FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you are breast-feeding or plan to do so.
Danish: Fortæl det til din læge, hvis du ammer eller planlægger at amme.
English: Serum calcium levels should be measured prior to initiating treatment, within 1 week of initiation or dose adjustment of Parsabiv and every 4 weeks during treatment.
Danish: Serum-calcium skal måles inden initiering af behandling med Parsabiv, inden for 1 uge efter initiering eller dosisjustering og hver 4. uge under behandlingen.
English: If PTH does not return to > 100 pg/mL following dose reduction, the dose should be stopped.
Danish: Dosering skal afbrydes, hvis PTH ikke vender tilbage til > 100 picog/ml efter reduktion af dosis.
English: Nausea Vomiting Diarrhoea
Danish: Kvalme Opkastning Diaré
English: Etelcalcetide is rapidly cleared in subjects with normal renal function, whilst in CKD patients requiring haemodialysis, etelcalcetide was predominantly eliminated by haemodialysis.
Danish: Etelcalcetid elimineres hurtigt hos personer med normal nyrefunktion, mens etelcalcetid overvejende blev elimineret ved hæmodialyse hos CKD-patienter med behov for dialyse.
English: • Stop Parsabiv until corrected serum calcium levels are ≥ 8.3 mg/dL (2.08mmol/L) and symptoms of hypocalcaemia (if present) have resolved.
Danish: • Afbryd Parsabiv, indtil korrigeret serum-calcium er ≥ 8,3 mg/dl (2,08 mmol/l), og eventuelle symptomer på hypokalcæmi er forsvundet.
English: Patients with lower screening PTH levels typically required lower doses (median average weekly doses of 15.0 mg, 21.4 mg, 27.1 mg, respectively, for patients with screening PTH levels < 600 pg/mL, 600 to ≤ 1,000 pg/mL, and > 1,000 pg/mL).
Danish: Patienter med lavere PTH-niveau ved screening havde typisk behov for lavere doser (median ugentlig gennemsnitsdosis på 15,0 mg, 21,4 mg og 27,1 mg for patienter med PTH-niveauer ved screening på henholdsvis
English: In vitro, etelcalcetide did not inhibit or induce CYP450 enzymes and was itself not a substrate for metabolism by CYP450 enzymes.
Danish: Etelcalcetid hæmmede eller inducerede ikke CYP-enzymer in vitro og var i sig selv ikke substrat for CYP-enzymer.
English: The primary endpoint in each study was the proportion of patients with > 30% reduction from baseline in PTH during the EAP (EAP, defined as weeks 20 to 27 inclusive).
Danish: Det primære endepunkt i begge studier var andelen af patienter med et fald på > 30 % i PTH i forhold til baseline i EAP (EAP var defineret som uge 20 til og med uge 27).
English: Reduction in PTH levels correlated with plasma etelcalcetide concentrations in haemodialysis patients.
Danish: Faldet i PTH korrelerede med plasmakoncentrationen af etelcalcetid hos patienter i hæmodialyse.
English: Closely monitor serum calcium (see section 4.5).
Danish: Serum-calcium skal monitoreres nøje (se pkt.
English: The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks to a maximum dose of 15 mg 3 times per week to achieve the desired parathyroid hormone (PTH) target.
Danish: Dosis kan forhøjes i trin på 2,5 mg eller 5 mg med intervaller på mindst 4 uger til en maksimumdosis på 15 mg 3 gange om ugen, så der opnås det ønskede mål for paratyreoideahormon (PTH).
English: Mean (SE) baseline PTH concentrations across the 2 studies were 846.9 (21.8) pg/mL, and 835.9 (21.0) pg/mL for the Parsabiv and placebo groups, respectively with approximately 21% of subjects enrolling across both studies having baseline PTH > 1,000 pg/mL.
Danish: Den gennemsnitlige (SE) PTH-koncentration ved baseline på tværs af de to studier var 846,9 (21,8) picog/ml og 835,9 (21,0) picog/ml for henholdsvis Parsabiv-gruppen og placebogruppen, hvoraf cirka 21 % af patienterne på tværs af de to studier havde PTH på > 1.000 picog/ml ved baseline.
English: Discontinuation of therapy as a result of undesirable effects was mainly due to low blood calcium, nausea, and vomiting.
Danish: Seponering som følge af bivirkninger skyldtes fortrinsvis lavt serum-calcium, kvalme og opkastning.
English: 6 See section 4.4.
Danish: 4.4 og 4.2.
English: • High potassium levels in blood
Danish: • Højt kaliumniveau i blodet
English: Headache Paraesthesia3
Danish: Hovedpine Paræstesi3
English: For further information regarding potential manifestations of hypocalcaemia and serum calcium monitoring please see sections 4.4 and 4.2 respectively.
Danish: Yderligere information om de potentielle manifestationer af hypokalcæmi og monitorering af serum-calcium findes under henholdsvis pkt.
English: The threshold for seizures may be lowered by significant reductions in serum calcium levels.
Danish: Krampetærsklen kan sænkes ved signifikante fald i serum-calcium.
English: Parsabiv contains the active substance etelcalcetide, which reduces parathyroid hormone known as PTH.
Danish: Parsabiv indeholder det aktive stof etelcalcetid, der nedsætter mængden af et hormon, der dannes i biskjoldbruskkirtlerne og kaldes for PTH (paratyreoideahormon).
English: By controlling the levels of PTH, Parsabiv helps to control calcium and phosphate in your body.
Danish: Parsabiv regulerer indholdet af PTH i blodet og er på den måde med til at regulere indholdet af calcium og fosfat i kroppen.
English: 1 vial (0.5 mL) 6 vials (0.5 mL) 12 vials (0.5 mL) 42 vials (0.5 mL)
Danish: 1 hætteglas (0,5 ml) 6 hætteglas (0,5 ml) 12 hætteglas (0,5 ml) 42 hætteglas (0,5 ml)
English: If patient's last administered dose was 2.5 mg or 5 mg, reinitiate at 2.5 mg once corrected serum calcium levels are ≥ 8.3 mg/dL (2.08 mmol/L) and symptoms of hypocalcaemia (if present) have resolved.
Danish: Hvis patientens seneste administrerede dosis var 2,5 mg eller 5 mg, reinitieres med en dosis på 2,5 mg, når korrigeret serum-calcium er ≥ 8,3 mg/dl (2,08 mmol/l), og eventuelle symptomer på hypokalcæmi er svundet.
English: How to use Parsabiv
Danish: Sådan skal du bruge Parsabiv
English: Mean percent change during the EAP, % (SE)
Danish: Gennemsnitlig procentvis ændring under EAP, % (SE)
English: Parsabiv is administered into the venous line of the dialysis circuit at the end of the haemodialysis treatment during rinse-back or intravenously after rinse-back.
Danish: Parsabiv administreres i venekateteret i dialysekredsløbet i slutningen af hæmodialysen, når blodet returneres til patienten, eller intravenøst, efter at blodet er returneret.
English: Blood calcium decreased1, 4
Danish: Fald i serum-calcium1, 4
English: Cases of seizures have been reported in patients treated with Parsabiv (see section 4.8).
Danish: Der er rapporteret tilfælde af krampeanfald hos patienter i behandling med Parsabiv (se pkt.
English: Patients receiving Parsabiv should not be given cinacalcet (see section 4.4).
Danish: Patienter, der behandles med Parsabiv, må ikke få cinacalcet (se pkt.
English: For patients in whom the dose is stopped, Parsabiv should be reinitiated at a lower dose once PTH returns to > 150 pg/mL (15.9 pmol/L) and pre-dialysis serum corrected calcium (cCa) ≥ 8.3 mg/dL (2.08 mmol/L).
Danish: Hos patienter, der har fået dosering afbrudt, skal Parsabiv reinitieres ved en lavere dosis, når PTH vender tilbage til > 150 picog/ml (15,9 picomol/l), og korrigeret serum-calcium inden dialyse (cCa) er ≥ 8,3 mg/dl (2,08 mmol/l).
English: Single doses up to 60 mg and multiple doses up to 22.5 mg 3 times a week at the end of dialysis in patients receiving haemodialysis were safely administered in clinical trials.
Danish: I kliniske studier var det sikkert at administrere enkeltdoser på op til 60 mg og flere doser på op til 22,5 mg 3 gange om ugen i slutningen af dialysen hos patienter, der var i hæmodialyse.
English: Parsabiv contains less than 1 mmol sodium per vial, that is to say essentially sodium-free.
Danish: Hjælpestof, som behandleren skal være opmærksom på Parsabiv indeholder mindre end 1 mmol natrium pr. hætteglas, dvs. det er i det væsentlige natriumfrit.
English: 1 vial (2 mL) 6 vials (2 mL) 12 vials (2 mL) 42 vials (2 mL)
Danish: 1 hætteglas (2 ml) 6 hætteglas (2 ml) 12 hætteglas (2 ml) 42 hætteglas (2 ml)
English: In the event of overdose, serum calcium should be checked and patients should be monitored for symptoms of hypocalcaemia (see section 4.4) and appropriate measures should be taken (see section 4.2).
Danish: I tilfælde af overdosering skal serum-calcium kontrolleres, og patienten skal monitoreres for symptomer på hypokalcæmi (se pkt.
English: Serum calcium levels should be closely monitored in patients with a history of a convulsion disorder while being treated with Parsabiv.
Danish: Serum-calcium skal monitoreres nøje hos patienter med kramper i anamnesen, mens de er i behandling med Parsabiv.
English: If the patient's last administered dose was 2.5 mg, Parsabiv may be reinitiated at the 2.5 mg dose level if PTH is > 300 pg/mL (31.8 pmol/L), and the most recent pre-dialysis serum cCa ≥ 8.3 mg/dL (2.08 mmol/L).
Danish: Hvis patientens sidst administrerede dosis var 2,5 mg, kan Parsabiv reinitieres ved en dosis på 2,5 mg, hvis PTH er > 300 picog/ml (31,8 picomol/l) og den seneste serum-cCa inden dialyse ≥ 8,3 mg/dl (2,08 mmol/l).
English: 1 vial (1 mL) 6 vials (1 mL) 12 vials (1 mL) 42 vials (1 mL)
Danish: 1 hætteglas (1 ml) 6 hætteglas (1 ml) 12 hætteglas (1 ml) 42 hætteglas (1 ml)
English: If a regularly scheduled haemodialysis treatment is missed, do not administer any missed doses.
Danish: Eventuelle manglende doser må ikke administreres, hvis en planlagt hæmodialysesession springes over.
English: Parsabiv reduces calcium levels.
Danish: Parsabiv nedsætter indholdet af calcium i blodet.
English: Parsabiv treatment should not be initiated in patients if the corrected serum calcium is less than the lower limit of the normal range (see section 4.3).
Danish: Behandling med Parsabiv bør ikke initieres, hvis korrigeret serum-calcium er under den nedre grænse for normalområdet (se pkt.
English: Each vial contains 0.5 mL solution for injection.
Danish: Hvert hætteglas indeholder 0,5 ml injektionsvæske.
English: Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of solution.
Danish: Hvert hætteglas indeholder 5 mg etelcalcetid (som hydrochlorid) i 1 ml opløsning.
English: The pharmacokinetics of etelcalcetide was characterised in CKD patients receiving haemodialysis.
Danish: Etelcalcetids farmakokinetik blev beskrevet hos CKD-patienter i hæmodialyse.
English: Each vial contains 2 mL solution for injection.
Danish: Hvert hætteglas indeholder 2 ml injektionsvæske.
English: Each vial contains 1 mL solution for injection.
Danish: Hvert hætteglas indeholder 1 ml injektionsvæske.
English: Serum calcium levels should be monitored in patients with a history of congestive heart failure while being treated with Parsabiv (see section 4.2), which may be associated with reductions in serum calcium levels.
Danish: Serum-calcium skal monitoreres hos patienter med kongestiv hjerteinsufficiens i anamnesen, som kan være forbundet med fald i serum-calcium (se pkt.
English: Since etelcalcetide lowers serum calcium, patients should be advised to seek medical attention if they experience symptoms of hypocalcaemia and should be monitored for the occurrence of hypocalcaemia (see section 4.2).
Danish: Da etelcalcetid sænker serum-calcium, skal patienterne monitoreres for hypokalcæmi (se pkt.
English: In secondary hyperparathyroidism too much PTH is produced by the parathyroid glands (four small glands in the neck).
Danish: Ved sekundær hyperparatyreoidisme producerer biskjoldbruskkirtlerne (fire små kirtler i halsen) for meget PTH. “Sekundær” betyder, at hyperparatyreoidismen skyldes en anden tilstand, for eksempel nyresygdom.
English: Parsabiv 5 mg solution for injection: Each vial contains 5 mg of etelcalcetide in 1 mL solution (5 mg/mL).
Danish: Parsabiv 5 mg injektionsvæske, opløsning: Hvert hætteglas indeholder 5 mg etelcalcetid i 1 ml opløsning (5 mg/ml).
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection Parsabiv 5 mg solution for injection Parsabiv 10 mg solution for injection
Danish: LÆGEMIDLETS NAVN Parsabiv 2,5 mg injektionsvæske, opløsning Parsabiv 5 mg injektionsvæske, opløsning Parsabiv 10 mg injektionsvæske, opløsning
English: Frequency category Adverse reactions
Danish: Frekvenskategori
English: Parsabiv 2.5 mg solution for injection: Each vial contains 2.5 mg of etelcalcetide in 0.5 mL solution (5 mg/mL).
Danish: Parsabiv 2,5 mg injektionsvæske, opløsning: Hvert hætteglas indeholder 2,5 mg etelcalcetid i 0,5 ml opløsning (5 mg/ml).
English: Parsabiv 10 mg solution for injection: Each vial contains 10 mg of etelcalcetide in 2 mL solution (5 mg/mL).
Danish: Parsabiv 10 mg injektionsvæske, opløsning: Hvert hætteglas indeholder 10 mg etelcalcetid i 2 ml opløsning (5 mg/ml).
English: Parsabiv 2.5 mg solution for injection Parsabiv 5 mg solution for injection Parsabiv 10 mg solution for injection etelcalcetide
Danish: Parsabiv 2,5 mg injektionsvæske, opløsning Parsabiv 5 mg injektionsvæske, opløsning Parsabiv 10 mg injektionsvæske, opløsning etelcalcetid
English: convulsions and stress-related findings were observed at clinical exposure levels.
Danish: Der blev observeret fald i serum-calcium forbundet med tremor, kramper og stressrelaterede fund ved kliniske eksponeringsniveauer.
English: Adynamic bone
Danish: Adynamisk knoglesygdom
English: Hyperkalaemia2
Danish: Krampeanfald6
English: What Parsabiv is and what it is used for What you need to know before you use Parsabiv How to use Parsabiv
Danish: Det skal du vide, før du begynder at bruge Parsabiv Sådan skal du bruge Parsabiv Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 10 mg solution for injection etelcalcetide
Danish: LÆGEMIDLETS NAVN Parsabiv 10 mg injektionsvæske, opløsning etelcalcetid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2.5 mg of etelcalcetide (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 2,5 mg etelcalcetid (som hydrochlorid).
English: Parsabiv 10 mg solution for injection
Danish: Parsabiv 10 mg injektionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection etelcalcetide
Danish: LÆGEMIDLETS NAVN Parsabiv 2,5 mg injektionsvæske, opløsning etelcalcetid
English: Parsabiv 2.5 mg solution for injection
Danish: Parsabiv 2,5 mg injektionsvæske, opløsning
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of etelcalcetide (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 10 mg etelcalcetid (som hydrochlorid).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 5 mg of etelcalcetide (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 5 mg etelcalcetid (som hydrochlorid).
English: If PTH is below 100 pg/mL (10.6 pmol/L), the dose should be reduced or temporarily stopped.
Danish: Dosis skal nedsættes eller dosering afbrydes midlertidigt, hvis PTH er under 100 picog/ml (10,6 picomol/l).
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 5 mg solution for injection etelcalcetide
Danish: LÆGEMIDLETS NAVN Parsabiv 5 mg injektionsvæske, opløsning etelcalcetid
English: Parsabiv 5 mg solution for injection
Danish: Parsabiv 5 mg injektionsvæske, opløsning
English: Etelcalcetide is intended for CKD patients receiving haemodialysis.
Danish: Etelcalcetid er beregnet til CKD-patienter, der er i hæmodialyse.
English: Patients were administered Parsabiv or placebo at a starting dose of 5 mg 3 times per week at the end of haemodialysis and titrated every 4 weeks through week 17 to a maximum dose of 15 mg 3 times per week to achieve target PTH level ≤ 300 pg/mL.
Danish: Dosis blev titreret hver 4. uge til og med uge 17 til en maksimumdosis på 15 mg 3 gange om ugen for at opnå målkoncentrationen af PTH på ≤ 300 picog/ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 2.5 mg solution for injection etelcalcetide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Parsabiv 2,5 mg injektionsvæske, opløsning etelcalcetid i.v.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription, or any other medicines that lower serum calcium.
Danish: Det gælder også medicin, som ikke er købt på recept eller anden medicin, som sænker indholdet af calcium i blodet.
English: If you start to get numbness or tingling around your mouth or in your extremities, muscle aches or cramps and seizures (fits), you should tell your doctor immediately.
Danish: Fortæl det straks til din læge, hvis du begynder at mærke følelsesløshed eller prikken omkring munden eller i arme og ben, eller hvis du får muskelsmerter eller muskelkramper og krampeanfald.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 10 mg solution for injection etelcalcetide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Parsabiv 10 mg injektionsvæske, opløsning etelcalcetid i.v.
English: The dosing regimen for Parsabiv was similar to that in the placebo-controlled studies (starting dose of 5 mg titrated every 4 weeks with 2.5 mg to 5 mg increments to a maximum of 15 mg 3 times a week).
Danish: 5 mg, titreret hver 4. uge i trin på 2,5-5 mg til maksimalt 15 mg 3 gange om ugen).
English: Each vial contains 10 mg of etelcalcetide (as hydrochloride) in 2 mL of solution.
Danish: Parsabiv 10 mg injektionsvæske, opløsning Hvert hætteglas indeholder 10 mg etelcalcetid (som hydrochlorid) i 2 ml opløsning.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 5 mg solution for injection etelcalcetide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Parsabiv 5 mg injektionsvæske, opløsning etelcalcetid i.v.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Parsabiv påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Each vial contains 2.5 mg of etelcalcetide (as hydrochloride) in 0.5 mL of solution.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Parsabiv 2,5 mg injektionsvæske, opløsning Hvert hætteglas indeholder 2,5 mg etelcalcetid (som hydrochlorid) i 0,5 ml opløsning.
English: Member State (EU/EEA)
Danish: Medlemsstat EU/EAA
English: *PFU: plaque forming units
Danish: * PFU = Plaquedannende enheder
English: 050552 Bucharest Romania
Danish: 050552 Bucharest
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrke, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: GLAXOSMITHKLINE (GSK) SRL - ROMANIA Costache Negri Street, No. 1-5
Danish: Rumænien GLAXOSMITHKLINE (GSK) SRL - ROMANIA Costache Negri Street, No. 1-5
English: United Kingdom Sanofi Pasteur MSD Limited Mallards Reach
Danish: Storbritannien Sanofi Pasteur MSD Limited Mallards Reach
English: VIANEX S.A Tatoiou Str.
Danish: Grækenland VIANEX S.A Tatoiou Str.
English: 2031 BN Haarlem
Danish: 2031 BN Haarlem The Netherlands
English: 18th km National Road Athens-Lamia New Erythraia P.C.
Danish: 18th km National Road Athens-Lamia
English: Kifissias Avenue 266 Halandri 15232, Athens Greece
Danish: Halandri 15232, Athens Greece
English: Merck Sharp & Dohme inovativna zdravila d.o.o., Smartinska cesta 140 1000 Ljubljana Slovenia
Danish: Slovenien Merck Sharp & Dohme inovativna zdravila d.o.o., Smartinska cesta 140
English: 18th km National Road Athens-Lamia New Erythraia P.C. 14671 Athens
Danish: New Erythraia P.C. 14671 Athens
English: GSK d.o.o Cvetkova ulica 29 1000 Ljubljana Slovenia
Danish: Slovenien GSK d.o.o Cvetkova ulica 29
English: United Kingdom SmithKline Beecham plc 980 Great West Road Brentford
Danish: Storbritannien SmithKline Beecham plc 980 Great West Road Brentford
English: Slovak Republic Merck Sharp & Dohme B.V Waarderweg 39
Danish: Merck Sharp & Dohme B.V Waarderweg 39
English: Merck Sharp & Dohme B.V. Waardeweg 39, 2031 BN Haarlem The Netherlands
Danish: Waardeweg 39, 2031 BN Haarlem The Netherlands
English: one dose (0.5 ml) contains: not less than 103.0 CCID50 of the measles virus Enders-Edmonston strain not less than 5 x 103.0 CCID50 of the mumps virus (Jeryl Lynn strain) not less than 103.0 CCID50 of the rubella virus strain
Danish: En dosis (0,5 ml) indeholder: ikke mindre end 103,0 CCID50 mæslingevirus Enders-Edmonston-stamme ikke mindre end 5 x 103,0 CCID50 fåresygevirus (Jeryl Lynn-stamme) ikke mindre end 103,0 CCID50 røde hundevirusstamme
English: Na Pankráci 17/1685
Danish: Na Pankráci 17/1685 140 21 Prague 4
English: Measles virus Edmonston 749D strain (live, attenuated) - 10
Danish: Mæslingevirus Edmonston 749D-stamme (levende, svækket) - 103,0 CCID50
English: PRIORIX TETRA one dose (0.5 ml) contains:
Danish: PRIORIX TETRA En dosis (0,5 ml) indeholder:
English: Mumps virus URABE AM-9 strain (live, attenuated) not less than 5 x 10
Danish: Fåresygevirus URABE AM-9 stamme (levende, svækket) - ikke mindre end 5 x
English: GlaxoSmithKline A.E.B.E
Danish: Grækenland GlaxoSmithKline A.E.B.E
English: Varicella virus (Oka/Merck): not less than 1350 PFU*
Danish: Varicellavirus (Oka/Merck): ikke mindre end 1.350 PFU*
English: Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103.0 CCID50 Live attenuated varicella virus (Oka strain)not less than 103.3 PFU*
Danish: Levende svækket røde hundevirus (Wistar RA 27/3 stamme) - ikke mindre end 103,0 CCID50 Levende, svækket varicellavirus (Okastamme) - ikke mindre end 103,3 PFU*
English: Priorix-Tetra one dose (0.5 ml) contains dose:
Danish: PRIORIX-TETRA En dosis (0,5 ml) indeholder:
English: derived from Jeryl Lynn strain) - not less than 104.4 CCID50
Danish: derived from Jeryl Lynn strain) - ikke mindre end 103,7 CCID50
English: Varivax one dose (0.5 ml) contains: varicella virus (zoster vivo) - 1350 PFU*
Danish: En dosis (0,5 ml) indeholder: Varicellavirus (zoster vivo) - 1.350 PFU*
English: Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104.4 CCID50
Danish: Levende, svækket fåresygevirus (RIT 4385 stamme fra Jeryl Lynn stamme) - ikke mindre end 104,4 CCID50
English: Priorix-Tetra lag one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10
Danish: Priorix-Tetra lag En dosis (0,5 ml) indeholder: Levende, svækket mæslingevirus (Schwarzstamme) - ikke mindre end 103,0 CCID50
English: Powder for suspension for injection
Danish: Pulver for injection, suspension
English: Measles, mumps, rubella and varicella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Danish: Mæslinge, fåresyge, røde hunde og skoldkoppe-vacciner (levende) med markedsføringstilladelse i den europæiske union Medlemsstat
English: CCID50 of the measles virus Enders-Edmonston strain, not less than 12500 CCID50 of the mumps virus (Jeryl Lynn strain); and not less than 10 CCID50of the Wistar RA 27/3 rubella virus strains
Danish: En dosis (0,5 ml) indeholder: ikke mindre end 103,0 CCID50 mæslingevirus Enders-Edmonston-stamme, ikke mindre end 12.500 CCID50 fåresygevirus (Jeryl Lynn-stamme); og ikke mindre end 103,0 CCID50 Wistar RA 27/3 røde hundevirusstamme
English: Live attenuated varicella-zoster virus (Oka strain) 103.3 PFU*
Danish: Levende, svækket varicella-zostervirus (Okastamme) 103,3 PFU*
English: Measles virus Schwartz strain (live, attenuated) - not less than 10
Danish: Mæslingevirus Schwartz-stamme (levende, svækket) - ikke mindre end
English: The Netherlands GlaxoSmithKline B.V Huis ter Heideweg 62
Danish: GlaxoSmithKline B.V Huis ter Heideweg 62 3705 LZ ZEIST The Netherlands
English: one dose (0.5 ml) contains: Rubella virus live attenuated (Strain Wistar RA 27/3M) - not less than 10 TCID50
Danish: En dosis (0,5 ml) indeholder: Røde hundevirus levende svækket (RA 27/3-stamme) - ikke mindre end 103,0 TCID50
English: Czech Republic GlaxoSmithKline, s.r.o.
Danish: GlaxoSmithKline, s.r.o.
English: Varicella, live attenuated (Oka/Merck strain) - 1350 PFU*
Danish: Varicella, levende, svækket (Oka/Merck stamme) - 1.350 PFU*