Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Botulinum toxin type A
Allergan Ltd
M03AX01
Botulinum toxin type A
50unit
Powder for solution for injection
Intramuscular
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 04090300; GTIN: 4024787430498
VISTABEL, 4 Allergan Units/0.1 ml, Powder for solution for injection FR/H/0230/001/WS/082 Allergan confidential PACKAGE LEAFLET: INFORMATION FOR THE USER VISTABEL, 4 ALLERGAN UNITS/0.1ML, POWDER FOR SOLUTION FOR INJECTION Botulinum toxin type A READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. _ _ Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What VISTABEL is and what it is used for 2. What you need to know before you use VISTABEL 3. How to use VISTABEL 4. Possible side effects 5. How to store VISTABEL 6. Contents of the pack and other information 1 WHAT VISTABEL IS AND WHAT IT IS USED FOR VISTABEL is a peripherally acting muscle relaxant. VISTABEL acts by blocking the nervous impulses directed towards all the muscles in which it has been injected. This prevents muscles from contracting, leading to a temporary and reversible paralysis. VISTABEL is used for the temporary improvement in the appearance of: vertical lines between the eyebrows seen at maximum frown and/or, fan-shaped lines from the corner of the eyes seen at maximum smile and/or, forehead lines seen at maximum raised eyebrows, when the severity of the facial lines has an important psychological impact in adult patients. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE VISTABEL DO NOT USE VISTABEL: If you are allergic (hypersensitive) to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6); If you are diagnosed with myasthenia gravis or Eaton Lambert Syndrome (chronic diseases affecting the muscles); If you have infection at the Citiți documentul complet
OBJECT 1 VISTABEL Summary of Product Characteristics Updated 29-Jan-2018 | Allergan Ltd 1. Name of the medicinal product VISTABEL, 4 Allergan Units/0.1 ml, Powder for solution for injection 2. Qualitative and quantitative composition Botulinum toxin type A 1 …………………4 Allergan Units per 0.1 ml of reconstituted solution. 1 of _Clostridium botulinum_ Allergan Units are not interchangeable with other preparations of botulinum toxin. Vial of 50 units. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for injection. White Powder 4. Clinical particulars 4.1 Therapeutic indications VISTABEL is indicated for the temporary improvement in the appearance of: • moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) and/or, • moderate to severe lateral canthal lines (crow's feet lines) seen at maximum smile and/or, • moderate to severe forehead lines seen at maximum eyebrow elevation, when the severity of the facial lines has an important psychological impact in adult patients. 4.2 Posology and method of administration _Posology _ Refer to specific recommendations for each indication described below. Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Allergan Units are different from other botulinum toxin preparations. _Elderly patients _ There is limited phase 3 clinical data with VISTABEL in patients older than 65 years (see section 5.1). No specific dose adjustment is required for use in the elderly. _Paediatric population _ The safety and effectiveness of VISTABEL in the treatment of glabellar lines seen at maximum frown, crow's feet lines seen at maximum smile, or forehead lines seen at maximum eyebrow elevation in individuals under 18 years of age have not been demonstrated. The use of VISTABEL is not recommended in individuals under 18 years (see section 4.4). _Method of Administration _ VISTABEL should only be administered by physicians with appropriate qualifications and exp Citiți documentul complet