Addiphos

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging 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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Addiphos and what is it used for
• 2. Important information before using Addiphos
• 3. How to use Addiphos
• 4. Possible side effects
• 5. How to store Addiphos
• 6. Contents of the packaging and other information

1. What is Addiphos and what is it used for

Addiphos is a medicine containing phosphates, administered intravenously when oral nutrition is impossible, insufficient, or contraindicated. Phosphates are inorganic salts required in small amounts for the proper functioning of the body.
Addiphos is indicated for use in adult patients as a component of comprehensive 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 the 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 hyperkalemia (high potassium levels in the blood) associated with:
• adrenal insufficiency (hormone-producing gland insufficiency);
• renal insufficiency;
• shock;
• dehydration (the patient has lost a lot of fluids or blood).

Addiphos should be diluted before administration. Addiphos will be added to another solution administered to the patient. The doctor or nurse will ensure the proper preparation of the solution with Addiphos before administering it to the patient.

Warnings and precautions

The medicine should be used with caution if:

• the patient is in a state where there is a risk of hyperkalemia (high potassium levels in the blood), e.g., in adrenal insufficiency, renal dysfunction, dehydration, and shock;
• the patient is in a state where sodium retention in the body may be harmful.

In patients using Addiphos, the doctor may order regular blood tests to check the patient's health.
Do not use Addiphos if you notice any solid particles in it. The doctor or nurse is responsible for checking Addiphos before administering it to the patient.

Addiphos and other medicines

Tell your 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 interaction between Addiphos and other medicines has been found.
Inform your doctor if the patient:

• takes a large amount of vitamin D,
• takes anabolic medicines (medicines that stimulate body growth, especially muscle), aminoglycosides (medicines used to treat infections), and diuretics (medicines that increase urine production).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
The doctor will decide whether to use Addiphos in women during pregnancy or breastfeeding.

Driving and using machines

Addiphos has no effect on the ability to drive vehicles or operate machines.

The medicine contains potassium and sodium

The medicine contains 1.5 mmol (or 59 mg) of potassium per dose, which should be taken into account in patients with reduced renal function and in patients controlling their potassium intake.
The medicine contains 34 mg of sodium (the main component of table salt) in 1 ml. This corresponds to 1.7% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Addiphos

This medicine is administered exclusively by medical personnel. The medicine must not be used by itself.
In case of doubts, consult a doctor.
The dosage is determined by the doctor individually for each patient, depending on their body weight and phosphate requirements.
Usually, the recommended dose of Addiphos is 5 to 15 milliliters per day.

Using a higher dose of Addiphos than recommended

It is unlikely that the patient will receive too high a dose of Addiphos, as the medicine is administered by medical personnel. If the patient thinks they have received a higher dose of Addiphos than recommended, they should immediately inform their doctor or nurse.
In case of any further doubts about using this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, Addiphos can cause side effects, although not everybody gets them.
There are no reports of side effects resulting from the use of phosphates.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Addiphos

The medicine should be stored out of sight and reach of children.

The doctor or pharmacist is responsible for ensuring the proper 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 specified month.
Do not use this medicine if you notice any solid particles in it.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Addiphos contains

• The active substances of the medicine 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
which corresponds 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 ingredients (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 what the packaging contains

The medicine is a concentrate for solution for infusion.
The packaging of the medicine is plastic vials containing 20 ml of concentrate, packed in 10 pieces in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer:

Marketing authorization holder in the Netherlands, the country of export:

Fresenius Kabi Nederland B.V., Amersfoortseweg 10E, 3712BC Huis ter Heide, 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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands export license number: RVG 11094

Parallel import license number: 12/22 Date of leaflet approval: 11.01.2022

Information intended exclusively for healthcare professionals:

Dosage and administration

Addiphos should not be administered undiluted.
Individual dosing is recommended, based on the determination of phosphate levels in the blood and the patient's need for supplementation. 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. The single dose should not exceed 0.24 mmol/kg body weight. In severe hypophosphatemia, a dose of up to 1.2 mmol/kg body weight over 24 hours may be indicated.
The need for phosphates also depends on the amount of calories and nitrogen administered. A daily dose of 10 to 30 mmol usually meets the patient's needs, weighing 70 kg during parenteral nutrition. Such administration can be ensured by using 5 to 15 ml of Addiphos per 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 found in patients with chronic kidney disease.
The sodium and potassium content should be taken into account. Most patients requiring parenteral nutrition have increased phosphate binding capacity. See also section 4.3 of the Summary of Product Characteristics.

Preparation of the medicine for use

Other medicines should be added under aseptic conditions.

Incompatibilities

Addiphos should not be added to an infusion solution containing ADDAMEL N due to the risk of precipitate formation.
Addiphos may be added or mixed only with those medicines for which compatibility has been documented.
Compatibility:
Up to 1000 ml of Vamin 14 Electrolyte-Free, Vamin 18 Electrolyte-Free, Vaminolact, or glucose solution (55-600 mg/ml) can be added with no more than 60 ml of Addiphos.
Up to 400 ml of sodium chloride 9 mg/ml can be added with no more than 20 ml of Addiphos.
For addition to non-PVC plastic bags, see the package inserts for Intralipid 10% and Intralipid 20%.
Infusion time:
Addiphos should be added to another solution under aseptic conditions one hour before the start of infusion.
An intravenous infusion with a rate corresponding to the administration of no more than 20 mmol of potassium per hour should be used to avoid the occurrence of hyperkalemia, as well as the maximum rate related to the solution to which Addiphos was added.
Stability:
In the case of introducing additional medicines into the infusion solution, the infusion should be completed within 24 hours of preparing the solution; this will prevent microbial contamination.
Any unused contents of the opened vial should be discarded, it must not be stored for further use.
Data on stability and pharmaceutical compatibility with medicines used for parenteral nutrition are available on request from the marketing authorization holder.

Storage conditions

Opened packaging may not be stored.
Unused medicine is not suitable for further use.
Do not store above 25°C. Do not freeze or allow to freeze.

Disposal of unused medicine

Any unused medicine or waste material should be disposed of in accordance with local regulations.