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Amiodarone Hydrochloride 50 Mg/Ml Concentrate For Solution For Injection And Infusion

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion


Amiodarone hydrochloride

Read all of this leaflet carefully before you start taking 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 only 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 Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is and what it is used for

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2.    What you need to know before Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is given

3.    How Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is used

4.    Possible side effects

5.    How to store Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion

6.    Contents of the pack and other information

What Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is and what it is used for


What you need to know before Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is given


How Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is used


Amiodarone Hydrochloride belongs to group of medicines called class III antiarrhythmics that are given to treat severe disturbances in heart rhythm and rapid heart rate.

Amiodarone Hydrochloride is used when the patient is not responding to other treatments or when other treatments cannot be used.

Amiodarone Hydrochloride must not be given if you:

• are allergic (hypersensitive) to amiodarone

hydrochloride or/and iodine or any of the

ingredients in this medicine (listed in section 6).

•    have certain heart problems such as a very slow heart beat (sinus bradycardia)

•    you have any other problems with your heartbeat and do not have a pacemaker fitted

•    have or have previously had thyroid problems

•    have severe breathing problems

•    have severe blood circulation problems or very low blood pressure are being treated with any other medicines which may cause heart rhythm disturbance (called torsades de pointes) - for list of medicines see section “Taking other medicines” below.

•    are pregnant or breastfeeding (use is allowed only in life-threatening circumstances)

This product must not be given to children, premature babies or neonates.

If you think any of the above situations applies to you, consult your doctor or pharmacist.

Warnings and precautions

Amiodarone Hydrochloride should be given

with care if you:

•    have low blood pressure.

•    have a weak heart (“cardiomyopathy”) or heart failure.

•    are an elderly person (> 60 years).

•    have liver problems. Treatment is to be started and normally monitored only under hospital or specialist supervision. This medicine contains benzylalcohol (see section “Important information about some of the ingredients of Amiodarone Hydrochloride”).

•    have any problems with your eyesight. This includes an illness called ‘optic neuritis’.

•    are to undergo a general anaesthetic.

•    require oxygen treatment.

•    are taking certain other medicines - for list of medicines see section - “Other medicines and Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion” below.

Other medicines and Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, herbal medicines or natural products. In particular, you should check with your doctor if you are taking any of the following to be sure that it is safe to give Amiodarone Hydrochloride:

Medicines which may cause heart rhythm disturbance (called torsades de pointes):

•    other medicines to treat irregular heart beat (e.g. quinidine, procainamide, disopyramide, sotalol, bretylium, flecainide).

•    some medicines used to treat infections (e.g. erythromycin injections, pentamide injections, co-trimoxazole, moxifloxacin and fluoroquinolones such as ciprofloxacin, ofloxacin, levofloxacin).

•    some medicines used to treat mental illness (e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride and sertindole).

   lithium and tricyclic anti-depressants (e.g. doxepin, maprotiline, amitriptyline).

•    certain antihistamines (e.g. terfenadine, astemizole, mizolastine).

   anti-malarials e.g. (quinine, mefloquine, chloroquine, halofantrine).

Or some other medicines such as:

   digoxin (taken for heart problems)

•    warfarin (blood thinning medications)

   phenytoin (most often used to treat epilepsy)

•    some medicines used to treat high blood pressure and angina (e.g. verapamil, diltiazem, beta-blockers)

•    ciclosporin, tacrolimus - used after

transplant operation to suppress the immune system

   medications to lower cholesterol levels

(statins - such as simvastatin, atorvastatin, lovastatin)

   tetracosactrin (used in some blood tests or sometimes in the treatment of Crohn's disease)

•    drugs which may change the levels of potassium or magnesium in your blood e.g. diuretics (water tablets), steroid tablets or amphotericin injection (an antifungal)

•    sildenafil (known as “Viagra”)

•    fentanyl (used for pain relief)

•    lidocaine (medication for regional anaesthesia)

   midazolam, triazolam (used to relieve anxiety or to help you relax before surgery)

•    ergotamine, dihydroergotamine (medication against migraine)

Ask your doctor if you are not sure what these medicines are.

Amiodarone Hydrochloride with food, drink and alcohol

Grapefruit juice can increase the blood level of amiodarone and should be avoided during treatment with Amiodarone Hydrochloride.

You should limit the amount of alcohol you drink whilst being treated with this medicine.

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine and for a few months after you have finished taking it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:

•    Make sure you use high factor sun cream

•    Always wear a hat and clothes which cover your arms and legs

Pregnancy and breast-feeding

Your doctor will prescribe Amiodarone Hydrochloride only if he/she considers the benefit of treatment outweighs the risks during your pregnancy. Amiodarone Hydrochloride can be used during pregnancy in the life-threatening circumstances only

You should not be given Amiodarone Hydrochloride if you are breast-feeding. If you are given Amiodarone Hydrochloride during pregnancy or breast-feeding, breast-feeding should be stopped.

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 this medicine.

Driving and using machines

Your doctor will tell you how long to wait before driving a car or using machines after you are given this medicine.

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion contains benzyl alcohol

This product contains benzylalcohol (20 mg/ml) as preservative. It may cause toxic reactions and allergic reactions in infants and children up to 3 years old.

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is given intravenously (into a vein) after dilution with 5% glucose solution and administered to you by your healthcare professional.

The dose of medicine given will depend upon your medical condition, your age and your bodyweight.

Adults (including elderly)

Starting dose

The standard recommended dose is 5 mg/kg bodyweight. However, this may vary depending upon your age and how well you respond to treatment.

This medicine will be diluted using 5% glucose solution before it is given to you over a period of 20 minutes to 2 hours. It will be given slowly, usually via a drip into a vein in your arm or chest. Depending on your response, you may be given further infusions up to 1200 mg (approximately 15 mg/kg bodyweight) in up to 500 ml 5% glucose per 24 hours.

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The following technical information is intended for medical or healthcare professionals only:

For single dose use only Discard any unused solution immediately after initial use as specified in the Summary of product characteristics.

The dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.

Solutions containing less than 300 mg of amiodarone (two vials) in 500 ml of glucose are not stable and must not be used. It should also be stressed that no other compounds are to be mixed to amiodarone infusion solution.

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion should be administered solely in 5% glucose solution.

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion must not be mixed with other medicinal products in the same syringe.

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion must not be used with saline or any other equipment or devices containing plasticizers such as DEHP.

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Maintenance dose:

10 - 20 mg per kg bodyweight in physiological glucose solution can be given every 24 hours (on average 600 to 800 mg/ 24 hours up to a maximum of 1200 mg/ 24 hours accordingly 4-5 ampoules, maximum 8 ampoules) for a few days.

In some conditions the medicine may be given as a slow injection of 150-300 mg in 10-20 ml 5% glucose over a minimum of 3 minutes. If Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and

Infusion is given in this way you will be closely monitored.

As soon as an adequate response has been obtained using intravenous treatment, you may be switched to oral treatment.

Elderly patients should be closely monitored during treatment, particularly for thyroid function.

Use in children and adolescents

There are only limited data on the efficacy and safety in children. Your doctor will decide on an appropriate dose.

Patients with liver and kidney problems

Although no dosage adjustment for patients with kidney or liver abnormalities has been defined during chronic treatment with oral amiodarone, close clinical monitoring is prudent for elderly patients.

If you have any further questions on the use of this product, ask your doctor or the other healthcare professionals.

If you are given more Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion than you should

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much. However, tell your doctor or pharmacist if you have any concerns.


than normal, pale skin, breathlessness and frequent infections. These can all occur if you have a very low number of the blood cells.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme

(www.mhra.gov.uk/yellowcard). By reporting side affects you can help provide more information on the safety of this medicine.


How to store Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion


4 Possible side effects


Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and vials after EXP. The expiry date refers to the last day of that month.

Concentrate

Do not store above 25°C. Keep the vials in the outer carton in order to protect from light.

Diluted medicinal product

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

For single use only.

Discard any unused solution.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately. These are very serious side effects and you may need urgent medical attention.

•    breathing difficulties

•    chest pain

•    severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), you may feel you are going to faint and there may be inflammation of some of your blood vessels.

If you experience any of the following tell your doctor as soon as possible.

Very common (may affect more than 1 in 10 people)

•    blurred eyesight or seeing a coloured halo in dazzling light

•    burning more easily in the sun (see ‘Protect your skin from sunlight’ in Section 2)

Common (may affect up to 1 in 10 people)

•    generally moderate slow heart rate

•    decrease in blood pressure

•    local injection site reactions including swelling, pain, redness, infection, and pigmentation changes (blue or grey marks on parts of your skin exposed to sunlight, especially the face)

•    feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat.These could be signs of an illness called ‘hyper-thyroidism’

•    feeling extremely tired, weak or ‘run-down’, weight gain, being unable to stand the cold, constipation and aching muscles. These could be signs of an illness called ‘hypo-thyroidism’

•    trembling when you move your arms or legs

•    muscle weakness

•    nightmares

•    problems sleeping

Uncommon (may affect up to 1 in 100 people)

•    feeling numb or weak, tingling or burning feelings in any part of your body

•    dizziness

Rare (may affect up to 1 in 1,000 people)

•    the excipients benzyl alcohol may cause hypersensitivity reactions

Very rare (may affect up to 1 in 10,000 people)

•    chest pain or palpitations, or abnormal heart rhythm

•    nausea

•    liver disorders

•    generalised allergic reactions such as swelling of the face, lips and/or tongue, shortness of breath, headaches, breathing difficulties (with or without fever)

•    inability to breathe

•    hot flushes

•    sweating

•    red, scaly patches of skin, loss of hair or loosening of nails (called ‘exfoliative dermatitis’)

•    loss of eyesight in one eye or your eyesight becomes dim and colourless. Your eyes may feel sore or tender and feel painful to move. This could be an illness called ‘optic neuropathy or neuritis’

•    skin rash

•    skin redness during radio-therapy

•    moving unsteadily or staggering, slurred or slow speech

•    headache (which is usually worse in the morning or happens after coughing or straining), feeling sick (nausea) fits, fainting, eyesight problems or confusion can occur. These could be signs of problems with your brain

•    headache

Not known (frequency cannot be estimated from the available data)

•    hives (itchy, lumpy rash)

•    back pain

•    weakness, bleeding or bruising more easily

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Contents of the pack and other information


What Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion contains

•    The active substance is amiodarone hydrochloride. Each 3 millilitre vial contains 150 mg of amiodarone hydrochloride.

One millilitre sterile concentrate contains 50 mg of amiodarone hydrochloride.

•    The other ingredients are benzyl alcohol (20.2 mg/ml), polysorbate 80, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

What Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion looks like and contents of the pack

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is a clear yellowish, sterile solution free from particles, contained in an amber glass vial closed with a rubber stopper and aluminium seal with a grey flip-off button.

The vials are packed in cartons containing 1, 5, 6, 10 or 25 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

or

Salutas Pharma GmbH Dieselstrasse 5 70839 Gerlingen Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57 1526 Ljubljana Slovenia

This leaflet was last revised in 05/2014.


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Intravenous infusion:

The calculated dose is diluted with 250 ml 5% glucose. See section 4.2 of the Summary of product characteristics.


Intravenous injection:

150-300 mg (corresponding to 3-6 ml Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion) is

diluted with 10-20 ml 5% glucose. See section 4.2 of the Summary of product characteristics.

Any unused product or waste material should be disposed of in accordance with local requirements.

The use of administration equipment or devices containing plasticizers such as DEHP (di-2-ethylhexylphthalate) in the presence of amiodarone may result in leaching out of DEHP. In order to minimise patient exposure to DEHP, in any case when the administration will take more than 2 hours, the final amiodarone dilution for infusion should preferably be administered through non DEHP-containing sets, like glass or polyolefin sets (PE, PP).


Diluted medicinal product

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.    SZ0“°


Artwork Proof Box

Ref: V009 - brand alignment & Art. 45 + Nat Phase

Proof no. Date prepared: 005.1 09/05/2014

Font size: 7.5pt

Colours:

■ Black □ □ □

Fonts:

Helvetica

^ Dimensions: 1 36 x 590.5 mm

__