ISOPURAMIN 3 % Infusion solution

Зміст інструкції

1. Isopuramin –10% solution for infusion
   1. What is ISOPURAMIN and what is it used for
   2. What you need to know before you are given ISOPURAMIN
   3. How ISOPURAMIN will be administered
   4. Possible side effects
   5. How to store ISOPURAMIN
   6. Package contents and other information

Isopuramin –10% solution for infusion

10% amino acid solution

Read this leaflet carefully before you are given this medicine as 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, ask your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What ISOPURAMIN is and what it is used for
• 2. What you need to know before you are given ISOPURAMIN
• 3. How ISOPURAMIN will be given to you
• 4. Possible side effects
• 5. How to store ISOPURAMIN
• 6. Contents of the pack and other information

1. What is ISOPURAMIN and what is it used for

ISOPURAMIN contains amino acids (substances used by your body for protein production).
ISOPURAMIN is used to provide food (nutrition) directly into the blood, when you cannot
take enough orally. This means that it is administered through a vein, together with
solutions rich in sugars and fats, in addition to salts, vitamins and trace elements, to meet the needs
nutritional requirements.
ISOPURAMIN is indicated in adults and children:

• If you are in a state of malnutrition of various kinds,
• If you are about to undergo or have recently undergone surgery,
• If you have extensive burns,
• If you suffer from a severe liver disease (decompensated hepatic cirrhosis),
• If you suffer from a kidney disease (nephrotic syndrome without renal insufficiency, acute and chronic uremia in periodic peritoneal dialysis or in extracorporeal dialysis), and are also undergoing dialysis, a method of blood filtration,
• If you are in a condition where a significant nitrogen intake is necessary for protein reconstruction. See your doctor if you do not feel better or if you feel worse.

2. What you need to know before you are given ISOPURAMIN

You will not be given ISOPURAMIN

• If you are allergic to one or more amino acids or to any of the other ingredients of this medicine (listed in section 6).
• If you do not produce urine (Acute and chronic Uremia in conservative medical treatment).
• If you are dehydrated.
• If you suffer from a severe liver disease (hepatic coma).
• If you suffer from high levels of sodium in the blood.
• If you suffer from a disorder related to amino acid metabolism.

Warnings and precautions
Consult your doctor or nurse before you are given ISOPURAMIN.
When used in children under 2 years of age, the solution (in bottles and administration sets) must be protected from exposure to light until the administration is completed. Exposure of Isopuramin 10% to ambient light, especially after the addition of trace elements and/or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure.
If you experience abnormal signs or symptoms of an allergic reaction, such as fever, chills, skin rashes or difficulty breathing, excessive sweating, nausea or headache, consult your doctor or nurse: the infusion will be stopped immediately.
ISOPURAMIN may cause the formation of precipitates in the blood. If you begin to have difficulty breathing or shortness of breath, consult your doctor or nurse: the infusion will be stopped immediately and further treatment may be necessary.
Some medications and diseases can increase the risk of developing infections or sepsis (bacteria in the blood).
There is a particular risk of infection or sepsis when a tube (central venous catheter) is placed in a vein. The doctor will carefully examine you to assess for any signs of infection.
If you are so severely malnourished that you require feeding through a vein, it is recommended to start parenteral nutrition slowly and carefully.
ISOPURAMIN may cause a stinging pain and redness at the site of intravenous administration if given in an arm.
The doctor will monitor your condition during the infusion, especially if you currently have problems with your liver, kidneys, heart or circulation.
Amino acid solutions can increase levels of ammonia or nitrogen-containing compounds in the blood. The doctor will check your blood tests for this.
The doctor must be informed of any serious conditions you have that affect fluids, sugars, fats, proteins and salts (metabolic disorders). These conditions will be corrected before taking ISOPURAMIN.

Tell your doctor if you have or have had:

• an allergic reaction while the infusion was being given. This will be stopped immediately.
• liver disease or insufficiency.
• heart failure (a special check may be required under the above conditions).
• hemodialysis. The maximum infusion volume you can tolerate must be considered.

During the infusion, blood and urine samples will be taken to monitor:

• the amount of fluid in the body;
• the amount of chemicals in the blood and urine;
• the acid-base balance (acidity in the blood and urine);
• liver and kidney function

Children and adolescents
The doctor will subject your child to frequent blood tests to check nitrogen levels in the blood, to avoid cases of hyperammonemia (high levels of nitrogen in the blood) that can occur during prolonged treatments. Electrolyte levels in the blood must also be monitored to ensure they are within acceptable levels.

Elderly
The doctor will ensure that elderly patients undergo frequent blood tests to check nitrogen levels in the blood, in order to avoid cases of hyperammonemia (high levels of nitrogen in the blood), which can occur during prolonged treatment.

Other medicines and ISOPURAMIN
Tell your doctor if you are taking, have recently taken or may take/may be given any other medicines.
No particular interactions have been reported.
To minimize the risk of any incompatibilities, it is advisable not to add other medicines to the solution.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before you are given this medicine.
No reliable data on toxicity or safety are available for use in pregnancy; use only if necessary and under direct medical supervision.

ISOPURAMIN contains sodium metabisulfite
Rarely, it can cause severe hypersensitivity reactions and bronchospasm.

3. How ISOPURAMIN will be administered

ISOPURAMIN will be administered by a healthcare professional. The doctor will determine the dose based on your
age, weight, clinical condition (nutritional status and severity of the disease), your nitrogen requirements
and your tolerance. The doctor will also decide how long the administration will last.
Method of administration
When used in children under 2 years of age, the solution (in vials and administration sets) must be protected from
light exposure until the administration is completed (see section 2).
You will receive this medicine through an injection into a vein.

If you are given too much ISOPURAMIN
Your doctor or nurse will monitor you during treatment.
If you are given too much ISOPURAMIN and/or it is given too quickly, you may develop
the following symptoms:

• elevated nitrogen levels in the blood (hyperazotemia)
• elevated ammonia levels in the blood (hyperammonemia) especially if you suffer from serious liver disorders
• elevated fluid levels (hypervolemia)
• an electrolyte imbalance
• elevated acid levels in the blood (acidosis). If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

The following side effects have been reported with ISOPURAMIN with an unknown frequency (the
frequency cannot be defined based on available data).

Laboratory tests:
An increase in liver enzyme levels called transaminases.
The following side effects represent those that are thought to have an association with the use of
ISOPURAMIN. These have been reported for similar products, with an unknown frequency (cannot be
defined based on available data):

• Severe allergic reactions, called anaphylactic and anaphylactoid reactions, which may cause: accelerated heartbeat, shock, low blood pressure, difficulty breathing, wheezing, sensation of constriction in the throat, rapid or deep breathing, vomiting nausea, general swelling, paleness, unstable circulatory condition with risk of death
• Other symptoms of allergic reaction: urticaria hypertension, skin reaction, redness of the skin (erythema), facial swelling, eyelid swelling
• Excess ammonia in the blood
• Alteration of the acid-base balance of the blood
• Headache
• Increased heart rate
• Bluish discoloration of the skin
• Respiratory disorders
• Reduced oxygen supply to the tissues
• Sensation of constriction in the throat
• Increased breathing rate
• Nausea and vomiting
• Tingling or numbness of the mouth
• Pain in the back of the mouth
• Liver failure
• Chronic liver disease, called cirrhosis
• Thickening of the liver
• Fatty liver
• Condition in which bile cannot flow from the liver to the duodenum
• Inflammation of the gallbladder
• Presence of one or more stones (gallstones) in the gallbladder
• Skin reactions
• Joint and muscle pain
• Elevated levels of urea and nitrogenous waste in the blood
• Local pain or reaction at the infusion site (irritation, swelling, heat, formation of a hard nodule, formation of necrotic tissue)
• Irritation, inflammation and formation of a blood clot in the vein into which the solution is infused
• Increased bilirubin in the blood
• Increased liver enzymes
• Increased temperature

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor. You can also report side effects directly through 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 ISOPURAMIN

When used in children under 2 years of age, the solution (in bottles and administration sets) must be protected from light exposure until the administration is completed (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 which is reported on the bag after Scad. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What ISOPURAMIN contains

• The active ingredients per 1000 ml of 10% amino acid solution are: L-Alanine g 7.00 L-Arginine g 11.70 L-Phenylalanine g 7.90 Glycine g 6.40 L-Isoleucine g 8.00 L-Histidine g 5.10 L-Leucine g 10.60 L-Lysine Acetate g 16.23 equivalent to L-Lysine g 11.50 L-Methionine g 7.20 L-Tyrosine g 0.30 L-Threonine g 9.50 L-Tryptophan g 3.20 L-Valine g 11.60
• The other components are L-Cysteine, Glacial Acetic Acid, Sodium metabisulfite(see section 2). ISOPURAMIN contains sodium metabisulfite, Water for injections.

Description of the appearance of ISOPURAMIN and package contents
ISOPURAMIN is presented as an infusion solution in vials of 250 ml and 500 ml.
It is available in the following packages:

• 30 vials of 250 ml of 10% amino acid solution
• 20 vials of 500 ml of 10% amino acid solution. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Baxter S.p.A.
Via del Serafico 89
00142 Rome

Manufacturer
BIEFFE MEDITAL S.p.A. – Pharmaceutical workshop of Grosotto (SO)
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The following information is intended exclusively for doctors or healthcare professionals:
The solution should only be administered if perfectly clear, ensuring that the vial does not have
imperfections in the closure or cracks, as this could compromise the sterility of the product.
Each vial should be used for a single administration, even if the solution is only partially used. The
residue should no longer be used.
Administration of the solution should be stopped if any chills or signs of intolerance appear.
The product must be used with caution in patients with renal impairment and hyperazotemia.
To minimize the risk of any incompatibilities, it is advisable not to add other drugs to the
solution.
Do not reconnect partially used infusions. Do not connect containers in series to avoid gas embolism
due to possible residual air contained in the primary container.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
The dosage depends on the patient's clinical picture, as prescribed by a doctor. A
flow rate of less than 40 drops in the first minute is recommended.
For correct nutritional therapy with Isopuramin 10%, it is appropriate to administer 35-45 Kcal/Kg/day
in the form of glucose or lipids. In this case, the administration of insulin, potassium, sodium,
chlorine, phosphorus, magnesium and other elements in relation to clinical needs is appropriate. The dosage depends on the
patient's clinical picture as prescribed by a doctor.
The start of parenteral nutrition, as well as the dosage (dose and frequency of administration) depend
on the following characteristics of the patient:

• age, weight, clinical condition,
• nitrogen requirement,
• metabolic capacity,
• supplementary nutrition that can be provided by parenteral and/or enteral route.

As indicated on an individual basis, vitamins and trace elements and other components (including glucose and
lipids) can be added to the parenteral nutrition regimen to meet nutritional needs and
prevent deficiencies and complications. When prolonged parenteral nutrition is required, concomitant administration of a fat emulsion should be considered to prevent essential fatty acid deficiency.
Method of administration
Isopuramin 10% is intended for intravenous use.
The osmolarity of a specific infusion solution must be taken into consideration when considering
peripheral administration.
Highly hypertonic parenteral solutions (>900 mOsm/l) must be administered through a
central venous catheter with the tip in a large central vein.
The flow rate must be adjusted taking into account the dose administered, the daily volume intake
and the duration of the infusion.
Parenteral medicines must be visually inspected for particles and
color change before administration.
When used in children under 2 years of age, the solution (in vials and administration sets) must be protected from light exposure until the completion of
administration.

Special warnings and precautions for use
Exposure to light of parenteral nutrition solutions, especially after the addition
of trace elements and/or vitamins, can cause the generation of peroxides and other degradation products.
When used in children under 2 years of age, Isopuramin 10% must be protected from ambient light
until the completion of administration.

Special precautions for disposal and handling:
When used in children under 2 years of age, protect from exposure to light until
completion of administration. Exposure of Isopuramin 10% to ambient light, especially
after the addition of trace elements and/or vitamins, generates peroxides and other degradation products that can
be reduced by protecting from light exposure.