soliris dosing for nmo

Administer Soliris ® (eculizumab) over 35 minutes at the recommended dosage regimen time points, or within 2 days of these time points. Dosing information for Soliris® (eculizumab). Patients were 19 to 75 years of age, and 91% were female. RECENT MAJOR CHANGES . About Neuromyelitis Optica. Neuromyelitis optica spectrum disorder (NMOSD) • Must be prescribed by or in consultation with a neurologist • Must have a diagnosis of neuromyelitis optica spectrum disorder • Must be anti-aquaporin-4 (AQP4) antibody positive Background: Neuromyelitis optica (NMO) is an autoimmune condition that predominantly causes severe optic neuritis and transverse myelitis. When does dosing adjustments need to be made? Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Studies evaluating the safety and efficacy of eculizumab for aHUS included a total of 25 pediatric patients (ages 2 months to 17 years). 1. Make sure any doctor who treats you knows that you've used Soliris. As body weight changes during the study, the participant's weight cohort and dose may change accordingly. We use cookies to give you the best online experience. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. There is no cure for neuromyelitis optica (NMO) at this time. Soliris is also used to treat myasthenia gravis in adults. In the Soliris PREVENT study of patients with anti-AQP4 antibody-positive NMOSD, Soliris was superior to placebo based on time to first adjudicated on-trial relapse (primary endpoint). BOSTON--(BUSINESS WIRE)--Aug. 27, 2019-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the European Commission (EC) has … Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s). Copyright © 2020, Alexion Pharmaceuticals, Inc. All rights reserved. This site is intended for healthcare professionals. Neuromyelitis optica spectrum disorder is a rare, relapsing, autoimmune, inflammatory disorder affecting the central nervous system (CNS). Soliris overview. If the infusion is slowed, the total infusion time should not exceed two hours in adults. Soliris is given as an infusion (drip) into a vein and the recommended dose depends on what it is used for, and for patients under 18 years of age, on their bodyweight. Select one or more newsletters to continue. Soliris® injection [prescribing information]. b Dosing schedule can occasionally vary by ±7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS), but the subsequent dose should be administered according to the original schedule. ... Soliris. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. -- Soliris ® Reduced the Risk of Adjudicated On-Trial Relapse by 94.2% Compared to Placebo (p < 0.0001) ---- Safety Profile Consistent with that Seen in Previous Studies and Real-World Use ---- Preparing for Regulatory Submissions in the US, European Union, and Japan---- Conference Call/Webcast Scheduled for Today, Monday, September 24, 2018 at 8:30 a.m. EDT-- ... NMO can be distinguished from multiple sclerosis on the basis of -- Soliris ® Reduced the Risk of Adjudicated On-Trial Relapse by 94.2% Compared to Placebo (p < 0.0001) ---- Safety Profile Consistent with that Seen in Previous Studies and Real-World Use ---- Preparing for Regulatory Submissions in the US, European Union, and Japan---- Conference Call/Webcast Scheduled for Today, Monday, September 24, 2018 at 8:30 a.m. EDT-- Provide two weeks of antibacterial drug prophylaxis to patients if Soliris must be initiated immediately and vaccines are administered less than two weeks before starting Soliris therapy. Soliris (eculizumab) is a drug indicated for the treatment of paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome (aHUS), generalised myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS [see Warnings and Precautions (5.2)]. o Soliris is dosed according to the US FDA labeled dosing for gMG: up to a maximum of 1200 mg every 2 weeks; and o Prescribed by, or in consultation with, a neurologist; and o Reauthorization will be for no more than 12 months. Dosing occurs in 2 phases. The admixture must not be heated in a microwave or with any heat source other than ambient air temperature. Usual Adult Dose of Soliris for Paroxysmal Nocturnal Hemoglobinuria: This briefing is based on information available at the time of research and a limited literature search. Dosing for patients with anti-AQP4 antibody-positive NMOSD consists of an induction phase followed by a maintenance phase.1. Historical relapse of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to the screening. Supplemental Soliris Dose With Each PE/PI Intervention. Because the likelihood of recurrence is greater than 90 percent and attacks are generally severe, ongoing treatment to suppress the immune system is considered necessary. By using our website, you agree to our use of cookies in accordance with our. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Outcome Measures. ... You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you are not vaccinated. Generic name: ECULIZUMAB 300mg in 30mLDosage form: injection, solution, concentrate. Administer the Soliris admixture by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients via gravity feed, a syringe-type pump, or an infusion pump. Dilute Soliris to a final admixture concentration of 5 mg/mL using the following steps: The final admixed Soliris 5 mg/mL infusion volume is 60 mL for 300 mg doses, 120 mL for 600 mg doses, 180 mL for 900 mg doses or 240 mL for 1200 mg doses (Table 3). Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. SOLIRIS ® (eculizumab) is the first and only approved medication for NMOSD in Europe-- 98% of adult anti-aquaporin-4 (AQP4) antibody-positive patients treated with SOLIRIS were relapse free compared to 63% receiving placebo at 48 weeks -. Prior to administration, the admixture should be allowed to adjust to room temperature [18°-25° C, 64°-77° F]. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. "Soliris provides the first FDA-approved treatment for neuromyelitis optica spectrum disorder, a debilitating disease that profoundly impacts patients' lives," said … Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Soliris® and Alexion® are registered trademarks and OneSource™ is a trademark of Alexion Pharmaceuticals, Inc. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. • 1200 mg for the fifth dose 1 week later, then • 1200 mg every 2 weeks thereafter. References 1. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Soliris ® (eculizumab) is the FIRST AND ONLY FDA-approved complement inhibitor indicated for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). It is not known if Soliris is safe and effective in children with PNH, gMG, or NMOSD. Indicated for neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. Complement Inhibitors (Soliris® & Ultomiris®) Page 2 of 10 UnitedHealthcare Oxford Clinical Policy Effective 11/01/2020 ©1996-2020, Oxford Health Plans, LLC Soliris and Ultomiris are unproven and not medically necessary for treatment of Shiga toxin E. colirelated hemolytic - Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS [see Warnings and Precautions (5.1)]. Reference 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. Extending the dosing interval of Soliris maintenance treatment from standard two weeks to three weeks may equally achieve therapeutic blood levels in most adults with atypical hemolytic uremic syndrome (aHUS), a study suggests.. Timing of Supplemental Soliris Dose. Please see Important Safety Information and full Prescribing Information, including Boxed WARNING, and Medication Guide. Initially, infusions are given weekly for 4 weeks, followed by a fifth dose 1 week later. Under the Soliris REMS, prescribers must enroll in the program. 1. At least two thirds of cases are associated with aquaporin-4 antibodies (AQP4-IgG) and complement-mediated damage to the central nervous system. The US Food and Drug Administration has approved eculizumab for the first treatment of adult patients with the rare autoimmune disease neuromyelitis optical spectrum disorder (NMOSD). 300 mg. ... Neuromyelitis Optica Spectrum Disorder. SOLIRIS is only available through a program called the SOLIRIS REMS. Doses 1-4: 900 mg IV qWeek for first 4 weeks, followed by. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS, If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician, If the infusion is slowed, the total infusion time should not exceed 2 hours, Monitor the patient for at least 1 hour following completion of the infusion for signs or symptoms of an infusion reaction, For adult patients with NMOSD, supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion, Patients who are not currently vaccinated against. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). In 2013, Soliris was granted ODD in both the U.S. and EU for the treatment of NMO. In Study ECU-NMO-301, 96 patients received Soliris at the recommended dosage regimen and 47 patients received placebo. SOLIRIS is a medicine that affects your immune system. Available for Android and iOS devices. Each vial contains 30 mL of 10 mg/mL sterile, preservative‐free solution. Posted: June 6, 2013. AQP4 antibody seropositive. It is not known if SOLIRIS … Transfer the recommended dose to an infusion bag. FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Most Recent Soliris Dose : Supplemental Soliris … Soliris is proven for the treatment … Table 2: Supplemental dose of Soliris after PE/PI Type of Intervention . Objectives: The objective of this study was to define a rituximab dosing strategy for NMO patients that achieves the lowest rate of relapses. Soliris-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant IST treatment. two (2) weeks prior to the administration of the first dose of Soliris 4. Neuromyelitis Optica Spectrum Disorder (NMOSD) Table 1: Dosing Recommendations in aHUS Patients Less Than 18 Years of Age, Table 2: Supplemental Dose of Soliris after PE/PI, Table 3: Preparation and Reconstitution of Soliris, We comply with the HONcode standard for trustworthy health information -, 300 mg per each plasmapheresis or plasma exchange session, Within 60 minutes after each plasmapheresis or plasma exchange, 600 mg per each plasmapheresis or plasma exchange session, 300 mg per infusion of fresh frozen plasma, 60 minutes prior to each infusion of fresh frozen plasma, 600 mg weekly for the first 4 weeks, followed by, 900 mg for the fifth dose 1 week later, then, 900 mg weekly for the first 4 weeks, followed by, 1200 mg for the fifth dose 1 week later, then. In a previous small, open-label study involving patients with AQP4-IgG–positive disease, eculizumab, a terminal complement i… 2.5 Dose Adjustment in Case of Plasmapheresis, Plasma Exchange, or Fresh Frozen Plasma Infusion For adult and pediatric patients with aHUS and adult patients with gMG, supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion (PE/PI) (Table 2). See Important Safety Information, including Boxed Warning, and full Prescribing Information. Boston, MA: Alexion Pharmaceuticals, Inc. Medically reviewed by Drugs.com. 1. Do not administer as an intravenous push or bolus injection. Indications and Usage (1.3) 10/2017 Dosage and Administration (2.4, 2.5) 10/2017 Dosage and Administration (2.5, 2.6, 2.7) 07/2018 For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: 900 mg weekly for the first 4 weeks, followed by; 1200 mg for the fifth dose 1 week later, then; 1200 mg every 2 weeks thereafter. Use caution when administering Soliris to patients with any systemic infection. For patients 18 years of age and older, Soliris therapy consists of: Administer Soliris at the recommended dosage regimen time points, or within two days of these time points [see Warnings and Precautions (5.4)]. You may need frequent medical tests for 8 to 12 weeks if you stop using this medicine for any reason. All fields are required. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The standard of care for an initial attack of NMO includes the following: Intravenous (into the vein) high-dose corticosteroids (methylprednisolone) Plasma Exchange (PLEX) if no improvement occurs with corticosteroids. The PNH dosing regimen for adult patients (≥18 years of age) consists of a 4-week initial phase followed by a maintenance phase: • Initial phase: 600 mg of Soliris administered via … Possible good news for patients with neuromyelitis optica (aka Devic’s syndrome) and for stock holders of Alexion Pharmaceuticals. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder. The dosing regimen will be based on the participant's body weight. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Diagnosis of NMO or NMOSD. Figure 2: Kaplan-Meier Survival Estimates for Time to First Adjudicated On-Trial Relapse in Study ECU-NMO-301 – Full Analysis Set Plasmapheresis or plasma exchange. Dosing regimen for adult patients with anti-AQP4 antibody-positive NMOSD 1. Table 9 displays the most common adverse events from Study ECU-NMO-301 that occurred in ≥ 5% of Soliris-treated patients and at a greater frequency than on placebo. Paroxysmal Nocturnal Hemoglobinuria (PNH) Recommended dosage of eculizumab … Neuromyelitis optica spectrum disorder (NMOSD) • 900mg weekly for first 4 weeks, followed by • 1200mg for the fifth dose 1 week later, then • 1200mg every 2 weeks thereafter. 2.4 Recommended Dosage Regimen – gMG and NMOSD For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: • 900 mg weekly for the first 4 weeks, followed by For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: For adult and pediatric patients with aHUS, and adult patients with gMG or NMOSD, supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion (PE/PI) (Table 2). For adults with anti-AQP4 antibody-positive Neuromyelitis Optica Spectrum Disorder. Soliris ® (eculizumab), a complement inhibitor, is the first and only medication approved by the FDA to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. 2.2 Recommended Dosage Regimen – PNH For patients 18 years of age and older, Soliris therapy consists of: • 600 mg weekly for the first 4 weeks, followed by • … Soliris For Treating NMO. With Soliris, A future with fewer relapses is possible. Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. Under the Soliris REMS , prescribers must enroll in the program (5.2). Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections. Get started with Soliris® treatment. • Maintenance phase: 900 mg of Soliris administered via a 25 – 45 minute (35 minutes ± 10 minutes) intravenous infusion for the fifth week, followed by 900 mg of Soliris administered via a 25 – 45 minute (35 minutes ± 10 minutes) intravenous infusion every 14 ± 2 days (see section 5.1). You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you are not vaccinated. Soliris is given weekly initially and then every two or three weeks. Last updated on Jan 29, 2021. 2.4 Recommended Dosage Regimen – gMG and NMOSD For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: • 900 mg weekly for the first 4 weeks, followed by If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Rituximab therapy has dramatically improved patient care, but standardized dosing regimens and guidelines are lacking. - New data published in NEJM confirm sustained three-year treatment effect - - Data will also be presented in Emerging Science session at American Academy of Neurology Annual Meeting - - SOLIRIS for NMOSD currently under regulatory review in the U.S., European Union and Japan; U.S. FDA Priority Review action date of June 28, 2019- BOSTON & PHILADELPHIA--(BUSINESS WIRE)--May 3, 2019-- … pyridostigmine, Mestinon, neostigmine, eculizumab, Ultomiris, satralizumab, ravulizumab, Enspryng, Prostigmin. Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion-related reaction. A relapsing disease course is common, especially in untreated patients. Supplemental dosing of Soliris is required in the setting of concomitant support with PE/PI (plasmapheresis or plasma exchange; or fresh frozen plasma infusion) (Table 2). Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. Soliris is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS) in adults and children who weigh at least 11 pounds (5 kilograms). Under the Soliris REMS, prescribers must enroll in the program. Please enter your information below to receive updates about anti-AQP4 antibody-positive NMOSD and Soliris. Soliris is also used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults. We use cookies to give you the best online experience. SOLIRIS prescription and dosage sizes information for physicians and healthcare professionals. Discard any unused portion left in a vial, as the product contains no preservatives. 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. Withdraw the required amount of Soliris from the vial into a sterile syringe. Important update: Information on COVID-19 from Alexion. If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. Importance A previous 2-year analysis of repeated rituximab treatment in patients with neuromyelitis optica (NMO) revealed significant improvements in relapse rates and disability. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Expanded Disability Status Scale score ≤ 7. Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. By checking this box and providing my information above, I am giving Alexion permission to contact me for marketing purposes or otherwise provide me with information about Alexion’s products, services, and programs or other topics of interest, and to conduct market research or surveys. Eculizumab (Soliris) for relapsing neuromyelitis optica spectrum disorders NIHR HSRIC ID: 6091 . Dosing Recommendations. Gently invert the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the product and diluent. Soliris® for NMOSD Patient Support. The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion. Admixed solutions of Soliris are stable for 24 h at 2°-8° C (36°-46° F) and at room temperature. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Eculizumab, sold under the brand name Soliris among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica.In people with PNH, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. The goal of PLEX is to lower the level of NMO-IgG in the blood. Dosing regimen consists of: 900 mg per dose, once weekly for the first 4 weeks, followed by; 1200 mg for the fifth dose 1 week later, followed by; 1200 mg per dose every 2 weeks afterwards; Q. Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord. The Guthy-Jackson Charitable Foundation. Three drugs have been approved by the US Food and Drug Administration (FDA) specifically for treatment of anti-AQP4 positive NMO: Soliris … We report the findings from the longest follow-up of rituximab treatment in NMO, which provide reassurance regarding the long-term efficacy and safety of rituximab in NMO. The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ... For acute attacks, the standard treatment is high-dose intravenous corticosteroids, ... Soliris overview. SOLIRIS® (eculizumab) Receives Approval in Japan for the Prevention of Relapse in Patients with Neuromyelitis Optica Spectrum Disorder ... (ECU-NMO-302), which is still underway. Risk of Discontinuation and Deviation from Recommended Dosing Schedule. Soliris is currently FDA approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS), and for adult patients with generalized myasthenia gravis (MG) who are … Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Dosing information. Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). The drug Soliris (eculizumab) may be a safe and effective treatment for that condition. If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early. Vaccinate patients according to current ACIP guidelines to reduce the risk of serious infection [see Warnings and Precautions (5.1 and 5.2)]. First NMO Treatment Approved ... Eculizumab (Soliris), an injectable drug, was approved for NMOSD adults who are anti-aquaporin-4 (AQP4) antibody positive, the agency announced. Please see Important Safety Information and full Prescribing Information, including Boxed Warning, ... Know and follow dosing schedule. Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. Soliris [package insert]. SOLIRIS is used to treat adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. 900 mg IV infusion every 7 days for the first 4 weeks, followed by a single dose of 1,200 mg IV infusion 7 days after the fourth dose, and then 1,200 mg IV infusion every 14 days. ... SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Highly elevated biological markers of cellular processes observed in patients with aHUS reinforce the chronic nature of aHUS. Dilute Soliris to a final concentration of 5 mg/mL by adding the appropriate amount (equal volume of diluent to drug volume) of 0.9% Sodium Chloride Injection, USP; 0.45% Sodium Chloride Injection, USP; 5% Dextrose in Water Injection, USP; or Ringer's Injection, USP to the infusion bag. See Important Safety Information, including Boxed Warning, and full Prescribing Information.

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