Package leaflet: Information for the user

SIFRAMIN 40 MG/ML INFUSION SOLUTION

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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What SIFRAMIN is and what it is used for
What you need to know before using SIFRAMIN
How to use SIFRAMIN
Possible side effects
How to store SIFRAMIN
Contents of the pack and other information

1. What SIFRAMIN is and what it is used for

SIFRAMIN contains a group of substances called amino acids, which are essential for the human body and used to nourish patients who cannot be fed orally (parenteral nutrition).
This medicine is indicated for supplementing protein substances to help recovery from coma caused by severe liver damage (hepatic coma).

2. What you need to know before using SIFRAMIN

Do not use SIFRAMIN

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 have problems metabolizing amino acids;
if you have severe kidney function problems (renal failure).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SIFRAMIN.
During treatment with SIFRAMIN, your doctor will carry out specific laboratory tests to monitor your levels of electrolytes (water and electrolyte balance) and blood pH (acid-base balance). If necessary, your doctor will restore the balance by administering corrective solutions. Furthermore, if deemed necessary by your doctor, you may be prescribed medicines to protect your stomach (H2-antagonists).
If you have diabetes, your doctor will monitor your sugar intake (caloric intake).

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
Not applicable.

3. How to use SIFRAMIN

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) over 24 hours. If you have any doubts, consult your doctor, pharmacist, or nurse.
The recommended dose is 1000 ml of solution on the first day of treatment, which will then be increased to 1500 ml from the second day onwards. Please note that one 500 ml bottle will be administered by slow intravenous infusion lasting approximately 8 hours.
At the same time, an adequate amount of 50-70% glucose (approximately 300-400 g over 24 hours) will be administered to you.
The solution should only be used if it is clear, free from visible particles, and if the container is intact.
If you use more SIFRAMIN than you should
If you think you have been given an excessive dose of SIFRAMIN, inform your doctor or another healthcare professional immediately.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.
No side effects have been reported following the use of SIFRAMIN.

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

5. How to store SIFRAMIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store below 25°C. Do not refrigerate or freeze. Keep in the
original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What SIFRAMIN contains

The active substances are L-amino acids with branched side chains. 1000 ml of solution contain 40 g of total amino acids, corresponding to 12.5 g of L-isoleucine, 15.5 g of L-leucine, and 12.0 g of L-valine. Each litre of solution contains 4.42 g of total nitrogen. pH 5.8–6.8.
The other component is water for injections.

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

The following information is intended exclusively for physicians or healthcare professionals

Posology and method of administration
For intravenous infusion. The solution should be administered at a dose of 1000 ml on the first day of treatment, while on the second day a volume of 1500 ml is recommended, bearing in mind that the content of a 500 ml bottle should be infused over 8 hours. It is necessary to infuse the solution mixed with 50-70% Glucose in adequate amounts (300-400 g within 24 hours).
The infusion should be administered over 24 hours as a slow infusion.
Use for slow drop-by-drop administration.

Storage
Protect from light and store at a temperature not exceeding 25°C.
Temperature fluctuations may cause the formation of crystalline precipitate. In such cases, before infusion, the solution must be reconstituted by heating until complete dissolution (a heating temperature of 70-80°C is recommended, then shake). The expiry date stated refers to the product when kept in intact packaging and stored correctly.

For further information, consult the Summary of Product Characteristics.