Pediaven Nn2

Leaflet accompanying the packaging: information for the user

Pediaven NN2, solution for infusion

composite product

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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Keep this leaflet, you may need to read it again.
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In case of any doubts, consult a doctor or nurse.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Pediaven NN2 and what is it used for
• 2. Important information before using Pediaven NN2
• 3. How to use Pediaven NN2
• 4. Possible side effects
• 5. How to store Pediaven NN2
• 6. Contents of the packaging and other information

1. What is Pediaven NN2 and what is it used for

Pediaven NN2 is a nutritional mixture containing an amino acid solution (essential components for protein production) and glucose (carbohydrates) with salts (electrolytes and trace elements) available in a plastic bag with two chambers, each with a capacity of 125 ml.
This medicine is a solution intended for intravenous infusion. It can be used in newborns who cannot receive oral nutrition.

2. Important information before using Pediaven NN2

When not to use Pediaven NN2:

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if the patient is allergic to the active substances or any of the other components of this medicine (listed in section 6);
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if the patient has congenital disorders of amino acid metabolism (if the body uses certain amino acids incorrectly);
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if the patient has severe hyperglycemia (high blood sugar level) and this condition is uncontrolled;
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if the patient's blood (serum) concentration of one of the salts (electrolytes) present in this medicine is elevated;
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if the patient is in an unstable general condition, for example after a serious injury or in the case of uncontrolled diabetes, metabolic acidosis (a problem caused by a large amount of acidic substances in the blood), severe infection (sepsis), acute shock, or coma.
Other general situations when not to use Pediaven NN2:
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if the patient has fluid in the lungs (acute pulmonary edema);
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if the patient has too much fluid in the body (overhydration);
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if the patient has untreated heart failure;
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if the patient has insufficient fluid in the body (hypotonic dehydration).
Do not administer Pediaven NN2 if any of the above situations apply to the patient.
In case of doubts, consult a doctor or nurse before administering Pediaven NN2 to the patient.

Warnings and precautions

Important information before starting treatment with Pediaven NN2 in a child:
Pediaven NN2 should be used with caution when fluid intake needs to be restricted, for example in certain heart, lung, or kidney diseases.
Tell your doctor if any side effects occur in the child during treatment, such as chills, sweating, fever, rash, or breathing problems. The infusion should be discontinued.
During use in newborns, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2). Exposure of Pediaven NN2 to light, especially after adding trace elements and (or) vitamins, leads to the formation of peroxides and other degradation products, which can be limited by providing light protection.
Elevated magnesium level in the blood
The amount of magnesium contained in Pediaven NN2 may cause an increase in magnesium levels in the blood.
This may manifest as follows: weakness, slowed reflexes, vomiting, decreased calcium levels in the blood, breathing problems, low blood pressure, and irregular heart rhythm. These symptoms may be difficult to detect, and therefore, the doctor may monitor the child's blood parameters, in particular if the child is at risk of elevated magnesium levels in the blood, especially kidney function disorders. If the magnesium level in the blood is elevated, the infusion will be discontinued or reduced.
The doctor will monitor the child's condition throughout the treatment period and may change the administered dose or recommend additional medications if necessary (mainly vitamins, fats, amino acids, or electrolytes).

Pediaven NN2 and other medicines

Tell your doctor about all medicines the child is currently taking or has recently taken, including those available without a prescription.

3. How to use Pediaven NN2

Dosage

Pediaven NN2 should always be used in accordance with the doctor's recommendations. The doctor will decide on the dose and duration of treatment, depending on the child's age, weight, metabolic and energy needs, clinical condition, and ability to metabolize oral and enteral nutrition (providing nutrition through a tube inserted into the digestive tract).
If nutrition is provided exclusively intravenously (intravenous administration), the doctor may recommend administering vitamins and fats at the same time. If vitamins have been added to the medicine, the bag should be protected from light.

Method of administration

Pediaven NN2 is administered exclusively by medical personnel and only intravenously.
During use in newborns, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).

Use of a higher than recommended dose of Pediaven NN2

Pediaven NN2 should always be used in accordance with the doctor's recommendations. In case of doubts that the child has taken a higher dose of the medicine than recommended, tell your doctor immediately.

Missing a dose of Pediaven NN2

Pediaven NN2 should always be used in accordance with the doctor's recommendations. Inform your doctor immediately if the child has not received an infusion of Pediaven NN2. Do not use a double dose to make up for a missed dose, and do not exceed the recommended infusion rate.
In case of any further doubts related to the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult a doctor immediately, who will discontinue the infusion, if the child experiences the following symptoms:
listed below:
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unusual signs or symptoms of an allergic reaction, such as sweating, chills, headaches, rash, or breathing problems.
Side effects related to parenteral nutrition (nutrition administered into a vein) may occur, especially at the beginning of treatment, including:
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leakage of the medicine outside the vein (extravasation), causing local inflammation or tissue necrosis;
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increased blood sugar levels (hyperglycemia);
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gastrointestinal disorders (nausea, vomiting);
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disturbances in water and electrolyte balance, such as changes in the concentration of the following electrolytes in the blood: sodium, potassium, chloride, magnesium, phosphorus;
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metabolic acidosis (a disturbance in the balance of acidic and alkaline substances in the body) caused by excessive intake of amino acids. Hyperazotemia (too high a level of nitrogen compounds in the blood) may occur, especially if the patient has kidney or respiratory problems;
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increased phenylalanine levels (an amino acid) in the blood in critically ill premature infants;
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thrombophlebitis (blood clots in the veins), which may occur especially if the infusion line is connected to the arm (peripheral venous administration);
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temporary liver function disorders;
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allergic reactions to certain amino acids.
Incorrect use (overdose or too rapid infusion) may lead to the occurrence of symptoms of hyperglycemia, hypercalcemia (elevated calcium levels in the blood), and hypervolemia (elevated blood volume in the veins).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the use of the medicine.

5. How to store Pediaven NN2

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after: EXP. The expiry date refers to the last day of the specified month.
Store at a temperature below 25°C. Do not freeze. Store in the outer bag. Use immediately after mixing the contents of the two chambers.
During use in newborns, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).

Shelf life of the medicine after mixing with additional substances

After mixing the two chambers, other components can be added through the port intended for the administration of additional substances. The medicine should be used immediately after adding other components.
Do not use this medicine if the packaging is damaged or signs of spoilage are visible.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pediaven NN2 contains

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The active substances of the medicine are:
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Other ingredients (excipients) are: acetic acid, hydrochloric acid (for pH adjustment), water for injections.
Osmolality of the solution: 790 mOsmol/l
pH of the solution: 4.8 – 5.5

Nutritional value in 250 ml in 1000 ml

glucose
amino acids
total nitrogen
total energy
non-protein energy
100 g
17 g
2.44 g
470 kcal
400 kcal

What Pediaven NN2 looks like and what the packaging contains

This medicine is an infusion solution, clear, colorless to slightly yellowish, free from solid particles. It is available in a dual-chamber bag (each chamber contains 125 ml of solution).
Pack size: 10 bags × 250 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria

Pediaven Start-Up

Belgium

Kidiamix Neo 2

Estonia

Pediaven NN2

France

Kidiaven Nouveau- Né 2

Spain

Pediaven NN2

Netherlands

Kidiamix Neo 2

Lithuania

Pediaven Start-Up

Latvia

Pediaven Start-Up

Poland

Pediaven NN2

Portugal

Pediaven NN2

Hungary

Pediaven NN2

Italy

Kidiamix G10%
Date of last revision of the leaflet:21.01.2020 r.
25.00 g
4.25 g
0.61 g
118 kcal
100 kcal
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Information intended exclusively for healthcare professionals:

Warnings and precautions for use

Pediaven NN2, solution for infusion, is a hypertonic solution. When administering peripheral intravenous injections, it is recommended to change the infusion site at least every 48 hours to reduce the risk of irritation.
Since the use of a central vein for infusion is associated with a risk of infection, it is essential to strictly follow aseptic procedures to avoid any infection, especially when inserting a catheter.
To avoid the risk associated with administering the infusion at a rate greater than recommended, it is crucial to perform the infusion at a regular and controlled rate.
Monitor osmolality and glucose concentration in serum, as well as water and electrolyte balance, acid-base balance, and liver function.
In case of any signs or symptoms of an anaphylactic reaction (especially fever, chills, sweating, rash, or shortness of breath), discontinue the infusion immediately.
During infusion, clinical and laboratory monitoring is necessary, especially at the beginning. Monitoring should be increased in the following cases:
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severe liver failure,
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severe kidney failure,
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metabolic acidosis (a disturbance caused by a high concentration of acidic substances in the blood),
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diabetes or glucose intolerance in premature infants.

Extravasation

As with all intravenously administered medicines, extravasation (see section 4. Possible side effects) may occur during infusion of this medicine.
Regularly check the infusion site to recognize signs of extravasation.
In case of extravasation, discontinue the infusion immediately, leaving the inserted catheter or cannula in place to allow for immediate treatment of the patient, aspirate any remaining fluid before removing the catheter or cannula, and elevate the affected limb (if applicable).
The management of extravasation may include non-pharmacological treatment, pharmacological treatment, and (or) surgical intervention. In case of significant extravasation, consult a surgeon.
Do not re-administer the infusion into the same central vein.

Method of administration

Central venous, peripheral venous, or umbilical venous infusion. The infusion time should be 24 hours.
To ensure complete parenteral nutrition, it is recommended to administer vitamins and fats simultaneously. However, Pediaven NN2 already contains trace elements. In some cases, depending on the patient's needs, Pediaven NN2 may be supplemented with amino acids and electrolytes (see "Pharmaceutical compatibility").
During use in newborns, the solution (in the bag and administration set) should be protected from light until the end of administration.

Infusion rate

The dose should be determined individually, depending on the patient's age, weight, metabolic and energy needs, and clinical condition.

Special precautions for the preparation of the medicine for use

Before use, remove the outer bag and check if the inner bag is undamaged (sealed). Do not use if the packaging is damaged.
Use only when the amino acid and glucose solutions are clear, colorless to slightly yellowish, and free from solid particles. The contents of the two separate chambers should be mixed before use and before any additional substances are added through the designated port.
Exposure to light of parenteral nutrition solutions, especially after adding trace elements and (or) vitamins, may have undesirable effects on the clinical response in newborns due to the formation of peroxides and other degradation products. During use in newborns, Pediaven NN2 should be protected from light until the end of administration.

Mixing the two chambers before use

• 1. Remove the outer bag and place the bag on a hard surface.
• 2. Gently roll the bag starting from the top (from the handle), squeezing until the vertical weld breaks. Turn the bag over several times, which should ensure thorough mixing of the mixture components.

For single use only. Dispose of any unused mixture.
Strictly follow validated aseptic conditions for handling the medicine and catheter, as well as perfusion.

Shelf life of the medicine after mixing

Chemical and physical stability of the dual-chamber bag after mixing has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage conditions during use and before administration.

Pharmaceutical compatibility

Pediaven NN2 can be mixed with or administered through the same infusion line as only those pharmaceutical solutions or parenteral nutrition solutions whose compatibility has been established.
Information on the volume of additional substances and their compatibility with Pediaven NN2 can be found in the Summary of Product Characteristics, section 6.6 Special precautions for disposal and handling of the medicinal product. There is a risk of precipitation of calcium salts.
Any additives should be combined with the medicine under aseptic conditions.

Special precautions for disposal and handling of the medicinal product

During use in newborns, protect from light until the end of administration. Exposure of Pediaven NN2 to light, especially after adding trace elements and (or) vitamins, leads to the formation of peroxides and other degradation products, which can be limited by providing light protection.