Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
ADDIPHOS
(170.1 mg + 133.5 mg + 14 mg)/ml, concentrate for solution for infusion
Potassium dihydrogen phosphate + Disodium phosphate dihydrate + Potassium hydroxide
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Addiphos is and what it is used for
Important information before using Addiphos
How to use Addiphos
Possible side effects
How to store Addiphos
Contents of the pack and other information

1. What Addiphos is and what it is used for

Addiphos is a phosphate-containing medicine administered intravenously when oral nutrition is
impossible, insufficient, or contraindicated. Phosphates are inorganic salts required in small amounts
for normal body function.
Addiphos is indicated for use in adult patients as a component of total parenteral nutrition, together
with proteins, fats, carbohydrates, other salts, and vitamins.

2. Important information before using Addiphos

When not to use Addiphos
Do not use this medicine:

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if the patient has hyperkalaemia (high potassium levels in the blood) associated with:
- adrenal insufficiency (a condition affecting hormone-producing glands);
- kidney failure;
- shock;
- dehydration (the patient has lost a significant amount of fluids or blood).

Addiphos must be diluted before administration. Addiphos will be added to another solution administered to the patient. The doctor or nurse will ensure proper preparation of the Addiphos solution before giving it to the patient.
Warnings and precautions
Use this medicine with caution if:

the patient is in a condition where there is a risk of hyperkalaemia (high potassium levels in the blood), e.g. adrenal insufficiency, kidney dysfunction, dehydration, or shock;
the patient is in a condition where sodium retention (retention of sodium in the body) may be harmful.

The doctor may order regular blood tests for patients receiving Addiphos to monitor their health status.
Do not use Addiphos if solid particles are observed in the solution. The doctor or nurse is responsible for checking the Addiphos solution before administration to the patient.
Addiphos with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No direct interactions between Addiphos and other medicines have been reported.
Inform the doctor if the patient:

is taking large amounts of vitamin D;
is taking anabolic agents (medicines stimulating body growth, especially muscle tissue), aminoglycosides (medicines used to treat infections), or diuretics (water pills).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The doctor will decide whether Addiphos should be used in pregnant or breastfeeding women.
Driving and operating machinery
Addiphos has no effect on the ability to drive or operate machinery.
Addiphos contains potassium and sodium
This medicine contains 1.5 mmol (or 59 mg) of potassium per dose, which should be taken into account in patients with impaired kidney function and in patients controlling dietary potassium intake.
This medicine contains 34 mg of sodium (main component of table salt) per 1 ml. This corresponds to 1.7% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Addiphos

This medicine is administered only by medical personnel. Self-administration of this medicine is not permitted.
If in doubt, consult a doctor.
The dosage is determined individually by the doctor for each patient, depending on body weight and
phosphate requirements.
The usual dose of Addiphos is 5 to 15 millilitres per day.
Use of a higher than recommended dose of Addiphos
It is unlikely that a patient will receive an excessive dose of Addiphos, as this medicine is administered by trained medical personnel. However, if a patient believes they have received a higher than recommended dose of Addiphos, they should immediately inform the doctor or nurse.
If there are any further doubts regarding the use of this medicine, consult the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
There are no reports of adverse reactions resulting from the use of phosphates.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Addiphos

Keep this medicine out of sight and reach of children.
Your doctor or pharmacist is responsible for ensuring appropriate storage, use, and disposal of Addiphos.
Do not store above 25°C. Do not freeze or allow to freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any solid particles in it.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Addiphos contains

The active substances in this medicinal product are: potassium dihydrogen phosphate, disodium phosphate dihydrate and potassium hydroxide.

1 ml of Addiphos contains:
active substances: amount:
potassium dihydrogen phosphate 170.1 mg
disodium phosphate dihydrate 133.5 mg
potassium hydroxide 14.0 mg
corresponding to the following contents:
phosphates 2 mmol P 62 mg
potassium 1.5 mmol K 59 mg
sodium 1.5 mmol Na 34 mg

Other components (excipients) are: water for injections.

The osmolality of the concentrate is: 3200 mOsm/kg water, pH: 6.2–6.5.
What Addiphos looks like and contents of the pack
The medicinal product is a concentrate for solution for infusion.
The pack consists of plastic vials containing 20 ml of concentrate, packed 10 vials in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer:
Marketing authorisation holder in the Netherlands, country of export:
Fresenius Kabi Nederland B.V., Amersfoortseweg 10E, 3712BC Huis ter Heide, the Netherlands
Manufacturer:
Fresenius Kabi Norge AS, Svinesundsveien 80, NO-1789 Halden, Norway
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in the Netherlands, country of export: RVG 11094
Parallel import authorisation number: 12/22

Information intended exclusively for medical professionals:

Dosage and administration
Addiphos must not be administered in undiluted form.
Individualized dosing, based on serum phosphate levels and the patient's requirement for supplementation, is recommended. A dose of 0.08 mmol/kg body weight over 6 hours is recommended for short-term, uncomplicated hypophosphatemia, and a dose of 0.16 mmol/kg body weight for long-term hypophosphatemia with complex etiology. A single dose exceeding 0.24 mmol/kg body weight should not be administered. In severe hypophosphatemia, administration of up to 1.2 mmol/kg body weight over 24 hours may be indicated.
Phosphate requirements also depend on the amount of calories and nitrogen administered. A daily dose of 10 to 30 mmol usually meets the requirements of a 70 kg patient receiving parenteral nutrition. This intake can be achieved by adding 5 to 15 ml of Addiphos to 500 to 1000 ml of infusion fluid. 5 to 15 ml of Addiphos corresponds to 7.5 to 22.5 mmol of both potassium and sodium.

Overdose
The only known clinical effect of hyperphosphatemia is ectopic calcification, most commonly observed in patients with chronic kidney disease.
The sodium and potassium content should be taken into account. Most patients requiring parenteral nutrition have an increased capacity to bind phosphates. See also section 4.3 of the Summary of Product Characteristics.

Preparation of the medicinal product for administration
Other medicinal products should be added under aseptic conditions.

Pharmaceutical incompatibilities
Addiphos must not be added to an infusion solution containing ADDAMEL N due to the risk of precipitate formation.
Addiphos may only be added or mixed with medicinal products with which compatibility has been documented.

Compatibility:
Up to 60 ml of Addiphos may be added to 1000 ml of Vamin 14 Electrolyte-Free, Vamin 18 Electrolyte-Free, Vaminolact, or glucose solution (55–600 mg/ml).
Up to 20 ml of Addiphos may be added to 400 ml of sodium chloride 9 mg/ml.
For addition to mixtures in non-phthalate plastic bags, refer to the package leaflets of Intralipid 10% and Intralipid 20%.

Infusion time:
Addiphos should be added to another solution under aseptic conditions one hour before starting the infusion.
Intravenous infusion should be administered at a rate not exceeding 20 mmol of potassium per hour to avoid hyperkalemia, and also not exceeding the maximum infusion rate applicable to the solution to which Addiphos has been added.

Stability:
When additional medicinal products are introduced into the infusion solution, the infusion should be completed within 24 hours of preparation to avoid microbiological contamination.
Any unused portion of an opened vial must be discarded and must not be stored for later use.
Data on stability and pharmaceutical compatibility with parenteral nutrition products are available upon request from the marketing authorization holder.

Storage conditions
After opening, the packaging must not be stored.
Any unused portion of the medicinal product is not suitable for further use.
Do not store above 25°C. Do not freeze and do not allow to freeze.

Disposal of unused medicinal product
Any unused residues or waste material of the medicinal product should be disposed of in accordance with local regulations.