Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
Botulinum Toxin Type A (UNII: E211KPY694) (Botulinum Toxin Type A - UNII:E211KPY694)
Merz Pharmaceuticals, LLC
Botulinum Toxin Type A
Botulinum Toxin Type A 50 [USP'U]
INTRAMUSCULAR
PRESCRIPTION DRUG
XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. Upper Limb Spasticity in Adult Patients XEOMIN is indicated for the treatment of upper limb spasticity in adult patients. Upper Limb Spasticity in Pediatric Patients, Excluding Spasticity Caused by Cerebral Palsy XEOMIN is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. XEOMIN is indicated for the treatment of cervical dystonia in adult patients. XEOMIN is indicated for the treatment of blepharospasm in adult patients. XEOMIN is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. XEOMIN is contraindicated in patients with: - Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) and Description (11)] . - Infection at t
XEOMIN for injection is a sterile white to off-white lyophilized powder supplied in Type 1 borosilicate glass single-dose vials with tamper-proof aluminum seals and bromobutyl rubber closures that are not made with natural rubber latex in the following pack sizes: Upper Limb Spasticity and Cervical Dystonia Chronic Sialorrhea and Blepharospasm Glabellar Lines Unopened vials of XEOMIN should be stored at or below 25°C (77°F). Refrigeration of unopened vials is not required. Do not use after the expiration date on the vial. Reconstituted XEOMIN may be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours until time of use [see Dosage and Administration (2.7)].
Biologic Licensing Application
Merz Pharmaceuticals, LLC ---------- This Medication Guide has been approved by the U. S. Food and Drug Administration. Revised: 9/2023 MEDICATION GUIDE XEOMIN® (Zeo-min) (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use What is the most important information I should know about XEOMIN? XEOMIN may cause serious side effects that can be life-threatening. Call your doctor or get medical help right away if you have any of these problems after treatment with XEOMIN: • Problems with swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN. • People with certain breathing problems may need to use muscles in their neck to help them breathe. These people may be at greater risk for serious breathing problems with XEOMIN. • Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems. • Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: • loss of strength and muscle weakness all over the body • double vision • blurred vision and drooping eyelids • hoarseness or change or loss of voice • trouble saying words clearly • loss of bladder control • trouble breathing • trouble swallowing These symptoms can happen hours to weeks after you receive an injection of XEOMIN.. These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What should I avoid while rec Lesen Sie das vollständige Dokument
XEOMIN- INCOBOTULINUMTOXINA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION MERZ PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE XEOMIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XEOMIN. XEOMIN (INCOBOTULINUMTOXINA) FOR INJECTION, FOR INTRAMUSCULAR OR INTRAGLANDULAR USE INITIAL U.S. APPROVAL: 2010 WARNING: DISTANT SPREAD OF TOXIN EFFECT _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ THE EFFECTS OF XEOMIN AND ALL BOTULINUM TOXIN PRODUCTS MAY SPREAD FROM THE AREA OF INJECTION TO PRODUCE SYMPTOMS CONSISTENT WITH BOTULINUM TOXIN EFFECTS. THESE SYMPTOMS HAVE BEEN REPORTED HOURS TO WEEKS AFTER INJECTION. SWALLOWING AND BREATHING DIFFICULTIES CAN BE LIFE THREATENING AND THERE HAVE BEEN REPORTS OF DEATH. THE RISK OF SYMPTOMS IS PROBABLY GREATEST IN CHILDREN TREATED FOR SPASTICITY BUT SYMPTOMS CAN ALSO OCCUR IN ADULTS, PARTICULARLY IN THOSE PATIENTS WHO HAVE UNDERLYING CONDITIONS THAT WOULD PREDISPOSE THEM TO THESE SYMPTOMS. (5.1) RECENT MAJOR CHANGES Dosage and Administration (2.8) 9/2023 Warnings and Precautions (5.8) 9/2023 INDICATIONS AND USAGE XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older (1.1) Upper limb spasticity in adults (1.2) Upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy (1.2) Cervical dystonia in adults (1.3) Blepharospasm in adults (1.4) Temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity in adults (1.5) DOSAGE AND ADMINISTRATION Chronic Sialorrhea: Chronic Sialorrhea in Adults: the recommended total dose is 100 Units per treatment session consisting of 30 Units per parotid gland and 20 Units per submandibular gland, no sooner than every 16 weeks (2.2) Chronic Sialorrhea in Pediatric Patients: the recommended dose is based Lesen Sie das vollständige Dokument