Primene 10%

Package Leaflet: Information for the User

PRIMENE 10%, Solution for Infusion

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is PRIMENE 10% and what is it used for
• 2. Important information before using PRIMENE 10%
• 3. How to use PRIMENE 10%
• 4. Possible side effects
• 5. How to store PRIMENE 10%
• 6. Contents of the pack and other information

1. What is PRIMENE 10% and what is it used for

PRIMENE 10% is a sterile solution of 20 L-amino acids, which quantitatively and qualitatively meets the child's protein requirements:

• contains all essential and non-essential amino acids for children;
• contains a relatively large amount of lysine;
• contains taurine;
• contains a relatively small amount of methionine;
• is characterized by a reduced content of phenylalanine and proline;
• essential amino acids account for 47.5% of the total amino acid content, and branched-chain amino acids account for 24%;
• clinical trials have shown that with a balanced energy supply, PRIMENE 10% allows for satisfactory growth and weight gain, as well as satisfactory psychomotor development in children;
• PRIMENE 10% does not contain electrolytes to facilitate individual treatment with electrolyte solutions.

Amino acids are building blocks that the body uses to produce proteins.
PRIMENE 10% may be part of nutritional mixtures consisting of sugars, fats, electrolytes, trace elements, and vitamins, provided that the compatibility and stability of PRIMENE 10% with other components of the mixture are known.
PRIMENE 10% is indicated for use:

• in children and infants, newborns born at term or preterm, with normal body weight or underweight, for the administration of food (nutrition) directly into the blood (intravenously), when oral or enteral nutrition is impossible, insufficient, or contraindicated. It is usually used with other solutions and components for nutrition, such as glucose, fats, mineral compounds, and vitamins.

PRIMENE 10% should only be used in a specialized medical care setting.

2. Important information before using PRIMENE 10%

When not to use PRIMENE 10%

• if the patient is hypersensitive (allergic) to the active substances or any of the other ingredients of this medicine (listed in section 6);
• in children with congenital disorders of metabolism of one or more amino acids.

If any of the above situations apply to the patient, PRIMENE 10% will not be administered.

Warnings and precautions

Before starting treatment with PRIMENE 10%, discuss it with your doctor or nurse.
When used in newborns and children under 2 years of age, the solution (in the bottle and administration set) should be protected from light until the end of administration. Exposure of PRIMENE 10% to light, especially after the addition of trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be limited by ensuring protection from light.

Allergic reactions

In case of any signs or symptoms of an allergic reaction (such as fever, sweating, shivering, headache, skin rash, or difficulty breathing), the infusion should be stopped immediately.

Formation of small particles in the pulmonary blood vessels

Breathing difficulties may also be a sign of the formation of small particles blocking the blood vessels in the lungs (pulmonary vascular deposits). If breathing difficulties occur, the doctor or nurse should be informed. They will decide on the actions to be taken.

Infection and sepsis

Some medicines and diseases can increase the risk of developing an infection or sepsis (presence of bacteria in the blood). There is a particular risk of infection or sepsis after the insertion of a tube (central venous catheter) into the patient's vein. The doctor will carefully monitor the patient to detect any signs of infection.

Changes in blood chemical composition

The doctor will check and monitor the patient's fluids, biochemical parameters, and other blood concentrations. Excess fluid in the tissues and edema may also occur. It is recommended to start parenteral nutrition slowly and with caution.

Hypertonic solution (high concentration of dissolved amino acids)

PRIMENE 10% is a solution containing a high concentration of dissolved amino acids.
It can be administered into a vein in the arm or into a large vein in the chest. If it is administered into a smaller vein in the arm, it may cause vein irritation. You should talk to your doctor or nurse if the patient experiences discomfort at the injection site or around the injection site.

Monitoring and adjustment

The doctor will monitor the patient's condition at the start of the infusion and during its duration. You should ensure that the doctor is informed about all severe conditions that may affect the body's ability to handle sugars, fats, proteins, and salt (metabolic disorders).
If any unusual symptoms occur, such as sweating, shivering, bruising, or irregular heartbeat, the infusion should be stopped and the doctor or nurse informed.
During the administration of the medicine, the doctor will regularly monitor the patient's blood parameters to check the effectiveness and safety of the medicine, especially if the patient has liver, kidney, adrenal, heart, or circulatory problems.

When to exercise special caution when using PRIMENE 10%

• if there are significant restrictions on the amount of water administered, for example, in the case of circulatory, respiratory, or renal disorders, PRIMENE 10% should be used with great caution;
• in the case of renal failure, the amount of nitrogen administered must be adjusted to the child's renal clearance;
• in the case of liver failure, it is recommended to monitor the blood ammonia concentration. It is necessary to carefully monitor the course of the infusion, biochemical parameters, and the child's clinical condition (with control of the basic acid-base balance).

PRIMENE 10% and other medicines

Tell your doctor about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Interactions with other medicines are not known.
PRIMENE 10% may be part of nutritional mixtures consisting of sugars, fats, electrolytes, trace elements, and vitamins, provided that the compatibility and stability of PRIMENE 10% with other components of the mixture are known.

Pregnancy and breastfeeding

PRIMENE 10% is indicated for use in children, infants, and newborns, so there is no data on the use of PRIMENE 10% in pregnant or breastfeeding women. If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.

Driving and using machines

PRIMENE 10% is indicated for use in children, infants, and newborns, so there is no data on the effect of PRIMENE 10% on the ability to drive vehicles or operate machinery.

3. How to use PRIMENE 10%

PRIMENE 10% can be administered to children, infants, and newborns (born at term or preterm).
This is a solution for infusion, administered through a plastic tube into a vein in the arm or into a large vein in the chest.

Dosage and duration of treatment

The doctor will decide on the dose of the medicine and how long it will be administered. This depends on the patient's age, body weight, clinical condition, protein requirements, and the body's ability to break down and utilize the components of PRIMENE 10%. Additional nutrition or protein may also be administered orally/enterally.

Method of administration

When used in newborns and children under 2 years of age, the solution (in the bottle and administration set) should be protected from light until the end of administration (see section 2).
Dosage
Depending on body weight, age, and protein catabolism in the child:
1.5 to 3.5 g of amino acids/kg body weight/24 hours, i.e., 0.23 to 0.53 g of nitrogen/kg body weight/24 hours or
15 to 35 ml of PRIMENE 10%/kg body weight/24 hours.
The infusion rate should not exceed 0.05 ml/kg body weight/minute.
Route of administration

• PRIMENE 10% should be administered through a central vein or peripheral vein;
• PRIMENE 10% used in parallel with other solutions or as a mixture should be administered, depending on the final osmolality of the infused solution, through peripheral veins or one of the central veins.

Infusion rate and duration
Recommended infusion rates:

• newborns and infants: continuous infusion (for 24 hours);
• children: continuous infusion (for 24 hours) or cyclic infusion (for 8 to 12 hours a day).

The infusion rate should take into account the administered dose, the characteristics of the administered solution, the daily volume of administration, and the duration of the infusion.
PRIMENE 10% is usually administered with energy-providing substances that meet the child's needs, in parallel or as part of nutritional mixtures.
PRIMENE 10% can be included as a component of nutritional mixtures containing sugars, fats, electrolytes, trace elements, and vitamins, after checking their compatibility and stability.

Overdose of PRIMENE 10%

Symptoms

In case of administration of too large a dose of the medicine or too rapid infusion, the patient may experience increased blood volume, increased blood acidity, or increased nitrogen content in the blood and urine. Objective symptoms may include nausea, vomiting, shivering, confusion, and rapid heartbeat. In such cases, the infusion must be stopped immediately.
The doctor will decide whether additional actions are necessary.
To prevent the occurrence of these events, the doctor will regularly monitor the patient's condition and perform blood tests during treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any changes in your well-being during or after treatment, you should immediately inform your doctor or nurse. The tests performed by the doctor during treatment should minimize the risk of side effects.
If any unusual signs or symptoms of an allergic reaction occur, such as abnormally low or high blood pressure, blue or purple discoloration of the skin, swelling of the face or eyelids, irregular heartbeat, difficulty breathing, vomiting, nausea, skin rash, elevated body temperature, excessive sweating, shivering, or tremors, the infusion should be stopped immediately.
The following side effects have been reported during the use of similar products:

• high blood levels of ammonia and nitrogen compounds;
• anaphylactic reactions, severe allergic shock, i.e., a reaction that develops rapidly and can be life-threatening if not treated;
• liver dysfunction, abnormal liver function test results;
• gallbladder inflammation, presence of gallstones in the gallbladder;
• increased blood acidity;
• formation of small particles blocking the blood vessels in the lungs;
• vein inflammation at the infusion site, vein irritation, pain, warmth, swelling, and hardening;
• in case of leakage of the infusion fluid into the surrounding tissues, severe local reactions may occur: skin necrosis, blistering, swelling, scarring, and skin discoloration.

You should immediately inform your doctor or nurse about any changes in your well-being during or after the infusion.

• in case of administration of too large a volume of the solution, children with renal failure may experience metabolic acidosis and increased urea nitrogen levels in the blood;
• amino acid solutions may accelerate the development of folic acid deficiency, which should be supplemented;
• injection into superficial veins may cause thrombophlebitis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or nurse. 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, PL 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PRIMENE 10%

The medicine should be stored out of the sight and reach of children.
When used in newborns and children under 2 years of age, the solution (in the bottle and administration set) should be protected from light until the end of administration (see section 2).
Do not use this medicine after the expiry date stated on the label and outer packaging.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use if the bottle is leaking, if the solution is cloudy or contains a precipitate.
Partially used containers should be destroyed.
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 pack and other information

What PRIMENE 10% contains

Active substances of the medicine:
100 ml of the solution for infusion contains:
L-Isoleucine 0.670 g
L-Leucine 1.000 g
L-Valine 0.760 g
L-Lysine 1.100 g
L-Methionine 0.240 g
L-Phenylalanine 0.420 g
L-Threonine 0.370 g
L-Tryptophan 0.200 g
L-Arginine 0.840 g
L-Histidine 0.380 g
L-Alanine 0.800 g
L-Aspartic acid 0.600 g
L-Cysteine 0.189 g
L-Glutamic acid 1.000 g
Glycine 0.400 g
L-Proline 0.300 g
L-Serine 0.400 g
L-Tyrosine 0.045 g
L-Ornithine hydrochloride 0.318 g
Taurine 0.060 g
Total nitrogen: 15 g/l
Amino acids: 100 g/l
Chlorides: 19 mmol/l
Other ingredients of the medicine are: L-malic acid, water for injections
Osmolality: 780 mOsm/l

What PRIMENE 10% looks like and contents of the pack

PRIMENE 10% is a clear, colorless or slightly yellow solution of amino acids, not containing electrolytes.
Pack sizes:
Glass bottles: 100 ml, 250 ml, 500 ml, and 1000 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw

Manufacturer:

Bieffe Medital S.p.a
Via Nuova Provinciale
I-23034 Grosotto
Italy
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
tel.: 22 488 37 77

Date of last revision of the leaflet: September 2019

Baxter and Primene are trademarks of Baxter International Inc.