Isoram

Package leaflet: information for the patient

ISORAM 4%, infusion solution

Amino acid solution
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, inform your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What ISORAM is and what it is used for

ISORAM contains amino acids (substances used by your body for protein production).
ISORAM is a solution for parenteral nutrition, meaning it is administered through a vein.
ISORAM is indicated in patients who:

• have experienced trauma or undergone surgery (Mechanical trauma - Surgical trauma - Postoperative period - Septic states - Post-traumatic stress conditions in cirrhotic patients).
• suffer from severe brain disease caused by severe liver disease (Hepatic encephalopathy).

2. What you need to know before using ISORAM

Do not take ISORAM

• if you are allergic to amino acids or to any of the other ingredients of this medicine (listed in section 6).
• if you have a congenital disease (present from birth) that prevents proper metabolism of amino acids.

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

• Your doctor will perform frequent blood tests/monitoring during treatment.
• Inform your doctor if:
  • • you have liver problems (hepatic insufficiency)
  • • you have severe lung problems (pulmonary embolism) or heart conditions such as myocardial infarction and heart failure
  • • you develop fever, chills, or reactions at the infusion site (where the infusion needle is inserted) during treatment.

Other medicines and ISORAM
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
No interactions are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before this medicine is administered.
Clinical data on the risk during pregnancy and breastfeeding are not available.
Your doctor will prescribe Isoram only if clearly needed.
Driving and using machines
Not applicable

3. How to use ISORAM

Dosage
The duration of treatment and the dose will be determined by your doctor based on your individual characteristics, as follows: your age, body weight, health status and nutritional status, and your daily requirement for nutrients.

Method of administration
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 (see section 2).
This medicine is administered intravenously.

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

If you have any doubts about the use of 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),
Dyspnoea (difficulty breathing),
Throat tightness,
Hyperventilation (increased respiratory rate),
Vomiting,
Nausea,
Oral paraesthesia (tingling around the mouth),
Oropharyngeal pain (pain in the mouth and throat),
Abdominal pain,
Hyperammonaemia,
Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic steatosis, Cholecystitis, Cholelithiasis
(liver problems),
Rash (skin irritation),
Pruritus,
Erythema (skin redness),
Arthralgia (joint pain),
Myalgia (muscle pain),
Thrombosis at the infusion site,
Phlebitis at the infusion site,
Pain at the infusion site,
Erythema (redness) at the infusion site,
Warmth at the infusion site,
Swelling at the infusion site,
Induration at the infusion site,
Generalised oedema (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, tell your doctor or nurse. You can also report side effects directly via the national reporting system at:
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 ISORAM

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

6. Package Contents and Other Information

What ISORAM Contains

• Active substances in 1000 ml of solution:
  L-Arginine 3.20 g
  L-Isoleucine 6.03 g
  L-Leucine 15.00 g
  L-Valine 18.21 g
  Total Amino Acids 42.44 g/l
  Total Nitrogen 5.45 g/l
  Theoretical Total Osmolality 353 mOsm/l
  Acetates (as HCO₃⁻) 19 mEq/l
  pH (adjusted with glacial Acetic Acid) 5.5 – 7.0

• Other component: Water for injections

Description of the Appearance of ISORAM and Contents of the Package
ISORAM is supplied as an infusion solution in 500 ml bottles.
The following pack size is available:
20 bottles of 500 ml

Marketing Authorization Holder and Manufacturer
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 exclusively for physicians or healthcare professionals:

Dosage and Administration
The initiation and duration of parenteral nutrition, as well as the dosage (dose and frequency of administration), depend on the following patient characteristics:

• Age, weight, clinical condition
• Nitrogen requirements
• Ability to metabolize the components of Isoram
• Daily protein requirements and supplemental nutrition that may be provided via parenteral and/or enteral routes

Since Isoram is a product intended for use within a metabolic rehabilitation or nutritional support program, it should rarely be used without concomitant caloric support. The dosages indicated below are only indicative 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 kcal/kg/day.

Hepatic Encephalopathy
1–2 bottles of 500 ml for intravenous infusion, corresponding to 500–1000 ml of solution.

Other Indications
The solution should generally be used in combination with other amino acid solutions, except under specific clinical conditions. In such cases, the recommended dosage is 1–3 bottles of 250 ml, corresponding to 250–750 ml of solution. Daily administration is recommended unless otherwise directed by the physician. However, the most rational way to use this product is through continuous 24-hour infusion.
If administered intermittently, a single 500 ml bottle or bag should be infused over no less than 4 hours (infusion rate of approximately 30 drops/minute).
Treatment should continue as long as nutritional or metabolic support is required.

Route of Administration
Isoram is intended for intravenous use. The preferred route is central venous infusion, but peripheral infusion is also possible.
The osmolality of the specific infusion solution must be considered when peripheral administration is contemplated.
The infusion rate should be adjusted according to the dose administered, the total daily volume, and the duration of infusion.

Special Populations

Children
The safety and efficacy of Isoram in children have not been established.

Elderly
Dosage should be determined cautiously, taking into account possible reductions in cardiac, renal, or hepatic function, as well as concomitant diseases or pharmacological therapies.

Patients with Renal Impairment
Administer with caution, as nitrogen tolerance may be altered and dosage adjustment may be necessary. In these patients, fluid and electrolyte status must be closely monitored.

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 required to detect possible signs of hyperammonemia.

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

Special Precautions for Disposal and Handling
Check the integrity of the container. Use only if the container is undamaged and the solution is clear and colorless or slightly yellow.
Crystallization of amino acids may occur on the neck of the bottle following temperature fluctuations. In such cases, shake the solution vigorously and, if necessary, warm in a water bath at 37°C until crystals are completely dissolved before administration.
When used in children under 2 years of age, the solution (in bottles and administration sets) must be protected from light exposure until the end of administration.

Special Warnings and Precautions for Use
Exposure to light of parenteral nutrition solutions, especially 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, Isoram must be protected from ambient light until the end of administration.

• Ensure the solution reaches room temperature before use
• Maintain aseptic conditions
• For single use only
• Do not reconnect partially used infusions
• Inspect the final solution for changes in color or particulate matter
• Do not connect containers in series, to avoid gas embolism due to possible residual air in the primary container

Special Precautions for Disposal and Handling
When used in children under 2 years of age, protect from light exposure until completion of administration. Exposure of Isoram to ambient light, particularly after addition of trace elements and/or vitamins, may generate peroxides and other degradation products; these can be minimized by protecting the solution from light.