NEOATRICON 1.5 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Neoatricon 1.5 mg/ml Solution for Infusion

dopamine hydrochloride

Read all of this leaflet carefully before your child starts using this medicine because it contains important information for your child.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Neoatricon and what is it used for
2. What you need to know before your child uses Neoatricon
3. How to use Neoatricon
4. Possible side effects
5. Storage of Neoatricon
6. Contents of the pack and other information

1. What is Neoatricon and what is it used for

Neoatricon contains the active substance dopamine hydrochloride. Dopamine is a substance that is produced naturally in the body. It increases blood pressure by activating specific receptors (targets), which causes the blood vessels to constrict.

Neoatricon is used to treat low blood pressure (hypotension) in newborn babies, infants, and children under 18 years of age.

2. What you need to know before your child uses Neoatricon

Do not give Neoatricon to your child

Talk to your doctor if you are not sure if any of the above applies to your child.

Warnings and precautions

Talk to your doctor or nurse before starting to use Neoatricon if:

• your child has any heart problems;
• your child is using or has recently used monoamine oxidase inhibitors (MAOIs), which are used, for example, to treat depression (see section "Other medicines and Neoatricon");
• your child has or has had a peripheral vascular disease (problems related to blood circulation in the hands and feet);
• your child has any kidney or liver disease;
• your child has low blood volume. Your child's doctor will take measures to ensure that their blood volume is normal before administering dopamine hydrochloride;
• your child has sepsis (a severe bacterial infection);
• your child has diseases associated with increased pressure in the arteries of the lungs;
• your child has a certain type of glaucoma (angle-closure glaucoma).

Your doctor will monitor your child to detect any adverse effects that affect the heart or kidneys while your child is receiving dopamine hydrochloride.

Your doctor will monitor your child's blood pressure and blood flow to reduce the risk of cerebral haemorrhage.

Neoatricon may increase the risk of infection, so your doctor will monitor your child closely and take infection prevention measures.

Your doctor will gradually reduce the use of Neoatricon to avoid low blood pressure.

Dopamine hydrochloride may cause changes in your child's blood test results. Your doctor may take blood samples to monitor them.

Other medicines and Neoatricon

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those bought without a prescription.

If your child is using other medicines, they should be used with caution, as some may interact with Neoatricon, for example:

• anaesthetics;
• certain medicines used to treat diabetes (e.g. repaglinide, sulfonylureas, etc.). Dopamine hydrochloride may increase blood glucose levels and interfere with antidiabetic medicines;
• certain medicines used to treat depression (tricyclic antidepressants), such as amitriptyline, desipramine, doxepin, imipramine, and nortriptyline;
• monoamine oxidase inhibitors (MAOIs), a type of medicine used to treat depression, such as selegiline, isocarboxazid, phenelzine, tranylcypromine, rasagiline, and linezolid;
• phenytoin, a medicine used to treat epilepsy;
• alpha-blockers and beta-blockers (medicines that are usually used to treat blood pressure and heart disorders), such as doxazosin, prazosin, terazosin, acebutolol, atenolol, bisoprolol, metoprolol, nadolol, nebivolol, and propranolol;
• ergotamine, a medicine used to treat headaches;
• metoclopramide, a medicine used to treat nausea and vomiting;
• guanethidine, a medicine used to treat high blood pressure;
• diuretics (medicines that increase urine production), such as bumetanide, torasemide, and furosemide.

If your child is taking any of the above medicines, talk to your doctor for more information about the possible consequences of these interactions.

Pregnancy and Breastfeeding

Neoatricon is indicated for use in children. 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.

If you are a woman of childbearing age, you should use an effective method of contraception during treatment with Neoatricon. The use of Neoatricon is not recommended during pregnancy.

However, your doctor will only use this medicine if the expected benefits outweigh any potential risk to your baby.

It is not known if Neoatricon is excreted in breast milk. However, since Neoatricon is rapidly eliminated from your body, you may use Neoatricon during breastfeeding.

Driving and Using Machines

Do not drive or use machines if you are taking this product.

Neoatricon contains Sodium Metabisulfite

In rare cases, this excipient may cause hypersensitivity reactions (severe allergy) and bronchospasm (excessive and prolonged contraction of the muscles of the airways that makes breathing difficult).

This medicine contains less than 23 mg of sodium in each dose; it is essentially "sodium-free".

3. How to Use Neoatricon

Dose and Method of Administration

Your doctor will decide the most suitable dose for your child. The dose will depend on your child's illness and body weight. The rate of administration will be carefully controlled and adjusted according to your child's response.

This medicine will be administered by infusion (drip) into a large vein under the supervision of a doctor. In newborns, the medicine may also be administered into the umbilical cord.

Your child's breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be closely monitored while they are receiving Neoatricon.

If your child's blood volume is low, they may be given a blood transfusion or a plasma expander (fluids that increase the volume of circulating blood) before they are given this medicine.

Tell your doctor or nurse if your child feels burning, pain, or swelling around the intravenous needle when dopamine hydrochloride is administered. If the infusion of the medicine leaks from the vein into the surrounding tissues, it can damage (e.g. blister; tissue death) the surrounding tissues. Tell your doctor if you or your child notice pain or swelling at the injection site so that they can receive the appropriate treatment.

If Too Much or Too Little Dopamine Hydrochloride is Administered

This medicine will be administered to your child in a hospital, under the supervision of a doctor. It is unlikely that your child will receive too much or too little dopamine hydrochloride. However, tell your doctor or nurse if you have any doubts.

4. Possible Side Effects

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

Serious Side Effects

If you notice any change in the way your child feels during or after treatment, tell your doctor immediately:

• severe allergic reaction: your child may experience a sudden rash with itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), and may feel like they are going to faint (frequency not known);
• gangrene (tissue death and decay; you may notice a change in skin colour even to black) (uncommon);
• severe palpitations (frequency not known); ventricular tachycardia up to ventricular fibrillation (uncommon).

These are serious side effects. Your child may need urgent medical attention.

Other Side Effects

If any of the following side effects occur, tell your doctor as soon as possible:

Common side effects (may affect up to 1 in 10 people)

• sinus tachycardia (fast heart rate);
• palpitations (strong or irregular heartbeats);
• angina pectoris (a type of chest pain caused by reduced blood flow to the heart);
• ectopic heartbeats (change in heartbeats that are otherwise normal);
• dyspnoea (difficulty breathing);
• hypotension (low blood pressure);
• vasoconstriction (narrowing of the blood vessels);
• nausea (feeling sick);
• vomiting;
• headache.

Uncommon side effects (may affect up to 1 in 100 people)

• hypertension (high blood pressure);
• abnormalities in the electrocardiogram (a tracing of the electrical currents in the heart; aberrant conduction);
• mydriasis (pupil dilation);
• bradycardia (slow heart rate);
• azotemia (abnormally high levels of nitrogen-containing compounds, such as urea, in the blood);
• episodes of abnormally fast heart rate (supraventricular and ventricular tachycardia);
• very rapid contractions of the lower chambers of the heart, which make the heart unable to pump blood effectively (ventricular fibrillation);
• piloerection (gooseflesh);
• gangrene (tissue death and decay; you may notice a change in skin colour even to black);
• necrosis of the skin (skin death).

Frequency not known (cannot be estimated from the available data)

• increased risk of bleeding after surgery in the abdominal (belly) area or in patients with a tendency to bleed in the gastrointestinal tract (stomach and intestine);
• increased hypoxaemia (low oxygen levels in the blood) in patients dependent on ventilators;
• decreased renal blood flow (kidneys) at higher doses, due to vasoconstriction;
• infection;
• suppression of pituitary function;
• local necrosis due to extravasation (leakage of the infusion from the vein and damage to the surrounding tissue).

Reporting of Side Effects

If your child experiences any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Neoatricon

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 vial and carton after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature. Keep the container in the outer packaging to protect it from light.

Neoatricon is a single-dose vial for single use. The medicine should be used immediately after the first opening. Any unused contents should be discarded.

Do not use this medicine if you notice that the solution is opaque, cloudy, or discoloured.

6. Contents of the Pack and Other Information

Composition of Neoatricon

The active substance is dopamine hydrochloride.

Neoatricon 1.5 mg/ml Solution for Infusion

Each millilitre of solution contains 1.5 milligrams of dopamine hydrochloride. Each 30 ml vial contains 45 mg of dopamine hydrochloride.

The other excipients are sodium metabisulfite (E223) (see section 2 "Neoatricon contains sodium metabisulfite"), water for injections, sodium hydroxide (for pH adjustment), and diluted hydrochloric acid (for pH adjustment).

Appearance and Packaging of the Product

Neoatricon solution for infusion is a clear, colourless or pale yellow solution. It is presented in a transparent glass vial with a rubber stopper and sealed with an aluminium flip-off cap.

Package Size

Neoatricon 1.5 mg/ml is presented in a single 30 ml vial, packaged in an outer carton.

Marketing Authorisation Holder

BrePco Biopharma Limited,

Suite One, The Avenue, Beacon Court,

Sandyford,

Dublin D18 HX31,

Ireland

Manufacturer

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park,

Paola PLA3000,

Malta

Date of Last Revision of this Leaflet

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

Instructions for Use and Handling

For intravenous use. Administer through a central line [umbilical venous catheter (UVC), peripherally inserted central catheter, or central venous catheter (CVC)]. If central access is not available, use a cannula in a large vein.

An appropriate measuring device is required in the infusion system to control the rate and flow.

For single use. Discard any unused contents.

Do not dilute.

Do not use if discolouration of the solution is observed.

The maximum acceptable duration for administration of a single vial is 24 hours.

Incompatibilities

Neoatricon solution for infusion should not be added to any alkaline intravenous solution, i.e. sodium bicarbonate. In the absence of compatibility studies, this medicine should not be mixed with others.

It is recommended to avoid mixtures containing gentamicin sulfate, cefalotin sodium, cefalotin neutral in sodium, or oxacillin sodium, unless all other viable alternatives have been exhausted. Mixtures of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible and result in the degradation of both drugs. They should not be mixed.

Mixtures of dopamine and amphotericin B in 5% glucose solution are incompatible, as a precipitate forms immediately after mixing.

Dosing Table for Patients with a Weight between 2 kg and 9 kg

The following dosing recommendations apply to the use of Neoatricon 1.5 mg/ml in patients with a body weight of 2 to 9 kg.

Instructions for In-Use Handling

This medicine does not require any special storage temperature. Keep the container in the outer packaging to protect it from light.