Pediaven Nn1

Leaflet attached to the packaging: information for the user

Pediaven NN1, 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 the doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Pediaven NN1 and what is it used for
• 2. Important information before using Pediaven NN1
• 3. How to use Pediaven NN1
• 4. Possible side effects
• 5. How to store Pediaven NN1
• 6. Contents of the packaging and other information

1. What is Pediaven NN1 and what is it used for

Pediaven NN1 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.
Pediaven NN1 is particularly indicated to provide nutritional support in newborns, premature and full-term, in the first 24 to 48 hours of life.

2. Important information before using Pediaven NN1

When not to use Pediaven NN1:

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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 concentration (in serum) 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 very large amount of acidic substances in the blood), severe infection (sepsis), acute shock or coma.
Other general situations when not to use Pediaven NN1:
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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 NN1 if any of the above situations apply to the patient.
In case of doubts, consult a doctor or nurse before administering Pediaven NN1 to the patient.

Warnings and precautions

Important information before starting treatment with Pediaven NN1 in children:
Pediaven NN1 should be used with caution when fluid intake needs to be restricted, for example in certain heart, lung or kidney diseases.
Tell the doctor if any side effects occur 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).
Elevated magnesium level in the blood
The amount of magnesium in Pediaven NN1 may cause an increase in magnesium levels in the blood.
This may manifest as: weakness, slowed reflexes, vomiting, decreased calcium levels in the blood, breathing problems, low blood pressure and irregular heart rhythm. These symptoms can be difficult to detect and therefore the doctor may monitor the child's blood parameters, especially if the child is at risk of elevated magnesium levels in the blood, particularly 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 NN1 and other medicines

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

3. How to use Pediaven NN1

Dosage

Pediaven NN1 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 placed in the digestive tract).
If nutrition is provided exclusively intravenously (administration into a vein), the doctor may recommend the administration of 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 NN1 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).

Using a higher dose of Pediaven NN1 than recommended

Pediaven NN1 should always be used in accordance with the doctor's recommendations. In case of doubts that the child has taken a higher dose of Pediaven NN1 than recommended, tell the doctor immediately.

Missing a dose of Pediaven NN1

Pediaven NN1 should always be used in accordance with the doctor's recommendations. Inform the doctor immediately if the child has not received an infusion of Pediaven NN1. 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 regarding 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:

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atypical 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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elevated 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 disorder caused by a very large amount of acidic substances in the blood) 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 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 or leg (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 the 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pediaven NN1

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 in 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 no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Pediaven NN1 contains

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The active substances of the medicine are:

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The other ingredients (excipients) are: hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Osmolality of the solution: 715 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
15 g
2.14 g
460 kcal
400 kcal

What Pediaven NN1 looks like and what the packaging contains

This medicine is a solution for infusion, 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, 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 Potassium Free

Belgium

Kidiamix Neo 1

Estonia

Pediaven NN1

France

Kidiaven Nouveau- Né 1

Spain

Pediaven NN1

Netherlands

Kidiamix Neo 1

Lithuania

Pediaven Start-Up Potassium Free

Latvia

Pediaven Start-Up Potassium Free

Poland

Pediaven NN1

Portugal

Pediaven NN1

Italy

Kidiamix G10% senza potassio
Date of last update of the leaflet:21.01.2020 r.
25.00 g
3.75 g
0.54 g
115 kcal
100 kcal
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Information intended exclusively for healthcare professionals:

Warnings and precautions for use

Pediaven NN1, solution for infusion is a hypertonic solution. It contains a low concentration of sodium (4.5 mmol/l) and chloride (5 mmol/l). It does not contain potassium and phosphorus. Therefore, the medicine should not be administered alone for more than 48 hours and calcium, phosphorus and potassium levels should be monitored.
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 the catheter.
To avoid the risk associated with administering the infusion at a rate greater than recommended, it is essential to administer 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 of treatment. 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 disorder caused by a very large amount 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 catheter insertion site for signs of extravasation.
In case of extravasation, discontinue the infusion immediately, leaving the catheter or cannula in place to allow for immediate treatment of the patient, aspirate the remaining fluid before removing the catheter or cannula and elevate the limb where extravasation occurred (if applicable).
The procedure after extravasation may include non-pharmacological treatment, pharmacological treatment and/or surgical intervention. In case of large extravasation, consult a surgeon.
Do not administer the infusion again through the same central vein.

Method of administration

Central venous, peripheral 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 NN1 already contains trace elements. In some cases, depending on the patient's needs, Pediaven NN1 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, clinical condition.
Pediaven NN1 does not contain potassium and phosphorus, and is therefore not indicated for parenteral nutrition lasting longer than the first 48 hours of life.

Special precautions for preparation and handling

Before use, remove the outer bag and check if the inner bag is intact (sealed). Do not use if the packaging is damaged.
Use only if the amino acid and glucose solutions are clear, colorless to slightly yellowish, free from solid particles. The contents of the two separate chambers should be mixed before use, and also before any additional substances are added through the designated port.
Exposure of parenteral nutrition solutions to light, especially after the addition of trace elements and/or vitamins, may have undesirable effects on the clinical response in newborns due to the formation of hydroperoxides and other degradation products. During use in newborns, protect Pediaven NN1 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 side), 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 NN1 can be mixed with or administered through the same infusion line as only those pharmaceutical or parenteral nutrition solutions whose compatibility has been established.
Information on the volume of additional substances and their compatibility with Pediaven NN1 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 mixed 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 NN1 to light, especially after the addition of trace elements and/or vitamins, leads to the formation of hydroperoxides and other degradation products, which can be limited by protecting from light.