mhra spcmhra spc

This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . >> Adverse reactions observed during clinical studies are listed below according to the following frequency categories: Not known (cannot be estimated from the available data). /Font 31 0 R >> endobj /Rotate 0 The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Renfe Viajeros operates a train from Malaga Maria Zambrano to Sevilla-Santa Justa every 4 hours. The recommended dose is a single 500 mg intravenous infusion administered following dilution (see sections 4.4 and 6.6). Over 15 weeks of follow-up, patients treated with pembrolizumab had stable global health status/QoL, while those treated with investigator's choice chemotherapy had a decline in global health status/QoL. Disease subtypes were 81% nodular sclerosis, 11% mixed cellularity, 4% lymphocyte-rich and 2% lymphocyte-depleted. 0086 136 9073 4191. domogres@spcfloorings.net. Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib). Hypophysitis occurred in 52 (0.7%) patients, including Grade 2, 3 or 4 cases in 23 (0.3%), 24 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab. The median duration of the post-progression therapy was 2.8 months. *, Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract. In KEYNOTE-051, 161 paediatric patients (62 children aged 9 months to less than 12 years and 99 adolescents aged 12 years to 17 years) with advanced melanoma or PD-L1 positive advanced, relapsed, or refractory solid tumours or lymphoma were administered pembrolizumab 2 mg/kg bw every 3 weeks. , Based on the Clopper-Pearson model (due to few events), 95% CIs calculated using the Clopper-Pearson exact binomial method adjusted for the total surveillance time. Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm. Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded. Response was assessed in KEYNOTE-087 and KEYNOTE-013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at Week 12. This medicinal product has been authorised under a so-called conditional approval scheme. In 1 month and 6 month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs; however, many animals in these studies were not sexually mature. Efficacy in Adolescents 12 through 17 years of age. Immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab. This service replaces the previously separate MHRA websites, one of which hosted SPC and PILs, the other PARs. No patients experienced hepatic VOD. Table 18: Response to pembrolizumab 2 or 10 mg/kg bw every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010, * Hazard ratio (pembrolizumab compared to docetaxel) based on the stratified Cox proportional hazard model, Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-052, a multicentre, open-label study for the treatment of locally advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. At the time of the updated analysis, the DFS hazard ratio (95% CI) was 0.68 (0.52, 0.89) in the subgroup of patients with M0-intermediate-high risk of recurrence, 0.60 (0.33, 1.10) in the subgroup of patients with M0-high risk of recurrence, and 0.28 (0.12, 0.66) in the subgroup of patients with M1 NED. The Kaplan-Meier curve based on the final analysis for OS is shown in Figure 17. A total of 1,019 adult patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (n=514) or placebo (n=505), for up to one year until disease recurrence or unacceptable toxicity. An analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS 20 [pembrolizumab plus chemotherapy: n=126 (49%) vs. standard treatment: n=110 (43%) and pembrolizumab monotherapy: n=133 (52%) vs. standard treatment: n=122 (48%)] (see Table 28). The key secondary outcome measure was OS. Randomisation was stratified by prior ASCT (yes vs. no) and disease status after frontline therapy (primary refractory vs. relapse less than 12 months after completion vs. relapse 12 months or more after completion). /Contents 15 0 R No clinical data are available on the possible effects of pembrolizumab on fertility. A subset of 104 participants received a booster dose of Nuvaxovid approximately 6months after receiving Dose2 of the primary series. The most common adverse reactions (reported in at least 20% of paediatric patients) were pyrexia (33%), vomiting (30%), headache (26%), abdominal pain (22%), anaemia (21%), cough (21%) and constipation (20%). /ExtGState 32 0 R Baseline characteristics and demographics were generally comparable between the pembrolizumab and placebo arms. Consider the benefit of treatment with pembrolizumab versus the risk of possible GVHD in patients with a history of allogeneic HSCT. These results reflect enrolment that occurred during the time period when the B.1.351 (Beta) variant was circulating in South Africa. Assessment of tumour status was performed every 9 weeks. You can also use the A-Z list to find the active substance. No patients experienced hepatic VOD. Patients must have received first-line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with recurrence/progression 12 months following completion of therapy. You have accepted additional cookies. Email Address: Registration No: HWS6_Hb,GKBLg;Nmva~i?~>Fvq59>LDz1b'~: X.i5jNq].gS1 k$~yr;_6Z\!*'+0W0SY3FuHI43#}l|Q~pg$S)-HPWl8{{n/f:9 9c(|2(?f`o$8H,$4E<>sQQvAck2eShaEx:o`lP7r4kDqk2E9adV&! What does SPC stand for in Cardiology? Patients who tolerated axitinib 5 mg twice daily for 2 consecutive treatment cycles (i.e. The safety of Nuvaxovid in adolescents was evaluated in an interim analysis of the paediatric expansion portion of an ongoing Phase 3 multicentre, randomised, observer-blinded, placebo-controlled study (Study 2019nCoV-301). Mutation status: 25% BRAF V600E, 24% KRAS/NRAS. Patients received pembrolizumab 200 mg every 3 weeks (n=210; KEYNOTE-087) or 10 mg/kg bw every 2 weeks (n=31; KEYNOTE-013) until unacceptable toxicity or documented disease progression. Frequencies are defined as: 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); and not known (cannot be estimated from the available data). >> Disease characteristics were: 21% HPV positive and 95% had stage IV disease (stage IVa 21%, stage IVb 6%, and stage IVc 69%). Table 29: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 expression in KEYNOTE-048 (CPS 1 to < 20), Based on the stratified Cox proportional hazard model, Response: Best objective response as confirmed complete response or partial response, KEYNOTE-040: Controlled study in HNSCC patients previously treated with platinum-containing chemotherapy. At final analysis, a total of 57 NSCLC patients aged 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control). The 15-minute observation period following vaccination with the mRNA COVID-19 vaccines has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction (as outlined in the Greenbook advice This follows careful review of the safety data by the MHRA and advice from the governments independent Commission on Human Medicines. EIR Vinyl Flooring ZXE2001. The primary efficacy outcome measures were OS and PFS as assessed by the investigator according to RECIST 1.1 in squamous cell histology, CPS 10, and in all patients. /Length 29 0 R Patients in the placebo arm were offered pembrolizumab as a single agent at the time of disease progression. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. Patients with the following conditions were excluded from clinical studies: active CNS metastases; ECOG PS 2 (except for urothelial carcinoma and RCC); HIV infection, hepatitis B or hepatitis C infection; active systemic autoimmune disease; interstitial lung disease; prior pneumonitis requiring systemic corticosteroid therapy; a history of severe hypersensitivity to another monoclonal antibody; receiving immunosuppressive therapy and a history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for greater than 12 weeks. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Dont include personal or financial information like your National Insurance number or credit card details. Based on method by Miettinen and Nurminen, Among KEYNOTE-087 patients, the baseline characteristics were median age 35 years (9% age 65 or older); 54% male; 88% White; and 49% and 51% had an ECOG performance status 0 and 1, respectively. << /Type /Page PFS results were consistent across pre-specified subgroups, MSKCC prognostic groups and PD-L1 tumour expression status. Working together across Sussex. Use of pembrolizumab in combination with chemotherapy. Nuvaxovid is for intramuscular injection only, preferably into the deltoid muscle of the upper arm. << A subset of 105 participants (Safety Analysis Set) were randomiszed to receive a booster dose of Nuvaxovid approximately 6months after receiving Dose2 of the primary series and received at least 1 dose of study vaccine; 104 of the 105 participants received Nuvaxovid (Full Analysis Set). Information on the original Spikevax COVID-19 vaccine can found on a separate page (link below). Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN, Grade 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN, In case of liver metastasis with baseline Grade 2 elevation of AST or ALT, hepatitis with AST or ALT increases 50% and lasts 1 week, Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), Based on severity and type of reaction (Grade 2 or Grade 3). You have rejected additional cookies. Table 16 summarises key efficacy measures and Figures 13 and 14 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up of 14.3 months. Key secondary efficacy outcome measures included OS and ORR. Week 12 Maria Zambrano to Sevilla-Santa Justa every 4 hours occurred during the period! Followed ( see sections 4.4 and 6.6 ) received a booster dose of Nuvaxovid approximately 6months after Dose2... 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