Seldomalfa

Italy
Brand name Seldomalfa
Form solution for infusion, powder and solvent for preparation
Active substance / Dosage
SODIUM PHOSPHOCREATINE
Prescription type Prescription only
ATC code
C01EB06
Registration number 020502
Manufacturer ALFASIGMA S.P.A.

Table of Contents

PACKAGE LEAFLET

Package leaflet: Information for the patient

SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for intramuscular use”
SELDOMALFA “20 mg/ml powder and solvent for infusion solution”
SELDOMALFA “100 mg/ml powder and solvent for infusion solution” (5 g)
SELDOMALFA “100 mg/ml powder and solvent for infusion solution” (10 g)
Creatine phosphate sodium salt
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 others, even if they have the same symptoms as yours, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact 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 using 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 SELDOMALFA is and what it is used for

SELDOMALFA contains the active substance creatine phosphate sodium salt.
SELDOMALFA belongs to the class of cardiac drugs known as “Other cardiac preparations”.
SELDOMALFA is used for cardioprotection during cardiac surgery, as an adjunct to specific solutions (called cardioplegic solutions) used during the phase of stopping and restarting 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 have severe kidney function disorders (chronic renal failure) and are taking SELDOMALFA at high doses (5–10 grams per day)

Warnings and precautions
Talk to your doctor or nurse before using SELDOMALFA.
Please note that:

  • rapid intravenous administration of high doses (more than 1 gram of creatine phosphate) may 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 intake of high amounts of phosphate salts, which may interfere with calcium metabolism, with the production of hormones regulating electrolyte (osmotic) balance, with kidney function, and with purine metabolism (certain substances that are components of DNA).

Use the vials of solvent supplied with SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for intramuscular use” exclusively for intramuscular administration and do not use them to dissolve other drugs, 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 corresponds to 4.51% of the maximum recommended daily dietary intake for 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 corresponds to 9% of the maximum recommended daily dietary intake for 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 corresponds to 45% of the maximum recommended daily dietary intake for 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 corresponds to 90% of the maximum recommended daily dietary intake for an adult.
Other medicines and SELDOMALFA
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.
SELDOMALFA has no known interactions with other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
SELDOMALFA is not contraindicated during pregnancy or breastfeeding.
Driving and using machines
SELDOMALFA has no effect or has a negligible effect on the ability to drive or operate machinery.

3. How to use SELDOMALFA

Use this medicine exactly as instructed by your doctor. 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 daily, as directed by the physician, for intramuscular administration only.
  • SELDOMALFA "20 mg/ml powder and solvent for solution for infusion": 1 vial, 1-2 times daily, as directed by the physician, for intravenous infusion over 30-45 minutes.
  • SELDOMALFA "100 mg/ml powder and solvent for solution for infusion": 1 vial daily for intravenous infusion over 45-60 minutes.

If you use more SELDOMALFA than you should
Since this medicine is administered by medical personnel, it is unlikely that an incorrect amount will be given.
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 gets them.
Not known (frequency cannot be estimated from the available data):

  • Hypersensitivity
  • Itchy skin rash (urticaria)

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 via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects may 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 stated on the packaging.
The expiry date refers to the last day of that month.
Do not use this medicine if the packaging is open or damaged.
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 SELDOMALFA contains
SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for intramuscular use”
The active substance is creatine phosphate sodium salt. Each vial contains 500 mg of creatine phosphate sodium salt.
Each solvent ampoule contains hydrochloride lidocaine, hydrochloric acid 1N, water for injectable preparations.

SELDOMALFA “20 mg/ml powder and solvent for infusion solution”
The active substance is creatine phosphate sodium salt. Each vial contains 1 g of creatine phosphate sodium salt.
Each solvent vial contains water for injectable preparations.

SELDOMALFA “100 mg/ml powder and solvent for infusion solution”
The active substance is creatine phosphate sodium salt. Each vial contains 5 g of creatine phosphate sodium salt.
Each solvent vial contains water for injectable preparations.

SELDOMALFA “100 mg/ml powder and solvent for infusion solution”
The active substance is creatine phosphate sodium salt. Each vial contains 10 g of creatine phosphate sodium salt.
Each solvent vial contains water for injectable preparations.

Description of the appearance of SELDOMALFA and contents of the package
SELDOMALFA “500 mg/4 ml powder and solvent for injectable solution for intramuscular use”
Presented as powder and solvent for injectable solution. Each package contains 6 vials of 500 mg lyophilisate and 6 ampoules of 4 ml solvent.

SELDOMALFA “20 mg/ml powder and solvent for infusion solution”
Presented as powder and solvent for infusion solution. Each package contains 1 vial of 1 g lyophilisate and 1 vial of 50 ml solvent.

SELDOMALFA “100 mg/ml powder and solvent for infusion solution”
Presented as powder and solvent for infusion solution. Each package contains 1 vial of 5 g lyophilisate and 1 vial of 50 ml solvent.

SELDOMALFA “100 mg/ml powder and solvent for infusion solution”
Presented as powder and solvent for infusion solution. Each package contains 1 vial of 10 g lyophilisate and 1 vial of 100 ml solvent.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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)

Black and white illustrative diagram with numbered steps for the

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