Active ingredients: D-Fructose-1,6-diphosphate
Hexaphosphine 0.5 g / 10 ml powder and solvent for solution for infusion
Hexaphosphine 5 g / 50 ml powder and solvent for solution for infusion
Hexaphosphine 10 g / 100 ml solution for infusion
Why is hexaphosphine used? What is it for?
Hexaphosphine contains D-fructose-1,6-diphosphate (FDP), a natural intermediate of glucose metabolism within cells. Hexaphosphine is a medicine used to treat known hypophosphataemia (low levels of phosphorus in the blood).
Contraindications When hexaphosphine should not be used
Do not take hexaphosphine:
- If you are allergic to D-fructose-1,6-diphosphate or any of the other ingredients of this medicine
- If you have a hereditary fructose intolerance
- If you have hyperphosphataemia (high levels of phosphorus in the blood)
- If you have kidney failure.
Precautions for use What you need to know before taking hexaphosphine
Talk to your doctor, pharmacist or nurse before taking hexaphosphine.
It is advisable to monitor the electrolyte concentrations in the blood during treatment. In patients with kidney problems it is recommended to monitor the phosphatemia (concentration of phosphorus in the blood), possibly decreasing the dosage.
Pain and local irritation may occur during the infusion (see section 4 "Possible side effects").
Children and adolescents
If agitation or sweating occurs during the use of hexaphosphine, especially in an infant or a child not yet weaned, the infusion should be stopped immediately and all appropriate measures should be taken, as these could be signs of fructose intolerance.
Interactions Which drugs or foods can modify the effect of hexaphosphine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Hexaphosphine must not be mixed with other medicinal products, as no studies have been carried out to verify whether D-Fructose-1,6-diphosphate can be mixed with other solutions without losing its characteristics.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Hexaphosphine does not affect or negligibly affect the ability to drive or use machines
Hexaphosphine contains sodium and sodium metabisulfite.
This medicinal product contains, in the strengths of 0.5 g / 10 ml, 5 g / 50 ml and 10 g / 100 ml, respectively 3 mmol, 30 mmol and 44 mmol of sodium. To be taken into consideration by people with reduced kidney function or who follow a low sodium diet.
Due to the presence of sodium metabisulfite, administration of hexaphosphine 10 g / 100 ml solution for infusion can rarely cause hypersensitivity reactions and bronchospasm (narrowing of the caliber of the bronchi).
Dosage and method of use How to use hexaphosphine: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended daily dose, depending on the severity of the conditions, is between 70 mg / kg and 160 mg / kg of the active ingredient, generally equal to 1 - 2 bottles per day of hexafosphine 5 g / 50 ml powder and solvent in adults. for solution for infusion, or 1 bottle per day of hexaphosphine 10 g / 100 ml solution for infusion, unless otherwise prescribed. Your doctor will decide the amount to administer based on your condition (amount of phosphorus in the blood, any parenteral nutrition) .
For higher dosages it is recommended to divide the total daily dose into two administrations.
For the administration of lower dosages, hexaphosphine 0.5 g / 10 ml powder and solvent for solution for infusion can be used.
Do not exceed the recommended dose.
Use in children and adolescents
The dosage will be established by the doctor taking into account the body weight
Method of administration
Hexaphosphine 0.5 g / 10 ml powder and solvent for solution for infusion
Reconstitute the solution in the vial of powder by withdrawing the water contained in the solvent vial using a syringe equipped with a suitable needle. Remove the aluminum tab of the vial and disinfect the stopper with a cotton swab soaked in alcohol, then insert the syringe needle into the vial through the center of the rubber stopper and direct the flow of water to the glass wall of the vial. Gently shake to favor complete solubilization, then administer the solution thus obtained intravenously.
Hexaphosphine 5 g / 50 ml powder and solvent for solution for infusion
First, proceed with the reconstitution of the solution under aseptic conditions using the following methods:
- Extract the aluminum tab of the powder bottle and disinfect the cap with a cotton swab dipped in alcohol;
- Remove a single cap from the disposable double-tipped perforator (pourer) and insert the tip into the powder bottle through the center of the rubber stopper;
- Extract the aluminum tab of the water bottle and disinfect the rubber stopper; remove the second cap from the pourer and insert the tip into the bottle of water, turning it upside down;
- Shake briefly to facilitate the flow of water into the powder bottle; once the bottle of water is empty, remove the pourer and shake to facilitate dissolution.
Administration of the reconstituted solution intravenously is then carried out as follows:
5. Disinfect the bottle cap again, then remove the spike cap located at the end of the infusion set and insert it into the center of the bottle cap;
6. Apply the hose clamp and tighten completely on the hose;
7. Remove the cap from the needle holder and apply the needle;
8. Press the drip tray to fill it about halfway, then open the hose clamp until all the air escapes from the set;
9. Close the hose clamp completely, insert the needle into the vein and slowly reopen the hose clamp until the desired flow is achieved.
It is recommended to administer the solution at a rate of approximately 10 ml / min.
Hexaphosphine 10 g / 100 ml solution for infusion
Administer the ready-made solution intravenously using the set contained in the package (or possibly another suitable device for intravenous infusion) and following the instructions above (from point 5. to point 9.) after having removed the disc by rotating it plastic cap of the bottle.
It is recommended to infuse the solution at a rate of approximately 10 ml / min.
Important: Use immediately after opening the containers. The reconstituted or ready-to-use solution should be clear and free from visible particles. It is used for a single and uninterrupted administration and any residue cannot be used
Overdose What to do if you have taken too much hexaphosphine
Excessive and / or too close doses of hexaphosphine could cause an excessive increase of phosphorus in the blood, which in turn can result in a reduction of calcium in the blood. In the event of an overdose, tell your doctor immediately or go to the emergency room of the nearest hospital.
Side Effects What are the side effects of hexaphosphine
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rapid infusion can cause pain and irritation at the injection site, particularly when using the "10 g / 100 ml solution for infusion" pack. In case of infusion at a rate greater than 10 ml / min. patients may also experience redness, palpitations and tingling in the extremities.
As with all intravenous infusion solutions, febrile reactions, injection site infections, venous thrombosis (blood clots in the veins) or phlebitis (inflammation of the veins), extravasal diffusion (leakage of fluid from the vein into surrounding tissues) may occur. allergic reactions of varying severity up to anaphylactic shock have been reported, albeit rarely.
In the event of an adverse reaction, interrupt the administration and keep the remaining fluid not administered for possible tests.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
Expiry and Retention
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 indicated refers to the last day of that month.
Do not store above 30 ° C.
Do not use this medicine if you notice any particles, abnormal coloring, numbness or precipitate. A slightly yellow color is considered normal.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What hexaphosphine contains
Hexaphosphine 0.5 g / 10 ml powder and solvent for solution for infusion
Each vial of powder contains:
Active ingredient: D-fructose-1,6-diphosphate sodium hydrate salt 0.5 g, equal to D-fructose-1,6-diphosphoric acid 0.375 g.
Each solvent vial contains:
Excipient: water for injections.
The reconstituted solution contains 50 mg / ml of D-fructose-1,6-diphosphate sodium hydroxide, equivalent to 37.5 mg / ml of D-fructose-1,6-diphosphoric acid. The same solution provides about 0.235 mEq / ml of phosphorus.
Hexaphosphine 5 g / 50 ml powder and solvent for solution for infusion
The powder bottle contains:
Active ingredient: D-fructose-1,6-diphosphate sodium hydrate salt 5 g, equal to D-fructose-1,6-diphosphoric acid 3.75 g.
The solvent bottle contains:
Excipient: water for injections.
The reconstituted solution contains 100 mg / ml of D-fructose-1,6-diphosphate sodium hydroxide, equal to 75 mg / ml of D-fructose-1,6-diphosphoric acid. The same solution provides about 0.47 mEq / ml of phosphorus.
Hexaphosphine 10 g / 100 ml solution for infusion
The bottle contains:
Active ingredient: D-fructose-1,6-diphosphate sodium hydroxide salt 10 g, equal to D-fructose-1,6-diphosphoric acid 7.5 g.
Excipients: sodium metabisulfite (E223), water for injections.
The solution contains 100 mg / ml of D-fructose-1,6-diphosphate sodium hydroxide, equal to 75 mg / ml of D-fructose-1,6-diphosphoric acid. The same solution provides about 0.47 mEq / ml of phosphorus.
Description of what hexaphosphine looks like and contents of the pack
Hexaphosphine 0.5 g / 10 ml powder and solvent for solution for infusion
The carton contains 4 vials of 0.5 g powder and 4 solvent vials of 10 ml.
Hexaphosphine 5 g / 50 ml powder and solvent for solution for infusion
The carton contains: a 5 g bottle of powder, a 50 ml bottle of solvent and an intravenous infusion set including a double-ended spike (pourer) for extemporaneous preparation of the solution.
Hexaphosphine 10 g / 100 ml solution for infusion
The carton contains a 100 ml bottle of ready-to-use infusion solution and an intravenous infusion set.
Hexaphosphine 10 g / 100 ml solution for infusion without infusion set
The carton contains 1 bottle or 20 bottles of 100 ml of ready-to-use infusion solution.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
HEXAFOSPHINE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
HEXAFOSPHINE 0.5 g / 10 ml powder and solvent for solution for infusion
Each vial of powder contains:
Active principle: d-fructose-1,6-diphosphate sodium hydrate salt 0.5 g, equal to d-fructose-1,6-diphosphoric acid 0.375 g.
The reconstituted solution contains 50 mg / ml of d-fructose-1,6-diphosphate sodium hydroxide, equivalent to 37.5 mg / ml of d-fructose-1,6-diphosphoric acid. The same solution provides about 0.235 mEq / ml of phosphorus.
HEXAFOSPHINE 5 g / 50 ml powder and solvent for solution for infusion
The powder bottle contains:
Active principle: d-fructose-1,6-diphosphate sodium hydrate salt 5 g, equal to d-fructose-1,6-diphosphoric acid 3.75 g.
The reconstituted solution contains 100 mg / ml of d-fructose-1,6-diphosphate sodium hydroxide, equal to 75 mg / ml of d-fructose-1,6-diphosphoric acid. The same solution provides about 0.47 mEq / ml of phosphorus.
HEXAPHOSPHINE 10 g / 100 ml solution for infusion
The bottle contains:
Active principle: d-fructose-1,6-diphosphate sodium hydroxide salt 10 g, equal to d-fructose-1,6-diphosphoric acid 7.5 g.
The solution contains 100 mg / ml of d-fructose-1,6-diphosphate sodium hydroxide, equal to 75 mg / ml of d-fructose-1,6-diphosphoric acid. The same solution provides about 0.47 mEq / ml of phosphorus.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
Solution for intravenous infusion.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Known hypophosphataemia.
04.2 Posology and method of administration
Dosage
The recommended daily dose, depending on the severity of the conditions, is between 70 mg / kg and 160 mg / kg of active ingredient generally equal to "1-2 bottles per day of HEXAFOSFINE" 5 g / 50 ml powder and solvent in adults for solution for infusion ", or 1 bottle per day of HEXAFOSFINE" 10 g / 100 ml solution for infusion ", unless otherwise prescribed.
The quantity to be administered must be established according to the degree of hypophosphatemia, in order to avoid an excessive load of phosphorus. In patients receiving total parenteral nutrition, the dosage should be determined taking into account the recommended daily intake levels of phosphorus.
For higher dosages it is recommended to divide the total daily dose into two administrations.
For the administration of lower dosages, HEXAFOSFINE "0.5 g / 10 ml powder and solvent for solution for infusion" can be used.
Do not exceed the recommended dose.
Pediatric population
Even in children, the dosage should be established taking into account the body weight.
Method of administration
For instructions on how to prepare the medicinal product before administration and on administration, see section 6.6.
04.3 Contraindications
Hereditary fructose intolerance, hyperphosphataemia, renal failure, hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
Extravasal diffusion during infusion may cause local pain and irritation.
It is advisable to monitor plasma concentrations of electrolytes during treatment. In patients with creatinine clearance below 50 ml / min it is recommended to monitor the phosphatemia, possibly decreasing the dosage.
HEXAFOSPHINE, in the dosages of 0.5 g / 10 ml, 5 g / 50 ml and 10 g / 100 ml, provides respectively 3 mmol, 30 mmol and 44 mmol of sodium. This should be taken into consideration if administration is intended for patients requiring controlled sodium intake levels.
Due to the presence of sodium metabisulfite, administration of HEXAFOSFINE "10 g / 100 ml solution for infusion" may rarely cause hypersensitivity reactions and bronchospasm.
Attention: Products for parenteral use must be visually inspected, before administration, when the container or solution allows it, to detect the presence of particles or abnormal coloring. Do not use if cloudiness or precipitate is observed.
Pediatric population
In the event that agitation or sweating occurs during the infusion of a solution to which HEXAFOSPHINE has been added, especially in a newborn or a child not yet weaned, especially if the presence of hypoglycaemia is ascertained, the existence of a hereditary fructose intolerance. In this case, the infusion must be suspended immediately and all appropriate measures must be taken to rebalance the metabolic situation.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known drug interactions.
04.6 Pregnancy and lactation
Non-clinical studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development (see section 5.3).
HEXAFOSFINE has been used in women in the third trimester of pregnancy with no observable adverse reactions.
04.7 Effects on ability to drive and use machines
HEXAFOSFINE has no or negligible influence on the ability to drive or use machines.
04.8 Undesirable effects
Rapid infusion can cause pain and irritation at the injection site, particularly when using HEXAFOSFINE "10 g / 100 ml solution for infusion". In case of infusion at a rate greater than 10 ml / min. patients may also experience redness, palpitations and tingling in the extremities.
As with all intravenous solutions for infusion, febrile reactions, injection site infections, venous thrombosis or phlebitis, extravasal spread may occur.
Allergic reactions of varying severity up to anaphylactic shock have been reported, albeit rarely.
In the event of an adverse reaction, interrupt the administration and keep the remaining fluid not administered for possible tests.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the link http: // www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No cases of overdose have been reported.
However, excessive and / or too close doses of HEXAFOSPHINE could in principle lead to hyperphosphatemia, which in turn can lead to hypocalcaemia.
Treatment of overdose is represented by immediate discontinuation of administration and correction of any resulting water and electrolyte imbalance.
Specific measures to reduce phosphorus may need to be implemented, such as oral administration of phosphorus chelating agents or renal dialysis.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other cardiac preparations, ATC code: C01EB07.
Phosphate is the major anion in intracellular fluids. It is present in plasma in both inorganic and organic form, as a constituent of phospholipids, enzymatic cofactors and nucleic acids. Phosphate plays a primary role in a variety of physiological processes, being involved for example in the formation of high energy bonds (ATP) , in the transport of oxygen to the tissues (2,3-diphosphoglycerate), in the regulation of glycolysis, in the maintenance of plasma and urinary pH.
Normal adult phosphatemia ranges from 0.8 to 1.5 mmol / l.
Hypophosphataemia is frequently found in a wide variety of clinical situations, both acute (transfusions, extracorporeal circulation) and chronic, such as alcoholism and alcohol withdrawal, respiratory failure due to chronic obstructive pulmonary disease, malnutrition, prolonged use of phosphate-binding anti-acids, severe and extensive burns, diabetic ketoacidosis, respiratory alkalosis, convalescence after surgery, hyperparathyroidism, Vitamin D deficiency. of adequate phosphate intake. Clinical signs of hypophosphatemia, such as paraesthesia, muscle hypotonia and hyperventilation, appear especially in the presence of severe phosphate deficiencies. However, even in the absence of obvious clinical signs, several metabolic functions can be impaired by a phosphate deficiency.
Mechanism of action and pharmacodynamic effects
Biochemical studies in vitro and in vivo they also indicate that FDP, administered in pharmacological doses, interacts with the cell membrane, facilitates the cellular uptake of circulating potassium and stimulates the enrichment of the pool of high-energy intracellular phosphates and 2,3-diphosphoglycerate.
It has also been shown that an adequate supply of phosphorus constitutes an important condition for an effective assimilation of amino acids and carbohydrates during parenteral nutrition.
Clinical efficacy and safety
The administration of highly metabolizable organic phosphates such as fructose-1,6-diphosphate allows a rapid restoration of the physiological concentrations of phosphate in the plasma. In mixtures for total parenteral nutrition, the compatibility of fructose-1,6-diphosphate with cations, and in particular with the calcium ion, is clearly superior to that of inorganic phosphate.
Pediatric population
See section 4.2. for information on pediatric use.
05.2 "Pharmacokinetic properties
Absorption
The plasma concentration of FDP measured within 5 minutes of the 250 mg / kg infusion in healthy volunteers is 770 mg / l.
Distribution
Eighty minutes after the end of the infusion, no measurable quantities of FDP are present. The disappearance of FDP from the plasma is due to its distribution in the extravascular compartment and its rapid metabolization to monophosphates, triosis phosphates and inorganic phosphate caused by the activity of phosphatases. and other enzymes of the erythrocyte membrane and plasma.
Elimination
The plasma elimination half-life ranges from 10 to 15 minutes.
05.3 Preclinical safety data
Non-clinical data reveal no risks for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
HEXAPHOSPHINE "0.5 g / 10 ml powder and solvent for solution for infusion":
The powder vial contains the active ingredient only and the solvent vial contains water for injections.
HEXAFOSPHINE "5 g / 50 ml powder and solvent for solution for infusion":
The powder bottle contains the active ingredient only and the solvent bottle contains water for injections.
HEXAPHOSPHINE "10 g / 100 ml solution for infusion":
Excipients: sodium metabisulfite (E223), water for injections.
06.2 Incompatibility
HEXAFOSFINE is incompatible with other infusion solutions that contain insoluble substances at a pH between 3.5 and 5.8 or with solutions containing calcium salts in high quantities in an alkaline environment.
In the absence of incompatibility studies, the medicinal product should not be mixed with other products.
06.3 Period of validity
HEXAFOSPHINE "0.5 g / 10 ml powder and solvent for solution for infusion" and "5 g / 50 ml powder and solvent for solution for infusion": 5 years;
HEXAFOSPHINE "10 g / 100 ml solution for infusion": 2 years.
The period of validity refers to the product in intact packaging, correctly stored.
The reconstituted solution is stable for at least 24 hours at room temperature.
06.4 Special precautions for storage
Store at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
HEXAFOSPHINE "0.5 g / 10 ml powder and solvent for solution for infusion", 4 vials 0.5 g powder + 4 solvent 10 ml ampoules
The active ingredient, in the form of a slightly yellow hygroscopic lyophilized powder, is contained in capped and sealed type I glass screen-printed vials.
Type I glass solvent vials contain water for injections.
HEXAFOSPHINE "5 g / 50 ml powder and solvent for solution for infusion", 1 bottle of 5 g powder + 1 bottle of solvent 50 ml
The active ingredient, in the form of a slightly yellow hygroscopic lyophilized powder, is contained in a capped and sealed type III glass bottle.
The solvent bottle, type I glass, capped and sealed, contains water for injections.
The package also contains an intravenous infusion set including a double-ended spike (transfer device) for extemporaneous preparation of the solution.
HEXAFOSPHINE "10 g / 100 ml solution for infusion", 1 bottle 100 ml
The slightly yellow ready-to-infusion solution is contained in a capped, capped type I glass bottle with a ligh cap. The package also contains an intravenous infusion set.
HEXAPHOSPHINE "10 g / 100 ml solution for infusion", 1 bottle 100 ml without infusion set
The solution ready for infusion, slightly yellow in color, is contained in a stoppered and sealed type I glass bottle with a cap.
HEXAFOSPHINE "10 g / 100 ml solution for infusion", 20 bottles 100 ml
The solution ready for infusion, slightly yellow in color, is contained in a stoppered and sealed type I glass bottle with a cap.
Instructions for Use
HEXAPHOSPHINE "0.5 g / 10 ml powder and solvent for solution for infusion"
Reconstitute the solution in the vial of powder by withdrawing the water contained in the solvent vial using a syringe equipped with a suitable needle. Remove the aluminum tab of the vial and disinfect the stopper with a cotton swab soaked in alcohol, then insert the syringe needle into the vial through the center of the rubber stopper and direct the flow of water to the glass wall of the vial. Gently shake to favor complete solubilization, then administer the solution thus obtained intravenously.
HEXAFOSPHINE "5 g / 50 ml powder and solvent for solution for infusion"
First, proceed with the reconstitution of the solution under aseptic conditions using the following methods:
• Extract the aluminum tab of the powder bottle and disinfect the cap with a cotton swab dipped in alcohol;
• Remove only one cap of the disposable double-tipped perforator (siphon) and insert the tip into the powder bottle through the center of the rubber stopper;
• Extract the aluminum tab of the water bottle and disinfect the rubber stopper; remove the second cap from the pourer and insert the tip into the bottle of water, turning it upside down.
• Shake briefly to facilitate the flow of water into the powder bottle; once the bottle of water is empty, remove the pourer and shake to facilitate dissolution.
Administration of the reconstituted solution intravenously is then carried out as follows:
• Disinfect the bottle cap again, then remove the spike cap located at the end of the infusion set and insert it into the center of the bottle cap;
• Apply the hose clamp and tighten completely on the hose;
• Remove the cap from the needle holder and apply the needle;
• Press the drip tray to fill it about halfway, then open the hose clamp until all the air escapes from the set;
• Close the hose clamp completely, insert the needle into the vein and slowly reopen the hose clamp until the desired flow is reached.
It is recommended to administer the solution at a rate of approximately 10 ml / min.
HEXAPHOSPHINE "10 g / 100 ml solution for infusion"
Administer the ready-made solution intravenously using the set contained in the package (or possibly another suitable device for intravenous infusion) and following the instructions above (from point 5. to point 9.) after having removed the disc by rotating it plastic cap of the bottle.
It is recommended to infuse the solution at a rate of approximately 10 ml / min.
Use immediately after opening the containers. The reconstituted or ready-to-use solution should be clear and free from visible particles. It is used for a single and uninterrupted administration and any residue cannot be used.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Biomedica Foscama Group S.p.A.
Via degli Offices of the Vicar, 49
00186 Rome - (Italy)
08.0 MARKETING AUTHORIZATION NUMBER
HEXAFOSPHINE "0.5 g / 10 ml powder and solvent for solution for infusion", 4 vials 0.5 g powder + 4 solvent vials 10 ml - AIC n. 008783108
HEXAFOSPHINE "5 g / 50 ml powder and solvent for solution for infusion", 1 bottle of 5 g powder + 1 bottle of solvent 50 ml - AIC n. 008783110
HEXAFOSPHINE "10 g / 100 ml solution for infusion", 1 bottle 100 ml - AIC n. 008783134
HEXAFOSPHINE "10 g / 100 ml solution for infusion", 1 bottle 100 ml without infusion set - AIC n. 008783146
HEXAFOSPHINE "10 g / 100 ml solution for infusion", 20 bottles 100 ml - AIC n. 008783159
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: November 22, 1957
Date of most recent renewal: 01 June 2010
10.0 DATE OF REVISION OF THE TEXT
13 May 2015
