Addiphos

Package Leaflet: Information for the User

ADDIPHOS

(170.1 mg + 133.5 mg + 14 mg)/ml, concentrate for solution for infusion
Potassium dihydrogen phosphate + Disodium phosphate dihydrate + Potassium hydroxide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 pack 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 a comprehensive intravenous diet, along 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 you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have hyperkalemia (high potassium levels in the blood) associated with:
• adrenal insufficiency (hormone-producing gland insufficiency);
• renal insufficiency;
• shock;
• dehydration (you have lost a lot 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 solution with ADDIPHOS before administering it to the patient.

Warnings and precautions

The medicine should be used with caution if:

• you are 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;
• you are 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 the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
No direct interaction between ADDIPHOS and other medicines has been found.
Tell your doctor if you:

• take large amounts of vitamin D;
• take 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your 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 machinery.

3. How to use ADDIPHOS

This medicine is administered only by medical personnel. You must not use it on your own.
In case of doubts, consult your doctor.
The dosage is determined by the doctor individually for each patient, depending on 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 you will receive too much ADDIPHOS, as the medicine is administered by medical professionals. If you think you have received a higher dose of ADDIPHOS than recommended, tell your doctor or nurse immediately.
In case of further doubts about using 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.
There are no reports of side effects resulting from the use of phosphates.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store ADDIPHOS

Store the medicine out of sight and reach of children.

The doctor or pharmacist is responsible for ensuring proper storage, use, and disposal of ADDIPHOS.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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

• The 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 contents of the pack

The medicine is a concentrate for solution for infusion.
The packaging of the medicine is polypropylene vials containing 20 ml of concentrate, packed in 10 pieces in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi AB
S-751 74 Uppsala
Sweden

Manufacturer

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway
To obtain more detailed information, contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89
Date of last revision of the leaflet:01.03.2024

Information intended for healthcare professionals only:

Dosage and administration

ADDIPHOS must not be administered undiluted.
Individual dosing, based on the determination of phosphate levels in the blood and the patient's need 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 in long-term hypophosphatemia with complex etiology.
A single dose of more than 0.24 mmol/kg body weight must not be exceeded. 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 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 medicines for which compatibility has been documented.
Compatibility:
Up to 1000 ml of the following medicines: Vamin 14 Electrolyte-Free, Vamin 18 Electrolyte-Free, Vaminolact, or glucose solution (55-600 mg/ml), no more than 60 ml of ADDIPHOS can be added.
Up to 400 ml of sodium chloride 9 mg/ml, no more than 20 ml of ADDIPHOS can be added.
For addition to non-phthalate plastic bags, see the package inserts of 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 microbiological 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 representative of the marketing authorization holder.

Storage conditions

After opening, the packaging may not be stored.
Unused medicine is not suitable for further use.
Store below 25°C.

Disposal of unused medicine

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