Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
LISDEXAMFETAMINE DIMESYLATE
MEDISON PHARMA LTD
N06BA12
CAPSULES
LISDEXAMFETAMINE DIMESYLATE 70 MG
PER OS
Required
SHIRE PHARMACEUTICAL CONTRACTS LTD, UK
LISDEXAMFETAMINE
Vyvanse is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients ages 6 years and above.Vyvanse is indicated for the treatment of Moderate to Severe Binge Eating Disorder (BED) for patient over 18 years.Limitation of Use:Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established
2019-12-31
VYVANSE PIL-1122-V1 Vyvanse-PIL-ENG-D26-F PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only VYVANSE 30 MG CAPSULES VYVANSE 50 MG CAPSULES VYVANSE 70 MG CAPSULES ACTIVE INGREDIENT AND QUANTITY: Each capsule of Vyvanse 30 contains: lisdexamfetamine dimesylate 30 mg Each capsule of Vyvanse 50 contains: lisdexamfetamine dimesylate 50 mg Each capsule of Vyvanse 70 contains: lisdexamfetamine dimesylate 70 mg Inactive ingredients and allergens – See section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. The medicine is not intended for children under the age of 6 years who have ADHD or patients under 18 years old with binge eating disorder (BED). 1. WHAT IS THIS MEDICINE INTENDED FOR? Vyvanse is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Vyvanse can help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Vyvanse is intended for treating moderate to severe binge eating disorder. It may reduce the number of binge eating days in BED patients. Vyvanse is not intended for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity. Vyvanse is intended only for patients over the age of 6 years who have ADHD and for patients over the age of 18 years with BED. THERAPEUTIC GROUP: CNS stimulant. It is not known if Vyvanse is safe and effective in children with ADHD under 6 years old or in patients with BED under 18 years old. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You or your child is sensitive (allergic) to the active ingredient (lisdexamfetamine dime Прочитайте повний документ
PHYSICIAN’S PRESCRIBING INFORMATION NAME OF THE MEDICINAL PRODUCT Vyvanse 30 mg Vyvanse 50 mg Vyvanse 70 mg QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is Lisdexamfetamine Dismesylate. For the full list of excipients, see section "DESCRIPTION" below. PHARMACEUTICAL FORM Capsules 1 INDICATIONS AND USAGE Vyvanse is a central nervous system (CNS) stimulant indicated for: • the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients ages 6 years and above. • the treatment of Moderate to Severe Binge Eating Disorder (BED) for patients over 18 years. Limitation of Use: VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established _[see Warnings and _ _Precautions (5.2)]_ . 2 DOSAGE AND ADMINISTRATION 2.1 PRE-TREATMENT SCREENING Prior to treating patients with CNS stimulants, including VYVANSE, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) _[see Warnings and Precautions (5.2)]_ . _ _ To reduce the abuse of CNS stimulants including VYVANSE, assess the risk of abuse, prior to WARNING: ABUSE AND DEPENDENCE CNS STIMULANTS, INCLUDING VYVANSE, OTHER AMPHETAMINE-CONTAINING PRODUCTS, AND METHYLPHENIDATE, HAVE A HIGH POTENTIAL FOR ABUSE AND DEPENDENCE. ASSESS THE RISK OF ABUSE PRIOR TO PRESCRIBING AND MONITOR FOR SIGNS OF ABUSE AND DEPENDENCE WHILE ON THERAPY _[SEE _ _WARNINGS AND PRECAUTIONS (5.1), AND DRUG ABUSE AND DEPENDENCE (9.2, 9.3)]. _ prescribing. After prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for VYVANSE use _[see Warnings _ _and Precautions (5.1), Drug Abuse and Dependence (9.)]_ . 2.2 GENERAL INSTRUCTIONS FOR USE Take VYVANSE by mouth in the morning with or without food; avoi Прочитайте повний документ