{"id":16073,"date":"2021-11-30T09:55:55","date_gmt":"2021-11-30T09:55:55","guid":{"rendered":"https:\/\/zeepedia.com\/?p=16073"},"modified":"2021-12-09T07:32:27","modified_gmt":"2021-12-09T07:32:27","slug":"lamzede","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/lamzede\/","title":{"rendered":"Lamzede &#8211; Velmanas alpha uses, dose and side effects"},"content":{"rendered":"\n<p>10 mg&nbsp;powder for&nbsp;infusion&nbsp;solution<br>velmanas alpha<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Lamzede is and what it is used for<\/h2>\n\n\n\n<p>Lamzede contains the active substance velmanas alfa, which belongs to a group of medicines called enzyme replacement therapies.&nbsp;It is used to treat patients with mild to moderate alpha-mannosidosis.&nbsp;It is given to treat the non-neurological symptoms of the disease.<\/p>\n\n\n\n<p>Alpha-mannosidosis is a rare genetic disease caused by a lack of\u00a0enzyme\u00a0et alpha-mannosidase that is needed to break down certain sugars (so-called mannose-rich\u00a0oligosaccharides\u00a0) in the body.\u00a0When this\u00a0enzyme\u00a0is missing or does not work properly, these sugars accumulate and cause the signs and symptoms present in the disease.\u00a0The typical manifestations of the disease include characteristic facial features, mental retardation, difficulty controlling movements, hearing and speech difficulties, frequent\u00a0infections, skeletal problems, muscle pain, and muscle weakness.<\/p>\n\n\n\n<p>Velmanas alfa is intended to replace the&nbsp;missing&nbsp;enzyme&nbsp;in patients with alpha-mannosidosis.&nbsp;This can improve the symptoms of the disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Lamzede<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Lamzede<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to velmanas alfa or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor before using Lamzede.<\/p>\n\n\n\n<p>If you are being treated with Lamzede, you may experience a&nbsp;side effect&nbsp;during or immediately after the drip (&nbsp;infusion&nbsp;one) used to give the medicine (see section 4).&nbsp;This is called an&nbsp;<strong>infusion-related reaction<\/strong>&nbsp;and can sometimes be severe.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Infusion-related reactions include dizziness, headache, nausea, low&nbsp;blood pressure&nbsp;, fatigue and fever.&nbsp;If you get an infusion-related reaction&nbsp;<strong>, tell your doctor immediately.<\/strong><\/li><li>If you get an infusion-related reaction, you may be given additional medicines to treat or help prevent future reactions.&nbsp;These medicines may include medicines used to treat&nbsp;allergies&nbsp;(&nbsp;antihistamines&nbsp;), medicines used to treat fever (antipyretics) and medicines used to reduce&nbsp;inflammation&nbsp;(&nbsp;corticosteroids&nbsp;).<\/li><li>If the infusion-related reaction is severe, your doctor will immediately discontinue the&nbsp;infusion&nbsp;and give you appropriate medical treatment.<\/li><li>If the infusion-related reactions are severe and \/ or the effect of this medicine is weakened, your doctor will take a blood test to see if you have&nbsp;any antibodies&nbsp;that may affect the results of your treatment.<\/li><li>In most cases, you can continue with Lamzede even if you get an infusion-related reaction.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Lamzede<\/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<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.<\/p>\n\n\n\n<p>Lamzede should be used during pregnancy only if needed medically.\u00a0It is not known if the alpha of velmanas passes into breast milk.\u00a0Lamzede can be used during breastfeeding.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Lamzede has no or negligible effect on the ability to drive and use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Lamzede contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per dose unit, ie essentially &#8216;sodium-free.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Lamzede<\/h2>\n\n\n\n<p>This medicine should only be used under the supervision of a doctor who has experience in the treatment of alpha-mannosidosis or other similar diseases and should only be given by healthcare professionals.<\/p>\n\n\n\n<p><strong>Dosage<\/strong><\/p>\n\n\n\n<p>The recommended\u00a0dose\u00a0of Lamzede is 1 mg\/kg body weight given once a week.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Use for children and adolescents<\/h2>\n\n\n\n<p>Lamzede can be given to children and adolescents with the same\u00a0dose\u00a0and frequency as adults.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Administration<\/h2>\n\n\n\n<p>Lamzede is supplied in a&nbsp;vial&nbsp;as a powder for&nbsp;solution&nbsp;for&nbsp;infusion&nbsp;mixed with water for injections before administration.<\/p>\n\n\n\n<p>Once reconstituted, the drug is given via an infusion pump (drip) into a vein for at least 50 minutes under the supervision of a physician.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0Most\u00a0side effects\u00a0occur during or shortly after\u00a0infusion\u00a0(&#8220;infusion-related reaction&#8221;, see section 2 Warnings and precautions).<\/p>\n\n\n\n<p>While you are being treated with Lamzede, you may experience some of the following reactions:<\/p>\n\n\n\n<p><strong><u>Serious&nbsp;side effects&nbsp;are<\/u><\/strong><\/p>\n\n\n\n<p><strong>Common&nbsp;<\/strong>side effects&nbsp;(may affect up to 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>unconsciousness (fainting, which may be preceded by a feeling of dizziness, dizziness or confusion)<\/li><li>acute&nbsp;renal failure&nbsp;(kidney problems recognized by fluid retention, swelling of the legs, ankles or feet, drowsiness, shortness of breath or fatigue)<\/li><li>hypersensitivity and severe&nbsp;allergic reaction&nbsp;(symptoms include localized or diffuse itching, dizziness, difficulty breathing, chest pain, chills, fever, gastrointestinal symptoms such as nausea, vomiting, diarrhea, or pain in the intestine, swelling of the throat, face, lips or tongue )<\/li><\/ul>\n\n\n\n<p><strong>If you get any of these\u00a0side effects, talk to your doctor immediately.<\/strong><\/p>\n\n\n\n<p><strong><u>Other&nbsp;side effects&nbsp;are<\/u><\/strong><\/p>\n\n\n\n<p><strong>Very&nbsp;<\/strong><strong>common&nbsp;<\/strong>side effects&nbsp;(may affect more than 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>diarrhea<\/li><li>weight gain<\/li><li>fever \/ elevated body temperature<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;<\/strong>side effects&nbsp;(may affect up to 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>slow&nbsp;pulse&nbsp;(&nbsp;bradycardia&nbsp;)<\/li><li>blue skin and lips (cyanosis)<\/li><li>psychotic behavior (mental illness with hallucinations, difficulty thinking clearly and understanding reality, anxiety), difficulty falling asleep<\/li><li>confused state, fainting, tremors, dizziness, headache<\/li><li>abdominal pain (stomach), stomach irritation caused by stomach acid (gastritis with acid regurgitation), nausea, vomiting<\/li><li>infusion site pain, chills, feeling hot, feeling sick, tiredness (fatigue)<\/li><li>skin rash (hives), increased sweating (&nbsp;hyperhidrosis&nbsp;)<\/li><li>nosebleeds<\/li><li>joint pain, back pain, joint stiffness, muscle pain, pain in&nbsp;extremity&nbsp;(hands, feet)<\/li><li>eye irritation, swelling of the eyelids (eyelid edema), redness of the eyes<\/li><li>increased appetite<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Lamzede<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the label and carton after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store and transport cold (2 \u00b0 C-8 \u00b0 C).<\/p>\n\n\n\n<p>Store in the original package.&nbsp;Sensitive to light.<\/p>\n\n\n\n<p>After\u00a0reconstitution, the drug should be used immediately.\u00a0If not used immediately, the reconstituted solution can be stored in a refrigerator for a maximum of 24 hours from 2 \u00b0 C to 8 \u00b0 C.<\/p>\n\n\n\n<p>This medicine must not be used if the reconstituted solution contains&nbsp;<strong>opaque particles or is discolored.<\/strong><\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the package 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 the alpha of velmanas.Each&nbsp;vial&nbsp;contains 10 mg of velmanas alfa.After&nbsp;reconstitution&nbsp;, one ml of the solution contains 2 mg of velmanas alfa (10 mg \/ 5 ml).<\/li><li>The other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, mannitol and&nbsp;glycine&nbsp;.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Lamzede is a white to off-white powder for\u00a0solution\u00a0for\u00a0infusion\u00a0provided in a\u00a0glass\u00a0vial.<\/p>\n\n\n\n<p>Each carton contains 1, 5, or 10 vials.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Chiesi Farmaceutici SpA<\/p>\n\n\n\n<p>Via Palermo 26 \/ A<\/p>\n\n\n\n<p>43122 Parma<\/p>\n\n\n\n<p>Italy<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Chiesi Farmaceutici SpA<\/p>\n\n\n\n<p>Via San Leonardo, 96<\/p>\n\n\n\n<p>43122 Parma<\/p>\n\n\n\n<p>Italy<\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Belgium \/ Belgique \/ Belgien<\/strong>Chiesi sa \/ nvTel: + 32 (0) 2 788 42 00<\/td><td><strong>Lithuania<\/strong>Chiesi Pharmaceuticals GmbHTel: + 43 1 4073919<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>Chiesi Bulgaria EOODTel: + 359 29201205<\/td><td><strong>Luxembourg \/ Luxemburg<\/strong>Chiesi sa \/ nvTel: + 32 (0) 2 788 42 00<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>Chiesi CZ sroTel: + 420 261221745<\/td><td><strong>Hungary<\/strong>Chiesi Hungary Kft.Tel .: + 36-1-429 1060<\/td><\/tr><tr><td><strong>Denmark<\/strong>Chiesi Pharma ABTel: + 46 8 753 35 20<\/td><td><strong>Malta<\/strong>Chiesi Farmaceutici SpATel: + 39 0521 2791<\/td><\/tr><tr><td><strong>Germany<\/strong>Chiesi GmbHTel: + 49 40 89724-0<\/td><td><strong>The Netherlands<\/strong>Chiesi Pharmaceuticals BVTel: + 31 88 501 64 00<\/td><\/tr><tr><td><strong>Eesti<\/strong>Chiesi Pharmaceuticals GmbHTel: + 43 1 4073919<\/td><td><strong>Norway<\/strong>Chiesi Pharma ABTel: + 46 8 753 35 20<\/td><\/tr><tr><td><strong>Greece<\/strong>Chiesi Hellas AEBE:\u0397\u03bb: + 30 210 6179763<\/td><td><strong>Austria<\/strong>Chiesi Pharmaceuticals GmbHTel: + 43 1 4073919<\/td><\/tr><tr><td><strong>Spain<\/strong>Chiesi Espa\u00f1a, SAUTel: + 34 93 494 8000<\/td><td><strong>Poland<\/strong>Chiesi Poland Sp.&nbsp;ZooTel .: + 48 22 620 1421<\/td><\/tr><tr><td><strong>France<\/strong>Chiesi SASTel: + 33 1 47688899<\/td><td><strong>Portugal<\/strong>Chiesi Farmaceutici SpATel: + 39 0521 2791<\/td><\/tr><tr><td><strong>Croatia<\/strong>Chiesi Pharmaceuticals GmbHTel: + 43 1 4073919<\/td><td><strong>Romania<\/strong>Chiesi Romania SRLTel: + 40 212023642<\/td><\/tr><tr><td><strong>Ireland<\/strong>Chiesi Farmaceutici SpATel: + 39 0521 2791<\/td><td><strong>Slovenia<\/strong>Chiesi Slovenija dooTel: + 386-1-43 00 901<\/td><\/tr><tr><td><strong>Iceland<\/strong>Chiesi Pharma ABPhone: +46 8 753 35 20<\/td><td><strong>Slovak Republic<\/strong>Chiesi Slovakia sroTel: + 421 259300060<\/td><\/tr><tr><td><strong>Italy<\/strong>Chiesi Italia SpATel: + 39 0521 2791<\/td><td><strong>Finland \/ Finland<\/strong>Chiesi Pharma ABPuh \/ Tel: +46 8 753 35 20<\/td><\/tr><tr><td><strong>.\u03a0\u03c1\u03bf\u03c2<\/strong>Chiesi Farmaceutici SpA:\u0397\u03bb: + 39 0521 2791<\/td><td><strong>Sweden<\/strong>Chiesi Pharma ABTel: +46 8 753 35 20<\/td><\/tr><tr><td><strong>Latvia<\/strong>Chiesi Pharmaceuticals GmbHTel: + 43 1 4073919<\/td><td><strong>United Kingdom<\/strong><strong>(Northern Ireland)<\/strong>Chiesi Farmaceutici SpATel: +39 0521 2791<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>This medicine has been authorized according to the rules of &#8220;authorization in exceptional cases&#8221;.&nbsp;This means that it has not been possible to obtain complete information about this medicine as the disease is rare.<\/p>\n\n\n\n<p>Every year, the European Medicines Agency reviews any new information and updates this leaflet when necessary.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lamzede contains the active substance velmanas alfa, which belongs to a group of medicines called enzyme replacement therapies. It is used to treat patients with mild to moderate alpha-mannosidosis. It is given to treat the non-neurological symptoms of the disease.<\/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":[2200,15579],"tags":[15301,15296,15297,15292,15295,15298,15293,15294],"class_list":["post-16073","post","type-post","status-publish","format-standard","hentry","category-medicines","category-l","tag-benefits-of-lamzede","tag-benefits-of-velmanas-alpha","tag-lamzede","tag-velmanas-alpha","tag-velmanas-alpha-side-effects","tag-what-is-lamzede","tag-what-is-velmanas-alpha","tag-what-velmanas-alpha-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/16073","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=16073"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/16073\/revisions"}],"predecessor-version":[{"id":16125,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/16073\/revisions\/16125"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=16073"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=16073"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=16073"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}