FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ZYPADHERA 210 mg powder for prolonged release injection olanzapine
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ZYPADHERA 210 mg pulver til depotinjektionsvæske olanzapin i.m.
English: You should not be given ZYPADHERA if you have:
Danish: Du må ikke få ZYPADHERA
English: Do not stop your treatment just because you feel better.
Danish: Hvis du har glemt af få en indsprøjtning med ZYPADHERA Du må ikke stoppe med din behandling, fordi du føler dig bedre tilpas.
English: Olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Olanzapinpamoatmonohydrat svarende til 405 mg olanzapin.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label ZYPADHER 405 mg powder for prolonged release suspension for injection
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket til hætteglas ZYPADHERA 405 mg pulver til depotinjektionsvæske, suspension
English: ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Danish: ZYPADHERA 405 mg pulver og solvens til depotinjektionsvæske, suspension Hvert hætteglas indeholder olanzapinpamoatmonohydrat svarende til 405 mg olanzapin.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ZYPADHERA 300 mg powder for prolonged release injection olanzapine
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ZYPADHERA 300 mg pulver til depotinjektionsvæske olanzapin i.m.
English: ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Danish: ZYPADHERA 210 mg pulver og solvens til depotinjektionsvæske, suspension Hvert hætteglas indeholder olanzapinpamoatmonohydrat svarende til 210 mg olanzapin.
English: The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Danish: Ændringerne i totalkolesterol, LDL-kolesterol, triglycerider og prolaktin ved faste (se pkt.
English: ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Danish: ZYPADHERA 300 mg pulver og solvens til depotinjektionsvæske, suspension Hvert hætteglas indeholder olanzapinpamoatmonohydrat svarende til 300 mg olanzapin.
English: NAME OF THE MEDICINAL PRODUCT ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection Olanzapine
Danish: ZYPADHERA 405 mg pulver og solvens til depotinjektionsvæske, suspension Olanzapin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/479/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/479/001
English: MARKETING AUTHORISATION NUMBER (S) EU/1/08/479/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/479/002
English: NAME OF THE MEDICINAL PRODUCT ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection Olanzapine
Danish: ZYPADHERA 210 mg pulver og solvens til depotinjektionsvæske, suspension Olanzapin
English: How ZYPADHERA is given
Danish: Sådan bliver du behandlet med ZYPADHERA
English: • anxiety
Danish: • Angst
English: Once the suspension has been removed from the vial, it should be injected immediately.
Danish: Når suspensionen er trukket op af hætteglasset, skal den anvendes straks.
English: NAME OF THE MEDICINAL PRODUCT ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection Olanzapine
Danish: ZYPADHERA 300 mg pulver og solvens til depotinjektionsvæske, suspension Olanzapin
English: MARKETING AUTHORISATION NUMBER (S) EU/1/08/479/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/479/003
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high
Danish: 5Observeret for fastende normalt niveau ved baseline (< 1,69 mmol/l), der blev øget til højt niveau (≥ 2,26 mmol/l).
English: Photosensitivity reaction
Danish: Lysfølsomhedsreaktion Alopeci
English: If you miss an injection of ZYPADHERA
Danish: Hvis du har fået for meget ZYPADHERA
English: Eli Lilly Nederland B.V. Tel: + 31(0) 30 6025800
Danish: Tel: + 31(0)30 6025800
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported11
Danish: rapporteret krampeanfald i anamnesen eller risikofaktorer for kramper11
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection
Danish: Ydre karton ZYPADHERA 405 mg pulver og solvens til depotinjektionsvæske, suspension
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection
Danish: Ydre karton ZYPADHERA 210 mg pulver og solvens til depotinjektionsvæske, suspension
English: While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking.
Danish: Ældre patienter med demens kan under behandling med olanzapin opleve slagtilfælde, lungebetændelse og urininkontinens.
English: One vial of powder for prolonged release suspension for injection.
Danish: Et hætteglas med pulver til depotinjektionsvæske, suspension.
English: Maintenance dose after 2 months of ZYPADHERA treatment
Danish: Brug af anden medicin sammen med ZYPADHERA
English: If you are given more ZYPADHERA than needed This medicine will be given to you under medical supervision, it is therefore unlikely that you will be given too much.
Danish: Denne medicin vil blive givet til dig under lægelig overvågning.
English: Unless a well-tolerated and effective dose regimen using oral olanzapine has been established in such patients, ZYPADHERA should not be used.
Danish: ZYPADHERA bør ikke anvendes, før et veltålt og effektivt dosisregime for brug af oral olanzapin er fastsat til disse patienter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection
Danish: Ydre karton ZYPADHERA 300 mg pulver og solvens til depotinjektionsvæske, suspension
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17 - < 6.2 mmol/l) to high
Danish: Ændring i total fastende kolesterolniveau fra let forhøjet niveau ved baseline (≥ 5,17< 6,2 mmol/l) til højt niveau (≥ 6,2 mmol/l) var meget almindeligt.
English: The 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose.
Danish: For patienter, som udviser tegn eller symptomer forenelige med overdosering af olanzapin, bør observationsperioden på 3 timer forlænges ud fra klinisk relevans.
English: STEP 1: Preparing materials Pack includes:
Danish: Rekonstitution TRIN 1: Klargøring af injektionsudstyret
English: Peel blister pouch and remove device.
Danish: Åben blisterlommen og fjern udstyret.
English: Oedema
Danish: Dosering
English: DO NOT ADMINISTER INTRAVENOUSLY OR SUBCUTANEOUSLY.
Danish: MÅ IKKE ADMINISTRERES INTRAVEVØST ELLER SUBKUTANT.
English: Engage the needle safety device.
Danish: Fastgør sikkerhedskanylens kanylebeskyttelsesudstyr.
English: Elderly
Danish: Dysartri
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Danish: Ændring i fastende triglyceridniveau fra let forhøjet niveau ved baseline (≥ 1,69< 2,26 mmol/l) til højt niveau (≥ 2,26 mmol/l) var meget almindeligt.
English: IM
Danish: Hjerte
English: You do not need to do anything about it.
Danish: Det behøver du ikke gøre noget ved.
English: Wash your hands with soap and water.
Danish: Vask dine hænder med sæbe og vand.
English: (months)
Danish: (måneder)
English: This suggests an immunologically related mechanism.
Danish: Dette tyder på en immunologisk relateret mekanisme.
English: Let the skin air dry.
Danish: Lad huden lufttørre.
English: Other warming methods should not be used.
Danish: Der må ikke bruges andre opvarmningsmetoder.
English: ≥ 75 to < 100*
Danish: ≥ 75 til < 100*
English: Week 66
Danish: Uge 66
English: 1230 Vienna
Danish: 1230 Wien
English: Then weekly monitoring until stable.
Danish: Derefter ugentlig monitorering indtil stabil.
English: This reaction typically resolves spontaneously after a few days of treatment.
Danish: Denne reaktion svinder typisk spontant efter få dages behandling.
English: Unchanged inotersen is the predominant circulating component.
Danish: Uændret inotersen er den fremherskende cirkulerende bestanddel.
English: It is important that you tell your doctor if you are already being treated with any of the following:
Danish: Det er vigtigt, at du fortæller det til din læge, hvis du allerede behandles med et eller flere af følgende:
English: mean (SD) 1 Based on clinical database
Danish: gennemsnit (SD) 1 Baseret på klinisk database
English: Definitive assessments were limited in some cases as covariates were limited by the overall low numbers.
Danish: I nogle tilfælde var de endelige vurderinger begrænsede, da kovariaterne var begrænsede af det samlede lave antal.
English: A risk to the breastfed newborn/infant cannot be excluded.
Danish: En risiko for ammende nyfødte/spædbørn kan ikke udelukkes.
English: Harcourt Centre, Harcourt Road Dublin 2, Ireland
Danish: Harcourt Centre, Harcourt Road Dublin 2, Irland
English: If you let go of the plunger too quickly, you may lose some of the medicine.
Danish: Hvis du slipper stemplet for hurtigt, kan du miste noget af medicinen.
English: Wait seconds
Danish: Vent sekunder
English: Dosing should be adjusted according to laboratory values as follows:
Danish: Doseringen bør justeres i henhold til laboratorieværdierne som følger:
English: For example, do not warm in a microwave or hot water, or near other heat sources.
Danish: Den må for eksempel ikke opvarmes i mikrobølgeovn eller varmt vand eller tæt på andre varmekilder.
English: Do not inject into the same site each time.
Danish: Du må ikke injicere det samme sted hver gang.
English: Corticosteroids recommended.
Danish: Kortikosteroider anbefales.
English: Non-V30
Danish: Ikke-V30
English: In addition to a prompt to include the contact details of the patient's physician and a call for reporting, the patient card should also:
Danish: Udover en påmindelse om at inkludere kontaktoplysninger om patientens læge og en anmodning om indberetning skal patientkortet også:
English: • To undergo all blood or urine tests as arranged by their doctor;
Danish: • At få foretaget alle de blod- eller urinprøver, som deres læge arrangerer
English: Do not let the needle touch any surface.
Danish: Lad ikke kanylen berøre nogen overflader.
English: Subjects that terminate the treatment early irrespective of the reason or have missing week 66 data are considered as non-responders.
Danish: Forsøgspersoner, der afbryder behandlingen for tidligt, uanset årsagen, eller som mangler data fra uge 66, anses for at være non-respondenter.
English: Tattoos and scars should also be avoided.
Danish: Steder med tatoveringer og ar bør også undgås.
English: You will only be treated with Tegsedi if these are all at acceptable levels and your doctor will repeat these checks regularly during treatment.
Danish: Du vil kun blive behandlet med Tegsedi, hvis de alle er på acceptable niveauer, og din læge vil gentage disse målinger regelmæssigt under behandlingen.
English: Inspection Area
Danish: Inspektionsområde
English: • Remove the plastic tray from the carton and check the expiry date.
Danish: • Tag plastbakken ud af æsken, og kontrollér udløbsdatoen.
English: It is normal to see air bubbles in the solution.
Danish: Det er normalt, at der er luftbobler i opløsningen.
English: It should be removed from refrigerated storage at least 30 minutes before use.
Danish: Den skal tages ud af køleskabet mindst 30 minutter inden brug.
English: Precautions prior to initiation of inotersen
Danish: Forholdsregler inden initiering af inotersen
English: This does not mean that the injection is finished.
Danish: Det betyder ikke, at injektionen er færdig.
English: 6.6 Special precautions for disposal and other handling Tegsedi should be inspected visually prior to administration.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Tegsedi skal inspiceres visuelt inden administration.
English: Treatment should be discontinued.
Danish: Behandlingen skal seponeres.
English: Statistical significance in favour of inotersen was demonstrated at all thresholds beyond a 0-point change.
Danish: Der blev påvist statistisk signifikans til inotersens fordel ved alle tærskelværdier ud over en 0-punktsændring.
English: Children and adolescents Tegsedi should not be used in children and adolescents under 18 years old.
Danish: Børn og unge Tegsedi må ikke anvendes til børn og unge under 18 år.
English: Genotoxicity/ carcinogenicity
Danish: Genotoksicitet/karcinogenicitet
English: Every week
Danish: Hver uge
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1296/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1296/001
English: Do not inject through clothing.
Danish: Du må ikke injicere gennem tøjet.
English: * If the subsequent test confirms the initial test result, then monitoring frequency and dosing should be adjusted as recommended in the table.
Danish: * Hvis den efterfølgende test bekræfter det første testresultat, bør monitoreringshyppighed og dosering justeres ifølge anbefalingerne i tabellen.
English: Patients and/or caregivers should be trained in the subcutaneous administration of Tegsedi.
Danish: Patienter og/eller plejepersonale bør have fået undervisning i subkutan administration af Tegsedi.
English: Some patients treated with inotersen have developed this condition.
Danish: Nogle patienter, der er blevet behandlet med inotersen, har udviklet denne tilstand.
English: The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional.
Danish: Den første injektion, der administreres af patienten eller plejepersonale, bør gives under vejledning af en passende uddannet sundhedsmedarbejder.
English: A responder was defined as a subject who had a change from baseline that was less than or equal to the threshold value.
Danish: En respondent blev defineret som en forsøgsperson, der havde en ændring fra baseline, som var mindre end eller lig med tærskelværdien.
English: Baseline demographics
Danish: Demografi ved baseline
English: 9/L should not reinitiate therapy.
Danish: 9/l, bør ikke få behandlingen reinitieret.
English: For consistency of dosing, patients should be instructed to receive the injection on the same day every week.
Danish: Af hensyn til doseringens kontinuitet skal patienterne instrueres i at tage injektionen på den samme dag hver uge.
English: LSM Difference (SE)
Danish: LSMforskel (SE)
English: This can lead to bruising as well as other more serious problems such as excessive bleeding and internal bleeding.
Danish: Det kan føre til blå mærker og andre mere alvorlige problemer, for eksempel kraftige blødninger og indre blødninger.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Hold the plunger fully down and wait 5 seconds
Danish: Hold stemplet helt ned, og vent 5 sekunder
English: However, inotersen is not pharmacologically active in mice and rabbits.
Danish: Inotersen er dog ikke farmakologisk aktivt hos mus og kaniner.
English: The apparent volume of distribution of inotersen at steady-state is 293 L in patients with hATTR.
Danish: Inotersens tilsyneladende fordelingsvolumen ved steady state er 293 l hos patienter med hATTR.
English: • To carry the card with them at all times during the treatment and up to 8 weeks following treatment discontinuation;
Danish: • Altid at have kortet på sig under behandlingen og i op til 8 uger efter behandlingens ophør
English: • To have a list of all other medicines they are using for any visit to a Health Care Professionals (HCP);
Danish: • At medbringe en liste over alle andre lægemidler, de anvender, ved besøg hos læge eller andet sundhedspersonale
English: The safety and efficacy of inotersen in children and adolescents below 18 years of age have not been established.
Danish: Inotersens sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: In the event of an overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.
Danish: I tilfælde af overdosering bør der gives supportiv behandling, herunder konsultation af en læge samt nøje observation af patientens kliniske status.
English: In addition, the corresponding frequency category for each ADR is based on the following convention: 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).
Danish: Desuden er den tilsvarende frekvensgruppe for hver bivirkning baseret på følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til <1/10), ikke almindelig (≥ 1/1.000 til <1/100), sjælden (≥ 1/10.000 til <1/1.000), meget sjælden (<1/10.000).
English: Transient increases of CRP and platelet levels may occur in some patients after initiation of inotersen.
Danish: Forbigående stigninger i CRP- og trombocytniveauer kan opstå hos nogle patienter efter initiering af inotersen.
English: Tegsedi may pass into breast milk.
Danish: Tegsedi kan passere over i modermælken.
English: Urinary recovery of the parent medicinal product is limited to less than 1% within the 24 hours post dose.
Danish: Forekomsten i urin af modersubstansen er begrænset til under 1 % inden for 24 timer efter dosering.
English: Patients were randomised 2:1 to receive either inotersen or placebo.
Danish: Patienterne blev randomiseret i forholdet 2:1 til at få enten inotersen eller placebo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 July 2018
Danish: Dato for første markedsføringstilladelse: 6. juli 2018
English: - An increase in the number of white blood cells called eosinophils in your blood
Danish: - En stigning i antallet af hvide blodlegemer, der kaldes for eosinofiler, i blodet
English: You may see a drop of liquid at the end of the needle.
Danish: Du vil muligvis kunne se en dråbe væske i enden af kanylen.
English: These events are usually either self-limiting or can be managed using symptomatic treatment.
Danish: Disse bivirkninger er normalt forbigående eller kan behandles symptomatisk.
English: Due to the prolonged activity of Tegsedi, however, your reduced vitamin A levels may persist.
Danish: På grund af Tegsedis langvarige aktivitet kan de reducerede niveauer af vitamin A dog vare ved.
English: Following distribution to the patient, can be stored 6 weeks below 30°C.
Danish: Kan efter udlevering til patienten opbevares i 6 uger ved under 30 °C.
English: Elderly population No overall differences in pharmacokinetics were observed between other adult and elderly patients.
Danish: Der blev ikke observeret nogen overordnede forskelle i farmakokinetik mellem ældre og andre voksne patienter.
English: Every 2 weeks
Danish: Hver 2. uge
English: TTR is a carrier protein for retinol binding protein 4 (RBP4) which is the principal carrier of vitamin A (retinol).
Danish: TTR er et bærerprotein for retinolbindingsprotein 4 (RBP4), som er den vigtigste bærer af vitamin A (retinol).
English: Following subcutaneous administration, elimination half-life for inotersen is approximately 1 month.
Danish: Efter subkutan administration er inotersens elimineringshalveringstid cirka 1 måned.
English: Pharmacotherapeutic group: Other Nervous System Drugs, ATC code: N07XX15
Danish: Farmakoterapeutisk klassifikation: Andre midler med virkning på nervesystemet, ATC-kode: N07XX15
English: If you develop glomerulonephritis, your doctor will treat you for this condition.
Danish: Hvis du får glomerulonefritis, vil din læge behandle dig for denne tilstand.
English: Injection should be avoided at the waistline and other sites where pressure or rubbing from clothing may occur.
Danish: Det skal undgås at injicere i taljen og andre steder, hvor der kan opstå tryk eller gnidninger fra tøjet.
English: Inotersen did not exhibit genotoxic potential in in vitro and in vivo and was not carcinogenic in transgenic rasH2 mice.
Danish: Inotersen udviste ikke genotoksisk potentiale in vitro og in vivo og var ikke karcinogent hos transgeniske rasH2-mus.
English: In the placebo group, mean serum TTR concentration decreased by 8.50% at Week 3 and then remained fairly constant throughout the treatment period.
Danish: I placebogruppen var den gennemsnitlige TTRkoncentration i serum reduceret med 8,50 % i uge 3 og forblev nogenlunde konstant i hele behandlingsperioden.
English: You may need to press a little harder on the plunger to make sure you have pushed it as far as it will go.
Danish: Du skal muligvis trykke lidt hårdere på stemplet for at sikre, at du har trykket det helt i bund.
English: In the pivotal Phase 2/3 study, 30.4% of patients treated with inotersen tested positive for anti-drug antibodies following 15 months of treatment.
Danish: I det pivotale fase 2/3-studie blev 30,4 % af de patienter, som fik inotersen, testet positive for antistoffer mod lægemidlet efter 15 måneders behandling.
English: Platelet and renal function tests should be monitored regularly.
Danish: Trombocytter og nyrefunktion bør monitoreres regelmæssigt.
English: There are no or limited amount of data from the use of inotersen in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af inotersen til gravide kvinder.
English: The most frequently observed adverse reactions during treatment with inotersen were events associated with injection site reactions (50.9%).
Danish: De hyppigst observerede bivirkninger under behandling med inotersen var forbundet med reaktioner på injektionsstedet (50,9 %).
English: Baseline demographic and disease characteristics are shown in Table 3.
Danish: Demografi ved baseline og sygdomskarakteristika vises i tabel 3.
English: Hold the plunger fully down and wait for 5 seconds.
Danish: Hold stemplet helt i bund, og vent 5 sekunder.
English: Week 66 Change n LSM (SE) 95% CI Difference in LSM (Tegsedi - Placebo) 95% CI P-value
Danish: Ændring i uge 66 n LSM (SE) 95 % CI Forskel i LSM (Tegsedi - placebo) 95 % CI P-værdi
English: Women of child-bearing age
Danish: Kvinder i den fertile alder
English: UPCR and eGFR should be monitored for 8 weeks following discontinuation of treatment.
Danish: UPCR og eGFR bør monitoreres i 8 uger efter seponering af behandlingen.
English: Dosing should be paused until 3 successive values > 100.
Danish: Dosering afbrydes indtil 3 værdier > 100 i træk.
English: Estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m
Danish: Estimeret glomerulær filtrationsrate (eGFR) < 45 ml/min/1,73 m
English: It is unknown whether inotersen/metabolites are excreted in human milk.
Danish: Det er ukendt, om inotersen/metabolitter udskilles i human mælk.
English: During the first 60 days of pregnancy, both too high and too low vitamin A levels may be associated with an increased risk of foetal malformation.
Danish: I de første 60 dage af en graviditet kan både for høje og for lave vitamin A-niveauer være forbundet med øget risiko for fostermisdannelse.
English: If the plunger does not rise up automatically when you release the pressure, it means the safety spring did not activate and you should push the plunger again but harder.
Danish: Hvis stemplet ikke automatisk løfter sig, når du slipper trykket, betyder det, at sikkerhedsfjederen ikke er aktiveret, og at du skal trykke på stemplet igen, men denne gang hårdere.