SELDOMALFA 20 mg /Ml Powder And Solvent For Intravenous Infusion Solution

Зміст інструкції

1. SELDOMALFA “20 mg/ml powder and solvent for infusion solution”, “100 mg/ml powder and solvent for infusion solution” (5 g), “100 mg/ml powder and solvent for infusion solution” (10 g)
   1. What is SELDOMALFA and what is it used for
   2. What you need to know before using SELDOMALFA
   3. How to use SELDOMALFA
   4. Possible side effects
   5. How to store SELDOMALFA
   6. Package contents and other information

SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for intramuscular use”

SELDOMALFA “20 mg/ml powder and solvent for infusion solution”, “100 mg/ml powder and solvent for infusion solution” (5 g), “100 mg/ml powder and solvent for infusion solution” (10 g)

sodium creatine phosphate salt
Read this leaflet carefully before using 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.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What is SELDOMALFA and what is it used for

SELDOMALFA contains the active substance sodium creatine phosphate .
SELDOMALFA belongs to the category of cardiac drugs known as “Other cardiac preparations”.
SELDOMALFA is used to protect the heart (cardioprotection) during cardiac surgery, in
addition to specific solutions (called cardioplegic solutions) used during the stopping and restarting
phase of the heart in cardiac procedures.

2. What you need to know before using SELDOMALFA

DO NOT use SELDOMALFA

• if you are allergic to creatine phosphate sodium salt or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from severe kidney dysfunction (chronic renal insufficiency) and are taking SELDOMALFA at high doses (5-10 grams per day)

Warnings and precautions
Consult your doctor or nurse before using SELDOMALFA
Please note that:

• rapid intravenous injection of high doses (greater than 1 gram of creatine phosphate) can cause a rapid drop in blood pressure;
• high doses of the product (5-10 grams per day) should only be used in selected patients and for short periods of time, as administration also involves
  the intake of high amounts of phosphate salts, which could interfere with calcium metabolism, with the production of hormones that regulate electrolytic (osmotic) balance, with
  renal function and with purine metabolism (some substances that make up
  DNA).
  Use the solvent vials of SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for
  intramuscular use” exclusively via the intramuscular route and do not use them to dissolve other
  medicines, as they contain lidocaine.

SELDOMALFA CONTAINS SODIUM
SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for intramuscular use”
contains 90.2 mg of sodium (main component of table salt) per dose. This is equivalent to
4.51% of the maximum recommended daily intake with the diet of an adult.
SELDOMALFA “20 mg/ml powder and solvent for infusion solution” contains 180 mg of sodium
(main component of table salt) per dose. This is equivalent to 9% of the maximum daily
recommended intake with the diet of an adult.
SELDOMALFA “100 mg/ml powder and solvent for infusion solution” (5 g) contains 900 mg of
sodium (main component of table salt) per dose. This is equivalent to 45% of the maximum daily
recommended intake with the diet of an adult.
SELDOMALFA “100 mg/ml powder and solvent for infusion solution” (10 g) contains 1800 mg
of sodium (main component of table salt) per dose. This is equivalent to 90% of the maximum daily
recommended intake with the diet of an adult.

Other medicines and SELDOMALFA
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
SELDOMALFA does not present interactions with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before using this medicine.
SELDOMALFA is not contraindicated in pregnancy or during breastfeeding.

Driving and operating machinery
SELDOMALFA does not affect or has a negligible effect on the ability to drive or operate
machinery.

3. How to use SELDOMALFA

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
The recommended dose is:

• SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for intramuscular use”: 1 vial, 1-2 times a day, according to medical advice, exclusively by intramuscular route.
• SELDOMALFA “20 mg/ml powder and solvent for infusion solution”: 1 vial, 1-2

times a day, according to medical advice, for intravenous infusion within 30-45 minutes.

• SELDOMALFA “100 mg/ml powder and solvent for infusion solution”: 1 vial per day for intravenous infusion within 45-60 minutes.

If you use more SELDOMALFA than you should
Because this medicine is administered by medical personnel, it is unlikely to be administered in an
incorrect quantity.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No known side effects.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. 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 SELDOMALFA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
Do not use this medicine if the packaging is opened or damaged.
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 SELDOMALFA contains
SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for intramuscular use”
The active ingredient is sodium creatine phosphate. Each vial contains 500 mg of creatine phosphate salt
sodium.
Each solvent vial contains lidocaine hydrochloride, 1N hydrochloric acid, water for injections.
SELDOMALFA “20 mg/ml powder and solvent for infusion solution”
The active ingredient is sodium creatine phosphate. Each vial contains 1 g of creatine phosphate salt
sodium.
Each solvent vial contains water for injections.
SELDOMALFA “100 mg/ml powder and solvent for infusion solution”
The active ingredient is sodium creatine phosphate. Each vial contains 5 g of creatine phosphate salt
sodium.
Each solvent vial contains water for injections.
SELDOMALFA “100 mg/ml powder and solvent for infusion solution”
The active ingredient is sodium creatine phosphate. Each vial contains 10 g of creatine phosphate salt
sodium.
Each solvent vial contains water for injections.

Description of the appearance of SELDOMALFA and contents of the pack
SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for intramuscular use”
It is presented as powder and solvent for injectable solution. Each pack contains 6
vials of lyophilized powder of 500 mg and 6 vials of solvent of 4 ml.
SELDOMALFA “20 mg/ml powder and solvent for infusion solution”
It is presented as powder and solvent for infusion solution. Each pack contains 1
vial of lyophilized powder of 1 g and 1 vial of solvent of 50 ml.
SELDOMALFA “100 mg/ml powder and solvent for infusion solution”
It is presented as powder and solvent for infusion solution. Each pack contains 1
vial of lyophilized powder of 5 g and 1 vial of solvent of 50 ml.
SELDOMALFA “100 mg/ml powder and solvent for infusion solution”
It is presented as powder and solvent for infusion solution. Each pack contains 1
vial of lyophilized powder of 10 g and 1 vial of solvent of 100 ml.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Alfasigma S.p.A. – Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)

Manufacturer of the drip set
MULTIMEDICAL S.r.l.
46019 Viadana (MN)
CE 0123