FrancophonIA/ELRC3.0 huggingface dataset:
English: Although patients with renal impairment were not studied with ZYPADHERA, it is recommended that a well-tolerated and effective dosage regimen using oral olanzapine is established in patients with renal impairment before treatment with ZYPADHERA is initiated (see section 4.2).
Danish: På trods af, at patienter med nedsat leverfunktion ikke blev undersøgt med ZYPADHERA, tilrådes det, at et veltolereret og effektivt dosisregime for brug af oral olanzapin er fastlagt til patienter med nedsat leverfunktion, før behandling med ZYPADHERA påbegyndes (se pkt.
English: ZYPADHERA is not recommended for treatment in the elderly population unless a well-tolerated and effective dose regimen using oral olanzapine has been established.
Danish: ZYPADHERA bør ikke anvendes til behandling af den ældre population, før et veltålt og effektivt dosisregime for brug af oral olanzapin er fastsat.
English: ZYPADHERA 210 mg, 300 mg or 405 mg powder and solvent for prolonged release suspension for injection must not be confused with olanzapine 10 mg powder for solution for injection.
Danish: ZYPADHERA 210 mg, 300 mg og 405 mg pulver og solvens til depotinjektionsvæske, suspension må ikke forveksles med olanzapin 10 mg pulver til injektionsvæske, opløsning.
English: If foam forms, let vial stand to allow foam to dissipate.
Danish: Hvis der dannes skum, så lad hætteglasset stå, indtil skummet forsvinder.
English: ZYPADHERA treatment groups of 150 mg and 300 mg given every 2 weeks (doses pooled for analysis) and 405 mg given every 4 weeks were non inferior to the combined doses of 10, 15 and 20 mg of oral olanzapine (doses pooled for analysis) as measured by rates of exacerbation of symptoms of schizophrenia (respective exacerbation rates, 10%, 10% 7%).
Danish: ZYPADHERA behandlingsgrupperne med 150 mg og 300 mg, som blev givet hver anden uge (doserne er lagt sammen til analysebrug), og 405 mg, som blev givet hver 4. uge, blev ikke dårligere end med de kombinerede doser på 10, 15 og 20 mg oral olanzapin (doserne er lagt sammen til analysebrug).
English: After reconstitution each ml of suspension contains 150 mg olanzapine.
Danish: Efter rekonstitution indeholder hver ml suspension 150 mg olanzapin.
English: The solvent ingredients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid and sodium hydroxide.
Danish: - Indholdsstoffer i solvens: Carmellosenatrium, mannitol, polysorbat 80, vand til injektionsvæsker, saltsyre, natriumhydroxid.
English: Thrombocytopenia
Danish: Trombocytopeni11
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter) omfatter nedsat kropstemperatur; unormal hjerterytme; pludselig uforklarlig død; betændelse i bugspytkirtlen, som giver voldsomme mavesmerter, feber og utilpashed; leversygdom, som viser sig ved gulfarvning af huden og af det hvide i øjnene; muskelsygdom, som viser sig med uforklarlig ømhed og smerter; forlænget og/eller pinefuld erektion.
English: 20 mg/day
Danish: 20 mg/dag
English: The most frequently (seen in ≥ 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension,
Danish: De hyppigst rapporterede (set hos ≥ 1 % af patienter) bivirkninger, som blev set i forbindelse med anvendelse af olanzapin i kliniske forsøg, var døsighed, vægtstigning, eosinofili, forhøjede niveauer af prolaktin, kolesterol, glucose og triglycerider (se pkt.
English: One Hypodermic syringe and safety needle.
Danish: En Hypodermic sprøjte og sikkerhedskanyle.
English: Bromobutyl stopper with rust colour seal.
Danish: Brombutylprop med rustfarvet forsegling.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for ZYPADHERA
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til ZYPADHERA i.m.
English: DO NOT INJECT INTRAVENOUSLY OR SUBCUTANEOUSLY.
Danish: INDSPRØJT IKKE INTRAVENØST ELLER SUBKUTANT.
English: • unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
Danish: • Unormale bevægelser særligt i ansigtet eller tungen (grimasser) (en almindelig bivirkning, som forekommer hos op til 1 ud af 10 patienter);
English: Patients treated with any antipsychoticmedicines, including ZYPADHERA, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Danish: Patienter, som behandles med antipsykotiske lægemidler, herunder ZYPADHERA, bør observeres for tegn og symptomer på hyperglykæmi (såsom polydipsi, polyuri, polyfagi og kraftesløshed).
English: Other symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension and convulsion.
Danish: Andre bemærkede symptomer inkluderer ekstrapyramidale symptomer, dysartri, ataksi, aggression, svimmelhed, svaghed, hypertension og krampe.
English: Adverse reactions seen with olanzapine pamoate
Danish: Bivirkninger set ved olanzapinpamoat
English: If the medicine is not used right away, it should be shaken vigorously to re-suspend.
Danish: Hvis medicinen ikke anvendes straks derefter, skal den rystes kraftigt for at genopblandes.
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Danish: Lever og galdeveje Forbigående, asymptomatisk forhøjede leveraminotransferas er (ALAT, ASAT), særlig initialt i behandlingen (se pkt.
English: If the 38 mm needle is to be used for the injection, attach the 50 mm safety needle to withdraw the required suspension volume.
Danish: • Hvis 38 mm kanylen anvendes til injektion, fastgøres 50 mm kanylen til sprøjten for at trække den nødvendige mængde suspension ud.
English: 10 mg/day
Danish: 10 mg/dag
English: Other common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and in early treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Danish: Andre almindelige bivirkninger (som forekommer hos op til 1 ud af 10 patienter) omfatter ændringer i mængden af visse blodceller, fedtstoffer i blodet samt forbigående forhøjede leverenzymer tidligt i behandlingen; forhøjet sukker i blodet og urinen; forhøjet urinsyre og kreatinkinase i blodet; øget sultfornemmelse; svimmelhed; rastløshed; rysten; unormale bevægelser (dyskinesi); forstoppelse; mundtørhed; hududslæt; tab af styrke; udpræget træthed; væskeophobning, som medfører hævede hænder, ankler eller fødder; feber; ledsmerter og seksuelle problemer såsom nedsat sexlyst (libido) hos mænd og kvinder eller rejsningsbesvær hos mænd.
English: Other uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching; rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose: abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Danish: Andre ikke almindelige bivirkninger (som forekommer hos op til 1 ud af 100 patienter) omfatter overfølsomhed (f.eks. hævelser i mund og hals, kløe, hududslæt); sukkersyge eller forværring af sukkersyge, af og til ledsaget af syreforgiftning (ketoacidose - ketonstoffer i blod og urin) eller bevidstløshed; krampeanfald, sædvanligvis hos patienter med tidligere krampeanfald (epilepsi); muskelstivhed eller muskelkramper (herunder øjenbevægelser); restless legs-syndrom (stærk uro i underbenene); problemer med at tale; stammen; langsom hjertefrekvens (puls); følsomhed overfor sollys; næseblod; udspilet mave; hukommelsestab eller glemsomhed; ufrivillig vandladning (urininkontinens); vandladningsbesvær; hårtab; manglende menstruation eller længere intervaller mellem menstruationerne; samt brystforandringer hos mænd og kvinder, såsom unormal produktion af brystmælk eller unormal vækst.
English: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials (see section 4.8).
Danish: Hos olanzapinbehandlede patienter i placebo-kontrollerede kliniske studier, er der set uønskede forandringer i lipidniveauer (se pkt.
English: While overdose is less likely with parenteral than oral medicinal products, reference information for oral olanzapine overdose is presented below:
Danish: Referenceinformation for oral olanzapin er angivet nedenfor, selvom overdosis er mindre sandsynlig ved parenteral end ved oral medicinering:
English: Suspension concentration is 150 mg/ml olanzapine.
Danish: Suspensionens koncentration er 150 mg olanzapin/ml.
English: Injection site abscess
Danish: Absces på injektionsstedet
English: ZYPADHERA is a powder and solvent for prolonged release suspension for injection.
Danish: ZYPADHERA er et pulver og solvens til depotinjektionsvæske, suspension.
English: The most commonly reported injection site related adverse reaction was pain (5%); some other injection site adverse reactions reported were (in decreasing frequency): nodule type reactions, erythema type reactions, non-specific injection site reactions, irritation, oedema type reactions, bruising, haemorrhage, and anaesthesia.
Danish: Andre rapporterede bivirkningsreaktioner var (efter faldende hyppighed): knudelignende reaktioner, erytemlignende reaktioner, ikke-specifikke bivirkningsreaktioner relateret til injektionsstedet, irritation, ødemlignende reaktioner, suggilation, blødning og anæstesi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/11/2008
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Open the pre-packaged Hypodermic syringe and needle with needle protection device.
Danish: Åbn pakken med Hypodermic sprøjten med påsat sikkerhedskanyle.
English: What ZYPADHERA looks like and contents of the pack ZYPADHERA powder for prolonged release suspension for injection comes as a yellow powder in a clear glass vial.
Danish: ZYPADHERA pulver til depotinjektionsvæske, suspension er et gult pulver i et klart hætteglas af glas.
English: What you need to know before you are given ZYPADHERA
Danish: Det skal du vide, før du begynder at bruge ZYPADHERA
English: hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Danish: Der er blevet rapporteret om agitation, hypertoni, hypotoni, tremor, døsighed, akut respirationsbesvær eller besvær ved fødeindtagelse.
English: After reconstitution: 1ml suspension contains 150 mg/ml olanzapine.
Danish: Efter rekonstitution: 1 ml suspension indeholder 150 mg/ml olanzapin.
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Danish: 3Observeret for fastende normalt niveau ved baseline (< 5,17 mmol/l), der blev øget til højt niveau (≥ 6,2 mmol/l).
English: Due to the slow dissolution of the olanzapine pamoate salt which provides a slow continuous release of olanzapine that is complete approximately six to eight months after the last injection, supervision by a clinician, especially during the first 2 months after discontinuation of ZYPADHERA, is needed when switching to another antipsychotic product and is considered medically appropriate.
Danish: Dette skyldes den langsomme opløsning af olanzapinpamoatsaltet, som sikrer en langsom kontinuerlig frigivelse af olanzapin, der først er fuldstændig cirka seks til otte måneder efter sidste injektion.
English: • Vial of ZYPADHERA powder for prolonged release suspension for injection
Danish: • Hætteglas med ZYPADHERA pulver til depotinjektionsvæske, suspension
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hours) and the clearance was reduced (17.5 versus 18.2 l/hr).
Danish: Selv om ZYPADHERA ikke kan tilrådes til behandling af den ældre population før et veltålt og effektivt dosisregime ved brug af oral olanzapin er fastsat, var den gennemsnitlige eliminationshalveringstid forlænget (51,8 versus 33,8 timer), og clearance var reduceret (17,5 versus 18,2 l/time) hos raske ældre (65 år og derover) versus ikke ældre personer.
English: anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Danish: 4.4), hududslæt, asteni, træthed, pyreksi, artralgi, forhøjet alkalisk fosfatase, høje niveauer af gammaglutamyltransferase, af urinsyre og af kreatinkinase samt ødemer.
English: 1) Description of post injection syndrome - Education about the 2 intramuscular formulations of olanzapine, including packaging differences - Description of reconstitution and proper administration technique - Recommendation for a 3-hour on-site observation period post injection - Recommendation that, immediately prior to a patient leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs or symptoms of overdose - Recommendation that the 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose - Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed - Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events - Recommendation for appropriate monitoring until the event resolves if an event should occur
Danish: Anbefaling af, at observationsperioden på 3 timer forlænges ud fra klinisk relevans for patienter, som udviser tegn eller symptomer forenelige med overdosering af olanzapin Anbefaling af, at patienterne informeres om, at de resten af dagen efter en injektion ikke skal køre eller betjene maskiner, skal være opmærksomme på tegn og symptomer på et tilfælde af postinjektionssyndrom og skal kunne få hjælp om nødvendigt Beskrivelse af de mest almindelige symptomer rapporteret ved overdosis af olanzapin, som repræsenterer den kliniske manifestation ved tilfælde af postinjektionssyndrom Anbefaling af passende monitorering i tilfælde af at en hændelse skulle opstå, indtil hændelsen er forsvundet
English: Olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Danish: Olanzapinpamoatmonohydrat svarende til 300 mg olanzapin.
English: • A recent heart attack, heart disease, sick sinus syndrome, (abnormal heart rhythms),
Danish: • Hvis du for nylig har haft et hjertetilfælde, hjertesygdom, unormal hjerterytme (syg sinussyndrom), ustabil angina pectoris eller lavt blodtryk
English: ZYPADHERA olanzapine powder and solvent for prolonged release suspension for injection
Danish: ZYPADHERA olanzapin pulver og solvens til depotinjektionsvæske, suspension
English: Olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Danish: Olanzapinpamoatmonohydrat svarende til 210 mg olanzapin.
English: Injection site pain
Danish: Smerter på injketionsstedet
English: Additional tapping may be required if clumps remain.
Danish: Det kan være nødvendigt at banke yderligere, hvis der stadigvæk er klumper (Se Figur B).
English: ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection
Danish: ZYPADHERA 210 mg pulver og solvens til depotinjektionsvæske, suspension ZYPADHERA 300 mg pulver og solvens til depotinjektionsvæske, suspension ZYPADHERA 405 mg pulver og solvens til depotinjektionsvæske, suspension
English: (Table 1)
Danish: (Tabel
English: 15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Danish: 15 Ændringer i de totale kolesterolniveauer fra normale ved baseline (< 4,39 mmol/l ved faste) til høje (≥ 5,17 mmol/l) var almindelige.
English: ZYPADHERA 405 mg powder: Type I glass vial.
Danish: ZYPADHERA 405 mg pulver: Hætteglas af type I-glas.
English: ZYPADHERA 300 mg powder: Type I glass vial.
Danish: ZYPADHERA 300 mg pulver: Hætteglas af type I-glas.
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l) were very common.
Danish: Ændring i fastende glucoseniveau fra let forhøjet niveau ved baseline (≥ 5,56< 7 mmol/l) til højt niveau (≥ 7 mmol/l) var meget almindeligt.
English: ZYPADHERA 210 mg powder: Type I glass vial.
Danish: ZYPADHERA 210 mg pulver: Hætteglas af type I-glas.
English: Other medicines and ZYPADHERA Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: 210 mg/2 weeks or 405 mg/4 weeks 150 mg/2 weeks or 300 mg/4 weeks
Danish: 150 mg/2 uger eller 300 mg/4 uger
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/l) to high (≥ 5.17 mmol/l) were very common.
Danish: Ændringer i de totale kolesterolniveauer ved faste fra grænsetilfælde ved baseline (≥ 4,39 - < 5.17 mmol/l) til høje (≥ 5,17 mmol/l) var meget almindelige.
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking ZYPADHERA and regularly during treatment.
Danish: Inden du påbegynder behandling med ZYPADHERA, samt jævnligt i løbet af behandlingen skal din læge tage blodprøver for at kontrollere indholdet af sukker og fedt i dit blod.
English: • Seizures
Danish: • Svimmelhed
English: Patients should be advised not to breast feed an infant if they are taking olanzapine.
Danish: Patienten bør frarådes at amme, hvis hun er i behandling med olanzapin.
English: In clinical trials with oral olanzapine, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF<500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
Danish: QTc-forlængelse blev defineret som Fridericia korrigeret QT [QTcF] ≥500 millisekunder [msek] på et hvilket som helst tidspunkt post-baseline hos patienter med baseline QTcF <500 msek.
English: Slowly withdraw the desired amount.
Danish: Træk langsomt den ønskede mængde op. Der vil være overskud af lægemidlet tilbage i hætteglasset.
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).
Danish: Venetrombose med en tidsmæssig sammenhæng med olanzapinbehandling er rapporteret med frekvensen ”ikke almindelig” (≥ 1/1.000 til < 1/100).
English: In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and oral olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Danish: 4.8), og oral olanzapin var ikke mere effektivt end placebo til behandling af psykotiske symptomer.
English: INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS
Danish: LISTE OVER HJÆLPESTOFFER
English: ZYPADHERA 210 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Danish: ZYPADHERA 210 mg: Hvert hætteglas indeholder olanzapinpamoatmonohydrat svarende til 210 mg olanzapin.
English: Sími: + 354 540 8000
Danish: Ísland Icepharma hf.Sími: + 354 540 8000
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Danish: Indehaver af markedsføringstilladelsen Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland.
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland.
English: ZYPADHERA 405 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Danish: ZYPADHERA 405 mg: Hvert hætteglas indeholder olanzapinpamoatmonohydrat svarende til 405 mg olanzapin.
English: ZYPADHERA 300 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Danish: ZYPADHERA 300 mg: Hvert hætteglas indeholder olanzapinpamoatmonohydrat svarende til 300 mg olanzapin.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label ZYPADHERA 210 mg powder for prolonged release suspension for injection
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket til hætteglas ZYPADHERA 210 mg pulver til depotinjektionsvæske, suspension
English: Once withdrawn from vial into syringe, the suspension should be used immediately.
Danish: Efter optrækning i sprøjten fra hætteglas skal suspensionen anvendes straks.
English: What is in this leaflet:
Danish: Pakken indeholder:
English: For obese patients, the 50 mm needle is recommended for injection: If the 50 mm needle is to be used for injection, attach the 38 mm safety needle to the syringe to withdraw the required suspension volume.
Danish: • Hvis 50 mm kanylen anvendes til injektion, fastgøres 38 mm kanylen til sprøjten for at trække den nødvendige mængde suspension ud.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ZYPADHERA 405 mg powder for prolonged release injection olanzapine
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ZYPADHERA 405 mg pulver til depotinjektionsvæske olanzapin i.m.
English: Do not administer intravenously or subcutaneously.
Danish: MÅ IKKE ADMINISTRERES INTRAVENØST ELLER SUBKUTANT.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Lilly S.A., Avda.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label ZYPADHERA 300 mg powder for prolonged release suspension for injection
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket til hætteglas ZYPADHERA 300 mg pulver til depotinjektionsvæske, suspension
English: High creatine phosphokinase11 High Gamma Glutamyltransfera se 10
Danish: Høje niveauer af gammaglutamyltransferase10