FrancophonIA/ELRC3.0 huggingface dataset:
English: Nifedipine Pharmamatch 30 and 60 mg prolonged release tablets (nifedipine) is 1,4 - dihydropyridine calcium antagonist used for symptomatic treatment of chronic stable angina pectoris as monotherapy or in combination with a beta-blocker and in the treatment of patients with light to moderate essential hypertension.
Danish: Nifedipine Pharmamatch, depottabletter 30 og 60 mg (nifedipin), er en calciumantagonist af 1,4-dihydropyridintypen, som anvendes til symptomatisk behandling af kronisk, stabil angina pectoris som monoterapi eller kombineret med en beta-blokker samt til behandling af patienter med let til moderat essentiel hypertension.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Nifedipine Pharmamatch 30 and 60 mg International Non-Proprietary Name (INN): Nifedipine
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE EFTER EN INDBRINGELSE I HENHOLD TIL ARTIKEL 29, STK. 21 FOR Nifedipine Pharmamatch 30 og 60 mg Internationalt fællesnavn (INN): Nifedipin
English: Pharmamatch BV submitted applications for mutual recognition of Nifedipine Pharmamatch retard 30 and 60 mg tablets on the basis of the marketing authorisation granted by the Netherlands on 29 November 2004.
Danish: Pharmamatch BV har indgivet ansøgninger om gensidig anerkendelse af Nifedipine Pharmamatch, depottabletter 30 og 60 mg, baseret på den markedsføringstilladelse, der er meddelt af Nederlandene den 29. november 2004.
English: Significant differences have been identified with regard to the proposed SPC compared to the SPC of the reference product in the UK.
Danish: Der er påpeget væsentlige forskelle mellem det foreslåede produktresumé og produktresuméet for referenceproduktet i Det Forenede Kongerige.
English: During the January 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Nifedipine Pharmamatch retard 30 and 60 mg tablets, that the objections raised by United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: På mødet i januar 2006 fandt CHMP på baggrund af alle de forelagte oplysninger og den faglige drøftelse i udvalget, at benefit-risk forholdet er gunstigt for Nifedipine Pharmamatch, depottabletter, 30 og 60 mg, at de af Det Forenede Kongerige rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: This is particularly important if you are taking the following medicines which may interact with Senstend:
Danish: Dette er navnlig vigtigt, hvis du tager følgende lægemidler, der kan vekselvirke med Senstend:
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: Hyppigheden af bivirkninger er defineret som: 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 beregnes af forhåndenværende data).
English: There is limited data on the efficacy and safety of Senstend in patients 65 years and over.
Danish: Der foreligger begrænsede data om sikkerhed og virkning ved Senstends hos patienter over 65 år.
English: However, there may be some exposure in female partners of men treated with Senstend.
Danish: Der kan dog forekomme nogen eksponering af kvindelige partnere til mænd, der behandles med Senstend.
English: Do not give this medicine to children or adolescents under 18 years of age.
Danish: Senstend må ikke gives til børn og unge under 18 år.
English: Absorption of Senstend in conjunctival tissues has not been determined.
Danish: Absorptionen af Senstend i konjunktivalt væv er ikke fastlagt.
English: The efficacy of Senstend was demonstrated in two multi-centre, multinational, randomised, double-blind, placebo controlled studies, both followed by an open-label phase.
Danish: Virkningen af Senstend blev påvist i to multinationale, randomiserede, dobbeltblindede, placebokontrollerede multicenterundersøgelser, begge efterfulgt af en åben fase.
English: Care should be taken not to allow Senstend to come in contact with the eye, as it may cause eye irritation.
Danish: Forsigtighed bør udvises for at undgå, at Senstend kommer i kontakt med øjet, da det kan medføre øjenirritation.
English: A study in rats showed that Senstend caused a reduction in sperm motility.
Danish: En undersøgelse hos rotter viste, at Senstend medførte nedsat motilitet af sædceller.
English: Senstend has no or negligible influence on the ability to drive and use machines.
Danish: Senstend påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Senstend is a combination of two medicines: lidocaine and prilocaine.
Danish: Senstend er en kombination af to lægemidler: lidocain og prilocain.
English: Human exposure from Senstend 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 Senstend er 20-30 gange under den mindste dosis, der ikke medførte tumorer, og 200 gange under den mindste dosis, der medførte tumorer.
English: However this study did not reproduce the circumstances of clinical use, as the concentration of Senstend 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 Senstend i direkte kontakt med sæd vil være mange gange lavere.
English: Adjusted mean change scores (Senstend 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 (Senstend 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: Senstend is not indicated for use by women.
Danish: Senstend er ikke bestemt til anvendelse hos kvinder.
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 Senstend 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 Senstend og fra 0,56 til 0,94 minutter i placebogruppen.
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 Senstend.
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 Senstend.
English: The risk of additional systemic toxicity should be considered when large doses of Senstend 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 Senstend til patienter, der i forvejen bruger andre lokalanæstetika eller strukturelt beslægtede lægemidler, f.eks. klasse I-antiarytmika såsom mexiletin.
English: The following side effects have been reported with Senstend in male patients:
Danish: Følgende bivirkninger med Senstend er indberettet hos mandlige patienter:
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: Lidocaine and prilocaine are excreted in human milk, but at therapeutic doses of Senstend 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: Senstend should not come into contact with a damaged ear drum.
Danish: Senstend må ikke komme i kontakt med en trommehinde, der er beskadiget.
English: The following side effects have been reported with Senstend in female partners:
Danish: Følgende bivirkninger med Senstend er indberettet hos kvindelige partnere:
English: Senstend 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 Senstend, hvis din partner er gravid, medmindre du bruger kondom som nævnt ovenfor for at undgå, at det ufødte barn udsættes for lægemidlet.
English: Senstend is only indicated for application to the glans penis.
Danish: Senstend er kun indiceret til påføring på glans penis.
English: Senstend 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: Senstend 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 Senstend and placebo (p < 0.0001).
Danish: For alle deltagernes tre månedlige vurderinger var der signifikant forskel mellem Senstend og placebo (p < 0,0001).
English: The prilocaine metabolite o-toluidine has genotoxic potential in vitro.
Danish: Prilocain-metabolitten o-toluidin har genotoksisk potentiale in vitro.
English: What you need to know before you use Senstend Do not use Senstend
Danish: Det skal du vide, før du begynder at bruge Senstend Brug ikke Senstend:
English: The recommended dose of Senstend is 3 sprays (3 sprays = 1 dose) on the head of the penis before sexual intercourse.
Danish: Den anbefalede dosis af Senstend er 3 sprayaktiveringer (3 sprayaktiveringer = 1 dosis) på hovedet af penis før samleje.
English: If you use Senstend with condoms, you may be more likely to be unable to develop or maintain an erection.
Danish: Hvis du bruger Senstend sammen med kondom, at der større mulighed for, at du for vanskeligt ved at opnå eller opretholde rejsning.
English: As Senstend is applied topically to the glans penis the risk of overdose is low.
Danish: Da Senstend påføres topikalt på glans penis, er risikoen for overdosering lav.
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 Senstend would prevent pregnancy.
Danish: Det kan ikke udelukkes, at Senstend har potentiale for at nedsætte motiliteten af sædceller efter klinisk anvendelse, hvorfor det ikke kan angives, om Senstend forhindrer graviditet.
English: Lidocaine can cross the blood brain barrier and the placenta and is distributed in breast milk.
Danish: Lidocain kan passere blod-hjernebarrieren og placenta og udskilles i modermælk.
English: Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Senstend 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; Senstend bør imidlertid anvendes med forsigtighed ved kendt tidligere lægemiddeloverfølsomhed hos patienten (eller dennes partner), navnlig hvis det ætiologiske lægemiddel ikke kendes med sikkerhed.
English: Plasma levels of these metabolites detected after administration of Senstend 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 Senstend lavt hos både mandlige og kvindelige deltagere, også efter doser mange gange over den kliniske dosis.
English: The lidocaine metabolite 2,6-xylidine has genotoxic potential in vitro.
Danish: Lidocain-metabolitten 2,6-xylidin har genotoksisk potentiale in vitro.
English: 66.2% of Senstend-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 Senstend, og 18,8 % af placebogruppen opnåede en gennemsnitlig IELT på over 2 minutter.
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid Senstend nøjagtigt efter lægens anvisning.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Senstend 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 Senstend i alle undergrupper af den pædiatriske population ved primær præmatur ejakulation (se pkt.
English: Senstend provides topical anaesthesia to the glans penis.
Danish: Senstend bevirker topikal anæstesi af glans penis.
English: 85.2% of subjects in the Senstend 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 Senstend opnåede en gennemsnitlig IELT på over 1 minut i løbet af 3 måneders behandling med Senstend, mens 46,4 % af placebogruppen havde en gennemsnitlig IELT på under 1 minut.
English: There is no relevant use of Senstend in the paediatric population for the indication of treatment of primary premature ejaculation in adult men.
Danish: Det er ikke relevant at anvende Senstend hos den pædiatriske population til indikationen behandling af primær præmatur ejakulation hos voksne mænd.
English: Symptoms of using too much Senstend are listed below.
Danish: Nedenfor er angivet symptomerne ved at bruge for meget Senstend.
English: As a precautionary measure, it is preferable to avoid the use of Senstend 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 Senstend, medmindre den mandlige partner anvender effektiv prævention af barrieretypen for at undgå risiko for eksponering af fosteret.
English: Although the systemic availability of prilocaine by cutaneous absorption of Senstend 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 Senstend er lav, bør der udvises forsigtighed ved anæmi, kongenit eller erhvervet methæmoglobinæmi eller samtidig behandling med midler, der vides at forårsage disse tilstande.
English: How to use Senstend
Danish: Sådan skal du bruge Senstend
English: Senstend may reduce the possibility of pregnancy, but is not a reliable contraceptive.
Danish: Senstend kan nedsætte muligheden for graviditet, men er ikke pålideligt som præventionsmiddel.
English: Common Hypoaesthesia of male genital, erectile dysfunction, genital burning sensation
Danish: Almindelig Hypæstesi af mandlige genitalier, erektil dysfunktion, genital brænden
English: In Senstend-treated subjects, IELT and IPE scores increased at the first measured timepoint.
Danish: Ved behandling med Senstend steg IELT- og IPE-score ved det første måletidspunkt.
English: Clinical trials have shown Senstend 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 Senstend 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: Contents of the pack and other information What Senstend contains
Danish: Pakningsstørrelser og yderligere oplysninger Senstend indeholder:
English: Senstend is a colourless to light yellow cutaneous spray, solution in an aluminium spray container with metering valve.
Danish: Senstend er en farveløs til bleggul kutanspray, opløsning, i en spraybeholder af aluminium med doseringsventil.
English: Other medicines and Senstend
Danish: Brug af anden medicin sammen med Senstend
English: Patients hoping to achieve conception should either avoid using Senstend, 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 Senstend eller, hvis det er essentielt at opnå penetration, vaske glans penis så grundigt som muligt før samleje.
English: In an in vitro study of rats Senstend 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 Senstend 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: Senstend sprayed onto a damaged tympanic membrane may cause ototoxicity of the middle ear.
Danish: Hvis Senstend sprayes på en beskadiget trommehinde, kan det medføre ototoksicitet i mellemøret.
English: Once the can is held upright (valve up), 1 dose of Senstend 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 Senstend på hele glans penis ved at aktivere ventilen tre gange.
English: The effectiveness of Senstend 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 Senstend 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: Senstend 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 Senstend 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: Holding the can upright (valve up), apply 1 dose (3 sprays) of Senstend 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 Senstend så hele hovedet af penis dækkes, idet hver sprayaktivering dækker en tredjedel.
English: Senstend is indicated for the treatment of primary premature ejaculation in adult men.
Danish: Senstend er indiceret til behandling af primær præmatur ejakulation hos voksne mænd.
English: If you use more Senstend than you should
Danish: Hvis du har brugt for meget Senstend
English: Due to the risk of partner transfer, patients hoping to achieve conception should either avoid using Senstend, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible 5 minutes after applying the spray but prior to intercourse (see section 4.6).
Danish: Patienter, der ønsker konception, bør på grund af risikoen for overførsel til partneren enten undgå at bruge Senstend eller, hvis det er essentielt at opnå penetration, vaske glans penis så grundigt som muligt 5 minutter efter påføring at sprayen, men før samleje (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 Senstend hos gravide kvinder.
English: Package leaflet: Information for the user Senstend 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Danish: Indlægsseddel: Information til brugeren Senstend, kutanspray, opløsning, 150 mg/ml + 50 mg/ml lidocain/prilocain
English: Therefore, patients hoping to achieve conception should either avoid using Senstend, or, if this medicine is essential to achieve penetration, should wash the penis as thoroughly as possible five minutes after Senstend has been applied, but prior to intercourse.
Danish: Patienter, der ønsker graviditet, bør derfor enten undgå Senstend eller - hvis penetration er vigtig for dem - vaske hovedet af penis så grundigt som muligt fem minutter efter påføring af Senstend, men før samleje.
English: Deterioriation was observed when Senstend was used with polyurethane-based female and male condoms (see section 4.4).
Danish: Der blev konstateret nedsat styrke af polyuretanbaserede femidomer og kondomer ved anvendelse sammen med Senstend (se pkt.
English: Senstend is indicated for the treatment of lifelong premature ejaculation in adult men.
Danish: Senstend anvendes til behandling af voksne mænd, der varigt lider af for tidlig sædafgang.
English: Senstend 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Danish: Senstend, kutanspray, opløsning, 150 mg/ml + 50 mg/ml lidocain/prilocain
English: vulvovaginal pruritus
Danish: Nyrer og urinveje
English: Common Vulvovaginal burning sensation, hypoaesthesia Uncommon Vulvovaginal discomfort, vaginal pain,
Danish: Vulvovaginalt ubehag, vaginale smerter, vulvovaginal pruritus
English: Talk to your doctor or pharmacist before using Senstend - if you, or your sexual partner, have been diagnosed with a genetic disease or other condition affecting your red blood cells (glucose-6-phosphate deficiency, anaemia or methaemoglobinaemia); - if you have a history of medicine sensitivities, especially if you are not certain which medicine causes sensitivity; - if you suffer from severe liver problems.
Danish: der berører de røde blodlegemer (glukose-6-fosfat-mangel, anæmi eller methæmoglobinæmi) - hvis du tidligere har været overfølsom over for lægemidler, navnlig hvis du ikke er sikker på,
English: They are very unlikely to happen if it is used as instructed:
Danish: Hvis Senstend bruges som anvist, er det meget usandsynligt, at du får sådanne symptomer:
English: A higher rate of erectile dysfunction and male genital hypoaesthesia may be experienced when using Senstend with male condoms.
Danish: Brug af Senstend sammen med kondom kan øge forekomsten af erektil dysfunktion og genital hypæstesi hos manden.
English: Senstend 150 mg/ml + 50 mg/ml cutaneous spray, solution
Danish: Senstend, kutanspray, opløsning, 150 mg/ml + 50 mg/ml
English: What Senstend looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: What Senstend is and what it is used for What you need to know before you use Senstend How to use Senstend
Danish: Det skal du vide, før du begynder at bruge Senstend Sådan skal du bruge Senstend Bivirkninger
English: Senstend is not approved for use by women.
Danish: Opbevar Senstend utilgængeligt for børn.