FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicines also have different flavours and different amounts of cyclodextrins and this could affect how the active substance is taken up into the body.
Danish: Lægemidlerne har også forskellig smag og forskellige mængder af cyclodextriner, og det kan påvirke optagelsen af det aktive stof i kroppen.
English: Flurbiprofen Geiser is a medicine used for the short-term relief of symptoms of sore throat.
Danish: Flurbiprofen Geiser er et lægemiddel, der anvendes til kortvarig lindring af ondt i halsen.
English: In addition Flurbiprofen Geiser has a different flavour and contains smaller amounts of substances called cyclodextrins, which help to stabilise the solution.
Danish: Flurbiprofen Geiser har desuden en anden smag og indeholder mindre mængder af såkaldte cyclodextriner, der medvirker til at stabilisere opløsningen.
English: Name Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: Package size Withdrawal Period
Danish: Indhold Pakningsstørrelse
English: Packaging Content
Danish: Indgivelsesvej Emballage
English: You will probably need to lie down until you feel better.
Danish: Du vil muligvis have behov for at ligge ned, indtil du får det bedre.
English: The majority of these reactions was reported to be of “mild” to “moderate” severity.
Danish: Hovedparten af disse reaktioner blev rapporteret til at være af ”mild” til ”moderat” alvorlighed.
English: Other symptoms may include:
Danish: Andre symptomer kan omfatte:
English: Long-term exposure (at least 48 weeks)
Danish: Langvarig behandling (mindst 48 uger)
English: The injection should be performed with steady, continuous pressure.
Danish: Injektionen skal foretages med et stadigt, kontinuerligt tryk.
English: • An uncommon but serious reaction might occur after you receive each injection.
Danish: • En ikke almindelig, men alvorlig reaktion kan opstå efter hver injektion, du får.
English: The doctor or nurse may also want to measure your blood pressure and pulse.
Danish: Lægen eller sygeplejersken vil måske også måle dit blodtryk og puls.
English: Patients should be closely monitored during this period.
Danish: Patienten bør følges nøje i denne periode.
English: No oral antipsychotic supplementation was allowed.
Danish: Ingen oral antipsykotisk supplering blev tilladt.
English: In some cases, these symptoms can lead to unconsciousness.
Danish: I nogle tilfælde kan disse symptomer medføre tab af bevidsthed.
English: People with this disease may also feel depressed, anxious or tense.
Danish: Mennesker med denne sygdom kan også føle sig deprimerede, angste eller anspændte.
English: Tolerance developed to the CNS depression.
Danish: Der udvikledes tolerance overfor CNS-depressionen.
English: During treatment dose may subsequently be adjusted on the basis of individual clinical status.
Danish: Under behandling kan dosis efterfølgende justeres på basis af den individuelle kliniske status.
English: The absorption and elimination are complete approximately six to eight months after the last injection.
Danish: Absorptionen og eliminationen er komplet efter omkring seks til otte måneder efter den sidste injektion.
English: Use in elderly (>75 years)
Danish: Brug til ældre (>75 år)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20-25°C.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -forhold forud for anvendelse brugerens ansvar og vil normalt ikke være længere end 24 timer ved 20 - 25 ºC.
English: These reactions occurred in <0.1% of injections and approximately 2% of patients.
Danish: Disse reaktioner opstod ved < 0,1 % af injektionerne og hos omkring 2 % af patienterne.
English: During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Danish: Under antipsykotisk behandling kan bedring i patientens kliniske tilstand vare fra flere dage til nogle uger.
English: Distribution Oral olanzapine is rapidly distributed.
Danish: Oral olanzapin distribueres hurtigt.
English: Powder None
Danish: Pulver Ingen.
English: • increase in blood pressure
Danish: • Stigning i blodtryk
English: ZYPADHERA can sometimes enter the bloodstream too quickly.
Danish: ZYPADHERA kan nogle gange komme for hurtigt ind i blodbanen.
English: Select and prepare a site for injection in the gluteal area.
Danish: Udvælg og forbered et injektionssted i glutealregionen.
English: It is important to note that there is more solvent in the vial than is needed to reconstitute.
Danish: Bemærk, at der er mere solvens i hætteglasset, end der er brug for til rekonstitution.
English: Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.
Danish: Patienten bør monitoreres omhyggeligt for tegn på tilbagefald i de første en til to måneder af behandlingen.
English: Close medical supervision and monitoring should continue until the patient recovers.
Danish: Tæt medicinsk kontrol og overvågning bør fortsætte, indtil patienten kommer sig.
English: In most cases, initial signs and symptoms related to this reaction have appeared within 1 hour following injection, and in all cases full recovery was reported to have occurred within 24 - 72 hours after injection.
Danish: I de fleste tilfælde havde de initiale tegn og symptomer relateret til denne reaktion vist sig inden for 1 time efter injektionen, og i alle tilfælde blev fuldstændig bedring rapporteret inden for 24-72 timer efter injektionen.
English: An education program to the health care professionals (HCP) (doctors-nurses-pharmacist) shall address,
Danish: Et undervisningsprogram til sundhedspersonalet (læger-sygeplejersker-farmaceuter) skal indeholde,
English: Although unlikely, you may get the symptoms more than 3 hours after the injection.
Danish: Selv om det er usandsynligt, kan du få symptomerne efter mere end 3 timer efter indsprøjtningen.
English: The suspended product will be yellow and opaque.
Danish: Det opslæmmede lægemiddel vil være gult og uigennemsigtigt.
English: Your doctor will decide how much ZYPADHERA you need and how often you need to be given an injection.
Danish: Din læge vil beslutte hvor meget ZYPADHERA, du har behov for og hvor ofte, du behøver at få en indsprøjtning.
English: Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Danish: Fortæl det til lægen, hvis du eller nogen i din familie tidligere har haft blodpropper, da denne type medicin kan være forbundet med dannelse af blodpropper.
English: − Promote awareness of appropriate metabolic monitoring by distributing utilized published antipsychotic guidelines
Danish: Forsøg på at fremme opmærksomheden på en passende metabolisk monitorering ved at uddele anvendte publicerede antipsykotiske retningslinjer.
English: A total of 1469 patients with schizophrenia were included in 2 pivotal trials:
Danish: I alt 1.469 patienter med skizofreni blev inkluderet i 2 pivotalstudier:
English: Patients should be advised about this potential risk and the need to be observed for 3 hours in a healthcare facility each time ZYPADHERA is administered.
Danish: Patienterne bør informeres om denne potentielle risiko og behovet for at blive observeret i 3 timer i et sundhedscenter, hver gang ZYPADHERA bliver administreret.
English: • Tell the doctor or nurse if you feel dizzy or faint after the injection.
Danish: • Fortæl det til din læge eller sygeplejerske, hvis du føler dig svimmel eller svag efter indsprøjtningen.
English: If any blood is drawn into the syringe, discard the syringe and the dose and begin reconstitution and administration procedure again.
Danish: Hvis der trækkes blod op i sprøjten, så kasser sprøjten og dosis og begynd proceduren med rekonstitution og administration igen.
English: These events occurred in about 0.1 to 1.1% of patients.
Danish: Disse bivirkningsreaktioner opstod hos omkring 0,1 til 1,1% af patienterne.
English: If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.
Danish: Hvis du har glemt at få en indsprøjtning, skal du kontakte din læge, for at du kan få den næste indsprøjtning så hurtigt som muligt.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a signficant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Patients who have been given too much olanzapine have also experienced the following symptoms:
Danish: Patienter, som har fået for meget olanzapin, har også haft følgende symptomer:
English: The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Danish: Den farmakokinetiske variabilitet, som blev set hos ældre er inden for intervallet for ikke ældre.
English: In order to identify the first ZYPADHERA dose for all patients the scheme in Table 1 should be considered.
Danish: For at finde frem til den første dosis af ZYPADHERA til alle patienter bør skemaet i Tabel 1 tages i betragtning.
English: Dogs tolerated single oral doses up to 100 mg/kg without mortality.
Danish: Hunde tolererede orale enkeltdoser på op til 100 mg/kg uden mortalitet.
English: The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats).
Danish: De mediane letaldoser var ca. 210 mg/kg (mus) og 175 mg/kg (rotter).
English: Tap the vial firmly and repeatedly on a hard surface until no powder is visible.
Danish: Bank hætteglasset fast og gentagne gange mod en hård overflade, indtil der ikke er noget synligt pulver.
English: Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Eftersom human erfaring er begrænset, bør olanzapin alligevel kun anvendes til gravide, hvis den potentielle gavnlige effekt retfærdiggør den potentielle risiko for fosteret.
English: • Reconstitution and Administration card (this leaflet)
Danish: • Rekonstitutions- og administrationskort (denne indlægsseddel)
English: The half-life of olanzapine after ZYPADHERA is 30 days compared to 30 hours following oral administration.
Danish: Halveringstiden af olanzapin efter indgift med ZYPADHERA er 30 dage sammenlignet med 30 timer efter oral administration.
English: The major circulating metabolite is the 10-N-glucuronide.
Danish: Den overvejende cirkulerende metabolit er 10-N-glucuronid.
English: Among all ZYPADHERA treated patients, sedation was reported by 4.7% of patients.
Danish: Blandt alle de patienter, som blev behandlet med ZYPADHERA, blev sedation rapporteret af 4.7 %.
English: Due to biochemical and physiological modification and reduction of muscular mass, this formulation is not recommended to be started in this sub-group of patients.
Danish: Som følge af biokemiske og fysiologiske forandringer samt reduktion af muskelmassen er denne lægemiddelform ikke tilrådet til denne undergruppe af patienter.
English: These symptoms typically resolve within 24 to 72 hours after your injection.
Danish: Disse symptomer forsvinder normalt i løbet af 24 til 72 timer efter indsprøjtningen.
English: All 3 ZYPADHERA treatment groups showed statistically significantly greater improvement than placebo beginning by end of Week 1.
Danish: Alle 3 ZYPADHERAbehandlingsgrupper viste statistisk signifikant større bedring end placebo fra slutningen af uge 1.
English: The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Danish: Det er ikke nødvendigt rutinemæssigt at ændre begyndelsesdosis og dosisforløb hos ikke-rygere i forhold til rygere.
English: Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Danish: På baggrund af resultater fra studier af mus og rotter blev det konkluderet, at olanzapin ikke er karcinogent.
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Danish: Brug ikke adrenalin, dopamin eller andre sympatomimetiske midler med beta-agonistaktivitet, da beta-stimulation kan forværre hypotension.
English: When indicated, dose escalation should be performed with caution in these patients.
Danish: Hvis det er indiceret, bør dosisoptrapning foretages med forsigtighed hos disse patienter.
English: Reconstituted ZYPADHERA remains stable for up to 24 hours in the vial.
Danish: Rekonstitueret ZYPADHERA er stabilt i op til 24 timer i hætteglasset.
English: 2) Recommendations for monitoring of patients for glucose, lipids, and weight
Danish: Anbefaling af monitorering af patienterne for glucose, lipider og vægt.
English: It is recommended that gloves are used as ZYPADHERA may irritate the skin.
Danish: Det tilrådes at anvende handsker, da ZYPADHERA kan irritere huden.
English: In a study of oral olanzapine given to Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Danish: I et forsøg hvor oral olanzapin blev givet til kaukasiske, japanske og kinesiske forsøgspersoner var der ingen forskel i de farmakokinetiske parametre blandt de tre populationer.
English: Final volume to inject (ml)
Danish: Slutvolumen, som skal indsprøjtes (ml)
English: However, the magnitude of the impact of gender, or smoking on olanzapine clearance is small in comparison to the overall variability between individuals.
Danish: Kønnets eller rygnings indvirkning på olanzapinclearance er dog lille sammenlignet med den totale variation mellem enkeltpersoner.
English: Reactions occurred rarely (<1 in 1,000 injections) between 1 and 3 hours, and very rarely (<1 in 10,000 injections) after 3 hours.
Danish: Reaktioner forekom sjældent (<1 af 1.000 injektioner) mellem 1 og 3 timer, og meget sjældent (<1 af 10.000 injektioner) efter 3 timer.
English: Do not use this product if you notice discolouration or other visible signs of deterioration.
Danish: Brug ikke lægemidlet hvis du bemærker en misfarvning eller andre tegn på nedbrydning.
English: A lower starting dose (150 mg every 4 weeks) should be considered for such patients.
Danish: En lavere startdosis (150 mg hver 4. uge) bør overvejes til disse patienter.
English: Only slight to moderate increase in olanzapine clearance has been observed.
Danish: Der er kun observeret en let til moderat øgning af olanzapins clearance.
English: Only remove the device with the engaged needle from the syringe when required by a specific medical procedure.
Danish: Fjern kun udstyret med den fastgjorte kanyle fra sprøjten, når det kræves ved en særlig medicinsk procedure.
English: 16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Danish: 16 Forhøjet plasma-prolaktin blev rapporteret hos 47,4 % af de unge patienter.
English: ZYPADHERA has not been studied in the paediatric population.
Danish: ZYPADHERA er ikke blevet undersøgt i den pædiatriske population.
English: Chemical and physical stability of the suspension in the vials has been demonstrated for 24 hours at 2025 °C.
Danish: Der er vist kemisk og fysisk stabilitet for suspensionen i hætteglasset i 24 timer ved 20 - 25 ºC.
English: Dystonia (including oculogyration)11 Tardive dyskinesia11
Danish: Dystoni (inklusive okulogyration)11 Tardiv dyskinesi11 Amnesi9
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 being given this injection.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Contact your doctor or hospital straight away if you experience any of the above symptoms.
Danish: Kontakt omgående din læge eller skadestue, hvis du får nogle af ovenstående symptomer.
English: Plasma concentrations remain measurable for several months after each ZYPADHERA injection.
Danish: Plasmakoncentrationerne forbliver målbare i flere måneder efter hver injektion med ZYPADHERA.
English: In patients with Parkinson's disease oral olanzapine may worsen the symptoms.
Danish: Hos patienter med Parkinsons sygdom kan oral olanzapin forværre symptomerne.
English: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Danish: Patienten bør rådes til at informere sin læge, hvis hun bliver gravid eller påtænker at blive gravid under behandling med olanzapin.
English: If this happens, you may have the symptoms listed below after your injection.
Danish: Hvis det sker, kan du få de nedenfor nævnte symptomer efter indsprøjtningen.
English: Unsuspended: visible clumps Suspended: no clumps Figure B: Check for unsuspended powder and repeat tapping if needed.
Danish: Ikke opslæmmet: Synlige klumper Opslæmmet: Ingen klumper Figur B: Kontroller for ikke opslæmmet pulver og gentag om nødvendigt ved at banke let.
English: Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Danish: 1Klinisk signifikant vægtstigning blev observeret på tværs af alle Body Mass Index (BMI) kategorier ved baseline.
English: DO NOT MASSAGE THE INJECTION SITE.
Danish: GNID IKKE PÅ INJEKTIONSSTEDET.
English: When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the dose.
Danish: Når mere end en parameter, som kan føre til nedsat metabolisme, er til stede (kvinder, ældre, ikkerygere), bør det overvejes at reducere dosis.
English: Three Hypodermic safety needles.
Danish: Tre Hypodermic sikkerhedskanyler.
English: ZYPADHERA is not recommended to be started if you are over 75 years.
Danish: ZYPADHERA-behandling bør ikke påbegyndes hvis du er over 75 år.
English: The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Danish: Den højere forekomst af dødsfald var ikke relateret til olanzapindosis (gennemsnitlig daglig dosis 4,4 mg) eller behandlingsvarighed.
English: In 44 patients with schizophrenia >65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Danish: Hos 44 patienter med skizofreni >65 år blev en dosis fra 5 til 20 mg/dag ikke forbundet med nogen anden bivirkningsprofil.
English: Do not drink any alcohol if you have been given ZYPADHERA as together with alcohol it may make you feel drowsy.
Danish: Drik ikke nogen form for alkohol, når du har fået ZYPADHERA, da det sammen med alkohol kan gøre dig døsig.
English: ZYPADHERA has not been systematically studied in elderly patients (> 65 years).
Danish: ZYPADHERA er ikke systematisk undersøgt hos ældre patienter (>65 år).
English: FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.
Danish: KUN TIL DYB GLUTEAL INTRAMUSKULÆR INJEKTION.
English: It is important that you carry on receiving ZYPADHERA for as long as your doctor has told you to.
Danish: Det er vigtigt, at du fortsætter med at få ZYPADHERA, så længe din læge har fortalt dig, at du skal have denne medicin.
English: You should not be given this injection if you are breast-feeding as small amounts of olanzapine can pass into breast milk.
Danish: Du bør ikke få denne indsprøjtning, hvis du ammer, da små mængder olanzapin kan overføres til modermælken.
English: The plasma protein binding of olanzapine is about 93% over the concentration range of 7 to about 1000 ng/mL.
Danish: Plasmaproteinbindingen af olanzapin er ca. 93 % over koncentrationsintervallet fra 7 til ca. 1000 ng/ml.
English: ZYPADHERA should only be administered by deep intramuscular gluteal injection by a healthcare professional trained in the appropriate injection technique and in locations where post-injection observation and access to appropriate medical care in the case of overdose can be assured.
Danish: ZYPADHERA bør kun administreres som en dyb intramuskulær gluteal injektion af en sundhedsperson med øvelse i den hensigtsmæssige injektionsteknik og i lokaler, hvor observation efter injektion og adgang til fornøden lægelig behandling i tilfælde af en overdosis kan sikres.
English: Because of this risk, do not drive or operate machinery for the remainder of the day after each injection.
Danish: På grund af denne risiko, bør du ikke køre bil eller betjene maskiner resten af dagen efter hver injektion.
English: Warnings and precautions Talk to your doctor or nurse before you are given ZYPADHERA
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sygeplejersken, før du får ZYPADHERA.
English: (See Figure C)
Danish: (Se Figur C).
English: Similar pharmacokinetic differences between males and females and smokers and non-smokers were observed in ZYPADHERA clinical trials.
Danish: Lignende farmakokinetiske forskelle mellem mænd og kvinder samt rygere og ikke-rygere blev observeret i kliniske forsøg med ZYPADHERA.
English: A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Danish: En undersøgelse af den totale ligevægt viste, at ca. 57 % af radioaktivt mærket olanzapin fandtes i urinen, især som metabolitter.
English: The first, an 8-week, placebo controlled trial conducted in adult patients (n=404) who were experiencing acute psychotic symptoms.
Danish: Det første, som var et 8-uger placebokontrolleret forsøg, blev udført med voksne patienter (n=404), som havde akutte psykotiske symptomer.
English: No specific investigations have been conducted in the elderly with ZYPADHERA.
Danish: Der er ikke udført specifikke studier hos ældre med ZYPADHERA.
English: Supplementation with oral olanzapine was not authorised in double-blind clinical studies.
Danish: Det var ikke tilladt at supplere med oral olanzapin i de dobbeltblindede kliniske studier.
English: Vial of suspension after reconstitution: 24 hours.
Danish: Hætteglas med suspension efter rekonstitution: 24 timer.
English: After reconstitution in the vial: 24 hours.
Danish: Efter rekonstitution i hætteglasset: 24 timer.
English: Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Danish: Meget almindelig: Vægtstigning13, forhøjede triglyceridniveauer14, øget appetit.
English: Determine which needle will be used to administer the injection to the patient.
Danish: Bestem hvilken kanylse, som skal bruges ved administration af injektionen til patienten.
English: In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Danish: I studier af op til 3 måneders varighed af mus og op til 1 års varighed af rotter og hunde var CNSdepression, antikolinerge effekter og perifere hæmatologiske forstyrrelser de dominerende effekter.
English: No information on the use of ZYPADHERA in patients >75 years is available.
Danish: Der er ingen tilgængelige data vedrørende brugen af ZYPADHERA til patienter >75 år.
English: Oral olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Danish: Oral olanzapin blev initieret på 2,5 mg/dag og titreret til maksimalt 15 mg/dag, baseret på lægens vurdering.
English: • been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Danish: • hvis du tidligere har fået konstateret øjenproblemer såsom visse former for øget tryk i øjet (glaukom).
English: RECONSTITUTION AND ADMINISTRATION INSTRUCTIONS
Danish: VEJLEDNING I REKONSTITUTION OG ADMINISTRATION
English: Figure A: Tap firmly to mix 10.
Danish: Figur A: Bank fast for at blande 10.