalede dosis er tre aktiveringer, der påføres glans penis.
English: Men satisfying the International Society for Sexual Medicine (ISSM) criteria for premature ejaculation (PE) who had a baseline IELT ≤ 1 minutes in at least 2 of the first 3 sexual encounters during screening were eligible to enrol.
Danish: For at være egnet til indrullering skulle de deltagende mænd opfylde kriterier fra ”International Society for Sexual Medicine (ISSM) vedrørende præmatur ejakulation og have en baseline-IELT ≤ 1 minut i mindst 2 at de første 3 seksuelle forhold under screeningen.
English: As this will reduce the ability to feel pain in these areas, extra care should be taken not to injure them until the numbness has worn off.
Danish: Dette nedsætter smertesansen disse steder, hvorfor I skal være ekstra forsigtige for at undgå læsioner af dem, indtil følelsesløsheden er gået over.
English: Uncommon Anorectal discomfort, oral parasthesia
Danish: Anorektalt ubehag, oral paræstesi
English: • Inability to develop or maintain an erection
Danish: • manglende evne til at opnå eller opretholde rejsning
English: • Glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate and other nitrate and nitrite medicines - used to treat angina (chest pain caused by the heart)
Danish: • glyceryltrinitrat (GTN, nitroglycerin), isosorbidmononitrat, erythrityltetranitrat, pentaerythritoltetranitrat og andre nitrater og nitritter - anvendes til behandling af angina (brystsmerter, som skyldes hjertet)
English: Fortacin is a colourless to light yellow cutaneous spray, solution in an aluminium spray container with metering valve.
Danish: Fortacin er en farveløs til bleggul kutanspray, opløsning, i en spraybeholder af aluminium med doseringsventil.
English: Hypersensitivity of the patient or their partner to the active substances or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed hos patienten eller dennes partner over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Adverse drug reactions in female partners
Danish: Bivirkninger hos kvindelige partnere
English: The clinical relevance of tumour findings in relation to short-term/intermittent use of lidocaine in humans is unknown.
Danish: Den kliniske relevans af fundet af tumorer i forhold til kortvarig/midlertidig brug af lidocain hos mennesker er ukendt.
English: Cutaneous spray, solution 6.5 ml
Danish: Kutanspray, opløsning 6,5 ml
English: Clinical trials have shown Fortacin to increase the intra-vaginal ejaculatory latency time (IELT), increase control over ejaculation and reduce the feelings of distress in patients with premature ejaculation as measured by the Index of Premature Ejaculation (IPE).
Danish: Kliniske undersøgelser har vist, at Fortacin øger den intravaginale latenstid for ejakulation (IELT), giver bedre kontrol over ejakulationen og mindsket frustration hos patienter med præmatur ejakulation, målt på indekset for præmatur ejakulation (IPE).
English: Symptoms of using too much Fortacin are listed below.
Danish: Nedenfor er angivet symptomerne ved at bruge for meget Fortacin.
English: What you need to know before you use Fortacin Do not use Fortacin
Danish: Det skal du vide, før du begynder at bruge Fortacin Brug ikke Fortacin:
English: • Nitrofurantoin - an antibiotic used to treat urinary and kidney infections
Danish: • nitrofurantoin - et antibiotikum til behandling af infektioner i urinveje og nyrer
English: Systemic exposure to lidocaine and prilocaine and their metabolites (respectively 2,6-xylidine and o-toluidine), is low following application to the glans penis in male patients and application to the cervix/vagina fornices in female subjects, at doses higher than recommended.
Danish: Den systemiske eksponering for lidocain og prilocain og metabolitter heraf (henholdsvis 2,6-xylidin og o-toluidin) er lav efter påføring af doser over den anbefalede dosis på glans penis hos mandlige patienter og på cervix og fornix vaginae hos kvinder.
English: The postnatal survival time of the offspring of rats treated during pregnancy and lactation with a dose toxic to the mother was shown to be reduced.
Danish: Der blev påvist nedsat postnatal overlevelsestid for afkommet af rotter, der var blevet behandlet under drægtighed og laktation med en dosis, der var toksisk for moderdyret.
English: Prilocaine is rapidly metabolised in both the liver, by cytochrome P450, and in the kidneys by amidases.
Danish: Prilocain metaboliseres hurtigt af cytokrom P450 i leveren og af amidaser i nyrerne.
English: Hypoaesthesia of male genital, erectile dysfunction, genital burning sensation
Danish: Almindelig Hypæstesi af mandlige genitalier, erektil dysfunktion, genital brænden
English: • Benzocaine - a local anaesthetic used to treat pain and itching
Danish: • benzocain - et lokalbedøvende middel til behandling af smerter og kløe
English: • Abnormal taste
Danish: • unormal smag
English: If you use more Fortacin than you should
Danish: Hvis du har brugt for meget Fortacin
English: Contents of the pack and other information What Fortacin contains
Danish: Pakningsstørrelser og yderligere oplysninger Fortacin indeholder:
English: • abnormal orgasm
Danish: Abnorm orgasme
English: • heart medicines (anti-arrhythmic medicines)
Danish: • hjertemedicin (lægemidler mod uregelmæssig hjerterytme)
English: Patients hoping to achieve conception should either avoid using Fortacin, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible prior to intercourse.
Danish: Patienter, der ønsker konception, bør enten undgå Fortacin eller, hvis det er essentielt at opnå penetration, vaske glans penis så grundigt som muligt før samleje.
English: Fortacin may reduce the possibility of pregnancy, but is not a reliable contraceptive.
Danish: Fortacin kan nedsætte muligheden for graviditet, men er ikke pålideligt som præventionsmiddel.
English: • loss of feeling in the mouth
Danish: • nedsat følsomhed i munden
English: Clinical studies have not been performed in patients with impaired renal function, however due to its method of administration and very low systemic absorption, no dosage adjustment is required.
Danish: Der er ikke udført kliniske undersøgelser hos patienter med nedsat nyrefunktion, men dosisjustering er ikke nødvendig på grund af administrationsmåden og den meget ringe systemiske absorption.
English: - The active substances are lidocaine and prilocaine.
Danish: - Aktive stoffer: lidocain og prilocain.
English: In an in vitro study of rats Fortacin has shown a reduction in sperm motility when 22.5 mg lidocaine and 7.5 mg prilocaine (i.e. the amount in 1 human dose) was in direct contact with rat sperm.
Danish: I en in vitro-undersøgelse hos rotter har Fortacin vist reduktion i motiliteten af sædceller, når disse var i direkte kontakt med 22,5 mg lidocain og 7,5 mg prilocain (dvs. mængden svarende til 1 human dosis).
English: Fortacin is indicated for the treatment of primary premature ejaculation in adult men.
Danish: Fortacin er indiceret til behandling af primær præmatur ejakulation hos voksne mænd.
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ\}.
English: Other medicines and Fortacin
Danish: Brug af anden medicin sammen med Fortacin
English: These adverse reactions caused discontinuation of treatment in 0.2% and 0.5% of patients, respectively.
Danish: 0,2 % og 0,5 % af patienterne.
English: Holding the can upright (valve up), apply 1 dose (3 sprays) of Fortacin to the entire head of the penis, by covering one third with each spray.
Danish: Hold dåsen opret (ventilen opad), og påfør en dosis (3 sprayaktiveringer) af Fortacin så hele hovedet af penis dækkes, idet hver sprayaktivering dækker en tredjedel.
English: Aluminium spray container with metering valve.
Danish: Spraybeholder af aluminium med doseringsventil.
English: Each dose consists of a total of 22.5 mg lidocaine and 7.5 mg prilocaine per application (1 dose is equal to 3 actuations).
Danish: Hver dosis består af i alt 22,5 mg lidocain og 7,5 mg prilocain pr. påføring (én dosis svarer til 3 aktiveringer).
English: The effectiveness of Fortacin in treating PE was assessed by measuring IELT and the co primary endpoints of ejaculatory control, sexual satisfaction, and distress using the IPE.
Danish: Effektiviteten af Fortacin til behandling af præmatur ejakulation blev vurderet ved måling af IELT og de sideordnede primære endepunkter ejakulationskontrol, seksuel tilfredsstillelse og frustration målt ved indeks for præmatur ejakulation (IPE).
English: Fortacin provides topical anaesthesia to the glans penis.
Danish: Fortacin bevirker topikal anæstesi af glans penis.
English: Embryotoxicity was observed in rabbits at doses toxic to the mother.
Danish: Hos kaniner iagttoges embryotoksicitet ved doser, der var toksiske for moderdyret.
English: Once the can is held upright (valve up), 1 dose of Fortacin should be applied to the entire glans penis, by actuating the valve 3 times.
Danish: Mens dåsen holdes opret (med ventilen opad), påføres der én dosis at Fortacin på hele glans penis ved at aktivere ventilen tre gange.
English: Each pack contains one spray container with 6.5 ml or 5 ml solution.
Danish: Hver pakning indeholder en spraybeholder med 6,5 ml eller 5 ml opløsning.
English: In vitro interaction studies with topical antifungal (clotrimazole, econazole, imidazole, nystatin, miconazole, ketoconazole), antibacterial (clindamycin, metronidazole) and antiviral medicinal products (acyclovir), showed no effect on antimicrobial activity.
Danish: In vitro interaktionsundersøgelser viste ingen indvirkning på den antimikrobielle aktivitet af topiske antimykotika (clotrimazol, econazol, imidazol, nystatin, miconazol, ketoconazol), antibakterielle midler (clindamycin, metronidazol) eller antivirale lægemidler (aciclovir).
English: Also contains: norflurane
Danish: Øvrige indholdsstoffer: norfluran
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SPRAY CONTAINER LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE SPRAYBEHOLDER
English: There are no adequate data from the use of lidocaine and prilocaine on fertility in humans.
Danish: Der foreligger ikke tilstrækkelige data om påvirkningen af fertiliteten hos mennesker ved brug af lidocain og prilocain.
English: Fortacin sprayed onto mucous membranes of the patient or their partner, such as the mouth, nose and throat, or transferred onto female genitalia or anal lining, could be absorbed and temporary local numbness/anaesthesia is likely to result.
Danish: Hvis Fortacin sprayes på patientens eller dennes partners slimhinder, såsom mund, næse og hals, eller overføres til kvindens genitalier eller analslimhinde, kan det absorberes med temporær lokal følelsesløshed til følge.
English: Hypersensitivities
Danish: Overfølsomhed
English: • pain or discomfort in and around the penis
Danish: • smerte eller ubehag i og omkring penis
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET PÅ YDERKARTON
English: There was also a significant difference over placebo in all domains for the responses from the partners (p < 0.0001).
Danish: Partnernes besvarelser viste ligeledes signifikant forskel fra placebo for alle segmenters vedkommende p < 0,0001).
English: Uncommon Genital erythema, ejaculation failure, paraesthesia of male genital, penile pain, penis disorder, pruritus genital
Danish: Genitalt erytem, ejakulationssvigt, paræstesi af mandlige genitalier, penissmerter, penislidelser, genital pruritus
English: Patients or their partner with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to medicinal product-induced methaemoglobinaemia (see section 4.5).
Danish: Glukose-6-fosfat dehydrogenasemangel eller kongenit eller idiopatisk methæmoglobinæmi hos patienten eller dennes partner medfører øget følsomhed over for lægemiddelinduceret methæmoglobinæmi (se pkt.
English: There are no or limited amount of data from the use of lidocaine and prilocaine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data om anvendelse af Fortacin hos gravide kvinder.
English: Precautions for use
Danish: Forsigtighedsregler vedrørende brugen:
English: Caution is advised in case of severe hepatic impairment (see section 4.4).
Danish: Der tilrådes forsigtighed ved svær leverfunktionsnedsættelse (se pkt.
English: Fortacin sprayed onto a damaged tympanic membrane may cause ototoxicity of the middle ear.
Danish: Hvis Fortacin sprayes på en beskadiget trommehinde, kan det medføre ototoksicitet i mellemøret.
English: Cutaneous use.
Danish: Til kutan anvendelse.
English: • feeling of burning in and around the vagina • reduced feeling in and around the vagina
Danish: • brænden i og omkring skeden • nedsat følsomhed i og omkring skeden
English: • Metoclopramide - used to treat feelings of sickness (nausea) and vomiting, including in patients with migraine
Danish: • metoclopramid - anvendes til behandling af kvalme og opkastning, navnlig hos patienter med migræne
English: Vulvovaginal burning sensation, hypoaesthesia Uncommon Vulvovaginal discomfort, vaginal pain, vulvovaginal pruritus
Danish: Vulvovaginalt ubehag, vaginale smerter, vulvovaginal pruritus
English: Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine.
Danish: - Hver ml opløsning indeholder 150 mg lidocain og 50 mg prilocain.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige (forekommer hos indtil 1 ud af 100 behandlede)
English: Contact your doctor or pharmacist if you experience any of these.
Danish: Sig det til lægen eller på apoteket, hvis du får nogen af disse symptomer.
English: Patients with severe hepatic disease, because of their inability to metabolise local anaesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine and prilocaine (see section 4.2).
Danish: Patienter med svær leversygdom har normalt højere risiko for toksiske plasmakoncentrationer af lidocain og prilocain på grund af manglende evne til metabolisering af lokalanæstetika (se pkt.