Fructo phosphate

Package leaflet: Information for the user

FRUCTO FOSFAN 0.5 g/10 ml powder and solvent for solution for infusion, 5 g/50 ml powder and solvent for solution for infusion

• Fructose-1,6-diphosphate

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

Contents of this leaflet:

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

1. What FRUCTO FOSFAN is and what it is used for

FRUCTO FOSFAN contains D-fructose-1,6-diphosphate (FDP), a natural intermediate in glucose metabolism within cells. FRUCTO FOSFAN is a medicinal product used for the treatment of confirmed hypophosphatemia (low levels of phosphorus in the blood).

2. What you need to know before using FRUCTO FOSFAN

Do not take FRUCTO FOSFAN:

• If you are allergic to D-fructose-1,6-diphosphate or to any of the other ingredients of this medicine (listed in section 6)
• If you have hereditary fructose intolerance
• If you have hyperphosphatemia (high levels of phosphorus in the blood)
• If you have renal failure

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking FRUCTO FOSFAN.
It is advisable to monitor blood electrolyte concentrations during treatment.
Extravasation into subcutaneous tissue during infusion may cause pain and local irritation.
In patients with kidney problems, serum phosphate levels (phosphorus concentration in blood) should be monitored, and dosage reduced if necessary.
During infusion, pain and local irritation may occur (see section 4 “Possible side effects”).

Children and adolescents
If agitation or sweating occurs during treatment with FRUCTO FOSFAN, especially if hypoglycemia (low blood sugar) is confirmed, particularly in a newborn or an infant not yet weaned, the infusion must be immediately stopped and appropriate measures taken, as these may be signs of fructose intolerance.

Other medicines and FRUCTO FOSFAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
FRUCTO FOSFAN must not be mixed with other medicinal products, as no studies have been conducted to verify whether D-fructose-1,6-diphosphate can be mixed with other solutions without losing its characteristics.

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

Driving and using machines
FRUCTO FOSFAN has no effect or negligible effect on the ability to drive vehicles or operate machinery.

FRUCTO FOSFAN contains sodium.
This medicine contains 3 mmol and 30 mmol of sodium per 0.5 g/10 ml and 5 g/50 ml doses, respectively. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.

3. How to Take FRUCTO FOSFAN

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended daily dose, depending on the severity of the condition, ranges between 70 mg/kg and 160 mg/kg of active substance, generally corresponding in adults to 1–2 vials per day of FRUCTO FOSFAN 5 g/50 ml powder and solvent for solution for infusion, unless otherwise prescribed by your doctor.
Your doctor will determine the amount to administer based on your individual condition (blood phosphorus levels, possible parenteral nutrition).
For higher doses, it is advisable to divide the total daily dose into two administrations.
For lower dosages, FRUCTO FOSFAN 0,5 g/10 ml powder and solvent for solution for infusion may be used.
Do not exceed the recommended doses.

Use in children and adolescents
The dosage will be determined by the doctor according to body weight.

Method of administration
FRUCTO FOSFAN 0,5 g/10 ml powder and solvent for solution for infusion
Reconstitute the solution in the vial of powder by drawing up the water from the solvent ampoule using a syringe equipped with a suitable needle. Remove the aluminum cap from the powder vial and disinfect the stopper with an alcohol-soaked cotton swab. Then insert the needle of the syringe into the vial through the center of the rubber stopper, directing the stream of water toward the glass wall of the vial. Gently shake to ensure complete dissolution, then administer the resulting solution by intravenous route.

FRUCTO FOSFAN 5 g/50 ml powder and solvent for solution for infusion
Reconstitute the solution under aseptic conditions as follows:

1. Remove the aluminum cap from the powder vial and disinfect the stopper with an alcohol-soaked cotton swab;
2. Remove only one cap from the single-use double-ended needle device (transfer set) and insert the tip into the powder vial through the center of the rubber stopper;
3. Remove the aluminum cap from the water vial and disinfect the rubber stopper; remove the second cap from the transfer set and insert the tip into the water vial, turning it upside down;
4. Shake briefly to facilitate the flow of water into the powder vial; once the water vial is completely emptied, remove the transfer set and shake to promote dissolution. The reconstituted solution is then administered intravenously as follows:
5. Disinfect the vial stopper again, then remove the cap from the infusion set needle and insert it into the center of the vial stopper;
6. Apply the clamp and completely close the tubing;
7. Remove the cap from the needle hub and attach the needle;
8. Squeeze the drip chamber to fill it about halfway, then open the clamp until all air has been expelled from the infusion set;
9. Completely close the clamp, insert the needle into the vein, and slowly reopen the clamp until the desired flow rate is achieved. It is recommended to administer the solution at a rate of approximately 10 ml/min.

Important: Use immediately after opening the containers. The reconstituted solution or the solution ready for use must be clear and free from visible particles. It is intended for single, uninterrupted administration only, and any unused residue must not be kept or reused.

If you take more FRUCTO FOSFAN than you should
Excessive and/or too frequent doses of FRUCTO FOSFAN may cause an excessive increase in blood phosphorus levels, which in turn may lead to a reduction in blood calcium levels.
In case of overdose, inform your doctor immediately or go to the nearest hospital emergency department.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Rapid infusion may cause pain and irritation at the injection site. If the infusion rate exceeds 10 ml/min, patients may additionally experience flushing, palpitations, and tingling in the extremities.
As with all intravenous infusion solutions, fever-related reactions, injection site infections, venous thrombosis (blood clots in veins), phlebitis (inflammation of veins), or extravasation (leakage of fluid from the vein into surrounding tissues) may occur.
Allergic reactions of varying severity, though rarely, have been reported, up to and including anaphylactic shock.
In case of an adverse reaction, discontinue administration and retain the remaining undelivered fluid for possible testing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
w.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 FRUCTO FOSFAN

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 label after Exp.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if you notice the presence of particles, abnormal discoloration, numbness, or precipitate. A slightly yellow colour is considered normal.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What FRUCTO FOSFAN contains
FRUCTO FOSFAN 0.5 g/10 ml powder and solvent for solution for infusion
Each vial of powder contains:
Active substance: sodium fructose-1,6-diphosphate hydrate 0.5 g, equivalent to fructose-1,6-diphosphoric acid 0.375 g.
Each solvent ampoule contains:
Excipient: water for injections.
The reconstituted solution contains 50 mg/ml of sodium fructose-1,6-diphosphate hydrate, equivalent to 37.5 mg/ml of fructose-1,6-diphosphoric acid. This solution provides approximately 0.235 mEq/ml of phosphorus.

FRUCTO FOSFAN 5 g/50 ml powder and solvent for solution for infusion
The powder vial contains:
Active substance: sodium fructose-1,6-diphosphate hydrate 5 g, equivalent to fructose-1,6-diphosphoric acid 3.75 g.
The solvent vial contains:
Excipient: water for injections.
The reconstituted solution contains 100 mg/ml of sodium fructose-1,6-diphosphate hydrate, equivalent to 75 mg/ml of fructose-1,6-diphosphoric acid. This solution provides approximately 0.47 mEq/ml of phosphorus.

Description of the appearance of FRUCTO FOSFAN and contents of the package
FRUCTO FOSFAN 0.5 g/10 ml powder and solvent for solution for infusion
The carton contains 5 powder vials of 0.5 g and 5 solvent ampoules of 10 ml.

FRUCTO FOSFAN 5 g/50 ml powder and solvent for solution for infusion
The carton contains: one powder vial of 5 g, one solvent vial of 50 ml, and an intravenous infusion set including a double-ended needle (transfer device) for the extemporaneous preparation of the solution.

Marketing Authorization Holder
BIOMEDICA FOSCAMA INDUSTRIA CHIMICO-FARMACEUTICA S.p.A.
Via dei Castelli Romani, 22
00071 Pomezia (RM), Italy

Manufacturer
BIOMEDICA FOSCAMA INDUSTRIA CHIMICO-FARMACEUTICA S.p.A.
Manufacturing site: Via Morolense, 87
03013 Ferentino (FR) – (Italy)