Inframin

Package leaflet: Information for the user

INFRAMIN infusion solution.

Please read this leaflet carefully before using this medicine 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.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What INFRAMIN is and what it is used for

INFRAMIN contains a group of substances called amino acids, which are essential for the human body and
used to nourish patients who cannot be fed by mouth (parenteral nutrition).
This medicine is indicated to supply protein substances to individuals suffering from kidney diseases
(acute and chronic renal failure) and/or undergoing mechanical blood filtration (peritoneal dialysis or hemodialysis).

2. What you should know before using INFRAMIN

Do not use INFRAMIN

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems metabolizing amino acids;
• if you suffer from severe liver disease (severe hepatic insufficiency);
• if you have serious heart function problems (myocardial insufficiency);
• if you have high levels of fluid in the body (hyperhydration);
• if you have low levels of sodium (hyponatremia) or potassium (hypokalemia) in the blood.

Warnings and precautions
Talk to your doctor or nurse before using INFRAMIN.
This medicine will be administered with caution if you suffer from kidney problems (renal insufficiency) with
difficulty urinating or absence of urine production (oliguria or anuria).
During treatment with INFRAMIN, your doctor will carry out regular laboratory tests to monitor levels of electrolytes (fluid and electrolyte balance), nitrogen (azotemia), creatinine (creatininemia), and urea (uremia) in your blood, and will take steps, if necessary, to restore balance by administering corrective solutions. Furthermore, if deemed necessary by your doctor, you will be prescribed medicines to protect your stomach (H2-antagonists).
Before and during administration of the medicine, you will be given a sugar solution orally or by injection (parenterally). If needed, an adequate amount of potassium will be administered to ensure proper utilization of amino acids by the body.

Other medicines and INFRAMIN
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
There are no available data regarding the effects of this medicine on the ability to drive or operate machinery.

INFRAMIN contains sodium metabisulfite
This medicine contains sodium metabisulfite. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

3. How to use INFRAMIN

Use this medicine exactly as directed by your doctor or nurse. If you have any doubts, consult your
doctor or nurse.
This medicine will be administered to you by a doctor or other specialized healthcare professional as a slow intravenous infusion (drop by drop into a vein), with an infusion rate not exceeding 20 drops per minute. If you have any doubts, consult your doctor, pharmacist, or nurse.
Your doctor will determine the dose and duration of treatment based on your health condition and body weight.
If you use more INFRAMIN than you should
Since this medicine will be administered by specialized personnel, it is unlikely that you will receive an excessive dose. However, if you think that you have been given too much INFRAMIN, inform your doctor or another healthcare professional immediately.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the infusion is administered too quickly, the following side effects may occur:

• nausea, vomiting;
• chills;
• stomach acidity and lesions (stress ulcer).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store INFRAMIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month and to the product kept in its original packaging and
properly stored.
Store the medicine at a temperature not exceeding 25°C and protect it from light. Do not freeze or refrigerate.
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 INFRAMIN contains

• The active substances are amino acids. 1000 ml of solution contain 53 g of total amino acids, corresponding to: 0.56 g of L-Isoleucine; 0.40 g of L-Threonine; 0.88 g of L-Leucine; 0.20 g of L-Tryptophan; 0.64 g of L-Lysine base (0.903 g of L-Lysine Acetate); 0.64 g of L-Valine; 0.26 g of L-Histidine; 0.88 g of L-Phenylalanine; 0.88 g of L-Methionine. Each litre of solution contains 6.54 g of total nitrogen. pH 5.8 - 6.8.
• The other components are: sodium metabisulfite, glacial acetic acid and water for injections.

Description of the appearance of INFRAMIN and contents of the pack
Bottles of 100 ml, 250 ml, 24x250 ml, 500 ml, 20x500 ml, 1000 ml.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
FRESENIUS KABI ITALIA S.r.l. – Via Camagre, 41 – 37063 Isola della Scala (VR)
Manufacturer
Fresenius Kabi Italia S.r.l. - Via Camagre, 41 - 37063 Isola della Scala (VR).
S.M. Farmaceutici S.r.l. – Zona Industriale – 85050 Tito (PZ)

The following information is intended for healthcare professionals only:

Dosage and method of administration
For intravenous infusion with a drip rate not exceeding 20 drops/min.
In cases of acute and chronic renal failure not undergoing dialysis treatment: up to 0.5 g of
amino acids/kg/day (equivalent to 500 ml for a 70 kg patient).
In cases of acute and chronic renal failure undergoing hemodialysis or peritoneal dialysis: up to 1
g of amino acids/kg/day (equivalent to 1000 ml for a 70 kg patient).
Maximum dosage: up to 1.5 g of amino acids/kg/day (equivalent to 1500 ml/day for a 70 kg patient).
In patients with kidney disease (chronic renal failure) not treated with hemodialysis or peritoneal dialysis,
the product may be used until oral protein intake becomes feasible. In cases of acute renal failure with adequate
urine output, treatment should be limited to a few days, with a maximum duration of two weeks.
Excessively rapid infusion should be avoided, as it may increase the risk of adverse effects.
The solution should only be used if clear, free from visible particles, and the container is intact.
It is intended for single and continuous administration; any residual solution must not be reused.
Storage
Store in the original packaging to protect the medicinal product from light. Do not store above 25°C.
For further information, refer to the Summary of Product Characteristics.