50 micrograms \/ ml, 0.5 mg \/ ml and 2 mg \/ ml Solution for injection \/ infusion
Baclofen<\/p>\n\n\n\n
Lionova is given as an injection into the spinal canal directly into the spinal fluid ( intrathecal injection ) and reduces severe muscle cramps (spasticity).<\/p>\n\n\n\n
Lionova is used for adults and children aged 4 years and up. It is used when other medicines taken orally (by mouth), including baclofen, have failed or caused unacceptable side effects .<\/p>\n\n\n\n Talk to your doctor, pharmacist or nurse before using Lionova:<\/p>\n\n\n\n Contact your doctor immediately if you notice any of these symptoms during treatment with Lionova:<\/p>\n\n\n\n Contact your doctor immediately if you think Lionova is not working as well as usual. It is important to check that there are no problems with the infusion pump.<\/p>\n\n\n\n Lionova is not recommended for children under<\/strong> 4 years. Children must have a sufficiently large body to accommodate the implanted infusion pump. There are limited clinical data in children under 4 years of age.<\/p>\n\n\n\n Some patients over 65 years of age have been treated with intrathecal baclofen during\u00a0clinical trials\u00a0without specific problems.\u00a0However, experience with baclofen tablets shows that this patient group may be more susceptible to\u00a0side effects\u00a0.\u00a0Elderly patients should therefore be closely monitored for the occurrence of\u00a0side effects.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Tell your doctor if you are taking any of the following medicines as they may affect or be affected by Leonova:<\/p>\n\n\n\n Do not drink alcohol during treatment with Lionova as it may lead to an unwanted increase or unpredictable change in the effect of the medicine.<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n There is limited experience with the use of intrathecal baclofen during pregnancy or lactation.\u00a0Leonova should not be used during pregnancy or breastfeeding unless the expected benefit to the mother outweighs the potential risk to the baby.<\/p>\n\n\n\n Lenovo passes into breast milk, but low levels are expected after\u00a0intrathecal\u00a0administration.\u00a0Leonova can thus be used during breastfeeding.<\/p>\n\n\n\n During treatment with Lionova, the ability to drive or use machines may be impaired.<\/p>\n\n\n\n Some people may feel drowsy, have dizziness, eye problems, difficulty controlling movement, or have hallucinations when treated with Leonova.\u00a0If this applies to you, do not drive or do anything that requires increased attention (such as the use of tools or machines) until these effects have disappeared.\u00a0Before driving or using machines, consult your doctor.<\/p>\n\n\n\n 50 micrograms \/ ml = 0.05 mg baclofen in a\u00a01 ml\u00a0ampoule\u00a0contains less than 1 mmol\u00a0sodium\u00a0(23 mg) per\u00a0dose\u00a0, ie essentially ‘sodium-free’. per\u00a0dos.\u00a0This corresponds to 0.9% of the maximum recommended daily\u00a0sodium\u00a0intake\u00a0for adults.<\/p>\n\n\n\n Always use this medicine exactly as your doctor or pharmacist has told you.\u00a0Ask your doctor or pharmacist if you are unsure.\u00a0Only your doctor can change your\u00a0dose.<\/p>\n\n\n\n Leonova should\u00a0only<\/strong>\u00a0be given by a specially trained doctor.<\/p>\n\n\n\n Dose one varies depending on the condition of each person. Your doctor will determine your dose after testing how you respond to this medicine.<\/p>\n\n\n\n First, your doctor will give you a single dose of Lionova to see if the medicine is right for you. During this period, your heart and lung function will be closely monitored. If your symptoms improve, a special pump that allows Lionova to be continuously inserted (implanted) into the chest or abdominal wall. Your doctor will give you all the information you need to use the infusion pump and dosing information. Make sure you understand everything.<\/p>\n\n\n\n You are more likely to get\u00a0side effects\u00a0if the starting dose is too high or the\u00a0dose is\u00a0increased too fast.\u00a0To avoid these effects, which can be serious, the medicine in the pump mustn’t run out.\u00a0Make sure you do not forget your hospital visits.<\/p>\n\n\n\n It is very important that you, and those who care for you, can recognize the signs of the\u00a0release\u00a0of Leonova.\u00a0These can come on suddenly or slowly as a result of the pump not working properly due to problems with the battery,\u00a0catheter,\u00a0or alarm.<\/p>\n\n\n\n If you notice any of the above signs, contact a doctor immediately. <\/strong>These signs can be followed by more serious side effects if you do not receive treatment immediately.<\/p>\n\n\n\n Method of administration<\/strong><\/p>\n\n\n\n Leonova should only be given in the spinal canal (\u00a0intrathecal\u00a0use).<\/p>\n\n\n\n Determined by the doctor.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n These occur more often at the beginning of treatment during the hospital stay, but can also occur later. For many of these side effects, there is also a link to the specific medical condition you are being treated for.<\/p>\n\n\n\n Side effects can occur with the following frequencies:<\/p>\n\n\n\n Common side effects are <\/strong>(may affect up to 1 in 10):<\/em><\/p>\n\n\n\n Seizures, headaches, nausea, vomiting, and difficulty urinating.<\/p>\n\n\n\n Has been reported <\/strong> (occurs in an unknown number of users):<\/em><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Appearance<\/em><\/p>\n\n\n\n Lionova is a clear, colorless solution for injection \/ infusion, pH 5.0 to 7.0.<\/p>\n\n\n\n Leonova 50 micrograms\/ml is supplied in cartons containing 5\u00a0glass ampoules of\u00a01 ml each.<\/p>\n\n\n\n Lionova 0.5 mg \/ ml is available in cartons containing 1 20 ml glass ampoule .<\/p>\n\n\n\n Leonova 2 mg\/ml in a carton containing 1\u00a0glass vial\u00a0of 5 ml and 5\u00a0glass ampoule\u00a0s of 5 ml each.<\/p>\n\n\n\n Marketing Authorisation Holder<\/em><\/p>\n\n\n\n Alternova A \/ S, Lodshusvej 11, 4230 Sk\u00e6lsk\u00f8r, Denmark<\/p>\n\n\n\n Bioindustry LIMSpA, Via De Ambrosius 2, 15067 Novi Ligure (AL), Italy<\/p>\n\n\n\n or<\/em><\/p>\n\n\n\n Orifarm Generics A \/ S, Energivej 15, 5260 Odense S, Denmark<\/p>\n\n\n\n This medicinal product is authorized under the European Economic Area under the names:<\/strong><\/p>\n\n\n\n Denmark, Sweden, Norway: Leonova<\/p>\n","protected":false},"excerpt":{"rendered":" Lionova is given as an injection into the spinal canal directly into the spinal fluid ( intrathecal injection ) and reduces severe muscle cramps (spasticity).2.<\/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":[9346,16027,16025,16026,16032,16028,16033,16031,9348,9347,16029,16030],"class_list":["post-16780","post","type-post","status-publish","format-standard","hentry","category-medicines","category-l","tag-baclofen","tag-baclofen-injection","tag-baclofen-side-effects","tag-benefits-of-baclofen","tag-benefits-of-lionova","tag-lionova","tag-lionova-injection","tag-lionova-side-effects","tag-what-baclofen-is-used-for","tag-what-is-baclofen","tag-what-is-lionova","tag-what-lionova-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/16780","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=16780"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/16780\/revisions"}],"predecessor-version":[{"id":16803,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/16780\/revisions\/16803"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=16780"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=16780"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=16780"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Lionova is used to treat severe, prolonged muscle spasm<\/strong> (spasticity) that occurs in various diseases, such as:<\/p>\n\n\n\n
The baclofen contained in Lionova may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.<\/p>\n\n\n\nWhat you need to know before using Lionova<\/h2>\n\n\n\n
Do not use Lionova<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
You will be closely monitored in an environment with complete equipment and personnel during the screening phase and during the period in which the correct dose is determined immediately after implantation of the infusion pump. You will be assessed regularly for the dose you need, for any side effects or signs of infection . The function of the administration system (pump and associated equipment) will also be checked.<\/p>\n\n\n\n
Treatment with Lionova must not be stopped abruptly due to the risk of discontinuation of effects. Make sure you do not forget to visit the hospital to replenish the infusion pump reservoir.<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Older<\/strong><\/p>\n\n\n\nOther drugs and Lionova<\/h2>\n\n\n\n
Concomitant use of anesthetics may increase the risk of heart failure and seizures.<\/p>\n\n\n\nLionova with alcohol<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Pregnancy<\/em><\/p>\n\n\n\n
Breast-feeding<\/em><\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and side effects can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\nLionova contains sodium<\/h2>\n\n\n\n
0.5 mg \/ ml = 10 mg baclofen in a\u00a020 ml\u00a0ampoule\u00a0contains 180 mg of sodium chloride corresponding to 70.81 mg of\u00a0sodium\u00a0(the main ingredient in table salt \/ table salt) per\u00a0dose\u00a0.\u00a0This corresponds to 3.5% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.
2 mg\/ml = 10 mg baclofen in a\u00a05 ml\u00a0ampoule\u00a0contains 45 mg of sodium chloride corresponding to 17.70 mg of\u00a0sodium\u00a0(the main ingredient in table salt\/table salt)<\/p>\n\n\n\nHow to be given Lionova<\/h2>\n\n\n\n
The recommended dose is:<\/strong><\/p>\n\n\n\n
Your\u00a0dose\u00a0depends on how you respond to the medicine.\u00a0You start with a low\u00a0dose\u00a0that is gradually increased over a few days with the doctor’s supervision until you get the right\u00a0dose.<\/p>\n\n\n\n
You must visit<\/strong> the doctor to refill the infusion pump, otherwise, the cramps may return as you will not receive a sufficiently high\u00a0dose\u00a0of Leonova.\u00a0<\/strong>As a result, your muscle cramps may worsen.<\/p>\n\n\n\n
If your muscle elasticity does not improve or if you start having cramps again, either gradually or suddenly,\u00a0contact your doctor immediately<\/strong>.<\/p>\n\n\n\nIf treatment with Lionova is stopped<\/h2>\n\n\n\n
Signs of release are:<\/em><\/p>\n\n\n\n
Usage time<\/strong><\/p>\n\n\n\n
During long-term treatment, some patients find Lionova less effective. Your doctor may recommend temporary treatment interruptions to counteract this.<\/p>\n\n\n\nPossible side effects<\/h2>\n\n\n\n
Very common\u00a0side effects\u00a0are\u00a0<\/strong>(can occur in more than 1 in 10):<\/em><\/p>\n\n\n\n
The following side effects are more common in patients with cerebral spasticity:<\/p>\n\n\n\n
Less common side effects are <\/strong>(may affect up to 1 in 100):<\/em><\/p>\n\n\n\n
Rare side effects are <\/strong>(may <\/em>affect up to 1 in 1000 people):<\/em><\/p>\n\n\n\n
For a description of the signs of\u00a0discontinuation, see “If treatment with Lionova is stopped”.<\/p>\n\n\n\n
For a description of signs of overdose, see “If you are given too much Leonova”.<\/p>\n\n\n\n
There have been reports of problems with the infusion pump and the administration system, e.g.\u00a0infection,\u00a0inflammation\u00a0of the membranes of the brain and spinal cord (\u00a0meningitis\u00a0), or\u00a0inflammation\u00a0at the tip of the administration system.<\/p>\n\n\n\nHow to store Lionova<\/h2>\n\n\n\n
No special storage instructions.
Do not use this\u00a0medicine\u00a0after the\u00a0expiry date which is stated on the carton and\u00a0ampoule\u00a0after EXP.\u00a0The expiration date is the last day of the specified month.
After the first opening: the product should be used immediately.<\/p>\n\n\n\n
Because the drug is restricted to hospital use, the hospital discards drugs that are no longer used.<\/p>\n\n\n\nContents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Pack sizes<\/em><\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Ti <\/em>llverkare<\/em><\/p>\n\n\n\n