Package leaflet: Information for the user

Pediaven G15, infusion solution
compound product
Please read all of this leaflet carefully before use, as 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 not listed in this leaflet, inform your doctor or nurse. See section 4.
Table of contents

What Pediaven G15 is and what it is used for
Important information before using Pediaven G15
How to use Pediaven G15
Possible side effects
How to store Pediaven G15
Contents of the pack and other information

1. What Pediaven G15 is and what it is used for

Pediaven G15 is a nutritional mixture containing an amino acid solution (components necessary for protein formation) and glucose (carbohydrates) with salts (electrolytes and trace elements), supplied in a plastic bag with two chambers, each with a capacity of 500 ml.
This medicine is a solution intended for intravenous infusion (intravenous infusion) administered by drip.
It may be used in infants, children and adolescents who cannot receive oral nutrition.

2. Important information before using Pediaven G15

When not to use Pediaven G15:
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 uses certain amino acids incorrectly);
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 concentration in the patient's blood (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 has severe malnutrition and there is a risk of developing "refeeding syndrome".

Other general situations when not to use Pediaven G15:
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 G15 must not be administered if any of the above situations apply to the patient.
If in doubt, consult a doctor or nurse before administering Pediaven G15 to the patient.

Warnings and precautions
Important information before starting treatment with Pediaven G15:
Pediaven G15 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 administration is completed. Exposure of Pediaven G15 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 G15 may cause an increase in magnesium concentration in the blood. This may manifest as: weakness, slowed reflexes, nausea, vomiting, decreased calcium concentration in blood, 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 there is a risk of elevated magnesium levels in blood, particularly in patients with impaired kidney function. If blood magnesium concentration is elevated, the infusion will be stopped or the rate 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, fats or electrolytes).

Pediaven G15 and other medicines
Tell the doctor about all medicines currently or recently taken by the patient, including medicines obtained without a prescription.

3. How to use Pediaven G15

Dosage
Pediaven G15 should always be used exactly as prescribed by the doctor. 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 via a tube placed in the gastrointestinal tract).
If nutrition is administered exclusively intravenously, the doctor 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 G15 is administered only by medical personnel and exclusively by intravenous route into a central vein (a large vein).
When used in children under 2 years of age, the solution (in the bag and infusion set) must be protected from light throughout the entire infusion period (see section 2).

Administration of a higher than recommended dose of Pediaven G15
Pediaven G15 should always be used as directed by the doctor. If there is any doubt that the patient has received more than the recommended dose, inform the doctor immediately.

Missed administration of Pediaven G15
Pediaven G15 should always be used as directed by the doctor. If a dose of Pediaven G15 has been missed, inform the doctor immediately. Do not administer a double dose to make up for the 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, who will stop the infusion, if the patient develops any of the
symptoms described below:
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 into a vein) may occur, especially
at the beginning of treatment, including:
increased blood sugar concentration (hyperglycemia);
gastrointestinal disturbances (nausea, vomiting);
excessive intake of amino acids may cause metabolic acidosis (disturbance in the balance of acidic and
basic substances in the body). Hyperazotemia (excess nitrogen compounds in the blood) may occur,
particularly in patients with kidney, liver, or respiratory problems;
transient disturbances in liver function;
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 adverse reactions 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 responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Pediaven G15

Keep this 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 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 children under 2 years of age, the solution (in the bag and administration set) must be protected from light until administration is completed (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 should 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. Such measures help protect the environment.

6. Contents of the Package and Other Information

What Pediaven G15 Contains
The active substances in this medicine are:
Active Substances Amino Acid Solution Glucose Solution Final Mixed Solution,
500 ml 500 ml 1000 ml
alanine 1.45 g 1.45 g
arginine 0.94 g 0.94 g
aspartic acid 0.94 g 0.94 g
acetylcysteine
(corresponds to cysteine)
0.31 g 0.31 g
(0.23 g) (0.23 g)
glutamic acid 1.63 g 1.63 g
glycine 0.48 g 0.48 g
histidine 0.48 g 0.48 g
isoleucine 0.71 g 0.71 g
leucine 1.61 g 1.61 g
lysine monohydrate
(corresponds to anhydrous lysine)
1.45 g 1.45 g
(1.29 g) (1.29 g)
methionine 0.30 g 0.30 g
phenylalanine 0.62 g 0.62 g
proline 1.29 g 1.29 g
serine 0.87 g 0.87 g
taurine 0.07 g 0.07 g
threonine 0.83 g 0.83 g
tryptophan 0.32 g 0.32 g
tyrosine 0.11 g 0.11 g
valine 0.83 g 0.83 g
dipotassium phosphate 1.39 g 1.39 g
selenium dioxide 0.05 mg 0.05 mg
glucose monohydrate
(corresponds to anhydrous glucose)
165.0 g 165.0 g
(150.0 g) (150.0 g)
calcium gluconate 2.69 g 2.69 g
magnesium lactate dihydrate 0.95 g 0.95 g
sodium chloride 1.75 g 1.75 g
potassium chloride 0.67 g 0.67 g
zinc acetate dihydrate 6.72 mg 6.72 mg
copper sulfate pentahydrate 1.00 mg 1.00 mg
sodium fluoride 1.11 mg 1.11 mg
manganese chloride tetrahydrate 0.36 mg 0.36 mg
potassium iodide 0.07 mg 0.07 mg
chromium chloride hexahydrate 0.10 mg 0.10 mg
iron(II) sulfate heptahydrate 2.49 mg 2.49 mg
cobalt chloride hexahydrate 0.61 mg 0.61 mg
ammonium molybdate tetrahydrate 0.09 mg 0.09 mg
Other components (excipients) are: glacial acetic acid (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
Osmolarity of the solution: 1091 mOsmol/l
pH of the solution: 4.8 – 5.5
Nutritional Value in 1000 ml
glucose 150 g
amino acids 15 g
total nitrogen 2.14 g
total energy 660 kcal
non-protein energy 600 kcal
What Pediaven G15 Looks Like and Contents of the Package
This medicine is an infusion solution, clear, colorless to slightly yellowish, free from particulate matter. It is available in a dual-chamber bag (each chamber contains 500 ml of solution).
Package 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 for marketing in the European Economic Area member states under the following names:
Austria Pediaven G15%
Belgium Kidiamix G15%
Estonia Pediaven G15
France Kidiaven G15%
Spain Pediaven G15
Netherlands Kidiamix G15%
Lithuania Pediaven G15%
Latvia Pediaven G15%
Poland Pediaven G15
Portugal Pediaven G15
Hungary Pediaven G15
Italy Kidiamix G15%

Information intended exclusively for medical professionals:

Warnings and precautions for use
Pediaven G15, infusion solution is a hypertonic solution.
Since the use of a central vein for infusion is associated with the risk of infection, strict adherence to aseptic procedures is essential to prevent any infection, particularly during catheter insertion.
To avoid the risk associated with infusion administration at a rate exceeding the recommended one, it is important that the infusion is administered 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.
Pediaven G15 must not be administered into a peripheral vein due to its high osmolarity.
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 very high levels of acidic substances in the blood),
- diabetes mellitus or glucose intolerance.

Extravasation
As with all intravenously administered medicinal products, extravasation may occur during infusion of this medicinal product (see section 4. Possible adverse reactions).
The catheter insertion site should be regularly checked for signs of extravasation.
If extravasation occurs, the infusion must be stopped immediately; however, the inserted catheter or cannula should be left in place to allow immediate initiation of patient treatment. The residual fluid remaining after 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 extensive extravasation, consultation with a surgeon is recommended.
Infusion should not be restarted through the same central vein.

Method of administration
Intravenous infusion into a central vein.
To ensure complete parenteral nutrition, it is recommended to administer vitamins simultaneously (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 G15 already contains trace elements. In some cases, depending on patient needs, pharmacological solutions and those intended for parenteral nutrition 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 administration is completed.

Infusion rate
The dose should be individually determined based on the patient's age, body weight, metabolic and energetic 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 lasts 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 glucose/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): 9 ml/kg body weight/hour (equivalent to 1.4 g glucose/kg body weight/hour),
- in children (2–11 years): 8 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 administration
Before use, remove the outer bag and check that the inner bag is intact (leak-proof). 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 of parenteral nutrition solutions to light, 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 G15 must be protected from light until administration is completed.

Mixing the two chambers before use

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

For single use only. Any unused portion of the mixture must be discarded.
Strict adherence to validated aseptic procedures regarding handling of the medicinal product, catheter, and infusion is required.

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 medicinal or parenteral nutrition solutions whose compatibility has been established may be added to Pediaven G15 or administered through the same infusion line.
Information regarding volumes of additional substances and their compatibility with Pediaven G15 is provided in the Summary of Product Characteristics, section 6.6 Special precautions for disposal and preparation of the medicinal product for administration. There is a risk of precipitation of calcium salts.
All additions must be made under aseptic conditions.

Special precautions for disposal and preparation of the medicinal product for administration
When used in children under 2 years of age, protect from light until administration is completed. Exposure of Pediaven G15 to light, particularly after addition of trace elements and/or vitamins, leads to formation of peroxides and other degradation products, which can be minimized by providing protection from light.

Pediaven g15