Isoselect

Package leaflet: Information for the patient

Isoselect 8% solution for infusion

Amino acid solution
Please read this leaflet carefully before this medicine is administered to you
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Isoselect is and what it is used for

Isoselect contains amino acids (substances used by the body for protein production).
Isoselect is a solution for parenteral nutrition, meaning it is administered into a vein.
Isoselect is indicated in patients for:

• the treatment of hepatic encephalopathy (impairment of brain function in patients with severe liver disease),
• providing nutrition if you have liver cirrhosis (a chronic liver disease),
• providing nutrition, either alone or in combination with other amino acid-containing solutions:
• if you have suffered trauma,
• during and after surgical procedures,
• if you have ongoing infections of various kinds,
• if you have liver disease and are under conditions of stress.

2. What you need to know before using Isoselect

Do not use Isoselect

• if you are allergic to one or more amino acids or to any of the other components of this medicinal product (listed in section 6).
• if you have a congenital disease (present from birth) that impairs the proper metabolism of amino acids.

Warnings and precautions
Talk to your doctor or nurse before using
Isoselect:
When used in children under 2 years of age, the solution (in bottles and administration sets) must be protected from exposure to light until administration is complete. Exposure of Isoselect to ambient light, especially after the addition of trace elements and/or vitamins, generates peroxides and other degradation products, which can be minimized by protecting the solution from light.

• if fever, chills, or reactions at the infusion site (where the infusion needle is inserted) occur during treatment.
• if you have severe lung problems (pulmonary embolism) or heart problems (heart failure).
• if you have liver problems (hepatic insufficiency).
• Your doctor will perform frequent blood tests/monitoring during treatment.

Other medicines and Isoselect
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.
No interactions are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before administration of this medicinal product.
Clinical data on the risk during pregnancy and breastfeeding are not available.
Your doctor will prescribe Isoselect only if clearly necessary.

Driving and using machines
Not applicable.

Isoselect contains sodium metabisulfite (E223).
Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

3. How to use Isoselect

Use this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor.
The duration of treatment and the dose will be determined by your doctor based on your individual characteristics: your age, body weight, general health status, nutritional status, and your daily requirements for nutrients.

Method of administration
When used in children under 2 years of age, the solution (in the vials and administration sets) must be protected from exposure to light until administration is complete (see section 2).

If you take more Isoselect than you should
In case of overdose, hypervolemia (increased fluid volume in the body), electrolyte disturbances (alterations in blood electrolyte levels), acidosis (pH imbalance in the blood), and increased blood urea (azotemia) may occur. In such cases, your doctor will perform specific laboratory tests and initiate appropriate treatment.

If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The frequency of the following adverse reactions is unknown (cannot be estimated from the available data).
Allergic reactions (anaphylactic and anaphylactoid reactions),
Urticaria,
Headache,
Seizures,
Tachycardia (increased heart rate),
Cyanosis (bluish discoloration of the skin and mucous membranes),
Shock,
Hypotension (low blood pressure),
Hypertension (high blood pressure),
Respiratory disorders,
Hypoxia (oxygen deficiency),
Stridor (noisy breathing),
Dyspnea (difficulty breathing),
Sensation of throat tightness,
Hyperventilation (increased respiratory rate),
Vomiting,
Nausea,
Oral paresthesia (tingling around the mouth),
Oropharyngeal pain (pain in the mouth and throat),
Abdominal pain,
Hyperammonaemia,
Hepatic failure, Liver cirrhosis, Liver fibrosis, Liver steatosis, Cholestasis, Cholecystitis,
Cholelithiasis (liver-related problems),
Rash (skin irritation),
Pruritus,
Erythema (skin redness),
Arthralgia (joint pain),
Myalgia (muscle pain),
Thrombosis at infusion site,
Phlebitis at infusion site,
Pain at infusion site,
Erythema (redness) at infusion site,
Warmth at infusion site,
Swelling at infusion site,
Induration at infusion site,
Generalized edema (fluid retention),
Pyrexia (fever),
Chills,
Hot flushes,
Pallor,
Changes in some blood tests (increased blood bilirubin, increased liver enzymes, altered blood urea).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or nurse.
You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Isoselect

When used in children under 2 years of age, the solution (in the vials and administration sets) must be protected from exposure to light until administration is complete (see section 2).
This medicinal product requires no special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Isoselect Contains
The active substances contained in 1000 ml of solution are:
L-Alanine 5.50 g
L-Arginine 7.80 g
L-Cysteine hydrochloride monohydrate 0.43 g, equivalent to L-Cysteine 0.30 g
L-Phenylalanine 0.27 g
Glycine 9.50 g
L-Isoleucine 7.09 g
L-Histidine 2.98 g
L-Leucine 11.84 g
L-Lysine acetate 10.72 g, equivalent to L-Lysine 7.60 g
L-Methionine 0.50 g
L-Proline 5.80 g
L-Serine 4.30 g
L-Threonine 5.80 g
L-Tryptophan 0.15 g
L-Valine 10.65 g

• Other components: sodium metabisulfite; water for injections.
  Total amino acids: 80.08 g/L
  Total nitrogen: 12.80 g/L
  Theoretical total osmolarity: 800 mOsm/L
  Sodium (Na⁺): 5 mEq/L
  Acetate (as HCO₃⁻): 105 mEq/L
  pH (adjusted with glacial acetic acid): 5.5 – 7.0

Description of the Appearance of Isoselect and Package Contents
Isoselect is a solution for infusion supplied in 500 ml vials.
Available pack size:
20 vials of 500 ml

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
BAXTER S.p.A.
Via del Serafico 89
00142 Rome, Italy

Manufacturer
Bieffe Medital S.p.A.
Via Nuova Provinciale
23034 Grosotto (SO), Italy

The following information is intended for healthcare professionals only:

DOSAGE AND ADMINISTRATION
As this product is intended for use within a metabolic reactivation or nutritional support program, it should rarely be used without concomitant caloric support. The dosage recommendations provided are indicative only and may vary significantly depending on the amount and source of calories administered. In general, the recommended dosages assume a concurrent caloric intake of at least 20–25 Cal/kg/day.
The infusion rate must be adjusted according to the administered dose, daily volume requirements, and duration of infusion.

Route of Administration
When used in children under 2 years of age, the solution (both in vials and administration sets) must be protected from light exposure until administration is complete.

HEPATIC ENCEPHALOPATHY
Controlled clinical studies demonstrating benefit with branched-chain amino acid-enriched, aromatic and sulfur-containing amino acid-poor solutions in improving hepatic coma have used average daily doses of 60–75 g, corresponding to one or (if tolerated) two vials per day. Since one 500 ml vial contains 40 g of amino acids, if a patient cannot tolerate more than 60 g of amino acids per day, one vial of Isoselect may be combined with one vial of a branched-chain amino acid solution, thereby further increasing the branched-chain amino acid supply.

OTHER INDICATIONS
The solution may be used alone or combined with other balanced amino acid solutions to increase the branched-chain amino acid supply. The goal is to achieve a total amino acid intake of 1.5–2 g per kg of body weight. For patients of average weight, the recommended dosage is 2–3 vials of 500 ml, corresponding to 1000–1500 ml of solution (80–120 g of amino acids). When used in combination with a high-concentration balanced amino acid solution, depending on individual patient requirements, one or two vials of Isoselect may be added to one 500 ml vial of balanced solution, for a total volume of 1000–1500 ml (90–130 g of amino acids).

Infusion should preferably be administered via central vein, although peripheral administration is also possible. Continuous 24-hour infusion is recommended, or alternatively, each single vial should be infused over no less than 4 hours (infusion rate of approximately 30 drops/minute).

Special Populations
Patients with Renal Impairment
Administer with caution, as nitrogen tolerance may be reduced, and dosage adjustment may be necessary. In these patients, careful monitoring of fluid and electrolyte balance is required.

Patients with Impaired Hepatic Function
Amino acid solutions must be used with caution in patients with pre-existing liver disease or hepatic insufficiency. Close monitoring is necessary to detect possible signs of hyperammonemia.

Incompatibilities
Additives may be incompatible.
Excessive addition of calcium and phosphate increases the risk of calcium phosphate precipitate formation.

Special Warnings and Precautions for Use
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, Isoselect must be protected from ambient light until administration is complete.

Special Precautions for Disposal and Handling
Infusion Administration:

• Warm the solution to room temperature before use.
• Maintain aseptic conditions.
• For single use only.
• Check container integrity. Use only if the container is undamaged and the solution is clear and colorless or slightly yellow.
• Do not reconnect partially used containers.
• Inspect the final solution for any discoloration or particulate matter.

When used in children under 2 years of age, protect from light exposure until administration is complete. Exposure of ISOSELECT to ambient light, particularly after addition of trace elements and/or vitamins, may generate peroxides and other degradation products; such formation can be minimized by protecting the solution from light.