Pediaven G15

Leaflet accompanying the packaging: information for the user

Pediaven G15, solution for infusion

composite product

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

­
Keep this leaflet, you may need to read it again.
­
In case of any doubts, consult a doctor or nurse.
­
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 G15 and what is it used for
• 2. Important information before using Pediaven G15
• 3. How to use Pediaven G15
• 4. Possible side effects
• 5. How to store Pediaven G15
• 6. Contents of the packaging and other information

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

Pediaven G15 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 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 G15

When not to use Pediaven G15:

­
if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
­
if the patient has congenital disorders of amino acid metabolism (if the body uses certain amino acids in the wrong way);
­
if the patient has severe liver or kidney disease without the possibility of dialysis;
­
if the patient has severe hyperglycemia (high blood sugar level) and this condition is uncontrolled;
­
if the patient's 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 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;
­
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 G15:
­
if the patient has fluid in the lungs (acute pulmonary edema);
­
if the patient has too much fluid in the body (overhydration);
­
if the patient has untreated heart failure;
­
if the patient has insufficient fluid in the body (hypotonic dehydration).
Pediaven G15 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 G15 to the patient.

Warnings and precautions

Important information before the patient starts using Pediaven G15:
Pediaven G15 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 magnesium level in the blood
The amount of magnesium in Pediaven G15 may cause an elevated magnesium level in the blood.
This may manifest as: weakness, slowed reflexes, nausea, vomiting, decreased calcium level 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 G15 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 G15

Dosage

Pediaven G15 should always be used according to 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 inserted into the digestive tract).
If nutrition is administered exclusively intravenously (into a vein), the doctor may recommend administering 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 G15 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 G15 than recommended

Pediaven G15 should always be used according to the doctor's recommendations.
In case of doubts that the patient has taken a higher dose of the medicine than recommended, tell the doctor immediately.

Missing a dose of Pediaven G15

Pediaven G15 should always be used according to the doctor's recommendations.
Inform the doctor immediately if the patient has not received an infusion of Pediaven G15.
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 related to 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 patient experiences the following symptoms:
described below:
­
unusual signs or symptoms of an allergic reaction, such as sweating, fever, chills, headaches, rash, or breathing problems.
Side effects related to parenteral nutrition (nutrition administered into a vein), especially at the beginning of treatment, may occur, including:
­
elevated blood sugar levels (hyperglycemia);
­
gastrointestinal disorders (nausea, vomiting);
­
excessive intake of amino acids can cause metabolic acidosis (imbalance of acidic and alkaline substances in the body).
Hyperazotemia (excessive amount of nitrogen compounds in the blood) may occur, especially if the patient has kidney, liver, or respiratory problems;
­
temporary liver function disorders;
­
allergic reactions to certain amino acids.
Incorrect use (overdose or too rapid infusion) may lead to the occurrence of hyperglycemia and hypervolemia (increased blood volume in the veins) symptoms.

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: [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 G15

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 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 ingredients can be added through the port intended for adding additional substances.
The medicine should be used immediately after adding other ingredients.
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 containers.
Ask the 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 G15 contains

­
The active substances of the medicine are:

Active substances Amino acid solution

Solution Solution after mixing, glucose ready for use

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
(corresponding to cysteine)

500 ml 500 ml

0.31 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
(corresponding to anhydrous lysine)
0.31 g
(0.23 g)
1.45 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
(corresponding to anhydrous glucose)
1.45 g
(1.29 g)
165.0 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
165.0 g
(150.0 g)
iron 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
­
The other ingredients (excipients) are: acetic acid, hydrochloric acid (for pH adjustment), water for injections.
Osmolality of the solution: 1091 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
150 g
15 g
2.14 g
660 kcal
600 kcal

What Pediaven G15 looks like and what the pack 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 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 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%
Date of last revision of the leaflet:21.01.2020
--------------------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:

Warnings and precautions for use

Pediaven G15, 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 during catheter insertion.
To avoid the risk associated with administering the infusion at a rate greater than recommended, it is crucial to perform 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 anaphylactic reaction (especially fever, chills, sweating, rash, or shortness of breath), discontinue the infusion immediately.
Pediaven G15 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 increased in the following cases:
­
severe liver failure,
­
severe kidney 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 medicines, extravasation (see section 4. Possible side effects) may occur during infusion of this medicine.
Regularly check the infusion 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, and aspirate the remaining fluid before removing the catheter or cannula.
The treatment of extravasation may include non-pharmacological treatment, pharmacological treatment, and (or) surgical intervention.
In case of significant extravasation, consult a surgeon.
Do not re-administer the infusion 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 G15 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").

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 perform regular clinical and biological assessments of 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:
­
in infants (1 month–2 years): 9 ml/kg body weight/hour (corresponding to 1.4 g glucose/kg body weight/hour),
­
in children (2–11 years): 8 ml/kg body weight/hour (corresponding to 1.2 g glucose/kg body weight/hour),
­
in adolescents (11–18 years): 3 ml/kg body weight/hour (corresponding 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 also before adding any other substances 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, Pediaven G15 should 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), 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.
Any unused mixture should be discarded.
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 G15 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 G15 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 G15 to light, especially after adding trace elements and (or) vitamins, may lead to the formation of peroxides and other degradation products, which can be limited by protecting from light.