FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with teicoplanin should be made taking into account the benefit of breastfeeding to the child and the benefit of teicoplanin therapy to the mother.
Danish: Det skal besluttes, om amning henholdsvis behandling med teicoplanin skal fortsættes/afbrydes under hensyntagen til fordelen ved amning for barnet og fordelen ved teicoplaninbehandling for moderen.
English: • you have a decrease in platelet count (thrombocytopenia)
Danish: • du har et nedsat antal blodplader (trombocytopeni)
English: Adults and elderly patients with kidney problems
Danish: Voksne og ældre patienter med nyreproblemer
English: Subcutaneous administration of teicoplanin at up to 40 mg/kg/day did not affect male and female fertility in the rat.
Danish: Subkutan administration af teicoplanin på op til 40 mg/kg/dag påvirkede ikke fertiliteten hos han- og hunrotter.
English: These include aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide, and ethacrynic acid (see section 4.4).
Danish: Disse omfatter aminoglykosider, colistin, amphotericin B, ciclosporin, cisplatin, furosemid og ethacrynsyre (se pkt.
English: • Gently roll the vial between the hands until the powder is completely dissolved.
Danish: • Rul forsigtigt hætteglasset mellem hænderne, indtil pulveret er helt opløst.
English: In pleural fluid and subcutaneous fat tissue the tissue/serum ratios are comprised between 0.2 and 0.5.
Danish: I pleuralvæske og subkutant fedtvæv ligger væv/serumforholdet mellem 0,2 og 0,5.
English: The injection will be given either as a bolus over 3 to 5 minutes or as a 30-minutes infusion.
Danish: Injektionen kan gives enten som bolus i løbet af 3 til 5 minutter eller som infusion over 30 minutter.
English: Infection caused by ‘Clostridium difficile' bacteria The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days.
Danish: Infektion forårsaget af ”Clostridium difficile”-bakterier Den anbefalede dosis er 100 til 200 mg gennem munden to gange om dagen i 7 til 14 dage.
English: Volume withdrawable from the solvent ampoule for reconstitution
Danish: Volumen, der kan udtrækkes fra ampul med opløsningsmiddel til rekonstitution
English: • you have a flushing of your upper part of your boby (red man syndrome)
Danish: • du har rødt udslæt på overkroppen (red man-syndrom)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL OF SOLVENT VIAL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER MÆRKAT TIL SOLVENSHÆTTEGLAS
English: Therefore, this SmPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Derfor repræsenterer denne tekst ikke nødvendigvis den gældende tekst.
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Danish: ADMINISTRATION Læs indlægssedlen inden brug.
English: Tell your doctor or nurse straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Fortæl det til lægen eller sundhedspersonalet med det samme, hvis du bemærker nogen af følgende alvorlige bivirkninger - du kan have brug for akut lægehjælp:
English: Bone and joint infections, and heart infections
Danish: Knogle- og ledinfektioner samt hjerteinfektioner
English: As teicoplanin is eliminated by renal route, teicoplanin elimination decreases according to the degree of renal impairment.
Danish: Da teicoplanin elimineres gennem nyrerne, aftager teicoplanin-eliminationen i takt med graden af nedsat nyrefunktion.
English: The intravenous injection may be administered either as a bolus over 3 to 5 minutes or as a 30-minute infusion.
Danish: Den intravenøse injektion kan administreres enten som bolus i løbet af 3 til 5 minutter eller som infusion over 30 minutter.
English: The reconstituted solution may be injected directly or alternatively further diluted, or orally administered.
Danish: Den rekonstituerede opløsning kan injiceres direkte eller alternativt fortyndes yderligere, eller den kan gives oralt.
English: Children (from 2 months to 12 years)
Danish: Børn (fra 2 måneder til 12 år):
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Targocid.
Danish: Hvis noget af det ovenstående gælder for dig (eller du ikke er sikker), så tal med din læge, apotekspersonalet eller sundhedspersonalet, inden du får Targocid.
English: • Slowly inject the entire content of the supplied solvent into the powder vial.
Danish: • Injicer langsomt hele indholdet i ampullen med den medfølgende solvens ind i hætteglasset med pulver.
English: Serious, life-threatening hypersensitivity reactions, sometimes fatal, have been reported with teicoplanin (e.g. anaphylactic shock).
Danish: Alvorlige, livstruende, til tider dødelige overfølsomhedsreaktioner er rapporteret med teicoplanin (f.eks. anafylaktisk shock).
English: Injection site abcess, chills (rigors)
Danish: Abcses på injektionsstedet, kulderystelser (rigor)
English: • difficulty in breathing or wheezing (bronchospasm)
Danish: • vejrtrækningsbesvær eller hiven efter vejret (bronkospasme)
English: Teicoplanin is not removed by haemodialysis and only slowly by peritoneal dialysis.
Danish: Teicoplanin fjernes ikke ved hæmodialyse og kun langsomt ved peritonealdialyse.
English: Teicoplanin distributed mainly in lung, myocardium and bone tissues with tissue/serum ratios superior to 1.
Danish: Teicoplanin distribueres primært til lunge-, myokardie- og knoglevæv med væv/serumforhold over 1.
English: Agranulocytosis, neutropenia
Danish: Agranulocytose, neutropeni
English: Preparation of reconstituted solution
Danish: Klargøring af rekonstitueret opløsning
English: They will decide whether or not you can keep breast-feeding, while you are given Targocid.
Danish: Lægen vil beslutte, hvorvidt du kan fortsætte med at amme, mens du får Targocid.
English: Do not use this medicine after the expiry date which is stated on the carton and label of the vial after EXP.
Danish: Brug ikke Targocid efter den udløbsdato, der står på pakningen og etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den pågældende måned.
English: Indications
Danish: Indikationer
English: This effect was not reported at 50 mg/kg/day A peri and postnatal study in rats showed no effects on the fertility of the F1 generation or on the survival and development of the F2 generation following subcutaneous administration of up to 40 mg/kg/day.
Danish: Et peri- og postnatalt studie med rotter viste ingen effekt på fertiliteten hos F1generationen eller på F2-generationens overlevelse og udvikling efter subkutan administration af op til 40 mg/kg/dag.
English: After six daily intramuscular administrations of 200 mg the mean (SD) maximum teicoplanin concentration (Cmax) amounts to 12.1 (0.9) mg/L and occurs at 2 hours after administration.
Danish: Efter seks daglige intramuskulære injektioner af 200 mg er den gennemsnitlige (SD) maksimale teicoplanin-koncentration (Cmax) 12,1 (0,9) mg/l og opnås 2 timer efter administration.
English: • raised in blood levels of creatinine (to monitor your kidney)
Danish: • forhøjet kreatinin i blodet (udtryk for din nyrefunktion)
English: • complicated urinary tract infections,
Danish: • komplicerede urinvejsinfektioner,
English: • feeling dizzy or headache
Danish: • svimmelhed eller hovedpine
English: • For people with mild and moderate kidney problems - the maintenance dose will be given every two days, or half of the maintenance dose will be given once a day.
Danish: • For personer med lette og moderate nyreproblemer - vedligeholdelsesdosis vil blive givet hver anden dag, eller halvdelen af vedligeholdelsesdosis vil blive givet én gang dagligt.
English: • water tablets (such as furosemide) - also called ‘diuretics' which may cause hearing problems and/or kidney problems.
Danish: • Vanddrivende medicin (såsom furosemid) - også kaldet ”diuretika”; kan forårsage problemer med hørelsen og/eller nyreproblemer.
English: Volume containing nominal teicoplanin dose (extracted by 5 mL syringe and 23 G needle)
Danish: Volumen, der indeholder nominel teicoplanin-dosis (udtrukket med 5 ml sprøjte og 23 G kanyle)
English: Rash, erythema, pruritus
Danish: Udslæt, erytem, pruritus
English: • 0.45% sodium chloride and 5% glucose solution
Danish: • 0,45 % natriumchlorid og 5 % glucoseopløsning
English: Adverse reactions should be monitored when teicoplanin doses of 12 mg/kg body weight twice a day are administered (see section 4.4).
Danish: Bivirkninger skal monitoreres, når der gives teicoplanin-doser på 12 mg/kg legemsvægt to gange dagligt (se pkt.
English: Each vial contains either 100 mg, 200 mg or 400 mg teicoplanin.
Danish: Hvert hætteglas indeholder enten 100 mg, 200 mg eller 400 mg teicoplanin.
English: Patients receiving teicoplanin in conjunction with or sequentially with other medicinal products with known neurotoxic/ototoxic potential (aminoglycosides, ciclosporin, cisplatin, furosemide and ethacrynic acid) should be carefully monitored and the benefit of teicoplanin evaluated if hearing deteriorates.
Danish: Patienter, der får teicoplanin samtidig med eller sekventielt med andre lægemidler med kendt neurotoksisk/ototoksisk potentiale (aminoglykosider, ciclosporin, cisplatin, furosemid og ethacrynsyre) skal monitoreres nøje, og fordelen ved teicoplanin skal evalueres, hvis hørelsen forringes.
English: Susceptibility
Danish: Følsomhed
English: Commonly susceptible species Aerobic Gram-positive bacteria Corynebacterium jeikeium a
Danish: Sædvanligvis følsomme arter Aerobe grampositive bakterier Corynebacterium jeikeium a
English: Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site different from that affected by beta-lactams.
Danish: Teicoplanin hæmmer væksten af følsomme organismer ved at interferere med cellevægsyntesen på et andet sted end betalaktamer.
English: • 0.18% sodium chloride and 4% glucose solution
Danish: • 0,18 % natriumchlorid og 4 % glucoseopløsning
English: The reconstituted solutions will contain 100 mg of teicoplanin in 1.5 mL, 200 mg in 3.0 mL and 400 mg in 3.0 mL.
Danish: De rekonstituerede opløsninger vil indeholde 100 mg teicoplanin i 1,5 ml, 200 mg i 3,0 ml og 400 mg i 3,0 ml.
English: In embryofetal development studies, no malformations were observed following subcutaneous administration of up to 200 mg/kg/day in the rat and intramuscular administration up to 15 mg/kg/day in the rabbit.
Danish: I studier vedrørende fosterudvikling blev der ikke observeret misdannelser efter subkutan administration af op til 200 mg/kg/dag hos rotter og efter intramuskulær administration på op til 15
English: Teicoplanin is administered by parenteral route (intravenously or intramuscularly).
Danish: Teicoplanin administreres parenteralt (intravenøst eller intramuskulært).
English: Special precautions must be taken when administering teicoplanin in patients who require concomitant treatment with ototoxic and/or nephrotoxic medicinal products for which it is recommended that regular haematology, liver and kidney function tests are carried out.
Danish: Særlige forholdsregler skal tages ved administration af teicoplanin til patienter, hvor samtidig behandling med ototoksiske og/eller nefrotoksiske lægemidler, for hvilke det anbefales, at hæmatologi samt lever- og nyrefunktion monitoreres regelmæssigt, er nødvendig.
English: 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: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.
English: Gram-positive anaerobes except Clostridium difficile PK/PD (Non-species related) breakpoints c,d
Danish: Grampositive anaerober undtagen Clostridium difficile Farmakokinetiske/farmakodynamiske (ikke-artsrelaterede) grænseværdier c, d
English: • Renal impairment:
Danish: • Nedsat nyrefunktion:
English: Powder for solution for injection/infusion or oral solution also contains: sodium chloride, sodium hydroxide (for pH adjustment).
Danish: Pulver til injektions-/infusionsvæske, opløsning eller oral opløsning indeholder også: natriumhydroxid (til justering af pH)
English: • For people with severe kidney problems or on haemodialysis - the maintenance dose will be given every three days, or one-third of the maintenance dose will be given once a day.
Danish: • For personer med alvorlige nyreproblemer eller i hæmodialyse - vedligeholdelsesdosis vil blive givet hver tredje dag, eller en tredjedel af vedligeholdelsesdosis vil blive givet én gang dagligt.
English: • you are taking other medicines which may cause hearing problems and/or kidney problems.
Danish: • du tager anden medicin, som kan forårsage høreproblemer og/eller nyreproblemer.
English: Since teicoplanin is mainly excreted by the kidney, the dose of teicoplanin must be adapted in patients with renal impairment (see section 4.2).
Danish: Da teicoplanin primært udskilles gennem nyrerne, skal teicoplanindosis tilpasses hos patienter med nedsat nyrefunktion (se pkt.
English: How Targocid is given
Danish: Sådan gives Targocid
English: Clostridium difficile infection-associated diarrhea and colitis The recommended dose is 100-200 mg administered orally twice a day for 7 to 14 days.
Danish: Diarré og colitis associeret med Clostridium difficile Den anbefalede dosis er 100-200 mg oralt to gange om dagen i 7 til 14 dage.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige (kan påvirke op til 1 ud af 100 personer)
English: Patients with renal insufficiency, and/or in those receiving teicoplanin in conjunction with or sequentially with other medicinal products with known nephrotoxic potential (aminoglycosides, colistin, amphotericin B, ciclosporin, and cisplatin) should be carefully monitored, and should include auditory tests.
Danish: Patienter med nedsat nyrefunktion og/eller patienter, der får teicoplanin samtidig med eller sekventielt med andre lægemidler med kendt nefrotoksisk potentiale (aminoglykosider, colistin, amphotericin B, ciclosporin, og cisplatin), skal monitoreres nøje, og auditive test skal inkluderes.
English: Teicoplanin should not be administered by intraventricular use.
Danish: Teicoplanin må ikke administreres intraventrikulært.
English: Renal failure has been reported in patients treated with teicoplanin (see section 4.8).
Danish: Nyresvigt er rapporteret hos patienter behandlet med teicoplanin (se pkt.
English: Red man syndrome (e.g. Flushing of the upper part of the body) (see section 4.4).
Danish: Red mansyndrom (f.eks. rødme af overkroppen) (se pkt.
English: Ear and Labyrinth disorders
Danish: Øre og labyrint
English: In particular, tell your doctor, pharmacist or nurse if you are taking the following medicines:
Danish: Du skal især fortælle det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager følgende medicin:
English: Rare (may affect up to 1 in 1000 people) • flushing of the upper body
Danish: Sjældne (kan påvirke op til 1 ud af 1.000 personer) • rødme af overkroppen
English: Targocid can be administered in the following infusion solutions: sodium chloride 9 mg/mL (0.9%) solution Ringer solution
Danish: Tilberedning af den fortyndede opløsning før infusion: Targocid kan administreres i følgende infusionsvæsker: Natriumchlorid 9 mg/ml (0,9 %) injektionsvæske Ringer-injektionsvæske
English: • feeling or being sick (vomiting), diarrhoea
Danish: • kvalme eller opkastning, diarré
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL OF POWDER VIAL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER MÆRKAT PÅ HÆTTEGLAS MED PULVER
English: Targeted trough concentrations during maintenance
Danish: Vedligeholdelsesdosis Mål for dalkoncentrationen under vedligeholdelsesbehan dling
English: Neonates and infants up to the age of 2 months:
Danish: Nyfødte og spædbørn op til 2 måneders alderen: Startdosis
English: Ototoxicity
Danish: Ototoksicitet
English: How to use Targocid
Danish: SÅDAN SKAL DU BRUGE TARGOCID
English: In blister fluids, synovial fluid and peritoneal fluid the tissue/serum ratios ranged from 0.5 to 1.
Danish: I blistervæsker, synovialvæske og peritonealvæske varierede væv/serumforholdet fra 0,5 til 1.
English: Water for injections [See Annex I - To be completed nationally]
Danish: Vand til injektionsvæsker [Se bilag I - Udfyldes nationalt]
English: What you need to know before you are given Targocid
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE TARGOCID
English: 800 mg intravenous (this equates to approximately 12 mg/kg body weight) every 12 hours for 3 to 5 administrations
Danish: 800 mg intravenøst (svarende til ca. 12 mg/kg legemsvægt) hver 12. time i alt 3 til 5 gange
English: If you forget to have Targocid
Danish: Hvis du ikke har fået Targocid
English: To treat certain infections, the solution may be taken by mouth (oral use).
Danish: Opløsningen skal tages gennem munden (oral anvendelse) til behandling af visse infektioner.
English: Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Inherently resistant bacteria All Gram-negative bacteria Other bacteria
Danish: Generelt resistente bakterier Alle gramnegative bakterier Andre bakterier Chlamydia spp.
English: - Complicated urinary tract infections
Danish: Komplicerede urinvejsinfektioner
English: For storage conditions of the reconstituted/diluted medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution/fortynding af lægemidlet, se pkt.
English: Preparation of the diluted solution before infusion Targocid can be administered in the following infusion solutions:
Danish: Targocid kan administreres i følgende infusionsvæsker:
English: • blistering of the skin, mouth, eyes or genitals - these may be signs of something called ‘toxic epidermal necrolysis' or ‘Stevens-Johnson syndrome' Tell your doctor or nurse straight away, if you notice any of the side effects above.
Danish: • blæredannelse på huden, i munden, på øjne eller kønsdele - det kan være tegn på 2 tilstande, der hedder ”toksisk epidermal nekrolyse” og ”Stevens-Johnsons syndrom "
English: • raised blood levels of liver enzymes
Danish: • øget indhold af leverenzymer i blodet
English: High Performance Liquid Chromatography (HPLC), or at least 15 mg/L when measured by
Danish: 10 mg/l målt ved højtryksvæskekromatografi (HPLC) eller mindst 15 mg/l målt ved fluorescenspolarisations-analyse (FPIA).
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationss tedet
English: Targocid and associated names (see Annex I) is indicated in adults and in children from birth for the parenteral treatment of the following infections (see sections 4.2, 4.4 and 5.1):
Danish: Targocid og relaterede navne (Se bilag I) er indiceret til parenteral behandling af følgende infektioner hos voksne og børn fra fødslen (se pkt.
English: In the elderly population the teicoplanin pharmacokinetics is not modified unless in case of renal impairment.
Danish: • Ældre patienter: Hos ældre personer ændres teicoplanins farmakokinetik kun, hvis nyrefunktionen er nedsat.
English: • ciclosporin - a medicine that affects the immune system which may cause hearing problems and/or kidney problems
Danish: • Ciclosporin - et lægemiddel, der påvirker immunsystemet; kan forårsage problemer med hørelsen og/eller nyreproblemer
English: • Week two: 20 mg/L in every other dialysis bag
Danish: • Uge 2: 20 mg/l i hver anden dialysepose
English: Volume of powder vial
Danish: Volumen af hætteglas med pulver
English: 400 mg intravenous or intramuscular (this equates to approximately 6 mg/kg body weight) every 12 hours for 3 administrations
Danish: 400 mg intravenøst eller intramuskulært (svarende til ca. 6 mg/kg legemsvægt) hver 12. time i alt 3 gange
English: Hypersensitivity to teicoplanin or to any of the excipients listed in section 6.
Danish: Overfølsomhed over for teicoplanin eller over for et eller flere af hjælpestofferne anført i pkt.
English: After a maintenance dose of 12 mg/kg once daily Ctrough values range from 18 to 30 mg/L.
Danish: Efter en vedligeholdelsesdosis på 12 mg/kg én gang dagligt varierer Cmin fra 18 til 30 mg/l.
English: • The other ingredients are sodium chloride and sodium hydroxide in the powder; and water for injections in the solvent.
Danish: • Øvrige indholdsstoffer: natriumchlorid og natriumhydroxid i pulveret.
English: • complicated skin and soft tissue infections,
Danish: • komplicerede infektioner i hud og bløddele,
English: Anaphylactic shock (see section 4.4)
Danish: Anafylaktisk shock (se pkt.
English: Uncommon (≥1/1,000 to
Danish: (≥1/1.000 til
English: Tests
Danish: Prøver
English: • amphotericin B - a medicine that treats fungal infections which may cause hearing problems and/or kidney problems
Danish: • Amphotericin B - et lægemiddel til behandling af svampeinfektioner; kan forårsage problemer med hørelsen og/eller nyreproblemer
English: Teicoplanin and aminoglycoside solutions are incompatible and must not be mixed for injection; however, they are compatible in dialysis fluid and may be freely used in the treatment of CAPD-related peritonitis.
Danish: Dog er teicoplaninog aminoglykosid-injektionsvæsker kompatible i dialysevæsker og kan frit bruges i behandlingen af CAPDrelateret peritonitis.
English: • Starting dose (on the first day): 16 mg for every kilogram of body weight, as an infusion through a drip into a vein.
Danish: • Startdosis (på den første dag): 16 mg per kilo legemsvægt, som en infusion gennem et drop ind i en vene (blodåre).
English: • hospital acquired pneumonia,
Danish: • lungebetændelse erhvervet på sygehus,
English: • For most Gram-positive infections, teicoplanin trough levels of at least 10 mg/L when measured by
Danish: • For de fleste grampositive infektioner er dalkoncentrationen af teicoplanin mindst
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Targocid and associated names [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN , STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til Targocid og relaterede navne [Se bilag I - Udfyldes nationalt]
English: thrombocytopenia, eosinophilia
Danish: Leukopeni, trombocytopeni, eosinofili
English: The starting dose is 6 mg for every kilogram of body weight, as a single injection into a vein, followed by:
Danish: Bughindebetændelse hos patienter i peritonealdialyse Startdosis er 6 mg for hvert kilo kropsvægt, som en enkelt injektion i en vene, efterfulgt af:
English: One single dose of 16 mg/kg body weight, administered intravenously by infusion on the first day.
Danish: En enkelt dosis på 16 mg/kg legemsvægt indgivet intravenøst den første dag.
English: Teicoplanin should be administered by the intravenous or intramuscular route.
Danish: Teicoplanin skal administreres intravenøst eller intramuskulært.
English: - Pneumonia
Danish: Lungebetændelse
English: teicoplanin Intramuscular, intravenous or oral uses
Danish: teicoplanin Intramuskulær, intravenøs eller oral brug
English: Powder for solution for injection/infusion or oral solution Sodium chloride
Danish: Pulver til injektions-/infusionvæske,,opløsning eller oral opløsning Natriumchlorid
English: Studies in animals have shown reproductive toxicity at high doses (see section 5.3): in rats there was an increased incidence of stillbirths and neonatal mortality.
Danish: 5.3): hos rotter var der en øget forekomst af dødfødsler og neonatal dødelighed.
English: Manufacturer [To be completed nationally]
Danish: Fremstiller [Udfyldes nationalt]
English: 12 mg/kg body weight intravenous or intramuscular once a day
Danish: 12 mg/kg legemsvægt intravenøst eller intramuskulært én gang dagligt
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection/infusion or oral solution 1 powder vial
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver til injektions-/infusionsvæske, opløsning eller oral opløsning 1 hætteglas med pulver
English: 5x1 powder vials
Danish: − 5x1 hætteglas med pulver