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Document: leaflet MAH GENERIC_PL 29831-0075 change

• leaflet MAH GENERIC_PL 25215-0003
• leaflet MAH GENERIC_PL 29831-0075

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Package leaflet: Information for the user Dobutamine 12.5mg/ml Concentrate for Solution for Infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, please ask your doctor or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may haim them, even if

as yours.

- If you get any side effects, talk to PHARMA CODE AREA    your doctor or nurse This includes

any possible side effects not listed in this leaflet. The name of your medicine is Dobutamine 12.5mg/ml

Concentrate for Solution for Infusion. In the rest of this leaflet it is

called Dobutamine Sterile Concentrate.

What is in this leaflet:

1.    What Dobutamine Sterile Concentrate is and what it is used for

2.    What you need to know before you are given Dobutamine Sterile Concentrate

3.    How Dobutamine Sterile Concentrate should be given

4.    Possible side effects

5.    How to store Dobutamine Sterile Concentrate

6.    Contents of the pack and other information

The active ingredient in Dobutamine Sterile Concentrate is

Dobutamine hydrochloride belongs to a group of medicines called ‘sympathomimetic agents'.

Dobutamine Sterile Concentrate is used for the treatment of heart failure due to:

It is also used to assist the function of the heart in patients having open heart surgery, or on a ventilator.

Paediatric Population

Dobutamine is indicated in all paediatric age groups (from neonates to 18 yeans of age) as inotropic support in tow cardiac output hypoperfusion states resulting from decompensated heart failure, following cardiac surgery, cardiomyopathies and in cardiogenic or septic shock.

z what™

You should not be given Dobutamine Sterile Concentrate if you: (used as a preservative see important information below) or any of the other ingredients (see “What Dobutamine Sterile Concentrate contains' in section 6) hayfever (atopy)

' he adrenal gland (phaeocht ,    ,

jstoa group of drugs

called monoamine oxidase inhibitors

(e.g phenelzine or isocarboxacid) or have taken such a dmg in the

last 14 days

Warnings and precautions

Speak to your doctor before being given Dobutamine Sterile Concentrate if you:

♦    are suffering from problems of an overactive thyroid gland

♦    have heart disease or problems with your heart rhythm

♦    have had a heart attack

♦    have an obstruction of blood flow from your heart

♦    suffer from hardening and nairowing of blood vessels (such as arteriosclerosis)

♦    have high blood pressure

♦    have a localised weakness of the wall of a blood vessel (aneurysm)

♦    sufferfromdiabetesmellitus

♦    have high pressure in your eye (glaucoma)

♦    do not have enough blood pumping around your body causing a very low blood pressure (cardiogenic shock).

Speak to your doctor before being given Dobutamine Sterile Concentrate if you are elderly.

If any of the above statements apply to you, speak to your doctor or nurse before you are given Dobutamine Sterile Concentrate.

Talk to your doctor or pharmacist if you need to take dobutamine for more than 3 days as you may become tolerant to it.

If you have hypovolaemia

♦    If you have hypovolaemia (a lower volume of blood in your body than you should have), or imbalances in oxygen and carbon dioxide levels in your blood, these conditions will need to be corrected before and during your dobutamine treatment.

Children

Increments in heart rate and blood pressure appear to be more frequent and intense in children than in adults. The new-born baby cardiovascular system has been reported to be less sensitive to dobutamine and hypotensive effect (low blood pressure) seems to be more often observed in adult patients than in small children. Accordingly, the use of dobutamine in children should be monitored closely.

Other medicines and Dobutamine Sterile Concentrate

Taking another medicine while you are being given Dobutamine Sterile Concentrate can affect how it or the other medicine works. Please inform your doctor or nurse if you are taking or have recently taken any other medicines, even those you may have bought yourself without a prescription.

It is particularly important that you tell your doctor or nurse if you are taking or need to take any of the following:

♦    drugs known as beta blockers used for high blood pressure

(e.g.propranolol, acebutolol, atenolol, bisoprolol, carvedilol, celiprolol, esmolol, labetolol, metoprolol, nadolol, nebivolol, oxprenolol, pindolol, sotalol, timolol) - since Dobutamine Sterile Concentrate interacts with these and your blood pressure could become too high and your heart rate may slow

♦    doxapram, used to treat severe breathing problems - since

if taken with Dobutamine Sterile Concentrate your blood pressure may become too high

♦    cimetidine, an ulcer healing drug - since this can increase the levels of Dobutamine Sterile Concentrate

Please also check with your doctor if you are taking or need to take any of the following or any other medication:

(e.g. cyclopropane, habthane)

♦    alpha-blockers, such as phenoxybenzamine. These drngs are used to treat high blood pressure and prostate problems

♦    otherdrngs used for heart problems, heart rhythm problems and high blood pressure ( e. g. quinidine and digoxin)

♦    some drugs taken for depression such as:

-    tricyclic antidepressants (e.g. amitriptyline, clomipramine, dosulepin / dothiepin doxepin, imipramine, lofepramine, nortriptyline, trimipramine, mianserin, trazodone)

-    monoamine oxidase inhibitors (e.g. phenelzine, isocarboxacid)

♦    Entacapone, used to treat Parkinson’s Disease.

♦    calcium chloride, used to treat a low level of calcium in the blood

♦    ergotamine and methyseiglde, used to treat migraine

♦    ergometiine, used to prevent or treat postnatal bleeding

♦    oxytocin, used to induce labour orto prevent or treat postnatal bleeding

' used in the treatment of Parkinson’s disease.

Pregnancy and breast-feeding

You should let your doctor know immediately if you are pregnant or trying for a baby before this medicine is administered.

You should not breast feed whilst taking Dobutamine Sterile Concentrate. You should let your doctor know if you are breastfeeding or want to start breast-feeding while you are having treatment with Dobutamine Sterile Concentrate.

1.    NAME OF THE MEDICINAL PRODUCT

Dobutamine I2.5mg/ml Concentrate for Soli

2.    QUALITATIVE AND QUANTITATIVE

3.    PHARMACEUTICAL FORM

Concentrate for solution for infu

4.    CLINICAL PARTICULARS

ted in adults as inotropic support in the short term treatme terised by low output cardiac failure, e.g. myocardial infarct

ig positive end expiratory pressure (PEEP)

ventilation.

Paediatric population

Dobutamine is indicated in all paediatric age groups (from neonates to 18 years of age) as inotropic support in low cardiac output hypoperfusio decompensated heart failure, following cardiac surgery, c cardiogenic or septic shock.

4.2 Posology and method of administration Dobutamine is administered by continuous intravenous infusion due to the short half-life of dobutamine. The solution must first be diluted to at least 50ml in an iv container with one of the following intravenous solutions:

Sodium Chloride Intravenous Infusion BP 5% Glucose Intravenous Infusion BP 5% Glucose + 0.9% Sodium Chloride Intravenous Infusion BP 5% Glucose + 0.45% Sodium Chloride Intravenous Infusion BP Sodium Lactate Intravenous Infusion BP

20ml Dobutamine Sterile Concentrate will yield the following concentrations when diluted:

In 250ml: 1000 micrograms/ml of dobutamine In 500ml: 500 micrograms/ml of dobutamine

In 50ml: 5,000 micrograms/ml (only appropriate in patients on restricted fluid intake, for administration by infusion pump for accuracy of dosing).

The prepared solution should be used within 24 hours.

After dilution, dobutamine should be administered intravenously through an intravenous needle or catheter. An iv drip chamber or other suitable metering device i essential for controlling the rate of flow in drops per minute.

Adults, including the elderly: minute have been

It is recommended that treatment with Paediatric population

For all paediatric age groups (neonates to 18 years) an initial dose of 5 micrograms/ kg/minute, adiusted according to clinical response to 2-20 micrograms/kg/minute _

produce a response.

There is reason to believe that the minimum effective dosage for children is higher than for adults. Caution should be taken in applying high doses, because there is also reason to believe that the maximum tolerated dosage for children is lower than the one for adults. Most adverse reactions (tachycardia in particular) are observed when dosage was higher thar/equal to 7.5 micrograms/kg/minute, but reducing or termination of the rate of dobutamine infusion is all that is required for a rapid reversal of undesirable effects.

A great variability has been noted between paediatric patients in regard to both the plasma concentration necessary to initiate a hemodynamic response (threshold) and the rate of hemodynamic response to increasing plasma concentrations, which demonstrates that the required dose for children cannot be determined a priori and should be titrated in order to allow for the supposedly smaller “therapeutic width" in children.

Method of administration

For continuous intravenous infusion using an infusion pump, dilute to a concentration of 0.5 to img/mL (max 5mg/mL if fluid restricted) with Glucose 5% or Sodium Chloride 0.9%. Infuse higher concentration solutions through central venous catheter only. Dobutamine intravenous infusion is incompatible with bicarbonate and other strong alkaline solutions.

Neonatel intensive care: Dilute 30mg/kg body weight to a final volume of 50mL of infusion fluid. An intravenous infusion rate of 0.5mL/hour provides a dose of 5 micrograms/kg/minute.

Previous hypersensitivity to dobutamine, sodium metabisulphite or other ingredients. Sulphites may cause hypersensitivity reactions including anaphylactic symptoms and lfe-threatening or serious asthmatic attacks in those affected. Hypersensitivity is observed more frequently in asthmatic or atopic patients.

Avoid the use of sympathomimetic agents in patients with phaeochromocytoma.

4.4    Special warnings and precautions for use

In general, sympathomimetic agents should be used with caution in patients who may be particularly susceptible to their effects, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease, acute heart failure, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension or aneurysms. Anginal pain may be precipitated in patients with ischaemic heart disease, particularly after myocardial infarction. Care is also required when sympathomimetic agents are given to patients with diabetes mellitus or closed angle glaucoma.

In particular, dobutamine should be avoided or used only with great caution in patients with marked obstruction of cardiac ejection, such as idiopathic hypertrophic subaortic stenosis. It may exacerbate pre-existing tachycardia and hypertension. Metabolic acidosis, hypoxia, hypercapnia and hypovolaemia should be corrected before and during dobutamine treatment. Use with caution in cardiogenic shock complicated by severe hypotension.

If an undue increase in heart rate or systolic blood pressure occurs during administration of dobutamine, or an arrhythmia is precipitated, the dose should be reduced or interrupted.

Special care should be taken with the use of dobutamine in the elderly Tolerance may occur with continuous infusions of dobutamine over more than 72 hours

Paediatric population

Dobutamine has been administered to children with low-output hypoperfusion states resulting from decompensated heart failure, cardiac surgery and cardiogenic and septic shock. Some of the haemodynamic effects of dobutamine hydrochloride may be quantitatively or qualitatively different in children as compared to adults. Increments in heart rate and blood pressure appear to be more frequent and intense in children. Pulmonary wedge pressure may not decrease in children, as it does in adults, or it may actually increase, especially in infants less than one year old. The neonate cardiovascular system has been reported to be less sensitive to dobutamine and hypotensive effect seems to be more often observed in adult patients then in small children.

Accordingly the use of dobutamine in children should be monitored closely bearing in mind these pharmacodynamic characteristics.

4.5    Interaction with other medicinal products and other forms of interactions

Alpha-blockers: Potential for hypotension and tachycardia to occur with concomitant administration of sympathomimetics and alpha-blockers such as phenoxybenzamine. Anaesthetics: Although it is less likely than adrenaline to produce ventricular arrhythmias, dobutamine should be used with extreme caution during anaesthesia with cyclopropane, halothane and other halogenated anaesthetics.

Anti-arrhythmics: An increased risk of arrhythmias may occur if sympathomimetic agents are given to patients receiving quinidine.

Antidepressants: Hypertension and an increased risk of arrhythmias may occur f sympathomimetic agents are given to patients receiving tricyclic antidepressants. Many sympathomimetics interact with MAOIs (possibility of hypertensive crisis), and should not be given to patients receiving such treatment or within 14 days of its termination.

Antihypertensives: Special care is advisable in patients receiving antihypertensive therapy in whom dobutamine may increase blood pressure.

Beta-blockers: The inotropic effects of dobutamine on the heart are reversed by concomitant administration of beta-blockers. Dobutamine may be ineffective or may have a slight vasoconstricting effect in patients who have recently received beta-blockers. There is a possibility of severe hypertension and bradycardia occurring with concurrent use of dobutamine and beta-blockers, especially non-selective beta-blockers.

Calcium Chloride: Calcium chloride infusion may reduce the cardiotonic effects of dobutamine.

Cardiac Glycosides: An increased risk of arrhythmias may occur if sympathomimetic agents are given to patients receiving cardiac glycosides.

Cimetidine: It is possible that cimetidine may inhibit the uptake and/or the metabolism of dobutamine by the liver with a subsequent increase in the degree and duration of its action.

Doxapram: An increased risk of hypertension with concomitant use of the sympathomimetic agents and doxapram.

Entacapone: The effects of dobutamine may be enhanced by concomitant administration of entacapone.

Ergot Alkaloids: Potential for ergotism to occur with concomitant administration of sympathomimetics and ergotamine or egometrine (ergonovine) or methysergide.

There is a possibility of ergotamine or egometrine (ergonovine) enhancing the pressor effect and severe hypertension occurring.

Oxytocin: There is a possibility of oxytocin enhancing the pressor effects of sympathomimetics with or without hypertension.

Rasagiline: Avoid concomitant use of sympathomimetics with rasagiline.

4.6    Pregnancy and lactation

Studies in rats and rabbits have revealed no evidence of a teratogenic effect of dobutamine. There are no adequate studies in human pregnancy and therefore dobutamine should not be used without very careful consideration of the balance of risk.