Pediaven g20

Package leaflet: Information for the user

Pediaven G20, infusion solution
composite product
Please read the entire leaflet carefully before use, as it contains important information for the patient.
­ Please keep this leaflet, as you may need to read it again.
­ If you have any doubts, please consult your doctor or nurse.
­ If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.
Table of contents

1. What Pediaven G20 is and what it is 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 pack and other information

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

Pediaven G20 is a nutritional mixture containing an amino acid solution (components necessary for protein synthesis) and glucose (carbohydrates) with salts (electrolytes and trace elements), supplied in a plastic bag with two compartments, each with a capacity of 500 ml.
This medicine is a solution intended for intravenous infusion (intravenous infusion) administered via an intravenous drip.
It may be used in infants, children, and adolescents who cannot receive nutrition orally.

2. Important information before using Pediaven G20

When not to use Pediaven G20:
­ 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
specific amino acids in an abnormal way);
­ if the patient has severe liver or kidney disease without possibility of dialysis;
­ 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 after 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 (septic shock), acute shock or
coma;
­ 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:
­ if the patient has fluid in the lungs (acute pulmonary oedema);
­ if the patient has excess fluid in the body (hypervolaemia);
­ if the patient has untreated heart failure;
­ if the patient has insufficient fluid in the body (hypotonic dehydration).

Pediaven G20 should not be administered if any of the above-mentioned conditions apply to the patient.
If in doubt, please consult a doctor or nurse before administering Pediaven G20 to the patient.

Warnings and precautions
Important information before the patient starts receiving Pediaven G20:

Pediaven G20 should be used with great caution when fluid intake must be restricted, for example in certain heart, lung or kidney diseases.

Inform the doctor if any adverse reactions occur during treatment, such as: chills, sweating, fever, rash or breathing difficulties. The infusion should be stopped.

When used in children under 2 years of age, the solution (in the bag and administration set) must be protected from light until the end of administration. Exposure of Pediaven G20 to light, particularly after addition of trace elements and (or) vitamins, may lead to the formation of peroxides and other degradation products. This can be minimized by protecting the solution from light.

Elevated magnesium levels in blood
The amount of magnesium contained in Pediaven G20 may cause an increase in blood magnesium concentration. This may manifest as: weakness, reduced reflexes, nausea, vomiting, decreased blood calcium levels, breathing difficulties, low blood pressure and irregular heartbeat. These symptoms may be difficult to detect, therefore the doctor may monitor the patient's blood parameters, especially if the patient is at risk of elevated blood magnesium levels, particularly kidney dysfunction. If blood magnesium concentration is elevated, the infusion will be stopped or reduced.

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

Pediaven G20 and other medicines
Inform the doctor about all medicines currently used or recently used by the patient, including medicines obtained without a prescription.

3. How to use Pediaven G20

Dosage
Pediaven G20 should always be used as directed by the physician. The physician will determine the dose
and duration of treatment depending on the patient's age, body weight, metabolic and energy requirements,
clinical condition, and ability to metabolize enteral nutrition (delivery of nutrients through a tube placed in the gastrointestinal tract).
If nutrition is administered exclusively intravenously, the physician may recommend concomitant administration of vitamins and lipids. If vitamins have been added to the solution, the bag must be protected from light.
Route of administration
Pediaven G20 is administered exclusively by medical personnel and only intravenously, via a central vein (into a large vein).
When administering to children under 2 years of age, the solution (in the bag and infusion set) must be protected from light until the end of the infusion (see section 2).
Administration of a higher than recommended dose of Pediaven G20
Pediaven G20 should always be used as directed by the physician. If there is any doubt that the patient has received more than the recommended dose, the physician must be informed immediately.
Missed administration of Pediaven G20
Pediaven G20 should always be used as directed by the physician. The physician must be informed immediately if a dose of Pediaven G20 infusion has been missed. 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 regarding the use of this medicinal product, consult your physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately, who will discontinue the infusion, if the patient experiences any of the
following symptoms:
- unusual signs or symptoms of an allergic reaction, such as sweating, fever, chills, headache, rash, or breathing difficulties.

Adverse reactions related to parenteral nutrition (nutrition administered intravenously) may occur, especially at the beginning of treatment, including:
- elevated blood sugar levels (hyperglycemia);
- gastrointestinal disturbances (nausea, vomiting);
- excessive intake of amino acids may lead to metabolic acidosis (disturbance in the acid-base balance in the body). Hyperazotemia (excess nitrogen-containing compounds in the blood) may occur, particularly in patients with kidney, liver, or respiratory problems;
- transient liver function disturbances;
- allergic reactions to specific amino acids.

Improper use (overdose or infusion too rapid) may lead to symptoms of hyperglycemia and hypervolemia (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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected]

Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of using this medicine.

5. How to store Pediaven G20

Keep this medicine 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 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) must be protected from light until administration is complete (see section 2).
Shelf life after mixing with additional substances
After mixing the two chambers, 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 required. These measures will help protect the environment.

6. Contents of the pack and other information

What Pediaven G20 contains
­ The active substances of the medicine are:

­ Other ingredients (excipients): glacial acetic acid (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
Osmolarity of the solution: 1400 mOsmol/l
pH of the solution: 4.8 – 5.5
Nutritional value in 1000 ml
glucose 200 g
amino acids 20 g
total nitrogen 2.85 g
total energy 880 kcal
non-protein energy 800 kcal
What Pediaven G20 looks like and contents of the pack
This medicinal product is an infusion solution, clear, colourless to slightly yellowish, free from particulate matter. It is available in a dual-chamber bag (each chamber contains 500 ml of solution).
Pack size: 4 bags × 1000 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89
This medicinal product is authorised in the European Economic Area countries 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%

Information intended solely for healthcare professionals:

Warnings and precautions for use
Pediaven G20, infusion solution is a hypertonic solution.
Since the use of a central vein for infusion carries a risk of infection, strict adherence to aseptic techniques is essential to prevent any infection, particularly during catheter insertion.
To avoid the risk associated with administering the infusion at a rate exceeding the recommended rate, it is important to administer the infusion at a regular and controlled rate.
Serum osmolality and glucose concentration, 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.
Pediaven G20 must not be administered via a peripheral vein due to its high osmolality.
Clinical and laboratory monitoring is required during infusion, particularly at the beginning. Monitoring should be intensified in the following cases:
- severe liver failure,
- severe renal failure,
- metabolic acidosis (a disorder caused by a very high concentration of acidic substances in the blood),
- diabetes or glucose intolerance.

Extravasation
As with all intravenously administered drugs, extravasation may occur during infusion of this medicinal product (see section 4. Possible adverse reactions).
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. The remaining fluid at the site of extravasation should be aspirated before removing the catheter or cannula.
Management following extravasation may include non-pharmacological treatment, pharmacological treatment, and/or surgical intervention. In case of significant extravasation, consultation with a surgeon is recommended.
Re-infusion should not be administered into the same central vein.

Method of administration
Intravenous infusion into a central vein.
To ensure complete parenteral nutrition, it is recommended to co-administer vitamins (maximum amount that can be added to the product, see Summary of Product Characteristics) and lipids (administered only via a Y-connector, not directly into the bag), unless contraindicated.
However, Pediaven G20 already contains trace elements. In certain cases, depending on patient needs, pharmaceutical solutions and parenteral nutrition preparations may be added to the bag, but only after verifying compatibility of the prepared mixture (see section "Pharmaceutical compatibility").
When used in children under 2 years of age, the solution (in the bag and administration set) must be protected from light until the end of administration.

Infusion rate
The dose should be determined individually according to the patient's age, body weight, metabolic and energy requirements, and clinical condition.
The physician should perform regular clinical and biological assessment of the patient's nutritional status and metabolic situation, particularly when parenteral nutrition is administered for longer than 14 days.
General dosage recommendations: glucose requirement in children averages 10–15 g/kg body weight/day at an infusion rate of 1–1.2 g/kg body weight/hour, and nitrogen requirement averages 200–300 mg/kg body weight/day.
The infusion rate must not exceed:
- in infants (1 month–2 years): 7 mL/kg body weight/hour (equivalent to 1.4 g glucose/kg body weight/hour),
- in children (2–11 years): 6 mL/kg body weight/hour (equivalent to 1.2 g glucose/kg body weight/hour),
- 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 of the medicinal product for use
Before use, remove the outer bag and inspect the inner bag for damage (integrity). 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 any addition of other substances through the designated port.
Exposure to light of parenteral nutrition solutions, particularly after addition of 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, Pediaven G20 must 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 side), applying pressure until the vertical seal breaks. Turn 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 after mixing
Chemical and physical stability of the double-chamber bag has been demonstrated for 24 hours at 25°C after mixing. From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for storage conditions and duration of storage prior to use lies with the user.

Pharmaceutical compatibility
Only pharmaceutical solutions or parenteral nutrition preparations whose compatibility has been established may be added to Pediaven G20 or administered through the same infusion line.
Information regarding volumes 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 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 children under 2 years of age, protect from light until the end of administration. Exposure of Pediaven G20 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.