Neoatricón 1.5 mg/ml solution for infusion
Spain
Table of Contents
Package leaflet: Information for the user
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, as you may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
Leaflet contents
- What Neoatricon is and what it is used for
- What you need to know before your child uses Neoatricon
- How to use Neoatricon
- Possible side effects
- How to store Neoatricon
- Contents of the pack and other information
1. What Neoatricon is and what it is used for
Neoatricon contains the active substance dopamine hydrochloride. Dopamine is a substance that occurs naturally in the body. It increases blood pressure by activating specific receptors (targets), causing blood vessels to constrict.
Neoatricon is used to treat hypotension (low blood pressure) in newborns, 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 if
- Your child is allergic to dopamine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- Your child has phaeochromocytoma (a tumor of the adrenal gland).
- Your child has untreated atrial or ventricular tachyarrhythmia (abnormal or irregular heartbeats in the upper or lower chambers of the heart) or ventricular fibrillation (dangerous, irregular, and uncoordinated contractions of the lower chambers of the heart).
- Your child has an overactive thyroid gland.
- Your child is receiving cyclopropane or halogenated hydrocarbon anesthetics.
Talk to your doctor if you are unsure whether any of the above situations apply to your child.
Warnings and precautions
Talk to your doctor or nurse before starting 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 peripheral vascular disease (circulation problems in the hands and feet);
- Your child has kidney or liver disease;
- Your child has low blood volume. Your child's doctor will take steps to restore blood volume to normal before administering dopamine hydrochloride;
- Your child has sepsis (a serious bacterial infection);
- Your child has conditions associated with increased pressure in the lung arteries;
- Your child has a certain type of glaucoma (angle-closure glaucoma).
Your doctor will monitor your child for any adverse effects affecting 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 hemorrhage.
Neoatricon may increase the risk of infection, so your doctor will closely monitor your child and take preventive measures against infections.
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 these.
Other medicines and Neoatricon
Tell your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those obtained without a prescription.
Special care is needed if your child is taking other medicines, as some may interact with Neoatricon, for example:
- Anesthetics;
- 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 commonly 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 medicines listed above, consult your doctor for further information about 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 plan to become pregnant, consult your doctor before using this medicine.
If you are a woman of childbearing potential, you should use an effective method of contraception during treatment with Neoatricon. The use of Neoatricon during pregnancy is not recommended.
However, your doctor will only use this medicine if the expected benefits outweigh any potential risk to the baby.
It is unknown whether Neoatricon is excreted in human breast milk. However, since Neoatricon is rapidly eliminated from the body, Neoatricon may be used during breastfeeding.
Driving and use of machines
Do not drive or operate machinery if you are taking this product.
Neoatricon contains sodium metabisulfite
Rarely, this excipient may cause hypersensitivity reactions (severe allergy) and bronchospasm (excessive and prolonged contraction of the muscles in the airways causing breathing difficulty).
This medicine contains less than 23 mg of sodium per dose; this is, essentially "sodium-free".
3. How to use Neoatricon
Dosage and method of administration
Your doctor will decide the most appropriate dose for your child. The dose will depend on your child's condition and body weight. The infusion rate will be carefully controlled and adjusted according to your child's response.
This medicine will be administered by intravenous infusion (drip) into a large vein under the supervision of a doctor. In newborns, the medicine may also be administered via the umbilical cord.
Your child's breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be closely monitored while receiving Neoatricon.
If your child has low blood volume, a blood transfusion or a plasma expander (fluids that increase the volume of circulating blood) may be given before administering this medicine.
Inform your doctor or nurse if your child feels burning, pain, or swelling around the intravenous needle when dopamine hydrochloride is administered. If the infusion leaks from the vein into surrounding tissues, it may damage (e.g., blistering; tissue necrosis) the surrounding tissues. Inform your doctor if you or your child notice pain or swelling at the injection site so that appropriate treatment can be provided.
If too much or too little dopamine hydrochloride is administered
This medicine will be given 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. However, inform your doctor or nurse if you have any concerns.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
Serious adverse reactions
If you notice any change in how your child feels during or after treatment, inform your doctor immediately:
- severe allergic reaction: your child may experience a sudden itchy rash
- (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), and may feel faint (frequency not known);
- gangrene (tissue decay and death; you may notice a change in skin color, even turning black) (uncommon);
- severe palpitations (frequency not known); ventricular tachycardia up to ventricular fibrillation (uncommon).
These are serious adverse effects. Your child may require urgent medical attention.
Other adverse reactions
If any of the following adverse effects occur, inform your doctor as soon as possible:
Frequent adverse effects (may affect up to 1 in 10 people)
- sinus tachycardia (fast heartbeat);
- palpitations (strong heartbeats that may be rapid or irregular);
- anginal pain (a type of chest pain caused by reduced blood flow to the heart);
- ectopic heartbeats (changes in otherwise normal heart rhythm);
- dyspnea (difficulty breathing);
- hypotension (low blood pressure);
- vasoconstriction (narrowing of blood vessels);
- nausea (feeling sick);
- vomiting;
- headache.
Uncommon adverse effects (may affect up to 1 in 100 people)
- hypertension (high blood pressure);
- electrocardiogram abnormalities (an electrical tracing of the heart; aberrant conduction);
- mydriasis (dilation of the pupil);
- bradycardia (slow heart rate);
- azotemia (abnormally high levels of nitrogen-containing compounds, such as urea, in the blood);
- episodes of abnormally rapid heart rate (supraventricular tachycardia and ventricular tachycardia);
- very rapid contractions of the lower chambers of the heart, causing the heart to be unable to pump blood effectively (ventricular fibrillation);
- piloerection (goosebumps);
- gangrene (tissue decay and death; you may notice a change in skin color, even turning black);
- skin necrosis (tissue death).
Frequency not known (cannot be estimated from available data)
- increased risk of bleeding after abdominal surgery or in patients with a tendency to bleed in the gastrointestinal tract (stomach and intestine);
- increased hypoxemia (low oxygen levels in the blood) in ventilator-dependent patients;
- decreased renal (kidney) blood flow at higher doses, due to narrowing of blood vessels;
- infection;
- suppression of pituitary function;
- local necrosis due to extravasation (leakage of infusion from the vein causing damage to surrounding tissue).
Reporting of adverse effects
If your child experiences any adverse effect, talk to your doctor or nurse, even if it is an effect not listed in this leaflet. You may also report adverse effects directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the vial and carton after "EXP". The expiry date is the last day of the month indicated.
This medicine does not require any special storage temperature. Store the container in the outer packaging in order to protect it from light.
Neoatricon is a single-use vial. The medicine must be used immediately after first opening. Any unused contents should be discarded.
Do not use this medicine if you observe that the solution is opaque, cloudy, or shows discoloration.
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 metabisulphite (E223) (see section 2 "Neoatricon contains sodium metabisulphite"), water for injections, sodium hydroxide (for pH adjustment) and diluted hydrochloric acid (for pH adjustment).
Appearance of the product and contents of the pack
Neoatricon solution for infusion is a clear, colourless or pale yellow solution. It is presented in a clear glass vial with a rubber stopper and sealed with an aluminium flip-off cap.
Pack size
Neoatricon 1.5 mg/ml is supplied 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 the most recent revision of this summary of product characteristics:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
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This information is intended for healthcare professionals only:
Infusion of dopamine hydrochloride solution should be initiated at a rate of 5 μg/kg/min and gradually increased in increments of 5 μg/kg/min. The recommended dose range is 5–10 μg/kg/min. Doses higher than 10 μg/kg/min up to a maximum of 20 μg/kg/min may be administered if considered justified.
Infusion rates can be calculated using the following formula:
[Dose (μg/kg/min) x Weight (kg) x 60 (minutes/hour)]
Infusion rate (mL/hour) = --------------------------------------------------------------------
Concentration (μg/mL)
Instructions for use and handling
For intravenous use. Administer via a central line [umbilical venous catheter (UVC), peripherally inserted central catheter (PICC), or central venous catheter (CVC)]. If central access is not available, use a cannula in a large vein.
An appropriate measuring device must be used in the infusion system to control the rate and flow.
For single use only. Discard any unused contents.
Do not dilute.
Do not use if discoloration of the solution is observed.
The maximum acceptable duration for administration from a single vial is 24 hours.
Incompatibilities
Neoatricon solution for infusion must not be added to any alkaline intravenous solutions, i.e., sodium bicarbonate. In the absence of compatibility studies, this medicine must not be mixed with other medicinal products.
Mixtures containing gentamicin sulphate, sodium cephalothin, sodium-neutral cephalothin, or sodium oxacillin should be avoided unless all other viable alternatives have been exhausted.
Mixtures of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible, leading to degradation of both drugs. They must not be mixed.
Mixtures of dopamine and amphotericin B in 5% glucose solution are incompatible, as a precipitate forms immediately after mixing.
In-use storage precautions
This medicine does not require special storage temperature conditions.
Keep the container in the outer packaging to protect from light.