PEDIAVEN Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Pediaven G20, solution for infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Pediaven G20 and what is it used for
4. Important information before using Pediaven G20
   1. When not to use Pediaven G20:
   2. Warnings and precautions
   3. Pediaven G20 and other medicines
5. How to use Pediaven G20
   1. Dosage
   2. Method of administration
   3. Using a higher dose of Pediaven G20 than recommended
   4. Missing a dose of Pediaven G20
6. Possible side effects
   1. Reporting side effects
7. How to store Pediaven G20
   1. Shelf life of the medicine after mixing with additional substances
8. Contents of the packaging and other information
   1. What Pediaven G20 contains
   2. Nutritional value per 1000 ml
   3. What Pediaven G20 looks like and what the pack contains
   4. Marketing authorization holder and manufacturer
   5. Marketing authorization holder
   6. Manufacturer
   7. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Austria
   9. Belgium
   10. Estonia
   11. France
   12. Spain
   13. Netherlands
   14. Lithuania
   15. Latvia
   16. Poland
   17. Portugal
   18. Italy
   19. Warnings and precautions for use
   20. Extravasation
   21. Method of administration
   22. Infusion rate
   23. The doctor will regularly assess the patient's nutritional status and metabolic situation, especially if parenteral nutrition lasts longer than 14 days.
   24. Special precautions for preparation and handling
   25. Mixing the two chambers before use
   26. Shelf life of the medicine after mixing
   27. Pharmaceutical compatibility
   28. Special precautions for disposal and handling

Leaflet accompanying the packaging: information for the user

Pediaven G20, 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 G20 and what is it used for
• 2. Important information before using Pediaven G20
• 3. How to use Pediaven G20
• 4. Possible side effects
• 5. How to store Pediaven G20
• 6. Contents of the packaging and other information

1. What is Pediaven G20 and what is it used for

Pediaven G20 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 containing two chambers, each with a capacity of 500 ml.
This medicine is a solution intended for administration by intravenous infusion.
It can be used in infants, children, and adolescents who cannot receive oral nutrition.

2. Important information before using Pediaven G20

When not to use Pediaven G20:

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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 liver or kidney disease without the possibility of dialysis;
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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 very large amount of acidic substances in the blood), severe infection (septic shock), acute shock, or coma;
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if the patient is in a state of severe malnutrition and there is a risk of developing "refeeding syndrome".
Other general situations when not to use Pediaven G20:
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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).
Pediaven G20 should not be administered if any of the above situations apply to the patient.
In case of doubts, consult a doctor or nurse before administering Pediaven G20 to the patient.

Warnings and precautions

Important information before starting treatment with Pediaven G20:
Pediaven G20 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.
When used in children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).
Elevated blood magnesium level
The amount of magnesium in Pediaven G20 may cause an increase in blood magnesium levels.
This may manifest as: weakness, slowed reflexes, nausea, 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 patient's blood parameters, especially if there is a 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 patient's condition throughout the treatment period and may change the administered dose or recommend additional medications if necessary (mainly vitamins, fats, or electrolytes).

Pediaven G20 and other medicines

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

3. How to use Pediaven G20

Dosage

Pediaven G20 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 patient's age, weight, metabolic and energy requirements, clinical condition, and ability to metabolize oral and enteral nutrition (nutrition delivered through a tube in the digestive tract).
If nutrition is administered exclusively intravenously (into a vein), the doctor may recommend simultaneous administration of vitamins and fats. If vitamins have been added to the medicine, the bag should be protected from light.

Method of administration

Pediaven G20 is administered exclusively by medical personnel and only intravenously, into a central vein (a large vein).
When used in children under 2 years of age, 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 G20 than recommended

Pediaven G20 should always be used in accordance with the doctor's recommendations. In case of doubts that the patient has taken a higher dose of Pediaven G20 than recommended, tell the doctor immediately.

Missing a dose of Pediaven G20

Pediaven G20 should always be used in accordance with the doctor's recommendations. Inform the doctor immediately if the patient has not received an infusion of Pediaven G20. 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 about using this medicine, consult a doctor.

4. Possible side effects

Like all medicines, Pediaven G20 can cause side effects, although not everybody gets them.
Consult a doctor immediately, who will discontinue the infusion, if the patient experiences the following symptoms:

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unusual signs or symptoms of an allergic reaction, such as sweating, fever, chills, headache, 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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increased blood sugar levels (hyperglycemia);
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gastrointestinal disorders (nausea, vomiting);
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excessive intake of amino acids can cause metabolic acidosis (imbalance of acidic and basic substances in the body). Hyperazotemia (too high a level of nitrogen compounds in the blood) may occur, especially if the patient has kidney, liver, or respiratory problems;
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temporary liver dysfunction;
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allergic reactions to certain amino acids.
Incorrect use (overdose or too rapid infusion) may lead to symptoms of hyperglycemia and hypervolemia (increased 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, 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]
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 G20

Keep the medicine out of the 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 month stated.
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.
When used in children under 2 years of age, 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 adding 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 G20 contains

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The active substances of the medicine are:

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The other ingredients (excipients) are: glacial acetic acid (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
Osmolality of the solution: 1400 mOsmol/l
pH of the solution: 4.8 – 5.5

Nutritional value per 1000 ml

glucose
amino acids
total nitrogen
total energy
non-protein energy
200 g
20 g
2.85 g
880 kcal
800 kcal

What Pediaven G20 looks like and what the pack 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 500 ml of solution).
Pack size: 4 bags × 1000 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 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 G20%

Belgium

Kidiamix G20%

Estonia

Pediaven G20

France

Kidiaven G20%

Spain

Pediaven G20

Netherlands

Kidiamix G20%

Lithuania

Pediaven G20%

Latvia

Pediaven G20%

Poland

Pediaven G20

Portugal

Pediaven G20

Italy

Kidiamix G20%
Date of last revision of the leaflet:21.01.2020
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Information intended for healthcare professionals only:

Warnings and precautions for use

Pediaven G20, solution for infusion, is a hypertonic solution.
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 crucial to administer the infusion at a regular and controlled rate.
Monitor osmolality and glucose concentration in serum, as well as water-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.
Pediaven G20 should not be administered into a peripheral vein due to its high osmolality.
During infusion, clinical and laboratory monitoring is necessary, especially at the beginning of treatment. Monitoring should be intensified 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 high concentration of acidic substances in the blood),
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diabetes or glucose intolerance.

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 to recognize 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, and aspirate the remaining fluid after extravasation before removing the catheter or cannula.
The procedure after extravasation may include non-pharmacological treatment, pharmacological treatment, and (or) surgical intervention. In case of significant extravasation, consult a surgeon.
Do not administer the infusion again into the same central vein.

Method of administration

Intravenous infusion, into a central vein.
To ensure complete parenteral nutrition, it is recommended to administer vitamins (maximum amount that can be added to the medicine, see Summary of Product Characteristics) and fats (administered only through a Y-connector, not directly into the bag), unless contraindicated.
However, Pediaven G20 already contains trace elements. In some cases, depending on the patient's needs, pharmaceutical solutions or those intended for parenteral nutrition may be added to the bag, but only after checking the compatibility of the prepared mixture (see "Pharmaceutical compatibility").
When used in children under 2 years of age, protect the solution (in the bag and administration set) 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 requirements, and clinical condition.

The doctor will regularly assess the patient's nutritional status and metabolic situation, especially if parenteral nutrition lasts longer than 14 days.

General dosage recommendations: glucose requirement in children is approximately 10-15 g/kg body weight/day with an infusion rate of 1–1.2 g/kg body weight/hour, and nitrogen requirement is approximately 200-300 mg/kg body weight/day.
The infusion rate should not exceed:
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in infants (1 month–2 years): 7 ml/kg body weight/hour (equivalent to 1.4 g glucose/kg body weight/hour),
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in children (2–11 years): 6 ml/kg body weight/hour (equivalent to 1.2 g glucose/kg body weight/hour),
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in adolescents (11–18 years): 3 ml/kg body weight/hour (equivalent to 0.5 g glucose/kg body weight/hour).

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, 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 of parenteral nutrition solutions to light, especially after adding trace elements and (or) vitamins, may lead to the formation of peroxides and other degradation products. When used in children under 2 years of age, protect Pediaven G20 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 procedures 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 G20 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 G20 can be found in the Summary of Product Characteristics, section 6.6 Special precautions for disposal and handling. 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

When used in children under 2 years of age, protect from light until the end of administration. Exposure of Pediaven G20 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 protecting from light.