Addaven (Concentrate) Instructions for Use

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

HP Halden Pharma, AS (Norway)

ATC Code

B05XA31 (Electrolytes in combination with other drugs)

Dosage Form

Addaven

Concentrate for solution for infusion: amp. 10 ml

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion

10 ml – ampoules (20 pcs.) – cardboard packs – By prescription

Clinical-Pharmacological Group

Trace elements for addition to parenteral nutrition solutions

Pharmacological Action

A complex of trace elements in amounts that are absorbed from the gastrointestinal tract and do not exert any pharmacodynamic action other than maintaining or replenishing the usual daily requirement.

Pharmacokinetics

With intravenous administration, the pharmacokinetics of the trace elements included in this product correspond to those when ingested with food.

Individual trace elements enter the tissues and maintain or restore the concentrations of each trace element depending on the metabolic needs of that tissue.

Copper and manganese are usually excreted in the bile, whereas selenium, zinc, and chromium (especially in patients receiving parenteral nutrition) are predominantly excreted in the urine.

The main route of molybdenum excretion is urinary excretion, although small amounts are excreted in the bile.

Iron is excreted in small amounts during desquamation of intestinal surface cells.

Premenopausal women lose 30-150 mg of iron during menstruation.

Indications

To provide the daily or moderately increased requirement for trace elements during parenteral nutrition.

Dosage Regimen

Administer intravenously as an infusion only after dilution. Dilute one 10 ml ampoule in a compatible infusion solution. Use a maximum infusion time of 8 to 12 hours.

The daily dose is body weight-dependent. For adults and adolescents with a body weight of 40 kg or more, administer 10 ml daily. For patients weighing 15 kg to 40 kg, administer 0.1 ml per kg of body weight daily; do not exceed the 10 ml maximum daily dose.

Adjust the dosage based on individual patient requirements, clinical status, and laboratory parameters. In patients with significant cholestasis, reduce or omit the dose due to impaired biliary excretion of copper and manganese.

For patients with acute renal impairment or end-stage renal disease, reduce the dose or discontinue administration; monitor trace element plasma concentrations.

Add the calculated dose to parenteral nutrition solutions immediately before administration. Inspect the final admixture visually for particulate matter and discoloration prior to infusion. Discard any unused portion of the ampoule.

Adverse Reactions

Parenteral administration of iron and iodine in rare cases can cause hypersensitivity reactions, including severe and potentially life-threatening anaphylactic reactions.

Contraindications

Hypersensitivity to the active substances; complete biliary tract obstruction; Wilson’s disease; hemochromatosis; children with body weight less than 15 kg.

Use in Pregnancy and Lactation

No adverse reactions were observed during pregnancy.

The active substances are excreted in breast milk and have an effect on newborns and infants. This effect is expected and predictable.

Use in Hepatic Impairment

Dosage regimen adjustment is required.

Use in Renal Impairment

Dosage regimen adjustment is required.

Pediatric Use

Contraindicated for use in children with body weight under 15 kg.

Geriatric Use

Used with consideration of the state of renal function.

Special Precautions

Clinical monitoring of patients for the appearance of signs and symptoms of hypersensitivity reactions is necessary.

If hypersensitivity reactions occur, the administration of this product should be immediately discontinued and necessary measures taken.

Use with caution in patients with hepatic insufficiency.

Liver dysfunction, including reduced bile secretion, may impede the excretion of trace elements, leading to a risk of their accumulation.

Patients with renal insufficiency should be cautious, as the urinary excretion of trace elements may be reduced.

In patients receiving long-term parenteral nutrition (more than 4 weeks), plasma concentrations of trace elements, especially manganese, must be monitored.

If a patient has a significantly increased requirement for any trace element, the treatment regimen should be adjusted by adding individual preparations.

Effect on ability to drive vehicles and operate machinery

Has no or negligible influence on the reaction speed when driving vehicles and operating machinery.

Drug Interactions

If oral iron preparations are prescribed simultaneously with this product, the total dose of iron should be determined to avoid its accumulation.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.