Pediaven nn2

Package leaflet: Information for the user

Pediaven NN2, infusion solution
compound preparation
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.
­ Keep this leaflet so that you can read it again if necessary.
­ If you have any questions, please consult your doctor or nurse.
­ If the patient experiences any adverse reactions, including any adverse reactions not listed in this
leaflet, inform the doctor or nurse immediately. See section 4.
Table of contents

1. What Pediaven NN2 is and what it is 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 pack and other information

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

Pediaven NN2 is a nutritional mixture containing an amino acid solution (components necessary for
protein formation), glucose (carbohydrates), and salts (electrolytes and trace elements), supplied in a
plastic bag with two compartments, each with a capacity of 125 ml.
This medicine is a solution intended for intravenous infusion (administered by drip into a vein).
It may be used in newborns who cannot receive oral feeding.

2. Important information before using Pediaven NN2

When not to use Pediaven NN2:
­ if the patient is allergic to the active substances or to any of the other ingredients of this medicine
(listed in section 6);
­ if the patient has inherited disorders of amino acid metabolism (when the body utilises certain amino
acids in an abnormal way);
­ if the patient has severe hyperglycaemia (high blood sugar level) and this condition is uncontrolled;
­ if the blood concentration (in serum) of one of the salts (electrolytes) present in this medicine is
elevated;
­ if the patient is in an unstable general condition, for example following a serious injury or in case of
uncontrolled diabetes, metabolic acidosis (a problem caused by a very high amount of acidic substances
in the blood), severe infection (severe sepsis), acute shock or coma.
Other general situations when not to use Pediaven NN2:
­ if the patient has fluid in the lungs (acute pulmonary oedema);
­ if the patient has too much fluid in the body (fluid overload);
­ if the patient has untreated heart failure;
­ if the patient has insufficient fluid in the body (hypotonic dehydration).
Pediaven NN2 should not be administered if any of the above-mentioned conditions apply to the
patient.
If in doubt, speak to a doctor or nurse before administering Pediaven NN2 to the patient.

Warnings and precautions
Important information before starting Pediaven NN2 in a child:
Pediaven NN2 should be used with great caution when fluid intake must be restricted, for example in
certain heart, lung or kidney diseases.
Tell the doctor if the child experiences any adverse reactions during treatment such as chills, sweating,
fever, rash or breathing difficulties. The infusion should be stopped.
When used in newborns, the solution (in the bag and administration set) must be protected from light until
the end of administration. Exposure of Pediaven NN2 to light, particularly after addition of trace elements
and (or) vitamins, leads to the formation of peroxides and other degradation products, which can be
minimised by protecting from light.

Elevated magnesium levels in blood
The amount of magnesium contained in Pediaven NN2 may cause an increase in magnesium blood levels.
This may manifest as: weakness, decreased reflexes, vomiting, decreased blood calcium levels, breathing
difficulties, low blood pressure and irregular heartbeat. These symptoms may 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 blood levels, particularly in case of impaired kidney function. If blood magnesium levels are
elevated, the infusion will be stopped or the dose reduced.

The doctor will monitor the child's condition throughout the treatment period and may adjust the dose
administered or recommend additional medications if necessary (mainly vitamins, fats, amino acids or
electrolytes).

Pediaven NN2 and other medicines
Tell the doctor about all medicines currently or recently taken by the child, including medicines obtained
without a prescription.

3. How to use Pediaven NN2

Dosage
Pediaven NN2 must always be used as prescribed by the doctor. The doctor will determine the dose size
and duration of treatment depending on the child's age, body weight, metabolic and energy requirements,
clinical condition, and ability to tolerate enteral nutrition (delivery of nutrients through a tube placed in the gastrointestinal tract).
If nutrition is administered exclusively intravenously (into the vein), the doctor may recommend co-administration of vitamins and lipids at the same time. If vitamins have been added to the product, the bag must be protected from light.
Route of administration
Pediaven NN2 is administered exclusively by medical personnel and only by intravenous route.
When used in newborns, the solution (in the bag and infusion set) must be protected from light until administration is completed (see section 2).
Administration of a higher than recommended dose of Pediaven NN2
Pediaven NN2 must always be used as prescribed by the doctor. If there is any doubt that the child has received more than the recommended dose, the doctor must be informed immediately.
Missed administration of Pediaven NN2
Pediaven NN2 must always be used as prescribed by the doctor. The doctor must be informed immediately if the child has not received an infusion of Pediaven NN2. Do not administer a double dose to make up for a missed dose and do not exceed the recommended infusion rate.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must contact the doctor immediately if the child develops any of the following symptoms, so that the infusion can be stopped:
­ atypical signs or symptoms of an allergic reaction, such as sweating, chills, headache, rash, or breathing difficulties.

Adverse reactions related to parenteral nutrition (nutrition administered intravenously) may occur, especially at the beginning of treatment, including:
­ leakage of the solution outside the vein (extravasation), causing local inflammation or tissue necrosis;
­ increased blood glucose levels (hyperglycaemia);
­ gastrointestinal disturbances (nausea, vomiting);
­ disturbances in water and electrolyte balance, such as changes in blood levels of the following electrolytes: sodium, potassium, chloride, magnesium, phosphorus;
­ metabolic acidosis (imbalance in acidic and basic substances in the body) caused by excessive intake of amino acids. Hyperazotemia (excess nitrogen-containing compounds in the blood) may occur, particularly in patients with kidney or respiratory problems;
­ increased blood phenylalanine (amino acid) levels in critically ill premature infants;
­ thrombophlebitis (blood clots in veins), which may occur especially if the infusion line is inserted into an arm vein (peripheral venous administration);
­ transient liver function disturbances;
­ allergic reactions to specific amino acids.

Improper use (overdose or infusion too rapid) may lead to symptoms of hyperglycaemia, hypercalcaemia (increased calcium levels in the blood), and hypervolaemia (increased blood volume in the vessels).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected]

Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pediaven NN2

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label following: EXP. The expiry date refers to the last day of the stated month.
Store below 25°C. Do not freeze. Store in the outer bag. Use immediately after mixing the contents of the two compartments.
When administering to neonates, protect the solution (in the bag and administration set) from light until the end of administration (see section 2).
Shelf life after mixing with additional substances
After mixing the two compartments, other components may be added via the port designated for additional substances. The medicine must be used immediately after adding any other components.
Do not use this medicine if the packaging is damaged or if there are signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Pediaven NN2 contains
­ The active substances are:
­ Other components (excipients) are: glacial acetic acid (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
Osmolarity of the solution: 790 mOsmol/l
pH of the solution: 4.8 – 5.5
Nutritional value in 250 ml in 1000 ml
glucose 25.00 g 100 g
amino acids 4.25 g 17 g
total nitrogen 0.61 g 2.44 g
total energy 118 kcal 470 kcal
non-protein energy 100 kcal 400 kcal
What Pediaven NN2 looks like and contents of the pack
This medicine is an infusion solution, clear, colourless to slightly yellowish, free from particulate matter. It is available in a dual-chamber bag (each chamber contains 125 ml of solution).
Pack size: 10 bags × 250 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warszawa
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
For further information, contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warszawa
tel.: +48 22 345 67 89
This medicinal product is authorised in the European Economic Area countries 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%

Information intended exclusively for healthcare professionals:

Warnings and precautions for use
Pediaven NN2, solution for infusion, is a hypertonic solution. When administering infusions via peripheral veins, 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 carries a risk of infection, strict adherence to aseptic procedures is essential to prevent any infection, particularly during catheter insertion.
To avoid risks associated with infusion rates exceeding the recommended rate, it is important to administer the infusion at a regular and controlled rate.
Serum osmolarity and glucose concentration, as well as fluid and electrolyte balance, acid-base balance, and liver function, should be monitored.
If any signs or symptoms of an anaphylactic reaction occur (especially fever, chills, sweating, rash, or dyspnea), the infusion must be stopped immediately.
Clinical and laboratory monitoring is required during infusion, particularly at the beginning. Monitoring should be intensified in the following cases:

• severe liver insufficiency,
• severe renal insufficiency,
• metabolic acidosis (a disorder caused by a very high concentration of acidic substances in the blood),
• diabetes or glucose intolerance in preterm infants.

Extravasation
As with all intravenously administered drugs, extravasation may occur during infusion of this medicinal product (see section 4. Undesirable effects).
The catheter insertion site should be regularly checked to detect signs of extravasation.
If extravasation occurs, the infusion must be stopped immediately, but the catheter or cannula should remain in place to allow immediate treatment of the patient. Any residual fluid remaining after extravasation should be aspirated before removing the catheter or cannula, and the affected limb should be elevated (if applicable).
Management following extravasation may include non-pharmacological treatment, pharmacological treatment, and/or surgical intervention. In the case of significant extravasation, consultation with a surgeon is recommended.
Infusion should not be restarted into the same central vein.

Method of administration
Infusion into central, peripheral, or umbilical vein. The duration of infusion should be 24 hours.
To ensure complete parenteral nutrition, concomitant administration of vitamins and lipids is recommended. However, Pediaven NN2 already contains trace elements. In certain cases, depending on patient needs, Pediaven NN2 may be supplemented with amino acids and electrolytes (see section "Pharmaceutical compatibility").
When used in neonates, the solution (in bag and administration set) must be protected from light until administration is completed.

Infusion rate
The dose should be individually adjusted according to patient age, body weight, metabolic and energy requirements, and clinical condition.

Special precautions for preparation of the medicinal product for use
Before use, remove the outer bag and inspect the inner bag for integrity (leakage). Do not use if the packaging is damaged.
Use only if amino acid and glucose solutions are clear, colorless to slightly yellowish, and free from particulate matter. The contents of the two separate chambers must be mixed before use, as well as before adding any other substances via the designated port.
Exposure to light of parenteral nutrition solutions, particularly after addition of trace elements and/or vitamins, may have adverse effects on clinical response in neonates due to the formation of peroxides and other degradation products. When used in neonates, Pediaven NN2 must be protected from light until administration is completed.

Mixing the two chambers before use

1. Remove the outer bag and place the bag on a hard surface.
2. Gently roll the bag from the top (handle side) downward, applying pressure until the vertical seal breaks. Invert the bag several times to ensure thorough mixing of the mixture components.

For single use only. Any unused portion of the mixture must be discarded.
Validated aseptic procedures must be strictly followed regarding handling of the medicinal product, catheter, and infusion.

Shelf-life of the product after mixing
Chemical and physical stability of the double-chamber bag has been demonstrated for 24 hours after mixing at 25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for storage conditions and duration of in-use storage prior to administration lies with the user.

Pharmaceutical compatibility
Only medicinal products or parenteral nutrition solutions whose compatibility has been established may be added to Pediaven NN2 or administered through the same infusion line. Information on the volume of additional substances and their compatibility with Pediaven NN2 is provided in the Summary of Product Characteristics, section 6.6 Special precautions for disposal and preparation of the medicinal product for use. There is a risk of precipitation of calcium salts.
All additions must be combined with the product under aseptic conditions.

Special precautions for disposal and preparation of the medicinal product for use
When used in neonates, protect from light until administration is completed. Exposure of Pediaven NN2 to light, particularly after addition of trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be minimized by providing protection from light.