{"id":5818,"date":"2020-12-26T15:16:22","date_gmt":"2020-12-26T15:16:22","guid":{"rendered":"https:\/\/zeepedia.com\/?p=5818"},"modified":"2022-11-28T17:14:24","modified_gmt":"2022-11-28T17:14:24","slug":"azzalure","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/azzalure\/","title":{"rendered":"Azzalure &#8211; Botulinum Toxin Type A uses, Dose, And Side Effects"},"content":{"rendered":"\n<p><strong> Azzalure 125 units Speywood,\u00a0Powder for\u00a0Solution\u00a0for\u00a0Injection, Botulinum Toxin Type A<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Azzalure Is And Who Is Azzalure Suitable For<\/h2>\n\n\n\n<p>Azzalure contains a substance, botulinum toxin type A, which causes muscles to relax.&nbsp;Azzalure acts on the connection between nerves and muscles and prevents the&nbsp;release&nbsp;of a chemical messenger called&nbsp;acetylcholine&nbsp;from the nerve endings.&nbsp;This prevents the muscles from contracting.&nbsp;This muscle relaxation is temporary and gradually diminishes.<br><\/p>\n\n\n\n<p>Some people feel mentally ill when they get wrinkles on their faces.&nbsp;Azzalure can be used in adults under 65 years of age for temporary improvement of moderate to pronounced glabella folds (vertical wrinkles between the eyebrows) and wrinkles at the sides of the eyes (crow&#8217;s feet).<br><\/p>\n\n\n\n<p>Botulinum toxin type A contained in Azzalure may also be approved for the treatment of other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<br><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"281\" src=\"https:\/\/zeepedia.com\/wp-content\/uploads\/2022\/11\/Azzalure.jpg\" alt=\"Azzalure\" class=\"wp-image-36609\" srcset=\"https:\/\/zeepedia.com\/medical\/wp-content\/uploads\/2022\/11\/Azzalure.jpg 400w, https:\/\/zeepedia.com\/medical\/wp-content\/uploads\/2022\/11\/Azzalure-300x211.jpg 300w\" sizes=\"auto, (max-width: 400px) 100vw, 400px\" \/><figcaption>Azzalure<\/figcaption><\/figure><\/div>\n\n\n<h2 class=\"wp-block-heading\">2. What You Need To Know Before You Use Azzalure<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do Not Use Azzalure Syringe<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are allergic to&nbsp;<em>Clostridium&nbsp;botulinum&nbsp;<\/em>toxin&nbsp;type A or any of the other ingredients of <em>Azzalure syringe<\/em> (listed in section 6)<\/li><li>If you have an&nbsp;infection&nbsp;at the planned injection site<\/li><li>If you have&nbsp;myasthenia gravis, Eaton-Lambert&#8217;s syndrome, or amyotrophic lateral sclerosis (&nbsp;ALS&nbsp;).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings And Cautions<\/h2>\n\n\n\n<p>Tell your doctor before getting an&nbsp;injection&nbsp;of Azzalure:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you have any neuromuscular disorders<\/li><li>If you often have difficulty swallowing food (&nbsp;dysphagia&nbsp;)<\/li><li>If you think you often have problems with food or drink getting into the airways so that you have a <a href=\"https:\/\/zeepedia.com\/medical\/diseases\/cough-in-children\/\">cough<\/a> or choking attack<\/li><li>If you have inflammation&nbsp;at the planned injection site<\/li><li>If the muscles at the planned injection site are weak<\/li><li>If you suffer from a bleeding disorder that means you bleed longer than normal, such as&nbsp;hemophilia&nbsp;(a hereditary bleeding disorder caused by a lack of&nbsp;coagulation factor&nbsp;)<\/li><li>If you have had surgery on your face or are likely to undergo facial surgery or other types of&nbsp;surgery&nbsp;soon<\/li><li>If you have already been given a second&nbsp;injection&nbsp;of botulinum toxin<\/li><li>If you did not get a significant improvement in your wrinkles after the last treatment with botulinum toxin.<\/li><\/ul>\n\n\n\n<p>This information will help your doctor make an informed decision about the risks and benefits of your treatment.<\/p>\n\n\n\n<p><em>Warnings:<\/em><\/p>\n\n\n\n<p>In very rare cases, the effect of botulinum toxin may cause muscle weakness at sites other than the injection site.<\/p>\n\n\n\n<p>When botulinum toxin has been used more frequently than every 12 weeks and at higher&nbsp;doses&nbsp;for the treatment of other conditions, antibody formation has been observed in rare cases in patients.&nbsp;The formation of neutralizing&nbsp;antibodies&nbsp;can reduce the effectiveness of treatment.<\/p>\n\n\n\n<p>If you visit a doctor for any reason, make sure you tell them that you have been treated with Azzalure.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children And Young People<\/h2>\n\n\n\n<p>Azzalure should not be used by people under 18 years of age.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other Medicines And Azzalure<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<p><strong>Azzalure syringe<\/strong> can affect other medicines that you take or have recently taken, in particular<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Antibiotics&nbsp;for&nbsp;infection&nbsp;(eg&nbsp;aminoglycosides&nbsp;such as gentamicin or amikacin)<\/li><li>Other muscle relaxants<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Azzalure With Food And Drink<\/h2>\n\n\n\n<p>You can be&nbsp;injected&nbsp;with Azzalure either before or after eating or drinking.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy And Breastfeeding<\/h2>\n\n\n\n<p>Azzalure should not be used during pregnancy unless clearly necessary.&nbsp;Azzalure treatment is not recommended if you are breastfeeding.&nbsp;If you are pregnant or planning to become pregnant or breastfeeding, talk to your doctor before using Azzalure.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving And Using Machines<\/h2>\n\n\n\n<p>You may experience temporary blurred vision or muscle weakness after treatment with Azzalure.&nbsp;If you are affected, do not drive or use machines.<\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.&nbsp;One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or&nbsp;side effects.<\/p>\n\n\n\n<p>Descriptions of these effects and&nbsp;side effects&nbsp;can be found in other sections.&nbsp;Read all the information in this leaflet for guidance.&nbsp;If you are not sure, talk to your doctor or pharmacist.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How To Use Azzalure<\/h2>\n\n\n\n<p>Azzalure should only be given by a doctor with appropriate qualifications and knowledge of this treatment, and who has the necessary equipment.<\/p>\n\n\n\n<p>Your doctor will prepare and give the&nbsp;injections.&nbsp;A&nbsp;vial&nbsp;of Azzalure should be used only for you and only during one treatment session.<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;of Azzalure is<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>For glabella folds: 50 units, which are injected with 10 units at each of the 5 injection sites in your forehead in the area above the nose and eyebrows.<\/li><li>For wrinkles at the side of the eyes (crow&#8217;s feet): 60 units injected with 10 units at each of the 6 injection sites, in the area of \u200b\u200bcrow&#8217;s feet, at both eyes.<\/li><\/ul>\n\n\n\n<p>The devices used for different botulinum toxin products are not the same.&nbsp;The Speywood units in Azzalure are not interchangeable with other botulinum toxin products.<\/p>\n\n\n\n<p>The effect of the treatment should be felt within a few days after the&nbsp;injections.<\/p>\n\n\n\n<p>The time period between treatments with Azzalure will be determined by your doctor.&nbsp;You should not be treated more often than every 12 weeks.<\/p>\n\n\n\n<p>Azzalure should not be used in patients under 18 years of age.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible Azzalure Side Effects<\/h2>\n\n\n\n<p>Like all medicines, Azzalure can cause&nbsp;side effects, although not everybody gets them.<\/p>\n\n\n\n<p><strong>Seek immediate medical attention if:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you have <a href=\"https:\/\/zeepedia.com\/medical\/diseases\/respiratory-difficulties-in-children\/\">difficulty breathing<\/a>, swallowing, or speaking<\/li><li>your face swells or your skin turns red or you get itchy, raised rashes.&nbsp;This may mean that you have had an&nbsp;allergic reaction&nbsp;to Azzalure.<\/li><\/ul>\n\n\n\n<p><strong>Tell your doctor if you notice any of the following side effects:<\/strong><\/p>\n\n\n\n<p><strong>For glabella folds:<\/strong><\/p>\n\n\n\n<p><strong>Very common Azzalure side effects (may affect more than 1 user in 10)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Redness<\/li><li>Swelling<\/li><li>Irritation<\/li><li>Rash<\/li><li><a href=\"https:\/\/zeepedia.com\/diseases\/dry-skin-and-itching\/\">Itching<\/a><\/li><li>Tingling<\/li><li><a href=\"https:\/\/zeepedia.com\/medical\/diseases\/brain-and-nerves\/pain\/\">Pain<\/a><\/li><li>Discomfort<\/li><li>Burning<\/li><li>Bruising at the injection site<\/li><li>Headache<\/li><\/ul>\n\n\n\n<p><strong>Common Azzalure side effects (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Tired eyes or blurred vision<\/li><li>Drooping upper eyelids<\/li><li>Swollen eyelids<\/li><li>Watery eyes<\/li><li>Dry eyes<\/li><li>Twitching of the muscles around the eye<\/li><li>Transient facial paralysis<\/li><\/ul>\n\n\n\n<p><strong>Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Visual disturbance<\/li><li>Blurred vision<\/li><li><a href=\"https:\/\/zeepedia.com\/medical\/diseases\/distinction-and-double-vision-in-adults\/\">Double vision<\/a><\/li><li>Dizziness<\/li><li>Itching<\/li><li>Rash<\/li><li>Allergic reactions<\/li><\/ul>\n\n\n\n<p><strong>Rare (&nbsp;<\/strong><strong>may affect up to 1 in 1,000 people&nbsp;<\/strong><strong>)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Itchy<\/li><li>Raised rash<\/li><li>Disorder of the eye movements<\/li><\/ul>\n\n\n\n<p><strong>For wrinkles on the side of the eyes (crow&#8217;s feet):<\/strong><\/p>\n\n\n\n<p><strong>Common (&nbsp;<\/strong><strong>may affect up to 1 in 10 people&nbsp;<\/strong><strong>)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Headache<\/li><li>Swollen eyelids<\/li><li>Bruising<\/li><li>Itching,&nbsp;and swelling around the eyes<\/li><li>Hanging upper eyelids<\/li><li>Transient facial paralysis<\/li><\/ul>\n\n\n\n<p><strong>Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dry eyes<\/li><\/ul>\n\n\n\n<p>These&nbsp;side effects&nbsp;usually appeared&nbsp;within the first week after the&nbsp;injections&nbsp;and did not last long.&nbsp;They were usually mild to moderate in their severity.<\/p>\n\n\n\n<p>In very rare cases,&nbsp;side effects&nbsp;in muscles other than those injected have been reported for botulinum toxin.&nbsp;These include severe <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Muscle weakness<\/li><li>Difficulty swallowing due to <a href=\"https:\/\/zeepedia.com\/medical\/diseases\/cough\/\">coughing<\/a><\/li><li>Suffocation attacks <\/li><\/ul>\n\n\n\n<p>If swallowed (if food or fluid enters the airways when you try to swallow, you may have respiratory problems such as&nbsp;infection&nbsp;of the lungs).&nbsp;If this happens, consult a doctor immediately.<\/p>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This includes any possible side effects not listed in this leaflet.&nbsp;You can also report side effects directly to the Medical Products Agency,&nbsp;www.lakemedelsverket.se.&nbsp;By reporting side effects, you can help increase drug safety information.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How To Store Azzalure<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Keep out of sight and reach of children.<\/li><li>Do not use <strong>speywood units syringe<\/strong> after the expiry date which is stated on the label and the carton after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<\/li><li>Store Azzalure in a refrigerator (2 -C-8 \u00baC).&nbsp;Do not freeze.<\/li><li>Your doctor will mix Azzalure into a solution for&nbsp;injection.<\/li><li>Chemical and physical in-use stability has been demonstrated for storage for up to 24 hours at 2 \u00b0 C to 8 \u00b0 C.&nbsp;From a&nbsp;microbiological&nbsp;point of view, unless the reconstitution method excludes the risk of&nbsp;microbial&nbsp;contamination, the product should be used immediately.&nbsp;If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">6. Contents Of The Packaging And Other Information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content Declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is botulinum toxin type A *.&nbsp;One&nbsp;vial&nbsp;contains 125 <strong>Speywood units syringe.<\/strong><\/li><li>The other ingredients are human albumin 200 g \/ l and&nbsp;lactose monohydrate.<\/li><\/ul>\n\n\n\n<p>*&nbsp;<em>Clostridium&nbsp;botulinum<\/em>&nbsp;(a&nbsp;bacterium&nbsp;)&nbsp;toxin&nbsp;A hemagglutinin complex.<\/p>\n\n\n\n<p>The <em>Speywood units syringe<\/em> in Azzalure are product specific and are not interchangeable with other botulinum toxin products.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What The Medicine Looks Like And The Contents Of The Pack<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Azzalure is a powder solution&nbsp;for&nbsp;injection.&nbsp;It comes in packs of 1 or 2 vials.<\/li><li>Azzalure is a white powder.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder And Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/www.ipsen.com\/\" rel=\"noopener\">Institute of Synthesis Products (IPSEN) AB<\/a><\/p>\n\n\n\n<p>Kista Science Tower<\/p>\n\n\n\n<p>F\u00e4r\u00f6gatan 33<\/p>\n\n\n\n<p>164 51 Kista<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Ipsen Biopharm Limited<\/p>\n\n\n\n<p>Ash Road<\/p>\n\n\n\n<p>Wrexham Industrial Estate<\/p>\n\n\n\n<p>Wrexham<\/p>\n\n\n\n<p>LL13 9UF<\/p>\n\n\n\n<p>UK<\/p>\n\n\n\n<p>Ipsen Manufacturing Ireland Limited<\/p>\n\n\n\n<p>Blanchardstown Industrial Park<\/p>\n\n\n\n<p>Blanchardstown<\/p>\n\n\n\n<p>Dublin 15<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p>This leaflet was last modified on 15 May 2019<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other sources of information<\/h2>\n\n\n\n<p>If you would like further information or if you would like to see the package leaflet in another format please contact your local representative:<\/p>\n\n\n\n<p>Galderma Nordic AB<\/p>\n\n\n\n<p>Seminariegatan 21<\/p>\n\n\n\n<p>SE-752 28 Uppsala<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">The following information is intended for healthcare professionals only:<\/h2>\n\n\n\n<p><strong>Azzalure injection points<\/strong> <strong>dosage&nbsp;and&nbsp;route of&nbsp;administration<\/strong><br><\/p>\n\n\n\n<p>See the package leaflet under point 3.<br><\/p>\n\n\n\n<p><strong>Special instructions for disposal and another handling<\/strong><br><\/p>\n\n\n\n<p>The instructions for use, handling, and destruction must be followed carefully.<br><\/p>\n\n\n\n<p>Preparation&nbsp;should be in accordance with good practice, especially with regard to aseptic.<\/p>\n\n\n\n<p>Azzalure must be diluted with sodium chloride 9 mg\/ml (0.9%)&nbsp;solution&nbsp;for&nbsp;injection.<\/p>\n\n\n\n<p>According to the dilution table below, the indicated amount of sodium chloride solution for&nbsp;injection&nbsp;9 mg\/ml (0.9%) should be withdrawn into a&nbsp;syringe&nbsp;to obtain a clear reconstituted solution with the following concentration:<br><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>Amount of solvent added (9 mg\/ml (0.9%) sodium chloride solution) to a 125 E bottle<\/td><td>Finished&nbsp;dose<\/td><\/tr><tr><td>0.63 ml<\/td><td>10 units per 0.05 ml<\/td><\/tr><tr><td>1.25 ml<\/td><td>10 units per 0.1 ml<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Correct measurement of 0.63 ml or 1.25 ml can be done by using syringes graded in steps of 0.1 ml and 0.01 ml.<\/p>\n\n\n\n<p>RECOMMENDATIONS FOR THE DESTRUCTION OF CONTAMINATED MATERIAL<\/p>\n\n\n\n<p>Immediately after use and before disposal, all unused reconstituted Azzalure (in the vial or in the syringe) should be inactivated with 2 ml of diluted sodium hypochlorite solution at a concentration of 0.55% or 1% (Dakin&#8217;s solution).<\/p>\n\n\n\n<p>Used vials, syringes, and materials should not be emptied but must be disposed of in appropriate containers and disposed of in accordance with local regulations.<br><\/p>\n\n\n\n<p>RECOMMENDATIONS IN THE EVENT OF ANY ACCIDENT IN THE HANDLING OF BOTULINUM TOXIN<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>All spills must be wiped up: either with an absorbent material soaked in sodium hypochlorite solution (bleach) in the case of the powder or with a dry absorbent material in the case of the finished product.<\/li><li>Contaminated surfaces should be cleaned with an absorbent material soaked in sodium hypochlorite solution (bleach) and then wiped off.<\/li><li>Follow the instructions above if a&nbsp;vial&nbsp;breaks.&nbsp;Carefully pick up the pieces of glass and dry the product.&nbsp;Be careful not to cut yourself.<\/li><li>If the product comes in contact with the skin, wash the skin area with sodium hypochlorite solution (bleach) and then rinse thoroughly with plenty of water.<\/li><li>If the product comes into contact with the eyes, rinse thoroughly with plenty of water or with an eyewash solution.<\/li><li>If the product comes in contact with a wound (cut or puncture wound), rinse with plenty of water and take appropriate medical measures depending on the&nbsp;dose injected.<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Azzalure can be used in adults under 65 years to recover the appearance of any severe glabellar lines and lateral canthal lines.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2201,2200],"tags":[9420,9424,8537,8540,9423,9419,9422,8539,9421,8538],"class_list":["post-5818","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-azzalure","tag-azzalure-powder","tag-botulinum-toxin-type-a","tag-botulinum-toxin-type-a-side-effects","tag-side-effects-of-azzalure","tag-side-effects-of-botulinum-toxin-type-a","tag-what-azzalure-is-used-for","tag-what-botulinum-toxin-type-a-is-used-for","tag-what-is-azzalure","tag-what-is-botulinum-toxin-type-a"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5818","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=5818"}],"version-history":[{"count":56,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5818\/revisions"}],"predecessor-version":[{"id":36610,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5818\/revisions\/36610"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5818"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5818"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5818"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}