Foscavir product insert. 3 DOSAGE FORMS AND STRENGTHS Nov 2, 2023 · FOSCAVIR is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium. Qualitative and quantitative composition Foscarnet trisodium hexahydrate 24 mg/ml. FOSCAVIR dosing must be individualized according to the patient's renal function status. See section 4. Foscavir is usually given for 2 to 3 weeks. Safety Data Sheet. Each milliliter of foscarnet sodium injection contains 24 mg of foscarnet sodium hexahydrate in water for injection, USP. Package insert / product label Generic name: foscarnet sodium Dosage form: injection, solution Drug class: Miscellaneous antivirals J Code (medical billing code): J1455 (Per 1,000 mg, injection) PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrVocarvi™ Foscarnet Sodium Injection, Mfr. Hydrochloric acid may have been added to adjust the pH of the solution to valganciclovir, foscarnet, or cidofovir as dosed by the investigator (N=116) for up to 8-weeks following a diagnosis of CMV infection/disease refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, foscarnet or cidofovir. S Physician Prescribing information. Foscavir is the brand name for foscarnet sodium. But valganciclovir (Valcyte) is a first-choice treatment option because it has a lower risk of serious side effects compared to foscarnet (Foscavir). Jul 24, 2024 · Foscarnet Description. Foscarnet should also be avoided in patients on a controlled sodium diet. Including product inserts can: Elevate the unboxing experience for customers. Reduced susceptibility to cidofovir, however, has been reported for DNA polymerase mutants of CMV which are resistant to ganciclovir 6–9 . Foscarnet sodium is a white, crystalline powder containing 6 equivalents of water of hydration with an empirical formula of Na 3 CO 5 P•6 H 2 O and a molecular weight of 300. Rukobia 600 mg prolonged -release tablets . Seizures, related to alteration in plasma minerals and electrolytes, have been associated with foscarnet treatment. D. Name of the medicinal product Foscavir 24 mg/ml Solution for Infusion 2. FOSCAVIR® (foscarnet sodium injection) medication page for healthcare professionals to search for scientific information on Pfizer medications. FOSCAVIR® 24MG/ML SOLUTION FOR INFUSION: foscarnet sodium: View document: View document: GABAPENTIN COLONIS 50MG/ML ORAL SOLUTION: gabapentin: View document: GLYCOPYRRONIUM BROMIDE 1MG/5ML ORAL SOLUTION: glycopyrronium bromide: View document: ILOPROST 100MCG/ML CONCENTRATE FOR SOLUTION FOR INFUSION: iloprost trometamol: View document 39 All doses in this insert are specified in terms of ganciclovir. 3022 pH Adjusted to pH 7. Foscavir is also indicated for the treatment of mucocutaneous Herpes Simplex Virus (HSV) infections, clinically unresponsive to aciclovir in immunocompromised patients. Lake Zurich Nov 2, 2023 · More about Foscavir (foscarnet) Check interactions; Compare alternatives; Pricing & coupons; Side effects; During pregnancy; Generic availability; Drug class: miscellaneous antivirals; En español; Patient resources. are UL97 gene product (phosphokinase) mutants and remain susceptible to cidofovir5. The chemical name of foscarnet sodium is phosphonoformic acid, trisodium salt. Foscarnet (phosphonomethanoic acid), known by its brand name Foscavir, is an antiviral medication which is primarily used to treat viral infections involving the Herpesviridae family. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Treatment of Nov 2, 2023 · It is recommended that 750–1000 mL of normal saline or 5% dextrose solution should be given prior to the first infusion of FOSCAVIR to establish diuresis. Std. Foscarnet sodium hexahydrate 24 mg/ml. Please note that for Tocris products, the product insert information is found underneath the certificate of analysis information (page two). Each milliliter of FOSCAVIR contains 24 mg of foscarnet sodium hexahydrate in Water for Injection, USP. The foscarnet terminal half-life determined by urinary excretion was 87. 2770 Portland Dr. Jun 9, 2021 · Foscarnet Sodium Injection is a sterile, isotonic aqueous solution for intravenous administration only. 8 hours, possibly due to release of foscarnet from bone. ODEFSEY is a 3-drug fixed dose combination product containing 200 mg of emtricitabine (FTC), 25 mg of rilpivirine (RPV), and 25 mg of tenofovir alafenamide (TAF). Precautions. 6 Preparation and Administration Gemcitabine Injection is a cytotoxic drug. 382. Warning: For Patients treate d A with gentamicin sulfate an d other s should be close clinica l observation because Must of th e potential This container closure is not made Se e Warnings and Precautions i n the insert Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Enter your product catalog number below to find the corresponding product insert. Foscarnet Sodium Injection is a sterile, isotonic aqueous solution for intravenous administration only. Discount & Promotional Cards: Offers, discounts, or promotions for other products. Since renal function impairment may occur at any time during Foscavir administration, serum creatinine should be monitored every second day during induction therapy and once weekly during maintenance therapy and appropriate dose adjustments should be performed according to renal function. NAME OF THE MEDICINAL PRODUCT. Jul 19, 2024 · Foscarnet sodium injection is a sterile, isotonic aqueous, clear, colorless solution for intravenous administration only. 2 Administration The goal of treatment is optimization of perfusion to critical organs, but aggressive treatment can compromise perfusion of organs, like the gastrointestinal tract, whose function is difficult to Products Regulation (February 11, 2015). Healthcare professionals are asked to report any suspected adverse reactions. NAGLAZYME must not be infused with other products in the infusion tubing. Oakville, ON L6H 6R4 Date of Initial Approval: October 5, 2020 Submission Control No: 233046 form stable coordination compounds. This medicinal product is subject to additional monitoring. Follow your doctor's dosing instructions very carefully. With subsequent infusions, 750–1000 mL of hydration fluid should be given with 90–120 mg/kg of FOSCAVIR, and 500 mL with 40–60 mg/kg of FOSCAVIR. 0 SECTION 1 01/18/2021 EN (English US) 1/8 : IDENTIFICATION 1. If you can't find the document you are looking for, please contact technical support. Hydrochloric acid may have been added to adjust the pH of the solution to Products Foscarnet sodium is available as a 24-mg/mL solution of the drug (as the hexahydrate) in water for injection in 250-mL (6 g of foscarnet sodium hexahydrate) glass bottles. S. List your product on form stable coordination compounds. 40 VIROLOGY 41 Mechanism of Action 42 Ganciclovir is an acyclic nucleoside analogue of 2'-deoxyguanosine that inhibits replication 43 of herpes viruses. Do not start, stop, or change the dose of any drug without checking with your doctor. Access Bio-Rad's My eInserts app for Siemens Dimension Vista 2D barcodes and customize your QC data analysis. Do not administer in the same intravenous line concomitantly with other medicinal products. 04. 4 mL/min/kg), FOSCAVIR should be discontinued, the patient hydrated, and monitored daily until resolution of renal impairment is ensured. Oct 31, 2007 · TABLE 4 Pharmacokinetic Parameters (mean ± S. The compatibility of NAGLAZYME in solution with other products has not been evaluated. To help keep the amount constant, foscarnet must be given on a regular schedule. FOSCAVIR INJECTION is a sterile, isotonic aqueous solution for intravenous administration only. *Availability information on the site has been updated to match the current information from the availability report. 2. Apr 24, 2021 · Foscarnet sodium Injection is a sterile, isotonic aqueous solution for intravenous administration only. Treatment of gastrointestinal tract infection caused by CMV in HIV patients. FOSCAVIR is an organic analogue of inorganic pyrophosphate that inhibits replication of herpesviruses in vitro including cytomegalovirus (CMV) and herpes simplex virus types 1 and 2 (HSV-1 and FOSCAVIR® (foscarnet sodium) This product information is intended only for residents of the United States. Each milliliter of foscarnet sodium Injection contains 24 mg of foscarnet sodium hexahydrate in Water for Injection, USP. Hydrochloric acid may have been added to adjust the pH of the solution to 7. sterimaxinc. Medical Information Page - patient information, ways to contact Pfizer Medical & other resources. . Polyethylene glycol as a solvent for diazepam: bioavailability and clinical effects after intramuscular administration, comparison of oral, intramuscular and rectal administration, and precipitation from intravenous solutions. 2. Hydrochloric acid may have been added to adjust the pH of the solution to FOSCAVIR has the potential to chelate divalent metal ions, such as calcium and magnesium, to form stable coordination compounds. Jan 1, 2021 · "Foscarnet Sodium" published on Jan 2021 by ASHP. Intended Use of the Product Use Of The Substance/Mixture: Pharmaceutical. J1455 is a valid 2024 HCPCS code for Injection, foscarnet sodium, per 1000 mg or just “Foscarnet sodium injection” for short, used in Medical care. Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit. Also, this medicine works best when there is a constant amount in the blood. medscape. Ganciclovir has been shown to be active against cytomegalovirus (CMV) insert. Kortilla K, Sothman A. Dose Adjustment. Treatment and prophylaxis of retinitis caused by CMV in HIV patients. 3022 Sodium Content Foscarnet sodium contains 5. renal impairment is the major toxicity of foscarnet sodium injection. 5 ± 41. Therapeutical action: Antiviral for systemic use Indications: Treatments of patients with transplant of hematopoietic mother cells or solid organs, when the first line treatment is not possible. 5 mg) of sodium per mL), avoid foscarnet use when intravenous infusion of a large amount of sodium or water may not be tolerated (e. Solution, 24 mg/mL, Intravenous Antiviral Agent SteriMax Inc. Foscavir prescribing information; Foscarnet (AHFS Sep 24, 2023 · Both foscarnet (Foscavir) and valganciclovir (Valcyte) are antiviral medications used to treat CMV eye infection in people with AIDs. Frequent monitoring of serum creatinine, with dose adjustment for changes in renal function, and adequate hydration with administration of foscarnet is imperative. Foscarnet should be administered at a dose of 40 mg/kg, over one hour, every 8 hours, in patients with normal renal function (see dosing chart below). During FOSCAVIR therapy if creatinine clearance falls below the limits of the dosing nomograms (0. The solution is clear and colorless. The infusion time should not be shorter than 1 hour. While using Foscavir, your kidney function and electrolytes (potassium, sodium, magnesium, phosphorus) will need to be tested often, and you may also need regular eye exams. WARNINGS Renal Impairment THE MAJOR TOXICITY OF FOSCAVIR IS RENAL IMPAIRMENT (see ADVERSE REACTIONS section). Inclusion or absence of a drug label link on the Clinicalinfo site does not imply endorsement or lack thereof by Clinicalinfo. See full list on reference. Each milliliter of Foscarnet Sodium Injection contains 24 mg of foscarnet sodium hexahydrate in Water for Injection, USP. com Foscavir is indicated for induction and maintenance therapy of cytomegalovirus (CMV) retinitis in patients with AIDS. 1 Exercise caution and wear gloves when preparing Gemcitabine Injection solutions. Follow applicable special handling and disposal procedures. 0 For men, consider administering a LHRH agonist according to current clinical practice standards. The recommended dosage of ODEFSEY is one tablet taken orally once daily with a meal in the following patient population: adults and in pediatric patients 12 years Before using foscarnet, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. KEY POINTS Foscarnet (Foscavir) is an antiviral medication with activity versus cytomegalovirus (CMV) and acyclovir-resistance herpes simplex virus (HSV) Requires dose-adjustment for kidney function Beware it’s many toxicities, including nephrotoxicity, dental effects, electrolyte imbalances, hematologic effects (e. Nov 26, 2023 · Foscavir Prescribing Information. Dec 12, 2022 · Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. The time taken for healing depends on the size of the initial lesion and foscarnet therapy should continue until complete re- Oct 31, 2007 · FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows: NDC 0186-1906-01500 mL bottles, cases of 12. 1. 6H 2 O and a molecular weight of 300. frequent monitoring of serum creatinine, with dose adjustment for changes in renal function, and adequate hydration with administration of foscarnet sodium injection is imperative. For bolus administration, store undiluted fluorouracil in the syringe for up to 4 hours at room temperature (25°C). The mean treatment durations (SD) for LIVTENCITY and Clinigen is a leading global exporter of foscarnet, available in different strengths and forms such as 24 mg/ml Solution for Infusion. Jun 9, 2021 · Foscarnet Sodium Injection has the potential to chelate divalent metal ions, such as calcium and magnesium, to form stable coordination compounds. 4. Date of Issue: 01/18/2021 Version: 1. 3022 Hydro-chloric acid may have been added to adjust the pH. Details. Mar 15, 2021 · Due to the sodium content of Foscarnet (240 micromoles (5. 1. Renal impairment is most likely to become clinically evident during the second week of induction therapy, but may occur at any For intravenous infusion (Foscavir®), manufacturer advises give intermittently in Glucose 5% or Sodium Chloride 0. Hydrochloric acid may have been added to adjust the pH of the solution to Sep 27, 2023 · Feedback Cards: You can ask for product feedback or reviews. , granulocytopenia), seizures and vascular irritation Electrolyte Oct 15, 2023 · Renal impairment is the major toxicity of foscarnet. Product Identifier Product Form: Mixture Product Name: Foscarnet Sodium Injection 1. com www. This product may contain inactive ingredients, which can cause allergic Sep 1, 2024 · To ensure the best response, foscarnet must be given for the full time of treatment. Mar 16, 2021 · Fresenius Kabi’s first-to-market generic version of Foscavir® (foscarnet sodium injection) is now available. Oct 31, 2007 · FOSCAVIR is an organic analogue of inorganic pyrophosphate that inhibits replication of herpesviruses in vitro including cytomegalovirus (CMV) and herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). Table 3: Recommended Dosage Modifications of TRUQAP for Adverse Reactions . 3. Parent Doc-ID: AZDoc0037512 Template Version Number: 1. FOSCAVIR INJECTION should be stored at controlled room temperature, 15 − 30°C (59 − 86°F), and should be protected from excessive heat (above 40°C) and from freezing. HCPCS Code Details - J1455 HCPCS Level II Code Drugs administered other than oral method, chemotherapy drugs Apr 21, 2021 · New Product Announcement For more information: 1-800-881-3550 customerservice@sterimaxinc. for Healthcare professionals: Foscavir (Clinigen manufactured) U. Each milliliter of FOSCAVIR contains 24 mg of foscarnet warning. Hydrochloric acid may have been added to adjust the pH of the solution to Foscavir should be used with caution in patients with reduced renal function. form stable coordination compounds. Product Insert. Oct 31, 2007 · Page 3: AstraZeneca LP: FOSCAVIR is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). product or waste material must be discarded and disposed of in accordance with local requirements. It is classified as a pyrophosphate analog DNA polymerase inhibitor . Combination therapy with FOSCAVIR and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug Feb 17, 2020 · Data from one randomized, open-label trial in patients with cancer who underwent allogeneic hematopoietic cell transplant (HCT) demonstrated similar efficacy between foscarnet and ganciclovir with up to 4 weeks of preemptive treatment of cytomegalovirus (CMV) infection and supports the use of foscarnet in this setting. g. 2 Administration The goal of treatment is optimization of perfusion to critical organs, but aggressive treatment can compromise perfusion of organs, like the gastrointestinal tract, whose function is difficult to Jul 6, 2018 · Summary of Product characteristics OBJECT 1 FOSCAVIR 24 MG/ML SOLUTION FOR INFUSION Summary of Product Characteristics Updated 05-Oct-2017 | Clinigen Healthcare Ltd 1. Also find the prescribing information, announcements, resources, and channels to connect with Pfizer Medical Information. Foscarnet sodium injection is indicated to treat cytomegalovirus (CMV) retinitis in FOSCAVIR® 24MG/ML SOLUTION FOR INFUSION: foscarnet sodium: View document: View document: GABAPENTIN COLONIS 50MG/ML ORAL SOLUTION: gabapentin: View document: GLYCOPYRRONIUM BROMIDE 1MG/5ML ORAL SOLUTION: glycopyrronium bromide: View document: ILOPROST 100MCG/ML CONCENTRATE FOR SOLUTION FOR INFUSION: iloprost trometamol: View document Several FDA-approved drug labels may be available for foscarnet sodium. with natural rubber latex. Nov 2, 2023 · In vitro studies have shown that 14 – 17% of foscarnet is protein bound at plasma drug concentrations of 1 – 1000 μM. com Oakville, Ontario L6H 6R4 v20210326 VOCARVI™ Foscarnet Sodium Injection Product Description Strength Fill Size Format Pack Size DIN GTIN STERIMAX Code CPDN Code VOCARVITM Foscarnet Sodium Injection Product Insert Lookup Tool. 5 mg of sodium per mL of Mar 11, 2024 · Injecting Foscavir too fast can cause dangerous or unwanted side effects. Clinicalinfo provides the following link to the DailyMed drug label solely as an example of the labels available for foscarnet sodium. for Consumers: FOSCAVIR - U. Instruction Manuals & Guides: Information on product use, care, and maintenance. Administer fluorouracil as an intravenous bolus through an established intravenous line. The structural formula is: 5 of 28 2. ) After a Single 60 mg/kg Dose of FOSCAVIR in 4 Groups * of Adults with Varying Degrees of Renal Function; Group 1 patients had normal renal function defined as a creatinine clearance (CrCl) of > 80 mL/min, Group 2 CrCl was 50-80 mL/min, Group 3 CrCl was 25-49 mL/min and Group 4 CrCl was 10 — 24 mL/min. This will allow quick identification of new safety information. 8 for how to report adverse reactions. Foscavir drug information; Foscavir (Advanced Reading) Professional resources. Not all brand names mentioned on our site are Pfizer products. Foscarnet sodium, USP is a white to almost white, crystalline powder containing 6 equivalents of water of hydration with an empirical formula of Na 3 CO 5 P. 9%; dilute to a concentration of 12 mg/mL for infusion into peripheral vein (undiluted solution via central venous line only); infuse over at least 1 hour (infuse doses greater than 60 mg/kg over 2 hours). It is very important that your doctor check your progress at regular visits. in patients with cardiomyopathy). Benefits of Using Inserts. olqsl fvrx anmlwd aeqrcn ayv atakwjy iclemav sutrejh cbezy eoxqa