natgillin/translations-raw huggingface dataset:
Denne procentdel var signifikant større end den procentdel, der blev observeret med insulin degludec (40,9%, oddsratio 2,28; p &lt; 0,0001), og tæt på den procentdel, som blev observeret med liraglutid (57,7%, oddsratio 1,13; p=0,3184).
The proportion was significantly larger than observed with insulin degludec (40.9%, odds ratio 2.28, p &lt; 0.0001) and similar to that observed with liraglutide (57.7%, odds ratio 1.13, p=0.3184).
I tre studier hos patienter, der var utilstrækkeligt kontrolleret på basalinsulin, blev det systoliske blodtryk reduceret med henholdsvis 5,4 mmHg for Xultophy og 1,7 mmHg for insulin degludec - en statistisk signifikant estimeret behandlingsforskel på -3,71 mmHg (p=0,0028), reduceret med 3,7 mmHg med Xultophy versus 0,2 mmHg med insulin glargin, - en statistisk signifikant estimeret behandlingsforskel på -3,57 mmHg (p=0,001) og reduceret med 4,5 mmHg med Xultophy versus 1,16 mmHg med insulin glargin U100 plus insulin aspart, med en statistisk signifikant anslået behandlingsforskel på -3,70 mmHg (p=0,0003).
In three trials with patients inadequately controlled on basal insulin, systolic blood pressure was reduced by 5.4 mmHg with Xultophy and 1.7 mmHg with insulin degludec, with a statistically significant estimated treatment difference of -3.71 mmHg (p=0.0028), reduced by 3.7 mmHg with Xultophy vs 0.2 mmHg with insulin glargine, with a statistically significant estimated treatment difference of -3.57 mmHg (p &lt; 0.001) and reduced by 4.5 mmHg with Xultophy vs 1.16 mmHg with insulin glargine U100 plus insulin aspart, with a statistically significant estimated treatment difference of -3.70 mmHg (p=0.0003).
I et 26 uges randomiseret, kontrolleret, åbent studie, hvor Xultophy blev anvendt som supplement til metformin alene eller i kombination med pioglitazon, medførte dette at 60,4% af de patienter, der blev behandlet med Xultophy, nåede et mål på HbA1c &lt; 7% uden bekræftede hypoglykæmiske episoder efter 26 ugers behandling.
Add-on to oral glucose-lowering medicinal products Adding Xultophy to metformin alone or in combination with pioglitazone in a 26-week randomised, controlled, open-label trial resulted in 60.4% of patients treated with Xultophy reaching a target of HbA1c &lt; 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.
Patienter (%), der når HbA1c &lt; 7% Alle patienter
Patients (%) achieving HbA1c &lt; 7% All patients
26% hos patienter med henholdsvis let (kreatinin-clearance, CrCl 50-80 ml/min), moderat (CrCl 3050 ml/min) og alvorlig (CrCl &lt; 30 ml/min) nedsat nyrefunktion samt dialysekrævende terminal nyreinsufficiens.
Liraglutide exposure was lowered by 33%, 14%, 27% and 26%, in patients with mild (creatinine clearance, CrCl 50-80 mL/min), moderate (CrCl 30-50 mL/min), and severe (CrCl &lt; 30 mL/min) renal impairment and in end-stage renal disease requiring dialysis, respectively.
A Endepunkter med bekræftet superioritet for Xultophy versus komparator B p &lt; 0,0001
A Endpoints with confirmed superiority of Xultophy vs comparator
Frekvens defineres som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), not known (cannot be estimated from the available data).
126, Kyprou &amp; 25th Martiou str., 164 52 Argyroupolis-Athen, Grækenland
126, Kyprou &amp; 25th Martiou str., 164 52 Argyroupolis-Athens, Greece
Til patienter i hæmodialyse og patienter med svært nedsat nyrefunktion (GFR &lt; 30 ml/min.)
For patients that require haemodialysis and in patients with severe renal impairment (GFR &lt; 30 ml/min), the dose should be reduced by 50%.
Storbritanien John Wyeth &amp; Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH Storbritanien
United Kingdom John Wyeth &amp; Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH United Kingdom
De mest almindeligt indberettede bivirkninger ( &gt; 1/10) fra kliniske undersøgelser var kvalme, mundtørhed, hovedpine og perspiration (incl.
The most commonly ( &gt; 1/10) reported adverse reactions in clinical studies were nausea, dry mouth, headache and sweating (including night sweats).
John Wyeth &amp; Brother Ltd trading as Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, Storbritanien
John Wyeth &amp; Brother Ltd trading as Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom
For antimikrobielle stoffer som paromomycin, hvis effekt er koncentrationsafhængig, er høje plasmaniveauer, hvad angår patogenets MIC (Cmax/MIC-ratio, også kaldet inhibitorisk kvotient (IQ)), en væsentlig determinant for klinisk effekt; en Cmax/MIC-ratio &gt; 8-10 foreslås for at opnå optimal effekt.
For antimicrobials like paromomycin, whose efficacy is concentration-dependent, high plasma concentration levels relative to the MIC of the pathogen (Cmax/MIC ratio, also known as the inhibitory quotient or IQ) are a major determinant of clinical efficacy; a Cmax/MIC ratio &gt; 8-10 is suggested to achieve optimal efficacy.
Hvad angår A. pleuropneumoniae, viser den farmakokinetiske/farmakodynamiske analyse baseret på den inhibitoriske kvotient (Cmax/MIC &gt; 8-10), at kun 10 % af målbakteriepopulationen vil være følsom over for paromomycin administreret i den anbefalede dosis.
Regarding A. pleuropneumoniae, the PK/PD analysis based on the inhibitory quotient (Cmax/MIC &gt; 8 to 10) shows that only 10% of the target bacterial population would be sensitive to paromomycin administered at the recommended posology.
Frekvensgrupperne er defineret ud fra følgende: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10) og ikke almindelig (≥1/1,000 til &lt; 1/100).
Frequency groups are defined by the following convention: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); and uncommon (≥1/1,000 to &lt; 1/100).
Effekten af Lonsurf på samlet overlevelse var ens hos patienter i alderen &lt; 65 år og ≥65 år.
Lonsurf on overall survival was similar in patients &lt; 65 years and ≥65 years of age.
Lonsurfs virkning og sikkerhed ved metastatisk kolorektal cancer blev sammenlignet mellem en højeksponerings-gruppe ( &gt; median) og en laveksponerings-gruppe (≤ median) baseret på median-AUC for trifluridin.
The efficacy and safety of Lonsurf in metastatic colorectal cancer was compared between a high exposure group ( &gt; median) and a low-exposure group (≤median) based on the median AUC value of trifluridine.
DCR (komplet respons, partielt respons eller stabil sygdom) var signifikant højere hos patienter, som blev behandlet med Lonsurf (44 % versus 16 %, p &lt; 0,0001).
The DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Lonsurf (44% vs 16%, p &lt; 0.0001).
ORR (komplet respons + partielt respons) var ikke signifikant højere hos patienter, som blev behandlet med Lonsurf (4,5 % versus 2,1 %, p-værdi = 0,2833), men DCR (komplet respons, partielt respons eller stabil sygdom) var signifikant højere hos patienter, som blev behandlet med Lonsurf (44,1 % versus 14,5 %, p &lt; 0,0001).
The ORR (complete response + partial response) was not significantly higher in patients treated with Lonsurf (4.5% vs 2.1 %, p-value = 0.2833) but the DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Lonsurf (44.1% vs 14.5%, p &lt; 0.0001).
OS- og PFS-fordelen blev observeret i alle relevante præspecificerede undergrupper, herunder race, geografisk område, alder ( &lt; 65; ≥ 65), køn, ECOG-PS, KRAS-status, tid siden diagnosticering af den første metastase, antal metastatiske steder og fokus for primær tumor.
The OS and PFS benefit was observed consistently, in all relevant pre-specified subgroups, including race, geographic region, age ( &lt; 65; ≥ 65), sex, ECOG PS, KRAS status, time since diagnosis of first metastasis, number of metastatic sites, and primary tumour site.
Lonsurf anbefales ikke til patienter med svært nedsat nyrefunktion (kreatininclearance [CrCl] &lt; 30 ml/min) eller terminal nyresygdom (som kræver dialyse), da Lonsurf ikke er undersøgt hos denne patientgruppe (se pkt.
Lonsurf is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance [CrCl] &lt; 30 mL/min or requiring dialysis, respectively), as Lonsurf has not been studied in these patients (see section 5.2).
Hos de 507 randomiserede patienter var medianalderen 63 år, 73 % var mænd, 70 % var hvide, 16 % var asiater og &lt; 1 % var sorte/afroamerikanere, og alle patienter havde ECOG PS på 0 eller 1 ved baseline.
Of the 507 randomised patients, the median age was 63 years, 73% were male, 70% were White, 16% were Asian, and &lt; 1% were Black/African American, and all patients had baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
OS- og PFT-fordelen blev konsekvent observeret i alle randomiserede strata og på tværs af de fleste præspecificerede undergrupper, herunder køn, alder ( &lt; 65; ≥ 65 år), etnisk oprindelse, ECOG PS, tidligere behandling med ramucirumab, tidligere behandling med irinotecan, antal af tidligere regimer (2; 3; ≥ 4), tidligere gastrektomi, fokus for primær tumor (gastrisk, gastroøsofageal overgang) og HER2-status.
The OS and PFS benefit was observed consistently, in all randomization strata and across most pre specified subgroups, including sex, age ( &lt; 65; ≥ 65 years), ethnic origin, ECOG PS, prior ramucirumab treatment, prior irinotecan treatment, number of prior regimens (2; 3; ≥ 4), previous gastrectomy, primary tumour site (gastric; gastroesophageal junction) and HER2 status.
&lt; 0,0001 (1-sidet og 2-sidet)
&lt; 0.0001 (1-sided and 2-sided)
Administration anbefales ikke til patienter med moderat eller svært nedsat leverfunktion ved baseline (National Cancer Institute [NCI] Criteria gruppe C og D, defineret ved total-bilirubin &gt; 1,5 × ULN), da der er observeret en højere forekomst af hyperbilirubinæmi grad 3 og 4 hos patienter med moderat nedsat leverfunktion ved baseline, selvom dette er baseret på meget begrænsede data (se pkt.
Administration is not recommended in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin &gt; 1.5 x ULN) as, a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see sections 4.4 and 5.2).
Lonsurf anbefales ikke til patienter med moderat eller svært nedsat leverfunktion ved baseline (National Cancer Institute [NCI] Criteria gruppe C og D, defineret ved total-bilirubin &gt; 1,5 × ULN), da der er observeret en højere forekomst af hyperbilirubinæmi grad 3 og 4 hos patienter med moderat nedsat leverfunktion ved baseline, selvom dette er baseret på meget begrænsede data (se pkt.
Lonsurf is not recommended for use in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin &gt; 1.5 x ULN), as a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see section 5.2).
PFS var signifikant bedre hos patienter, der fik Lonsurf plus BSC sammenlignet med placebo plus BSC (HR på 0,57; 95 % CI [0,47 til 0,70]; p &lt; 0,0001 (se tabel 7, Figur 3 og Figur 4).
PFS was significantly improved in patients receiving Lonsurf plus BSC compared to placebo plus BSC (HR of 0.57; 95% CI [0.47 to 0.70]; p &lt; 0.0001 (see Table 7, Figure 3 and Figure 4).
PFS var signifikant bedre hos patienter, der fik Lonsurf plus BSC (hazard ratio: 0,48; 95 % CI [0,41 til 0,57]; p &lt; 0,0001 (se tabel 6, figur 1 og figur 2).
PFS was significantly improved in patients receiving Lonsurf plus BSC (hazard ratio: 0.48; 95% CI [0.41 to 0.57]; p &lt; 0.0001 (see Table 6, Figure 1 and Figure 2).
Hazard ratio for progression eller død, 0,48 (95% CI, 0,41-0,57) P &lt; 0,0001 ved log-rank test
Hazard ratio for progression or death, 0.48 (95% CI, 0.41-0.57) P &lt; 0.0001 by log-rank test
Hazard ratio for progression eller død, 0,57 (95 % CI, 0,47-0,70) p &lt; 0,0001 (1-sidet og 2-sidet)
Hazard ratio for progression or death, 0.57 (95% CI, 0.47-0.70) P &lt; 0.0001 (1-sided and 2-sided)
Hazard ratio for død, 0,68 (95% CI, 0,58-0,81) P &lt; 0,0001
Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P &lt; 0.0001
En opdateret OS-analyse blev udført ved 89 % (N = 712) af hændelserne og bekræftede den klinisk relevante og statistisk signifikante overlevelsesfordel ved Lonsurf plus BSC sammenlignet med placebo plus BSC (hazard ratio: 0,69; 95 % CI [0,59 til 0,81]; p &lt; 0,0001) med en median OS på 7,2 måneder versus 5,2 måneder og en 1-årig overlevelsesrate på henholdsvis 27,1 % og 16,6 %.
An updated OS analysis, carried out at 89% (N = 712) of events, confirmed the clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.69; 95% CI [0.59 to 0.81]; p &lt; 0.0001) and a median OS of 7.2 months vs 5.2 months; with 1-year survival rates of 27.1% and 16.6%, respectively.
&lt; 75 x 10
&lt; 50 × 109/L
En OS-analyse af studiet blev gennemført som planlagt ved 72 % (N = 574) af hændelserne, og demonstrerede en klinisk relevant og statistisk signifikant overlevelsesfordel ved Lonsurf plus BSC sammenlignet med placebo plus BSC (hazard ratio: 0,68; 95 % konfidensinterval [CI] [0,58 til 0,81]; p &lt; 0,0001) med en median OS på henholdsvis 7,1 måneder versus 5,3 måneder og en 1-årig overlevelsesrate på henholdsvis 26,6 % og 17,6%.
An OS analysis of the study, carried out as planned at 72% (N = 574) of events, demonstrated a clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.68; 95% confidence interval [CI] [0.58 to 0.81]; p &lt; 0.0001) and a median OS of 7.1 months vs 5.3 months, respectively; with 1-year survival rates of 26.6% and 17.6%, respectively.
Behandling må ikke startes, hvis det absolutte neutrofiltal er &lt; 1,5 ×10
Treatment must not be started if the absolute neutrophil count is &lt; 1.5 ×109/L, if the platelet counts are &lt; 75× 109/L, or if the patient has an unresolved Grade 3 or 4 non-haematological clinically relevant toxicity from prior therapies.
InfektiÃ¸s enteritis Lungeinfektion Infektion i galdevejene Influenza
Biliary tract infection Influenza
• CTCAE* grad 4 neutropeni ( &lt; 0,5 x 10
• CTCAE* Grade 4 neutropenia ( &lt; 0.5 x 109/L) or thrombocytopenia ( &lt; 25 × 109/L) that results in more than 1 week's delay in start of next cycle
Behandling med Lonsurf plus BSC resulterede i en statistisk signifikant forlængelse af tiden med ECOG-PS &lt; 2 sammenlignet med placebo plus BSC. Mediantiden til PS ≥ 2 for Lonsurf-gruppen og placebo-gruppen var henholdsvis 5,7 måneder og 4,0 måneder med en hazard ratio på 0,66 (95 % CI: [0,56, 0,78]), p &lt; 0,0001.
The median time to PS ≥ 2 for the Lonsurf group and placebo group was 5.7 months and 4.0 months, respectively, with a hazard ratio of 0.66 (95% CI: [0.56, 0.78]), p &lt; 0.0001.
p-værdi &lt; 0,001.
p-value &lt; 0.001.
De observerede forskelle var &lt; 10% og hos størstedelen af forsøgspersonerne blev de uønskede hændelser rapporteret som værende let til moderat i intensitet (se pkt.
The differences observed were &lt; 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity (see section 4.5).
Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Merck Sharp &amp; Dohme Corp.
Name and address of the manufacturer(s) of the biological active substance(s) Merck Sharp &amp; Dohme Corp.
Et studie, der dokumenterede sikkerheden og immunogeniciteten af qHPV-vaccine blev udført med 126 hiv-inficerede forsøgspersoner på mellem 7 og 12 år med baseline CD4% ≥15 og mindst 3 måneder med højaktiv antiretroviral terapi (HAART) for forsøgspersoner med CD4% &lt; 25 (hvoraf 96 fik qHPV-vaccine).
A study documenting safety and immunogenicity of qHPV vaccine has been performed in 126 HIV infected subjects aged 7 to12 years with baseline CD4% ≥15 and at least 3 months of highly active antiretroviral therapy (HAART) for subjects with a CD4% &lt; 25 (of which 96 received qHPV vaccine).
Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Merck Sharp &amp; Dohme B.V.
Name and address of the manufacturer(s) responsible for batch release Merck Sharp &amp; Dohme B.V.
Storbritannien Brown &amp; Burk UK Limited
Brown &amp; Burk UK Limited
Irbesartan/Hydrochlorot hiazide Brown &amp; Burk 150mg/12.5mg Filmcoated tablets irbesartan/ hydrochlorothiazid
Irbesartan/Hydrochlorot hiazide Brown &amp; Burk 150mg/12.5mg Filmcoated tablets irbesartan/ hydrochlorothiazide
Irbesartan/Hydrochlorot hiazide Brown &amp; Burk 300mg/12.5mg Filmcoated tablets irbesartan/ hydrochlorothiazid
Irbesartan/Hydrochlorot hiazide Brown &amp; Burk 300mg/12.5mg Filmcoated tablets irbesartan/ hydrochlorothiazide
Irbesartan/Hydrochlorot hiazide Brown &amp; Burk 300mg/25mg Filmcoated tablets irbesartan/ hydrochlorothiazid
Irbesartan/Hydrochlorot hiazide Brown &amp; Burk 300mg/25mg Filmcoated tablets irbesartan/ hydrochlorothiazide
Infusioner bÃ¸r finde sted pÃ¥ en specialiseret krÃ¦ftafdeling.
Infusions should be carried out in a specialised cancer ward.
Vaccination skal udsættes under enhver sygdom med feber &gt; 38,5° C.
Vaccination should be postponed during any illness with fever &gt; 38.5°C.
Udbredt anvendelse af et vaccinationsprogram med 2 doser i USA og lande såsom Finland og Sverige har resulteret i en reduktion af incidensen på &gt; 99 % for hver af de 3 målsygdomme.
Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a &gt; 99% reduction in the incidence of each of the 3 targeted diseases.
[Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til &lt; 1/10), Ikke almindelig (≥ 1/1.000 til ≤ 1/100), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)]
Adverse reactions are ranked under headings of frequency using the following convention: [Very common (≥1/10); Common (≥1/100 to &lt; 1/10); Uncommon (≥1/1,000 to ≤1/100); Not known (cannot be estimated from the available data)]
Blandt disse børn blev de vaccinerelaterede bivirkninger, der er opsummeret under punkt b., observeret hos personer efter vaccination med M-MRVAXPRO (bortset fra enkeltstående indberetninger med en hyppighed &lt; 0,2 %).
Among these children, the vaccine-related adverse reactions, summarised in section b, were observed in individuals following vaccination with M-M-RVAXPRO (excluding isolated reports with frequency &lt; 0.2%).
I det fulde analysesæt (vaccinerede forsøgspersoner uanset deres antistof-titer ved baseline) sås høje serobeskyttelsesrater på &gt; 99 % over for parotitis og rubella efter dosis 2, uafhængigt af det vaccinerede barns alder ved første dosis.
In the Full Analysis Set (vaccinated subjects regardless of their antibody titre at baseline), high seroprotection rates of &gt; 99% were elicited to mumps and rubella post-dose 2, regardless of the age of the vaccinee at the first dose.
Svær humoral eller cellulær immundefekt (primær eller erhvervet), f.eks. svær kombineret immundefekt, agammaglobulinæmi og AIDS, eller symptomgivende hiv-infektion, eller en aldersspecifik CD4+ T-lymfocytprocent hos børn under 12 måneder: CD4+ &lt; 25 %; børn mellem 1235 måneder: CD4+ &lt; 20 %; børn mellem 36-59 måneder: CD4+ &lt; 15 % (se pkt.
Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ &lt; 25% %; children between 1235 months: CD4+ &lt; 20%; children between 36-59 months: CD4+ &lt; 15% (see section 4.4).
Virkningen af komponenterne i den tidligere formulering af mæslinge-, parotitis- og rubellavaccine fremstillet af Merck &amp; Co., Inc. blev fastslået i en serie dobbeltblinde kontrollerede forsøg i marken, som viste en høj grad af beskyttende virkning fremkaldt af de enkelte vaccinekomponenter.
The efficacy of the components of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. was established in a series of double-blind controlled field trials, which demonstrated a high degree of protective efficacy afforded by the individual vaccine components.
Tabel 1: Serobeskyttelsesrater over for mæslinger, parotitis og rubella 6 uger efter dosis 1 og 6 uger efter dosis 2 af den firevalente mæslinge-, parotitis-, rubella- og varicellavaccine fremstillet af Merck &amp; Co., Inc. - Fuldt analysesæt
Table 1: Seroprotection Rates to Measles, Mumps, and Rubella 6 Weeks Post-Dose 1 and 6 Weeks Post-Dose 2 of the quadrivalent measles, mumps, rubella and varicella vaccine manufactured by Merck &amp; Co., Inc. - Full Analysis Set
Kliniske undersøgelser af 284 tredobbelt seronegative børn i alderen 11 måneder til 7 år viste, at den tidligere formulering af mæslinge-, parotitis- og rubellavaccine fremstillet af Merck &amp; Co., Inc. er meget immunogen og sædvanligvis veltålt.
Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. is highly immunogenic and generally well tolerated.
Publicerede kliniske data støtter samtidig indgivelse af den tidligere formulering af mæslinge-, parotitis- og rubellavaccine fremstillet af Merck &amp; Co., Inc. og andre børnevaccinationer, herunder DTaP (eller DTwP), IPV (eller OPV), HIB (Haemophilus influenzae type b med Hepatitis B-vaccine) og VAR (varicella).
Published clinical data support concomitant administration of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. with other childhood vaccinations, including DTaP (or DTwP), IPV (or OPV), HIB (Haemophilus influenzae type b), HIB-HBV (Haemophilus influenzae type b with Hepatitis B vaccine), and VAR (varicella).
Vurdering af immunogenicitet hos børn i 9-12-måneders alderen ved indgivelse af første dosis En klinisk undersøgelse af 1.620 raske spædbørn blev gennemført med den firevalente mæslinge-, parotitis-, rubella- og varicellavaccine fremstillet af Merck &amp; Co., Inc..Vaccinen blev administreret i et 2-dosis-vaccinationsprogram givet med 3 måneders mellemrum til børn, der var mellem 9 og 12 måneder på tidspunktet for 1. dosis.
Evaluation of immunogenicity in children from 9 to 12 months of age at the time of first dose A clinical study was conducted with the quadrivalent measles, mumps, rubella and varicella vaccine manufactured by Merck &amp; Co., Inc., administered with a 2-dose schedule, the doses being given 3 months apart in 1,620 healthy subjects from 9 to 12 months of age at the time of first dose.
* Disse bivirkninger er indberettet i forbindelse med brug af M-M-RVAXPRO eller mæslinge-, fåresyge- eller røde hunde-vaccine fremstillet af Merck &amp; Co., Inc. eller vaccinens monovalente (enkelt)komponenter efter markedsføring og/eller under kliniske studier.
*These side effects were reported with the use of M-M-RVAXPRO or with the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc., or with its monovalent (single) components, during post-marketing use and/or during clinical studies.
Men da det er påvist, at M-M-RVAXPRO har samme sikkerheds- og immunogenicitetsprofil som den tidligere formulering af den kombinerede mæslinge-, parotitis- og rubellavaccine fremstillet af Merck &amp; Co., Inc., kan erfaring med denne vaccine tages i betragtning.
However, since M-M-RVAXPRO has been shown to have safety and immunogenicity profiles similar to the previous formulation of the combined measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc., experience with this vaccine can be considered.