NEOATRICON 1.5 mg/mL Infusion solution

Зміст інструкції

1. Neoatricon 1.5 mg/mL solution for infusion
   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. How to store Neoatricon
   6. Package Contents and Other Information
2. Neoatricon 4.5 mg/mL solution for infusion
   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. How to store Neoatricon
   6. Package contents and other information

Neoatricon 1.5 mg/mL solution for infusion

dopamine hydrochloride

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Neoatricon is and what it is used for
• 2. What you need to know before the child uses Neoatricon
• 3. How to use Neoatricon
• 4. Possible side effects
• 5. How to store 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 naturally present
in the body that increases blood pressure by activating specific receptors
(targets) capable of causing constriction of blood vessels.
Neoatricon is used for the treatment of hypotension (low blood pressure) in newborns, in
early infancy and in children and adolescents under the age of 18 years.

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

Your child must not use Neoatricon

• if they are allergic to dopamine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if they have a pheochromocytoma (a tumor of the adrenal gland);
• if they have an uncorrected 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);
• if they have an overactive thyroid gland;
• if they are taking anesthetics based on cyclopropane or halogenated hydrocarbons.

If you are not sure whether any of the above conditions apply to your child, consult your doctor.

Warnings and precautions
Talk to your doctor or nurse before using Neoatricon if your child:

• has heart problems;
• is taking or has recently taken monoamine oxidase inhibitors (MAOIs), used for example for the treatment of depression (see section «Other medicines and Neoatricon»);
• suffers from or has suffered from peripheral vascular diseases (problems related to blood circulation at the level of the hands and feet);
• suffers from kidney or liver diseases;
• has a low blood volume. The doctor will take the necessary measures to ensure that the child has a normal blood volume before administering dopamine hydrochloride;
• suffers from sepsis (a serious bacterial infection);
• suffers from diseases associated with increased pressure in the pulmonary arteries;
• suffers from a certain form of glaucoma (narrow-angle glaucoma).

The doctor will monitor the child for any adverse effects on the
heart or kidneys during the administration of dopamine hydrochloride.
The doctor will check the child's blood pressure and blood flow to reduce the risk of
bleeding in the brain.
Neoatricon may increase the risk of infection, so the doctor will carefully monitor the
child and measures to prevent infections will be put in place.
The doctor will gradually reduce the use of Neoatricon to prevent the child from having a drop
in blood pressure.
Dopamine hydrochloride may cause changes in the results of the child's blood tests. The
doctor may take blood samples to monitor the occurrence of these changes.

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 available without a prescription.
Particular care must be taken if the child is taking other medicines, as
some of them may interact with Neoatricon, for example:

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

If your child is taking any of the medicines listed above, consult your doctor for further
information on the possible consequences of these interactions.

Pregnancy and breastfeeding
Neoatricon is indicated in children. If you are pregnant, suspect or are planning a
pregnancy or if you are breastfeeding, ask your doctor for advice before using this
medicine.
If you are a woman of childbearing potential, you should use an effective method of contraception during treatment with
Neoatricon. Neoatricon is not recommended during pregnancy.
However, your doctor will prescribe this medicine only if the expected benefits outweigh the potential risks
to the baby.
It is not known whether Neoatricon is excreted in breast milk. However, since Neoatricon is eliminated
rapidly from the body, you may use the medicine while breastfeeding.

Driving and using machines
Do not drive vehicles or use machines while taking this product.

Neoatricon contains sodium metabisulfite
Rarely, this excipient can cause serious hypersensitivity reactions (severe allergy) and
bronchospasm (excessive and prolonged contraction of the muscles of the airways with resulting
difficulty breathing).
This medicine contains less than 23 mg of sodium per dose, i.e. it is essentially «sodium-free».

3. How to use Neoatricon

Dosage and method of administration
The doctor will decide the most suitable dose for the child. The dose will depend on the child's health
condition and their body weight. The rate of administration will be carefully monitored and
adjusted based on the 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 can also be administered into the umbilical cord.
The child's breathing, blood pressure, oxygen levels, kidney function and other vital signs will be
carefully observed during the administration of Neoatricon.
If the child's blood volume is low, a blood transfusion or a «plasma expander» (fluids that increase the
volume of blood in circulation) may be administered before this medicine is given.
Inform the doctor or nurse if the child feels burning, pain or swelling at the site surrounding
the needle inserted into the vein when dopamine hydrochloride is administered. If the infusion of
the medicine leaks out of the vein into the surrounding tissues, it may damage them (e.g.
causing blisters or tissue death). Inform the doctor if you notice or the child feels any pain or
swelling at the injection site so that appropriate treatment can be administered.

If an excessive or insufficient amount of dopamine hydrochloride is administered
This medicine will be administered to the child in hospital, under the supervision of a doctor. It is
unlikely that the child will receive an excessive or too low dose. However, inform the doctor or
nurse if you have any concerns.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious adverse reactions
If you notice changes in how your child feels during or after treatment, inform your
doctor immediately:

• severe allergic reaction - the child may develop a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing) and may feel a sensation of impending faintness (frequency not known);
• gangrene (decay and death of tissue, where you may notice a change in skin color that may even become black) (uncommon frequency);
• severe palpitations (frequency not known); ventricular tachycardia up to ventricular fibrillation (uncommon).

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

Other adverse reactions
If any of the following occurs, inform your doctor as soon as possible.
Common side effects (may affect up to 1 in 10 people):

• sinus tachycardia (fast heartbeat);
• palpitation (a forced, rapid or irregular heartbeat);
• anginal pain (a type of chest pain caused by reduced blood flow to the heart);
• ectopic heartbeat (a change in heartbeat that is otherwise normal);
• dyspnea (shortness of breath);
• hypotension (low blood pressure);
• vasoconstriction (narrowing of blood vessels);
• nausea;
• vomiting;
• headache.

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

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

Not known (frequency cannot be estimated based on available data):

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

Reporting of side effects
If your child experiences any side effect, including those not listed in this
leaflet, please inform . You can also report side effects
directly through the national reporting system detailed in Annex V. * By reporting side
effects you can help provide more information on the safety of this
medicine.

5. How to store 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 label of the vial and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store the
vials in the cardboard box to protect the medicine from light.
Neoatricon is only available in single-dose vials. After first opening, the medicine must
be used immediately. Any unused medicine must be discarded.
Do not use this medicine if you notice that the solution is opaque, cloudy or discoloured.

6. Package Contents and Other Information

What Neoatricon contains
The active ingredient is dopamine hydrochloride.

Neoatricon 1.5 mg/mL solution for infusion
Each millilitre of solution contains 1.5 milligrams of dopamine hydrochloride. Each vial
contains 45 mg of dopamine hydrochloride in 30 mL.
The other ingredients 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).

Description of Neoatricon and package contents
Neoatricon solution for infusion is a clear, colourless to pale yellow solution. It is
available in a transparent glass vial with a rubber stopper and an aluminium tear-off seal.
Number of dosage units
Neoatricon 1.5 mg/mL is presented as a 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
Pharmacox Healthcare Ltd.
KW20A Kordin Industrial, Park
Paola PLA3000
Malta
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.
<------------------------------------------------------------------------------------------------------------------------>

The following information is intended only for healthcare professionals.
Instructions for use and handling
Intravenous use. Administer via a central line [umbilical venous catheter (UVC),
long cannula or surgically placed central venous line (CVL)]. If central access is not available
use a cannula in a large vein.
The infusion system must have an appropriate measuring device to control rate and
flow.
For single use. Discard any unused medicinal product.
Do not dilute.
Do not administer if the solution shows any alteration in colour.
The maximum acceptable duration for single administration of a vial is 24 hours.

Incompatibilities
Neoatricon solution for infusion must not be added to alkaline intravenous solutions, i.e.
sodium bicarbonate. In the absence of compatibility studies, this medicinal product must not be mixed
with other medicinal products.
Avoid combinations containing gentamicin sulfate, cephalothin sodium, neutral cephalothin sodium or
oxacillin sodium, unless all other practicable alternatives have been exhausted.
Combinations of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible
and therefore result in degradation of both drugs, and should therefore not be mixed.
Mixtures of dopamine and amphotericin B in 5% glucose solution are incompatible as
precipitation forms immediately after mixing.

Dosage table for patients weighing between 2 kg and 9 kg
The following dosage recommendations apply to the use of Neoatricon 1.5 mg/mL in
patients with a body weight of 2 kg to 9 kg
Precautions for storage during use

This medicinal product does not require any particular storage temperature.
Store the vials in the carton to protect the medicinal product from light.

Neoatricon 4.5 mg/mL solution for infusion

dopamine hydrochloride

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Neoatricon is and what it is used for
• 2. What you need to know before the child uses Neoatricon
• 3. How to use Neoatricon
• 4. Possible side effects
• 5. How to store 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 naturally present
in the body that increases blood pressure by activating specific receptors
(targets) capable of causing constriction of blood vessels.
Neoatricon is used for the treatment of hypotension (low blood pressure) in newborns, in
early infancy and in children and adolescents under the age of 18 years.

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

Your child must not use Neoatricon

• if they are allergic to dopamine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if they have a pheochromocytoma (a tumor of the adrenal gland);
• if they have an uncorrected 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);
• if they have an overactive thyroid gland;
• if they are taking anesthetics based on cyclopropane or halogenated hydrocarbons.

If you are not sure whether any of the above conditions apply to your child, consult your doctor.

Warnings and precautions
Talk to your doctor or nurse before using Neoatricon if your child:

• has heart problems;
• your child is taking or has recently taken monoamine oxidase inhibitors (MAOIs), which are used, for example, for the treatment of depression (see section «Other medicines and Neoatricon»);
• suffers from or has suffered from peripheral vascular diseases (problems related to blood circulation at the level of the hands and feet);
• suffers from kidney or liver diseases;
• has a low blood volume. The doctor will take the necessary measures to ensure that the child has a normal blood volume before administering dopamine hydrochloride;
• suffers from sepsis (a serious bacterial infection);
• suffers from diseases associated with increased pressure in the pulmonary arteries;
• suffers from a certain form of glaucoma (narrow-angle glaucoma).

The doctor will monitor the child for any adverse effects on the
heart or kidneys during the administration of dopamine hydrochloride.
The doctor will check the child’s blood pressure and blood flow to reduce the risk of
bleeding in the brain.
Neoatricon may increase the risk of infection, so the doctor will carefully monitor the
child and infection prevention measures will be put in place.
The doctor will gradually reduce the use of Neoatricon to prevent the child from having a drop
in blood pressure.
Dopamine hydrochloride may cause changes in the results of the child’s blood tests. The
doctor may take blood samples to monitor the occurrence of these changes.

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 available without a prescription.
Particular care must be taken if the child is taking other medicines, as
some of them may interact with Neoatricon, for example:

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

If your child is taking any of the medicines listed above, consult your doctor for further
information about the possible consequences of these interactions.

Pregnancy and breastfeeding
Neoatricon is indicated in children. If you are pregnant, suspect or are planning a
pregnancy or if you are breastfeeding, ask your doctor for advice before using this
medicine.
If you are a woman of childbearing potential, you should use an effective contraceptive method during treatment with
Neoatricon. Neoatricon is not recommended during pregnancy.
However, your doctor will prescribe this medicine only if the expected benefits outweigh the potential risks
to the child.
It is not known whether Neoatricon is excreted in breast milk. However, since Neoatricon is eliminated
rapidly from the body, you may use the medicine while breastfeeding.

Driving and using machines
Do not drive vehicles or use machines while taking this product.

Neoatricon contains sodium metabisulfite
Rarely, this excipient may cause serious hypersensitivity reactions (severe allergy) and
bronchospasm (excessive and prolonged contraction of the muscles of the airways with resulting
difficulty breathing).
This medicine contains less than 23 mg of sodium per dose, i.e. it is essentially “sodium-free”.
.

3. How to use Neoatricon

Dosage and method of administration
The doctor will decide the most appropriate dose for the child. The dose will depend on the child's health
condition and their body weight. The rate of administration will be carefully monitored and
adjusted based on the 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 can also be administered into the umbilical cord.
The child's breathing, blood pressure, oxygen levels, kidney function and other vital signs will be
carefully observed during the administration of Neoatricon.
If the child's blood volume is low, a blood transfusion or a «plasma expander» (fluids that increase
blood volume in circulation) may be administered before this medicine is given.
Inform the doctor or nurse if the child feels burning, pain or swelling at the site surrounding
the needle inserted into the vein when dopamine hydrochloride is administered. If the infusion of
the medicine leaks out of the vein into the surrounding tissues, it may damage them (causing for
example blisters or tissue death). Inform the doctor if you notice or the child feels any pain or
swelling at the injection site so that appropriate treatment can be administered.

If an excessive or insufficient amount of dopamine hydrochloride is administered
This medicine will be administered to the child in hospital, under the supervision of a doctor. It is
unlikely that the child will receive an excessive or too low dose. However, inform the doctor or
nurse if you have any concerns.

4. Possible side effects

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

Serious adverse reactions
If you notice changes in how your child feels during or after treatment, inform
your doctor immediately:

• severe allergic reaction - your child may develop a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which can cause difficulty swallowing or breathing) and may feel a sensation of impending faintness (frequency not known);
• gangrene (decay and death of tissue, where you may notice a change in skin color that may even become black) (uncommon frequency);
• 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 adverse reactions
If any of the following occur, tell your doctor as soon as possible.
Common side effects (may affect up to 1 in 10 people):

• sinus tachycardia (fast heartbeat);
• palpitation (a forced, rapid or irregular heartbeat);
• anginal pain (a type of chest pain caused by reduced blood flow to the heart);
• ectopic heartbeat (a change in heartbeat that is otherwise normal);
• dyspnea (shortness of breath);
• hypotension (low blood pressure);
• vasoconstriction (narrowing of blood vessels);
• nausea;
• vomiting;
• headache.

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

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

Not known (frequency cannot be estimated based on available data).

• increased risk of bleeding after surgery in the abdominal area or in patients with a tendency to bleed in the gastrointestinal tract (stomach and intestines);
• increased hypoxemia (low oxygen level in the blood) in ventilator-dependent patients;
• decreased renal blood flow at higher doses, due to narrowing of blood vessels; infection; suppression of pituitary function; local necrosis due to extravasation (leakage of the infusion from the vein and damage to surrounding tissue).

Reporting of side effects
If your child gets any side effect, talk to your . You can also report side effects
directly through the national reporting system detailed in Appendix V. * By reporting side
effects you can help provide more information on the safety of this
medicine.

5. How to store 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 label of the vial and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store the
vials in the cardboard box to protect the medicine from light.
Neoatricon is only available in single-dose vials. After first opening, the medicine must
be used immediately. Any unused medicine should be discarded.
Do not use this medicine if you notice that the solution is opaque, cloudy or discolored.

6. Package contents and other information

What Neoatricon contains
The active ingredient is dopamine hydrochloride.

Neoatricon 4.5 mg/mL solution for infusion
Each millilitre of solution contains 4.5 milligrams of dopamine hydrochloride. Each vial
contains 225 mg of dopamine hydrochloride in 50 mL.
The other ingredients 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).

Description of the appearance of Neoatricon and contents of the pack
Neoatricon solution for infusion is a clear, colourless or pale yellow solution. It is
available in a transparent glass vial with a rubber stopper and an aluminium tear-off seal.
Number of dosage units
Neoatricon 4.5 mg/mL is presented as a 50 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
Pharmacox Healthcare Ltd.
KW20A Kordin Industrial, Park
Paola PLA3000
Malta
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.
<------------------------------------------------------------------------------------------------------------------------>

The following information is intended only for healthcare professionals.
Instructions for use and handling
Intravenous use. Administer through a central line [umbilical venous catheter (UVC),
long cannula or surgically placed central venous line (CVL)]. If a central access is not available
use a cannula in a large vein.
The infusion system must have an appropriate measuring device to control rate
and flow.
For single use only. Discard any unused medicine.
Do not dilute.
Do not administer if the solution shows any alteration in colour.
The maximum acceptable duration for single administration of a vial is 24 hours.

Incompatibilities
Neoatricon solution for infusion must not be added to alkaline intravenous solutions, i.e.
sodium bicarbonate. In the absence of compatibility studies, this medicine must not be mixed
with other medicines.
Avoid combinations containing gentamicin sulfate, cephalothin sodium, neutral cephalothin sodium or
oxacillin sodium, unless all other practicable alternatives have been exhausted.
Combinations of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible
resulting in degradation of both drugs, which therefore must not be mixed.
Mixtures of dopamine and amphotericin B in 5% glucose solution are incompatible as
precipitate forms immediately after mixing.

Dosage table for patients weighing between 10 kg and 66 kg
The following dosage recommendations apply to the use of Neoatricon 4.5 mg/mL in patients with
a body weight of 10.0 kg to 66 kg.

Precautions for storage during use
This medicine does not require any particular storage temperature.
Store the vials in the cardboard box to protect the medicine from light.