PrSoliris ® (eculizumab). x��Z[o�6~���Gi�e�.� G�W�!u��>d]�X������x�DJ�H�)�Bu,��x.$כ��/w����l�9�>�}���>���~}s��������������NO�; ���J�����(8|�2���f ���l�>�s��ТҊ|Q��l�:`������u���I!�G� ���QRE#�cQ�TYD SOLIRIS prescription and dosage sizes information for physicians and healthcare professionals. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Summary Safety Review - SOLIRIS (eculizumab) and BEXSERO (Multicomponent Meningococcal B Vaccine [recombinant, adsorbed]) - Assessing the Potential Risk of Hemolysis and Low Hemoglobin in Patients Treated with Soliris and Vaccinated with Bexsero; Date modified: 2018-08 … PI documents can be found by searching this website or by using the PI search database in eBusiness Services. N Engl J Med. Usual Adult Dose of Soliris for Paroxysmal Nocturnal Hemoglobinuria: 600 mg IV every week for 4 weeks, followed by 900 mg IV at week 5, then 900 mg IV every 2 weeks Comments:-Administer this drug IV over 35 minutes in adults.-Administer this drug at the recommended time, or within 2 days of the recommended time. What the medication is used for. All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is … INCLUDING PATIENT MEDICATION INFORMATION. 2009; 360:542-4. http://www.ncbi.nlm.nih.gov/pubmed/19179328?dopt=AbstractPlus, 26. <> In clinical trials for PNH and atypical HUS, no patients experienced an infusion reaction which required discontinuation of Soliris. Streptococcus pneumonia, therefore, they should receive pneumococcal polysaccharide vaccine at least eight weeks after receiving Prevnar® 13. SOLIRIS net product sales were $976.7 million, compared to $791.9 million in the fourth quarter of 2017, representing a 23 percent increase. Product Monograph, originally provided to the Board in early February 2009, described the "usual dose" of Soliris for a PNH patient as "600 mg of Soliris every 7 days for the first 4 weeks", followed by "900 mg of Soliris for the fifth dose 7 days later", and then "900 mg of Soliris every 14 days thereafter. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out. Br J Haematol. US Food and Drug Administration. Where availablelinks to product information (PI) pdf documents are provided. B A dose of Men -C ACYW 135 received in grade 7 or later (i.e., minimum age of 11 years and 8 months) is considered a GlaxoSmithKline Inc. (2019, February 25) Bexsero® Multicomponent meningococcal B vaccine (recombinant, adsorbed). 2012; 27:2323-6. http://www.ncbi.nlm.nih.gov/pubmed/22890512?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=3491201&blobtype=pdf, 29. 3. Accessed 2007 Aug 15. De très nombreux exemples de phrases traduites contenant "is designed specifically for consumers" – Dictionnaire français-anglais et moteur de recherche de traductions françaises. Do not freeze. �ߟ���cH�Iw�;��M�J*iaʴ����f��L�-�*��!�6��g���������A}�7��n���;��V�^����__m.�^����g�RTd�9�6��9. %���� 1996; 348:573-77. http://www.ncbi.nlm.nih.gov/pubmed/8774569?dopt=AbstractPlus. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747). ), May be prescribed only by clinicians enrolled in the program.1 24 Clinicians must agree to counsel patients regarding risk of meningococcal infection, provide educational materials, and ensure patient compliance with meningococcal vaccination requirements.1 24, Additional information about the Soliris REMS program available at 888-765-4747.1. a The mean (SD) terminal elimination half-life and clearance of ravulizumab-cwvz in patients with PNH are 49.7 (8.9) days and 0.08 (0.022) L/day, respectively. In: Lee RG, Bithell TC, Foerster J et al, eds. Refer to the administration reference tables below for minimum infusion duration. 7. Discard any unused portion left in a vial, as the product contains no preservatives. 2.2 I keep seeing different years associated with the product monograph guidance and … 5. The diluted solution of Soliris should be administered by intravenous infusion over 25 – 45 minutes in adults and 1-4 hours in paediatric patients via gravity feed, a syringe-type pump, or an infusion pump. ECULIZUMAB (SOLIRIS ... • Within this relatively small RCT, there were no serious indications of harm beyond those already identified in the product monograph for eculizumab. Please consult the Product Monograph 1 for further information about the vaccine. Paris, France; 2013 Apr 29. pyridostigmine, Mestinon, neostigmine, Soliris, Ultomiris, satralizumab, ravulizumab, Enspryng, Prostigmin. Product Monograph – SOLIRIS®. … The manufacturer has updated the Canadian product monograph for Soliris to include the risk of hemolysis with vaccines against Neisseria meningitidis and recommendations on timing of vaccination to minimize this risk. The purpose of the pre-hearing conference was to allow parties to identify or circumscribe the issues related to the hearing and resolve any other issues that may facilitate the conduct of the hearing. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. You can also use the TGA's MedSearch appavailable for Apple and Android devices. PRODUCT MONOGRAPH. Do not freeze. If urgent treatment with eculizumab is necessary in an unvaccinated patient, administer meningococcal vaccine as soon as possible.1 Vaccination can reduce, but does not eliminate, risk of meningococcal infection; cases of meningococcal septicemia reported in patients treated with eculizumab despite immunization.1 6 10 36, Prophylactic use of antibiotics (e.g., penicillin) also has been employed and is recommended by some clinicians;1 27 29 31 35 however, benefits and risks of antibiotic prophylaxis not established.1, Monitor closely for early manifestations of meningococcal infection during therapy.1 (See Advice to Patients.) However, eculizumab has been associated with significant but rare harms in other populations, such as anemia, high blood pressure and infections, particularly meningococcal infections. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Brands: Soliris. See the Pneumococcal Polysaccharide Vaccine #07.290 and Pneumococcal Conjugate #07.291 Vaccine … Individuals prescribed eculizumab (Soliris®) are at increased risk of serious infections, especially with encapsulated bacteria, such as . Eculizumab . Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Blood. Currently, only final marketed product categories are included. 5 0 obj None . ), For injection, concentrate, for IV infusion only. Please consult the Product Monograph. Chemical Name: Disulfide with human-mouse monoclonal 5G.1.1 light chain anti-(human complement C5 α-chain) (human-mouse monoclonal 5G1.1 heavy chain) immunoglobulin dimer N Engl J Med. Half-life of eculizumab is 11.25-17.25 days. Cheshire, CT; 2007 Mar 16. 1995; 333:1253-8. http://www.ncbi.nlm.nih.gov/pubmed/7566002?dopt=AbstractPlus, 9. 2004; 350:552-59. http://www.ncbi.nlm.nih.gov/pubmed/14762182?dopt=AbstractPlus, 17. Chesire, CT; 2011 Sept. 22. PI documents can be found by searching this website or by using the PI search database in eBusiness Services. Review type 1 (RT1): New Drug Review Full review of new chemical or biologic agents . The Canadian Product Monograph of SOLIRIS has been updated to include this new safety information. Long-term eculizumab improves clinical outcomes in atypical hemolytic uremic syndrome. PNHSource website. Hillmen P, Young NS, Schubert J et al. 19. Accessed 2007 Jul 5. Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. KANUMA Product Monograph alexion.com. The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. Soliris 300 mg concentrate solution for injection summary of product characteristics. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Insufficient protection by Neisseria meningitidis vaccination alone during eculizumab therapy. Health Canada is committed to ensuring that such requests are justifiable and … �qp�i(-C�G`�Gj.4��=R _P0�����Z���f����p��쑌S���f�p�l�+����pnùGb�G(�t���Ԛ3�Ό�,��oc������7���;�3�v�t}����K:`�j PRODUCT MONOGRAPH. Hill A, Hillmen P, Richards SJ et al. ), Also increases risk of S. pneumoniae and Hib infections in children; administer appropriate vaccinations.1 (See Vaccinations under Dosage and Administration. ), Unvaccinated patients must receive an appropriate polyvalent meningococcal vaccine series at least 2 weeks prior to first dose of eculizumab and receive revaccination of booster doses thereafter according to current vaccination guidelines.1 5 6 (See Vaccinations under Dosage and Administration.) Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Administer the prepared solution immediately following preparation. http://www.ncbi.nlm.nih.gov/pubmed/24021908?dopt=AbstractPlus, 30. See https://www.accessdata.fda.gov/scripts/cder/rems/. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. 4. Member of the Executive Management Team for the Affiliate. REVIEW TYPE . IgG2/4 kappa immunoglobulin containing human framework (i.e., variable and constant regions) and murine complementarity-determining regions.1, Hemolysis in PNH results from a genetic deficiency of glycosylphosphatidylinositol (GPI)-linked complement inhibitor CD-59 on the surface of RBCs (PNH erythrocytes), which renders such erythrocytes sensitive to persistent terminal complement-mediated destruction.1 4 8 9 10 18 20, In patients with PNH, eculizumab prevents destruction of PNH erythrocytes that lack complement protection with CD-59 by binding specifically and with high affinity to complement protein C5, preventing activation of terminal complement components (cleavage to C5a and C5b and subsequent formation of C5b–C9 terminal complement complex).1 3 10 19, In patients with aHUS, an acquired or inherited defect in regulation of the alternative complement pathway results in uncontrolled terminal complement activation; this leads to platelet activation, endothelial cell damage, thrombotic microangiopathy, and damage to multiple organ systems (e.g., CNS, kidneys, heart, GI tract).1 22 31 Eculizumab blocks formation of terminal complement, thereby inhibiting complement-mediated thrombotic microangiopathy.1, Importance of patients fully understanding risks and benefits of therapy prior to initiation.1 21, Risk of serious meningococcal infections and other systemic infections (e.g., S. pneumoniae, Hib infections).1 21, Importance of immunization against meningococcal infections at least 2 weeks prior to initiation of therapy and revaccination or booster doses according to current guidelines while on therapy.1 6 21 Advise patients that vaccination may not prevent infection; importance of informing clinician immediately if manifestations of meningococcal infection (headache with nausea, vomiting, fever, stiff neck or back; temperature ≥39.4°C; fever with rash; confusion; severe muscle aches with flu-like symptoms; light sensitivity) develop.1 21, Advise parents/caregivers of children with aHUS that their child should be vaccinated against S. pneumoniae and Hib infections prior to initiation of therapy.1, Importance of informing patients with PNH that discontinuance of therapy may cause sudden hemolysis; importance of monitoring for hemolysis for at least 8 weeks following treatment discontinuance.1 21, Importance of informing patients with aHUS that discontinuance of therapy may result in a worsening of disease symptoms or problems related to thrombotic microangiopathy.1, Importance of patients carrying a patient safety card (describing symptoms requiring immediate medical attention) at all times during treatment and for 3 months following discontinuance of therapy because the risk of meningococcal infection may persist for weeks after the last dose is given.1 21, Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.1 21, Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1 21, Importance of informing patients of other important precautionary information.1 21 (See Cautions.). PRODUCT MONOGRAPH PrSOLIRIS ... As with all protein products, administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. It is designed for consumers and care givers. i����˔r,Vh*�b+CI2�&^��OK.�|A�y>��=65;�-��tݏ�H�X�LR��G �K�=���ۑ.�ҁ9E1�c��2��B�Rb�B����XG'��������*6�7x���2:����99l�t��Kܫ��U|7�%3�ib|�����Q Eculizumab in the treatment of atypical hemolytic uremic syndrome in infants. Alexion Pharmaceuticals, Inc. Soliris (eculizumab) medication guide. 2013; 13:819-20. http://www.ncbi.nlm.nih.gov/pubmed/23289494?dopt=AbstractPlus. Parker C, Omine M, Richards S et al. Bexsero Product Monograph ca.gsk.com. 2009; 360:544-6. http://www.ncbi.nlm.nih.gov/pubmed/19179329?dopt=AbstractPlus, 27. 3. ), Must dilute commercially available 10-mg/mL eculizumab concentrate for IV infusion prior to administration.1, Withdraw appropriate dose of eculizumab from vial, add to infusion bag, and dilute with 5% dextrose, 0.9% sodium chloride, 0.45% sodium chloride, or Ringer’s injection to provide a final concentration of 5 mg/mL.1 6 (See Table 1. Blood. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. The Canadian Product Monograph of SOLIRIS has been … Product Monograph Cytogam® CYTOMEGALOVIRUS IMMUNOGLOBULIN INTRAVENOUS (HUMAN) Liquid Formulation, Solvent Detergent Treated Passive Immunizing Agent Pharmaceutical Standard: Professed Manufactured by: CSL Behring AG Wankdorfstrasse 10 CH-3000 Berne 22 Switzerland For: Saol Therapeutics Research Limited Dublin, Ireland Lapeyraque AL, Malina M, Fremeaux-Bacchi V et al. ATC Class: L04AA25 stream �7j����-(�wO� �Z5��C ��%+J PNH Source. Indications for use of provincially funded vaccine. Manufacturer. The diluted solution of Soliris should be administered by intravenous infusion over 25 – 45 minutes (35 ... initiate Soliris treatment less than 2 weeks after receiving a tetravalent meningococcal vaccine must . 2012; 59:707-10. http://www.ncbi.nlm.nih.gov/pubmed/22196848?dopt=AbstractPlus, 31. Alberta Immunization Policy - Biological Products Pneumococcal PolysaccharidePNEUMOVAX® 23 August 10, 2015 Pneumococcal Vaccine, 23-valent Polysaccharide: PNEUMOVAX 23 Revision Date: August10, 2015 Please consult the Product Monograph 1 … *[R�u=Xwk7*�R���6�c��(�%�Miu8Jl!TZR���VB�������K ��s����Z�{�����t 5. 2 0 obj Refer to the administration reference tables below for minimum infusion duration. Infusion must be administered through a 0.2 or 0.22 micron filter. Available for Android and iOS devices. 5. 97 414). N Engl J Med. US Food and Drug Administration. The pre-hearing conference will resume in Ottawa on . Eculizumab for congenital atypical hemolytic-uremic syndrome. For more information, please visit the . Do not shake. Insights From the Use in Clinical Practice of Eculizumab in Adult Patients With Atypical Hemolytic Uremic Syndrome Affecting the Native Kidneys: An Analysis of 19 Cases. For instructions on dilution of the medicinal product before administration, see section 6.6. Meningococcal sepsis complicating eculizumab treatment despite prior vaccination. The product's dosage form is injection, solution, concentrate and is administered via intravenous form. 5. Compendium of Monographs - Guidance Document This document outlines and describes what a monograph is and how it can be used in a product application for natural health products sold in Canada. Struijk GH, Bouts AH, Rijkers GT et al. The product should be mixed gently. Notice - Product Monograph Implementation Plans [2020-01-13] Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products [2013-02-21] … © Copyright 2021, Selected Revisions May 27, 2019. 9th ed. You can enter the product name, licence details, sponsor details, active ingredient names or the ARTG number to get results. Anon. PRODUCT MONOGRAPH ANDRIOL (testosterone undecanoate capsules) 40 mg Androgen Merck Canada Inc. You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country.
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