Search results with tag "Summary of product characteristics"
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euSUMMARY OF PRODUCT CHARACTERISTICS . 2 1. NAME OF THE MEDICINAL PRODUCT ... Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed. 3 ... 1. NAME OF THE MEDICINAL PRODUCT Tecfidera 120 mg gastro-resistant hard capsules . Tecfidera 120 mg .
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euSUMMARY OF PRODUCT CHARACTERISTICS. 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THEMEDICINAL PRODUCT
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eudisease progression (see the Summary of Product Characteristics (SmPC) for posology of nivolumab). Treatment modification Management of suspected adverse drug reactions may require temporary treatment interruption and/or dose reduction of CABOMETYX therapy (see Table 1). When dose reduction is necessary in
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eu1 . ANNEX I. SUMMARY OF PRODUCT CHARACTERISTICS . 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eufructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euanti-epileptic agents (including levetiracetam. A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known. Therefore, patients should be monitored for signs of depression and/or suicidal ideation and
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eucurrent summary of product characteristics. The administration schedule must be carefully followed. If a planned dose of SARCLISA is missed, administer the dose as soon as possible and adjust the treatment schedule accordingly, maintaining the treatment interval. Dose adjustments No dose reduction of SARCLISA is recommended.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - …
www.ema.europa.euSpinraza is indicated for the treatment of 5q Spinal Muscular Atrophy. 4.2 Posology and method of administration Treatment with Spinraza should only be initiated by a physician with experience in the management of spinal muscular atrophy (SMA). The decision to treat should be based on an individualisedexpert evaluation of the expected benefits of
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euThe safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established. No data are available. b In case of delay, the booster should not be given later than 24 months of age. c See section 5.1. The need for and timing of further booster doses has not yet been determined. d See section 5.1.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euof delaying Soliris therapy outweighs the risks of developing a meningococcal infection. Patients who ... official guidance on the appropriate use of antibacterial agents. Cases of serious or fatal meningococcal infections have been reported in Soliris-treated patients. Sepsis is …
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euThis medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT. Spikevax dispersion for injection
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eu2 1. NAME OF THE MEDICINAL PRODUCT OPDIVO 10 mg/mL concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate for solution for infusion contains 10 mg of nivolumab.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euOsteonecrosis of the jaw Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials in patients receiving Zometa. Post-marketing experience and the literature suggest a greater frequency of reports of ONJ based on tumour type (advanced breast cancer, multiple m yeloma). A study showed that ONJ was
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eu4.1 Therapeutic indications Primary prevention of venous thromboembolic events (VTE)in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18years of age.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euThe safety and efficacy of Abilify Maintena in the treatment of schizophrenia in patients 65 years of age or older has not been established (see section 4.4). ... The safety and efficacy of Abilify Maintena in children and adolescents aged 0 to 17 years have not …
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euPatients with locally advanced or metastatic lung cancer should receive treatment until disease ... 30mL of liquid should be administeredas per the naso-gastric tube manufacturer’s instructions with ... incidence of ILD was 10.9% in patients of Japanese ethnicity, 1.6% in patients of Asian ethnicity and 2.5% in non-Asian patients (see section ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euMonitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors. Use of alternative methods to monitor glycaemic control is advised. Lactose The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euresistance-associated protein 2 (MRP2), breast cancer resistance protein (BCRP) and the organic anion transporting polypeptide 1B1 (OATP1B1). In vivo studies have shown that enzalutamide is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19. Coadministration of - enzalutamide (160 mg once daily) with single oral
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ec.europa.eu5 (n=15,185) or placebo (n=15,166) (NCT04470427). At the time of vaccination, the mean age of the population was 52 years (range 18-95); 22,831 (75.2%) of …
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eudamaging agents and radiotherapy. Some of the patients had a history of bone marrow dysplasia. If MDS and/or AML are confirmed while on treatment with Zejula, treatment should be discontinued and the patient treated appropriately. Hypertension, including hypertensive crisis
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euthe dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other concurrent therapy (see sections 4.4 under hepatocellular injury and 5.2).
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eudominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease (see section 5.1). ... Tolvaptan may cause adverse reactions related to water loss such as …
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euThe safety and efficacy buprenorphine in children and adolescents below 16 years of age have not been established (see section 4.4). No data are available. Method of administration Buvidal is intended for subcutaneous administration only. It should be injected slowly and completely
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euThe suspension is an opalescent, colourless to pale brownish liquid. 4. CLINICAL PARTICULARS . 4.1 Therapeutic indications Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in: ... As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy. ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euTreatment: The following weight -adjusted dosing regimens are recommended for treatment of infants and children 1 year of age or older: ... Haemodialysis patients 30 mg after each haemodialysis session Peritoneal dialysis patients* 30 mg (suspension or capsules) single dose
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euon hepatocytes. The potential for interactions with mepolizumab is therefore considered low. 4.6 Fertility, pregnancy and lactation. Pregnancy . There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eumyocardial infarctions in the Ofevgroup (1.6%) compared to the placebo group (0.5%), while adverse events reflecting ischaemic heart disease were balanced between the Ofev and placebo groups. In the INBUILD trial, myocardial infarction …
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euRINVOQ 30 mg prolonged-release tablets . Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 30 mg of upadacitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM. Prolonged-release tablet . RINVOQ 15 mg prolonged-release tablet s . Purple 14 x 8 mm, oblong biconvex prolonged- release tablets ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euHypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active severe infections (see section 4.4). 4.4 Special warnings and precautions for use : Traceability : In order to improve traceability of biological medicinal …
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - …
www.ema.europa.euconfirmed Stevens–Johnson syndrome (SJS) or Toxic epidermal necrolysis (TEN) Permanently discontinue Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, myasthenia gravis, myasthenic syndrome, Guillain-Barré syndrome) For any of the following: • Grade 2 or Grade3 clinical signs or
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eudacarbazine [D] [AVD]) is 1.2 mg/kg administered as an intravenous infusion over 30 minutes on days 1 and 15 of each 28-day cycle for 6 cycles (see section 5.1). Primary prophylaxis with growth factor support (G-CSF), beginning with the first dose, is
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eutreatment in patients when the ANC count is < 1,000/mm. 3. and/or the platelet count is < 50,000/mm. 3. G-CSF (or GM-CSF) may be given as concomitant therapy to support the blood count when the ANC count is < 1,000/mm. 3. in subsequent cycles. Hepatic Impairment Caelyx pegylated liposom al pharmacokinetics determined in a small number of ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euVerzenios is indicated for the treatment of women with hormone receptor (HR) -positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy , or in women who have received prior endocrine therapy.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eu14 weeks (i.e. after 4 doses), no additional treatment with infliximab should be given. Re-administration for Crohn’s disease and rheumatoid arthritis . If the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last infusion. In clinical studies, delayed hypersensitivity reactions have been ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eu- with uncontrolled or significant cardiac disease, including recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia. - taking antiarrhythmic medicinal products or other substances that are known to lead to QT prolongation (see section 4.5). - with hypokalaemia and/or hypomagnesaemia.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euPregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour haemodialysis treatment (see Table 1). > @ (m ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euindicated dose in the presence of normal renal function is 10mg twice daily. Patients with severe renal impairment should remain on a reduced dose even after haemodialysis (see section5.2). ... Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections .
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eudose-titration or more than 2 weeks after completing the dose-titration phase, TLS risk should be reassessed to determine if restarting at a reduced dose is necessary (e.g., all or some levels of the dose-titration; see Table 5). Acute Myeloid Leukaemia. The venetoclax daily dose-titration is 3 days with azacitidine or decitabine (see Table 2).
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.eu4 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euComprehensive instructions for administration are given in the package leaflet and the user manual. Doses less than 80 mg which require dose preparation should only be administered by a healthcare ... NSAIDs, sulfasalazine, or methotrexate. Cytochrome P450 substrates . Results from an interaction study in patients with moderate-to-severe ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euPatients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table1 (see section4.4). Patients with pre-existing severe neuropathy may be treated withVELCADE only after careful risk/benefit assessment. Table1: Recommended* posology modifications for bortezomib-related neuropathy
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euonce weekly. Benlysta should be used in combination with corticosteroids and mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance. The patient’s condition should be evaluated continuously. Missed doses . If a dose is missed, it should be administered as soon as possible.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euAnkylosing spondylitis 5mg/kg given as an intravenous infusion followed by additional 5mg/kg infusion doses at 2 and 6weeks after the first infusion, then every 6 to 8weeks. If a patient does not respond by 6weeks (i.e. after 2doses), no additional treatment with infliximab should be given. Psoriatic arthritis
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euplatelet count is achieved, normally around 50,000-75,000/µl. FBCs including platelet counts and peripheral blood smears should be obtained monthly thereafter. Dose reductions on the daily dose by 25 mg should be considered if platelet counts exceed the required target. It is recommended to wait for
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euanti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate (see sections 4.4, 4.5 and 5.1 for available data on different combinations). ... biologic and conventional disease- modifying antirheumatic drugs (DMARDs). If a patient develops herpes zoster, treatment should be temporarily interrupted until the ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euspecific viral inactivation and removal procedures. Excipients with known effects . Each 10 mL vial contains 2.3 mmol (52.6 mg) sodium. ... 4.1 Therapeutic indications ... practice guidelines. Paediatric population .
SUMMARY OF PRODUCT CHARACTERISTICS
assets.publishing.service.gov.ukSUMMARY OF PRODUCT CHARACTERISTICS This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT
SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euFor use in combination, see the Summary of Product Characteristics (SmPC) for the concomitant therapies. Patients should be treated with KEYTRUDA until disease progression or unacceptable toxicity (and up to maximum duration of therapy if specified for an indication). Atypical responses (i.e. an initial
SUMMARY OF PRODUCT CHARACTERISTICS - GOV.UK
assets.publishing.service.gov.ukSpikevax is indicated for active immunisation to prevent COVID-19 caused by ... and treat this condition. The risk of myocarditis after a third dose (0.5 mL, 100 micrograms) or booster ... products (e.g. paracetamol-containing products) may be used.
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