Pediaven g25

Patient Information Leaflet

Pediaven G25, infusion solution
compound preparation
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
­ Keep this leaflet so that you can read it again if necessary.
­ If you have any questions, please consult your doctor or nurse.
­ If you experience any side effects, including any not listed in this leaflet, inform your doctor or nurse. See section 4.
Leaflet Contents

1. What Pediaven G25 is and what it is used for
2. What you need to know before using Pediaven G25
3. How to use Pediaven G25
4. Possible side effects
5. How to store Pediaven G25
6. Contents of the pack and other information

1. What Pediaven G25 is and what it is used for

Pediaven G25 is a nutritional mixture containing amino acids (components essential for protein formation), glucose (carbohydrates), and 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 (given by drip into a vein).
It can be used in infants, children, and adolescents who cannot receive oral nutrition.

2. Important information before using Pediaven G25

When not to use Pediaven G25:
­ 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 processes 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 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 has severe malnutrition and there is a risk of developing "refeeding syndrome".

Other general situations when not to use Pediaven G25:
­ 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 G25 should not be administered if any of the above situations apply to the patient.
If in doubt, please consult a doctor or nurse before administering Pediaven G25 to the patient.

Warnings and precautions
Important information before starting treatment with Pediaven G25:
Pediaven G25 should be used with great caution when fluid intake needs to be restricted, for example in certain heart, lung or kidney diseases.

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

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 G25 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 G25 may cause an increase in blood magnesium concentration.
This may manifest as: weakness, decreased 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 there is a risk of elevated magnesium levels, particularly in patients with impaired kidney function. If blood magnesium levels are 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, lipids or electrolytes).

Pediaven G25 and other medicines
Tell the doctor about all medicines currently used or recently used by the patient, including medicines obtained without a prescription.

3. How to use Pediaven G25

Dosage
Pediaven G25 should always be used as directed by the physician. The physician will determine the dose
and duration of treatment based on the patient's age, body weight, metabolic and energy requirements,
clinical condition, and ability to tolerate oral or enteral nutrition (delivery of nutrients through a tube
placed in the gastrointestinal tract).
If nutrition is administered exclusively intravenously (into a vein), the physician may recommend
simultaneous administration of vitamins and fats. If vitamins have been added to the solution, the bag
must be protected from light.

Route of administration
Pediaven G25 is administered exclusively by medical personnel and only intravenously, via a central
vein (into 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 until the end of the infusion (see section 2).

Administration of a higher than recommended dose of Pediaven G25
Pediaven G25 should always be used as directed by the physician. If there is any suspicion that the
patient has received more than the recommended dose, this should be reported to the physician
immediately.

Missed administration of Pediaven G25
Pediaven G25 should always be used as directed by the physician. If a dose of Pediaven G25 infusion
has been missed, the physician should be informed immediately. Do not administer a double dose to
compensate for the 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 product may cause adverse reactions, although not everyone experiences them.
You must contact the doctor immediately, who will stop the infusion, if the patient develops any of the
following symptoms:
­ atypical 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 glucose levels (hyperglycaemia);
­ gastrointestinal disturbances (nausea, vomiting);
­ excessive intake of amino acids may lead to metabolic acidosis (disturbance in the balance between acidic and alkaline substances in the body). Hyperazotaemia (excess nitrogen-containing compounds in the blood) may occur, particularly in patients with kidney, liver, or respiratory disorders;
­ transient disturbances in liver function;
­ allergic reactions to specific amino acids.
Improper use (overdose or infusion administered too rapidly) may result in symptoms of hyperglycaemia and hypervolaemia (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 the doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pediaven G25

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 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, 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 intended for administration of additional substances. The medicine should be used immediately after addition of 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 G25 contains
­ The active substances of the medicine are:

­ Other ingredients (excipients) are: glacial acetic acid (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
Osmolarity of the solution: 1790 mOsmol/l
pH of the solution: 4.8 – 5.5
Nutritional value in 1000 ml
glucose 250 g
amino acids 25 g
total nitrogen 3.56 g
total energy 1100 kcal
non-protein energy 1000 kcal
What Pediaven G25 looks like and contents of the pack
This medicinal product is an infusion solution, clear, colourless 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 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 countries under the following names:
Austria Pediaven G25%
Belgium Kidiamix G25%
Estonia Pediaven G25
France Kidiaven G25%
Spain Pediaven G25
Netherlands Kidiamix G25%
Lithuania Pediaven G25%
Latvia Pediaven G25%
Poland Pediaven G25
Portugal Pediaven G25
Italy Kidiamix G25%

Information intended exclusively for healthcare professionals:

Warnings and precautions for use
Pediaven G25, solution for infusion 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 one, 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.
Pediaven G25 must not be administered into a peripheral vein due to its high osmolarity.
Clinical and laboratory monitoring is required during the infusion, particularly at the beginning. Monitoring should be intensified in the following cases:
- severe hepatic insufficiency,
- severe renal insufficiency,
- 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 medications, 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.
In the event of extravasation, the infusion must be stopped immediately, while 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 cases of extensive extravasation, consultation with a surgeon is recommended.
Infusion must 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 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 G25 already contains trace elements. In certain cases, depending on the patient's needs, pharmacological solutions and solutions intended for parenteral nutrition may be added to the bag, but only after verifying the 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 individually adjusted according to the patient's age, body weight, metabolic and energy requirements, and clinical condition.
The physician should perform regular clinical and biological assessments 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): 6 mL/kg body weight/hour (equivalent to 1.4 g glucose/kg body weight/hour),
- in children (2–11 years): 5 mL/kg body weight/hour (equivalent to 1.2 g glucose/kg body weight/hour),
- in adolescents (11–18 years): 2 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 check that the inner bag is intact (leak-proof). 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 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 lead to the formation of peroxides and other degradation products. When used in children under 2 years of age, Pediaven G25 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 firm surface.
2. 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 mixture components.

For single use only. Any unused portion of the mixture must be discarded.
Strict adherence to validated aseptic conditions is required 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 the duration and conditions of storage prior to use lies with the user.

Pharmaceutical compatibility
Only medicinal products or solutions intended for parenteral nutrition, whose compatibility has been established, may be added to Pediaven G25 or administered through the same infusion line.
Information regarding the volume of additional substances and their compatibility with Pediaven G25 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 made 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 G25 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.