{"id":5327,"date":"2020-12-15T11:57:48","date_gmt":"2020-12-15T11:57:48","guid":{"rendered":"https:\/\/zeepedia.com\/?p=5327"},"modified":"2021-07-28T18:30:04","modified_gmt":"2021-07-28T18:30:04","slug":"amiodaron-hameln","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/amiodaron-hameln\/","title":{"rendered":"Amiodarone Hameln &#8211; Amiodarone hydrochloride uses, dose and side effects"},"content":{"rendered":"\n<p> 50 mg\/ml concentrate for solution for injection or infusion&nbsp;<br>amiodarone hydrochloride<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Amiodarone Hameln is and what it is used for<\/h2>\n\n\n\n<p>Amiodarone&nbsp;is a so-called&nbsp;antiarrhythmic&nbsp;and is used to treat an irregular heartbeat.&nbsp;Amiodarone&nbsp;works by controlling the heart if it is not beating normally.<\/p>\n\n\n\n<p>As a&nbsp;solution for injection,&nbsp;amiodarone is&nbsp;usually&nbsp;given&nbsp;only when a quick response is required or if you are unable to take tablets.<\/p>\n\n\n\n<p>Your doctor will give you an&nbsp;injection&nbsp;and you will be monitored in a hospital or under the supervision of a specialist.<br><\/p>\n\n\n\n<p>Amiodarone contained&nbsp;in&nbsp;Amiodarone&nbsp;Hameln may also be approved for the treatment of other conditions not mentioned in this leaflet.&nbsp;Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you receive Amiodarone Hameln<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Amiodarone Hameln<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to&nbsp;amiodarone, iodine, or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if your heart beats slower than usual (so-called&nbsp;sinus bradycardia&nbsp;) or if you have a disease that causes irregular heartbeats (eg sinoatrial heart block or diseased sinus syndrome).<\/li><li>if you have any other heart problems and&nbsp;<strong>do not<\/strong>&nbsp;have a pacemaker, for example, if you have&nbsp;AV block&nbsp;(a type of conduction disorder in the heart).<\/li><li>if your&nbsp;thyroid gland is&nbsp;not working properly.&nbsp;Your doctor should examine your thyroid function before taking this medicine.<\/li><li>if you are taking certain other medicines that may affect your heartbeat (see also &#8220;Other medicines and&nbsp;Amiodarone&nbsp;Hameln&#8221;).<\/li><li>if the person being given the medicine is a premature baby or a newborn baby or children under 3 years of age.<\/li><\/ul>\n\n\n\n<p><strong>You must not be given&nbsp;Amiodarone&nbsp;Hameln:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are pregnant or breastfeeding (use is only permitted in life-threatening situations).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Special care should be taken by the physician and close and regular monitoring (eg&nbsp;ECG&nbsp;and&nbsp;blood pressure, liver and thyroid function) is required:<\/p>\n\n\n\n<p>&#8211; if you have a weak heart or&nbsp;heart failure.<\/p>\n\n\n\n<p>&#8211; if you have low&nbsp;blood pressure.<\/p>\n\n\n\n<p>&#8211; if you have liver problems.<\/p>\n\n\n\n<p>&#8211; if you have any lung problems including&nbsp;asthma.<\/p>\n\n\n\n<p>&#8211; if you have problems with your&nbsp;thyroid gland.<br><\/p>\n\n\n\n<p><strong><em>Ask your doctor if any of the above apply to you or have previously affected you.<\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Amiodarone Hameln<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.&nbsp;This is especially important with the following medicines as they may&nbsp;interact&nbsp;with amiodarone:<\/p>\n\n\n\n<p>\u2022 Medicines for irregular heartbeat (eg&nbsp;quinidine,&nbsp;procainamide,&nbsp;disopyramide,&nbsp;and sotalol).<\/p>\n\n\n\n<p>\u2022 Medicines to improve the blood supply to the brain (eg wine stoves).<\/p>\n\n\n\n<p>\u2022 Medicines for mental illness (eg sultopride, pimozide) and certain other types of medicines called phenothiazines (eg thioridazine).<\/p>\n\n\n\n<p>\u2022 Medicines used for indigestion (eg cisapride).<\/p>\n\n\n\n<p>\u2022 Medicines for&nbsp;infection&nbsp;(eg moxifloxacin, erythromycin).<\/p>\n\n\n\n<p>\u2022 Injections of pentamidine (used in certain types of&nbsp;pneumonia&nbsp;).<\/p>\n\n\n\n<p>\u2022 Some antidepressants (eg amitriptyline, clomipramine, dosulepin, doxepine, imipramine, lofepramine, nortriptyline, trimiprimine, maoprotiline).<\/p>\n\n\n\n<p>\u2022 Antihistamines for hay fever, rash, or other&nbsp;allergies&nbsp;(eg terfenadine).<\/p>\n\n\n\n<p>\u2022 Medicines for&nbsp;malaria&nbsp;(eg halofantrine).<br><\/p>\n\n\n\n<p><strong>Not recommended<\/strong><\/p>\n\n\n\n<p>The use of the following medicines with&nbsp;amiodarone&nbsp;is not recommended:<\/p>\n\n\n\n<p>\u2022&nbsp;<strong>Beta-blockers,<\/strong>&nbsp;drugs for heart disease and high&nbsp;blood pressure&nbsp;(e.g. propranolol).<\/p>\n\n\n\n<p>\u2022&nbsp;<strong>Calcium antagonists,<\/strong>&nbsp;drugs for chest pain (angina), or high&nbsp;blood pressure&nbsp;(such as&nbsp;diltiazem&nbsp;or verapamil).<br><\/p>\n\n\n\n<p><strong>Caution<\/strong><\/p>\n\n\n\n<p>The following medicines&nbsp;should be used with&nbsp;amiodarone&nbsp;with caution.&nbsp;These drugs can cause low potassium levels in the blood, which can increase the risk of life-threatening heart rhythm disorders.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Laxatives&nbsp;&#8211; used for constipation (eg <a href=\"https:\/\/zeepedia.com\/medical\/medicines\/toilax\/\">bisacodyl<\/a>, senna).<\/li><li>Corticosteroids&nbsp;&#8211; used for&nbsp;inflammation&nbsp;(eg&nbsp;prednisolone&nbsp;).<\/li><li>Tetracosactide &#8211; used in the investigation of certain hormonal problems.<\/li><li>Diuretics&nbsp;(&nbsp;diuretics&nbsp;) e.g.&nbsp;furosemide&nbsp;.<\/li><li>Amphotericin when given directly into a vein &#8211; used against fungal infections.<\/li><\/ul>\n\n\n\n<p>Amiodarone&nbsp;may increase the effects of the following medicines:<br><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Blood thinners (eg&nbsp;warfarin&nbsp;).&nbsp;Your doctor should adjust the&nbsp;dose&nbsp;one and monitor the treatment closely.<\/li><li>Phenytoin&nbsp;&#8211; used to treat seizures.<\/li><li>Digoxin&nbsp;&#8211; used for heart problems.&nbsp;Your doctor should monitor your treatment closely and may adjust the digoxin dose.<\/li><li>Flecainide&nbsp;&#8211; used for irregular heartbeats.&nbsp;Your doctor should monitor your treatment closely and may adjust the dose of flecainide.<\/li><li>Statins, medicines for high&nbsp;cholesterol&nbsp;(eg&nbsp;simvastatin&nbsp;or atorvastatin).<\/li><li>Ciclosporin or tacrolimus &#8211; used to prevent rejection after transplantation.<\/li><li>Fentanyl&nbsp;&#8211; used to relieve pain.<\/li><li>Lidocaine&nbsp;&#8211; a local anesthetic.<\/li><li>Sildenafil &#8211; used to treat erection problems.<\/li><li>Midazolam and triazolam &#8211; are used to help you relax before a medical procedure.<\/li><li>Ergotamine&nbsp;&#8211; used for&nbsp;migraines.<\/li><\/ul>\n\n\n\n<p><strong>Surgery<\/strong><\/p>\n\n\n\n<p>If you are going to have surgery, you must tell the doctors who are treating you that you have received&nbsp;amiodarone.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Amiodarone Hameln with food, drink, and alcohol<\/h2>\n\n\n\n<p>Do not drink grapefruit juice while using&nbsp;amiodarone&nbsp;as grapefruit juice may increase the risk of&nbsp;side effects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>Your doctor will only prescribe&nbsp;Amiodarone&nbsp;Hameln if he or she believes the benefits outweigh the risks during pregnancy.&nbsp;Amiodarone&nbsp;Hameln should only be used during pregnancy in life-threatening situations.<\/p>\n\n\n\n<p>You should not be treated with&nbsp;Amiodarone&nbsp;Hameln if you are breast-feeding.&nbsp;If you receive&nbsp;amiodarone&nbsp;during pregnancy or breast-feeding, breast-feeding should be stopped.<\/p>\n\n\n\n<p>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Amiodarone&nbsp;may affect the ability to drive or use machines.&nbsp;Do not drive or use machines if you are affected.&nbsp;In that case, consult a doctor.<br><\/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 increased 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.&nbsp;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.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Amiodarone Hameln contains benzyl alcohol<\/h2>\n\n\n\n<p>This medicine contains 22.2 mg\/ml benzyl alcohol which may cause allergic reactions.&nbsp;Benzyl alcohol is associated with the risk of serious&nbsp;side effects&nbsp;such as difficulty breathing (so-called &#8220;gasping syndrome&#8221;) in young children.<\/p>\n\n\n\n<p>Do not give this medicine to newborns (up to 4 weeks of age).&nbsp;When a doctor considers the drug to be clearly necessary, it can be given to young children (younger than 3 years) for a period of (normally) no more than a week.<\/p>\n\n\n\n<p>If you have impaired liver or kidney function, are pregnant, or breast-feeding (see section 2-Pregnancy and breast-feeding), consult your doctor or pharmacist before using this medicine.&nbsp;Large amounts of benzyl alcohol can be stored in the body and cause&nbsp;side effects&nbsp;(metabolic&nbsp;acidosis&nbsp;).<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How Amiodarone Hameln is given<\/h2>\n\n\n\n<p>Amiodarone&nbsp;is given into a vein (&nbsp;intravenously&nbsp;as an&nbsp;injection&nbsp;or&nbsp;infusion&nbsp;) and is administered by a doctor or nurse.<br><\/p>\n\n\n\n<p><strong>Dosage<\/strong><\/p>\n\n\n\n<p>The daily dose of&nbsp;amiodarone&nbsp;depends on the severity of the disease.&nbsp;Dose&nbsp;one and the duration of treatment is determined by the doctor who adjusts the&nbsp;dose individually.<\/p>\n\n\n\n<p>Unless your doctor prescribes otherwise, the usual&nbsp;dose is&nbsp;5 mg\/kg body weight.&nbsp;The drug is injected for at least 3 minutes.<br><\/p>\n\n\n\n<p><em>When&nbsp;Amiodarone&nbsp;is given as an injection:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>shall&nbsp;dose&nbsp;s above 5 mg\/kg body weight is not used.<\/li><li>dose&nbsp;one&nbsp;should&nbsp;be given as a slow&nbsp;injection&nbsp;for at least 3 minutes (unless you are receiving the medicine for resuscitation).<\/li><li>the doctor must wait at least 15 minutes before receiving another&nbsp;injection.<\/li><li>Repeated or&nbsp;continuous&nbsp;use may cause&nbsp;inflammation&nbsp;of the vein and damage the skin at the injection site (the surrounding skin may feel hot and tender and&nbsp;redness&nbsp;may occur).&nbsp;In such a situation, it is recommended that your doctor use a central venous catheter.<\/li><\/ul>\n\n\n\n<p><em>When&nbsp;Amiodarone&nbsp;is given as an infusion:<\/em><\/p>\n\n\n\n<p>a&nbsp;dose of&nbsp;5 mg\/kg body weight diluted in 250 ml&nbsp;glucose&nbsp;50 mg\/ml should be used.<\/p>\n\n\n\n<p>dose&nbsp;one&nbsp;should&nbsp;be given for a period of between 20 minutes and 2 hours.<\/p>\n\n\n\n<p>&#8211;&nbsp;The administration&nbsp;one can be repeated 2-3 times a day.<\/p>\n\n\n\n<p>Side effects&nbsp;that occur during treatment usually occur when too large amounts of&nbsp;amiodarone&nbsp;have been used.&nbsp;Therefore, the lowest possible&nbsp;dose of&nbsp;amiodarone should&nbsp;be given.&nbsp;This reduces&nbsp;side effects&nbsp;to a minimum.&nbsp;See also &#8220;If you have been given too much&nbsp;Amiodarone&nbsp;Hameln&#8221;.<br><\/p>\n\n\n\n<p><em>Adults<\/em><\/p>\n\n\n\n<p>The usual&nbsp;dose&nbsp;is 5 mg for each kilogram of your bodyweight for 20 minutes to 2 hours.<\/p>\n\n\n\n<p>You may then receive an additional&nbsp;dose&nbsp;of 10 to 20 mg for each kilogram of body weight every 24 hours depending on your illness.<\/p>\n\n\n\n<p>In an&nbsp;emergency, your doctor may decide to give you a&nbsp;dose&nbsp;of 150 mg to 300 mg as a slow&nbsp;injection&nbsp;of 3 minutes.<\/p>\n\n\n\n<p>Your doctor will monitor how you respond to&nbsp;Amiodarone&nbsp;and&nbsp;dose&nbsp;one will be adjusted accordingly.<br><\/p>\n\n\n\n<p><em>Children and young people<\/em><\/p>\n\n\n\n<p>There are only limited data on the efficacy and safety of children.&nbsp;Your doctor will determine the correct&nbsp;dose.<br><\/p>\n\n\n\n<p><em>Older<\/em><\/p>\n\n\n\n<p>As with all patients, it is important that the lowest effective&nbsp;dose&nbsp;is used.&nbsp;Your doctor will carefully calculate how much&nbsp;Amiodarone&nbsp;you should be given and closely monitor your heart rate and thyroid function.<br><\/p>\n\n\n\n<p>Your doctor will switch to&nbsp;amiodarone&nbsp;in tablet form as soon as it is considered appropriate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more Amiodarone Hameln than you should&nbsp;<\/h2>\n\n\n\n<p>Because you are receiving this medicine in a hospital or under the supervision of a doctor, it is unlikely that you will receive too much.<br><\/p>\n\n\n\n<p>If you have nevertheless received a higher&nbsp;dose&nbsp;than recommended, you will be closely monitored by your doctor and receive supportive care if necessary.<\/p>\n\n\n\n<p>You may experience the following side effects: nausea, vomiting, constipation, and sweating.&nbsp;You may have an abnormally slow or fast heart rate.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th scope=\"col\"><strong>Side effects&nbsp;are grouped according to the following frequencies:<\/strong><\/th><\/tr><\/thead><tbody><tr><td>Very common<\/td><td>occurs in more than 1 user in 10<\/td><\/tr><tr><td>Usual<\/td><td>occurs in 1 to 10 users out of 100<\/td><\/tr><tr><td>Less common<\/td><td>occurs in 1 to 10 users out of 1,000<\/td><\/tr><tr><td>Rare<\/td><td>occurs in 1 to 10 users out of 10,000<\/td><\/tr><tr><td>Very rare<\/td><td>occurs in more than 1 user in 10,000<\/td><\/tr><tr><td>No known frequency<\/td><td>can not be calculated from available data<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The following&nbsp;side effects&nbsp;have been reported:<br><\/p>\n\n\n\n<p><strong>Very common:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Blurred vision or seeing colored rings at the dazzling light<\/li><\/ul>\n\n\n\n<p><strong>Usual:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Slow heart rate<\/li><li>Drop-in blood pressure and fast heart rate.&nbsp;These&nbsp;side effects&nbsp;occur immediately after&nbsp;injection.&nbsp;The effects are usually moderate and short-lived.&nbsp;They can be serious if you have been given too much&nbsp;Amiodarone&nbsp;Hameln too quickly.<\/li><li>At the place where you are given&nbsp;injection&nbsp;one or&nbsp;infusion&nbsp;one, you can experience:<ul><li>pain<\/li><li>skin redness or change in skin color<\/li><li>local tissue death<\/li><li>leakage of fluid (from blood vessels to surrounding&nbsp;tissue&nbsp;)<\/li><li>swelling caused by fluid accumulation in the skin<\/li><li>inflammation&nbsp;or inflamed blood vessels<\/li><li>induration<\/li><li>infection<\/li><\/ul><\/li><li>Tremors when moving arms or legs<\/li><li>Itchy, red rash (&nbsp;eczema&nbsp;)<\/li><\/ul>\n\n\n\n<p><strong>Uncommon:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>A feeling of weakness or numbness, stinging or burning sensation in any part of the body<\/li><\/ul>\n\n\n\n<p><strong>Rare:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Allergic reactions.&nbsp;<em>Symptoms of such reactions include:<\/em><ul><li>low&nbsp;platelet count&nbsp;accompanied by a bruising and bleeding tendency<\/li><li>blood vessel diseases<\/li><li>kidney diseases<\/li><\/ul><\/li><li>The excipient benzyl alcohol may cause&nbsp;hypersensitivity reactions.<\/li><\/ul>\n\n\n\n<p><strong>Very rare:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Feeling sick, feeling confused or weak, nausea, decreased appetite, irritation.&nbsp;This can be a disease called inadequate&nbsp;ADH&nbsp;&#8211;&nbsp;secretion&nbsp;(SIADH, &#8220;Syndrome of Inappropriate anti-diuretic&nbsp;hormone&nbsp;secretion&#8221;).<\/li><li>Headache<\/li><li>Increased pressure in the skull accompanied by headache, nausea, and vomiting<\/li><li>Severe heart rate<\/li><li>The occurrence of new cardiac arrhythmias or exacerbation of existing cardiac arrhythmia<\/li><li>Conduction disorders<\/li><li>Hot flashes<\/li><li>Breathing difficulties<\/li><li>Lung injury<\/li><li>Nausea<\/li><li>Abnormal liver function values<\/li><li>Acute&nbsp;dysfunction of the liver<\/li><li>Sweating<\/li><li>Loss of vision in one eye or blurred vision \/ affected color vision.&nbsp;Your eyes may feel sore or irritated and hurt to touch.&nbsp;This may be a sign of a disease called&nbsp;optic neuropathy&nbsp;or&nbsp;neuritis&nbsp;(&nbsp;inflammation&nbsp;of the&nbsp;optic nerve&nbsp;).<\/li><li>Anaphylactic&nbsp;shock<em>.&nbsp;Symptoms of anaphylactic&nbsp;shock&nbsp;include:<\/em><ul><li>severe drop in blood pressure<\/li><li>pallor<\/li><li>restlessness<\/li><li>weak and fast heartbeats<\/li><li>cold and sticky skin<\/li><li>impaired consciousness<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>No known frequency<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Hyperthyroidism&nbsp;(overactive&nbsp;thyroid gland&nbsp;) &#8211; you may feel extreme restlessness or anxiety, weight loss, and increased sweating.&nbsp;You may have difficulty coping with high temperatures.&nbsp;Talk to your doctor as soon as possible if you experience any of these symptoms.<\/li><li>Hypothyroidism&nbsp;(underactive&nbsp;thyroid gland&nbsp;) &#8211; you may feel extreme fatigue, weakness and fatigue, weight gain, constipation, and muscle aches.&nbsp;You may have difficulty coping with low temperatures.<\/li><li>Sudden&nbsp;inflammation&nbsp;of the pancreas (&nbsp;acute&nbsp;pancreatitis&nbsp;);&nbsp;confusion (&nbsp;delirium&nbsp;);&nbsp;life-threatening skin reactions characterized by rash, blisters, skin detachment, and pain (&nbsp;toxic epidermal necrolysis,&nbsp;Stevens-Johnson syndrome, bullous&nbsp;dermatitis, drug reaction with&nbsp;eosinophilia&nbsp;and systemic symptoms (DRESS)).<\/li><\/ul>\n\n\n\n<p><strong>Reporting of&nbsp;side effects&nbsp;ar<\/strong><\/p>\n\n\n\n<p>If you get&nbsp;any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This also applies to&nbsp;side effects&nbsp;that are not mentioned in this information.&nbsp;You can also report&nbsp;side effects&nbsp;directly (see details below).&nbsp;By reporting&nbsp;side effects, you can help increase drug safety information.<br><\/p>\n\n\n\n<p>The Medical Products Agency<\/p>\n\n\n\n<p>Box 26<\/p>\n\n\n\n<p>751 03 Uppsala<\/p>\n\n\n\n<p>www.lakemedelsverket.se<br><\/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.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Amiodarone Hameln<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Your doctor or pharmacist is responsible for storing&nbsp;Amiodarone&nbsp;Hameln.&nbsp;They are also responsible for ensuring that unused medicines are discarded according to current instructions.<\/li><li>Do not store above 25 \u00b0 C.&nbsp;Store in a cold place.&nbsp;Do not freeze.&nbsp;Keep the&nbsp;vial&nbsp;are in the outer carton.&nbsp;Sensitive to light.<\/li><li>A diluted solution should be used immediately.<\/li><li>Keep this medicine out of the sight and reach of children.<\/li><li>Do not use this medicine after the expiry date which is stated on the carton after EXP.&nbsp;The expiration date is the last day of the specified month.<\/li><li>Do not use this medicine if the solution is cloudy or contains particles or if the container is damaged.<\/li><li>For single use only.&nbsp;Unused solution should be discarded.<\/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<p>The active substance is amiodarone hydrochloride.<\/p>\n\n\n\n<p>Each milliliter of concentrate for solution for injection\/infusion contains 50 milligrams (mg) of amiodarone hydrochloride equivalent to 46.9 mg of&nbsp;amiodarone.<\/p>\n\n\n\n<p>1&nbsp;ampoule&nbsp;of 3 ml&nbsp;Amiodarone&nbsp;Hameln contains 150 mg of amiodarone hydrochloride.<br><\/p>\n\n\n\n<p>One&nbsp;ampoule&nbsp;of&nbsp;Amiodarone&nbsp;Hameln diluted as recommended in 250 ml&nbsp;glucose&nbsp;50 mg\/ml contains amiodarone hydrochloride at a concentration of 0.6 mg\/ml.<br><\/p>\n\n\n\n<p><em>Other ingredients are:<\/em><\/p>\n\n\n\n<p>Polysorbate 80 (E433)<\/p>\n\n\n\n<p>Benzyl alcohol<\/p>\n\n\n\n<p>Water for injections.<\/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<p>Amiodarone&nbsp;Hameln is a clear, pale yellow,&nbsp;sterile&nbsp;particle-free solution.<br><\/p>\n\n\n\n<p><em>Pack sizes:<\/em><\/p>\n\n\n\n<p>Amiodarone&nbsp;Hameln is available as a 5 ml&nbsp;ampoule&nbsp;of glass with 3 ml concentrate for solution for injection or infusion, in packs of 5 or 10&nbsp;ampoules.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><em>Marketing Authorisation Holder:<\/em><\/p>\n\n\n\n<p>hameln pharma gmbh<\/p>\n\n\n\n<p>Inselstra\u00dfe 1<\/p>\n\n\n\n<p>31787 Hameln<\/p>\n\n\n\n<p>Germany<br><\/p>\n\n\n\n<p><em>Manufacturer:<\/em><\/p>\n\n\n\n<p>HBM Pharma sro<\/p>\n\n\n\n<p>Sklabinsk\u00e1 30<\/p>\n\n\n\n<p>03680 Martin<\/p>\n\n\n\n<p>Slovakia<br><\/p>\n\n\n\n<p>hameln rds as<\/p>\n\n\n\n<p>Horn\u00e1 36<\/p>\n\n\n\n<p>90001 Modra<\/p>\n\n\n\n<p>Slovakia<br><\/p>\n\n\n\n<p><strong>This medicinal product is authorized under the European Economic Area under the names:<\/strong><\/p>\n\n\n\n<p><em>Bulgaria:&nbsp;<\/em>Amiodarone&nbsp;Hameln 50 mg\/ml<\/p>\n\n\n\n<p><em>Denmark:&nbsp;<\/em>Amiodarone&nbsp;Hameln<\/p>\n\n\n\n<p><em>Finland<\/em>&nbsp;:&nbsp;Amiodarone&nbsp;Hameln 50 mg \/ ml Injection \/ Infusion Concentrate, most commonly<\/p>\n\n\n\n<p><em>Croatia:<\/em>&nbsp;Amiodarone Hameln 50 mg \/ ml octopine concentrate for injection \/ infusion<\/p>\n\n\n\n<p><em>Netherlands:&nbsp;<\/em>Amiodarone&nbsp;HCl&nbsp;Hamelin 50 mg\/ml<\/p>\n\n\n\n<p><em>Norway:&nbsp;<\/em>Amiodarone&nbsp;Hameln<\/p>\n\n\n\n<p><em>Poland:&nbsp;<\/em>Amiodarone&nbsp;Hameln<\/p>\n\n\n\n<p><em>Slovakia:&nbsp;<\/em>Amiodarone&nbsp;Hameln 50 mg \/ ml<\/p>\n\n\n\n<p><em>Slovenia:<\/em>&nbsp;Amjodaron Hameln 50 mg \/ ml concentrate for injection \/ infusion<\/p>\n\n\n\n<p><em>United Kingdom:&nbsp;<\/em>Amiodarone&nbsp;Hydrochloride 50 mg\/ml Concentrate for Solution for Injection \/ Infusion<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><em>Czech Republic:&nbsp;<\/em>Amiodarone&nbsp;Hameln<\/p>\n\n\n\n<p><em>Germany:&nbsp;<\/em>Amiodarone&nbsp;-Hameln 50 mg\/ml concentrate for the preparation of an injection\/infusion solution<\/p>\n\n\n\n<p><em>Hungary:&nbsp;<\/em>Amiodarone&nbsp;Hameln 50 mg\/ml<\/p>\n\n\n\n<p><em>Austria:&nbsp;<\/em>Amiodarone&nbsp;Hameln 50 mg \/ ml concentrate for the preparation of an injection \/ infusion solution<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Amiodarone is a so-called antiarrhythmic and is used to treat an irregular heartbeat. Amiodarone works by controlling the heart if it is not beating normally.<\/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":[10629,10632,6622,6625,10633,6626,10631,10628,10630,6623],"class_list":["post-5327","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-amiodarone-hameln","tag-amiodarone-hameln-injection","tag-amiodarone-hydrochloride","tag-amiodarone-hydrochloride-injection","tag-side-effects-of-amiodarone-hameln","tag-side-effects-of-amiodarone-hydrochloride","tag-what-amiodarone-hameln-is-used-for","tag-what-amiodarone-hydrochloride-is-used-for","tag-what-is-amiodarone-hameln","tag-what-is-amiodarone-hydrochloride"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5327","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=5327"}],"version-history":[{"count":6,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5327\/revisions"}],"predecessor-version":[{"id":12752,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5327\/revisions\/12752"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5327"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5327"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5327"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}