PATIENT INFORMATION LEAFLET

Sodium Acetate 1M Fresenius Kabi Concentrate for Infusion Solution

Read this leaflet carefully before you start using this medicine.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask your doctor or pharmacist.

- If you experience any side effects, consult your doctor or pharmacist or nurse, even

if they are not listed in this leaflet. See section 4.

ACETATO SÓDICO 1M FRESENIUS KABI belongs to the group of intravenous medications known as intravenous solutions, additives and/or concentrates

ACETATO SÓDICO 1M FRESENIUS KABI is indicated for:

- Replacement of electrolytes in parenteral nutrition

- Correction of hyponatremia (low sodium content in the blood)

- Correction of severe acidosis

Do not use SODIUM ACETATE 1M FRESENIUS KABI:

• if you are allergic (hypersensitive) to sodium acetate or to any of the other components of

Sodium Acetate 1M Fresenius Kabi.

• if you have severe kidney disease.
• if you have severe liver disease (cirrhosis).
• if you have severe heart disease and other situations where edema (fluid retention) and/or sodium retention coexist.
• if you have problems with urine production.

Warnings and precautions

Sodium acetate should be administered slowly to avoid sodium overload and fluid retention. It should be used with caution in patients with conditions such as metabolic or respiratory alkalosis, as well as in situations where acetate levels are elevated or its use is difficult, such as severe hepatic insufficiency.

Its intravenous administration may lead to fluid and electrolyte overload.

Care should be taken in the administration of fluids, especially with other solutions that contain sodium

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Sodium Acetate 1M Fresenius Kabi does not affect the ability to drive or operate machinery.

Follow exactly the administration instructions for Acetate Sodium 1M Fresenius Kabi as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will instruct healthcare personnel on the most suitable dose for your needs. The normal dose in parenteral nutrition is up to 160 mmol/day of acetate sodium.

Your doctor will inform you of the duration of your treatment with ACETATE SODIUM 1M FRESENIUS KABI. Please do not discontinue treatment.

Use in children

The normal dose in newborns less than 32 weeks of gestation is 3 mmol/kg/day

If you use more ACETATE SODIUM 1M FRESENIUS KABI than you should:

The symptoms in case of overdose are summarized in the table of excess sodium in blood described in the following section “POSSIBLE ADVERSE EFFECTS”. Your doctor will take the necessary measures correcting the metabolic situation along with vital support measures.

Like all medications, ACETATO SÓDICO 1M FRESENIUS KABI can produce adverse effects, although not everyone will experience them.

The main adverse effects, due to excessive administration, would consist of excessive sodium in the blood, manifested by nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivation and lacrimation, excessive sweating, fever, tachycardia, hypertension, renal failure, pulmonary and peripheral edema, respiratory arrest, headache, dizziness, restlessness, weakness, muscle tremors, and rigidity, convulsions, coma, and death.

There may be fluid retention with swelling of the feet, weight gain, and edema in chronic administration.

Ifyou consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication

This medication does not require any special temperature for conservation. Do not refrigerate. Store in the original packaging to protect it from light.

Keep out of the reach and sight of children.

Use only if the solution is clear. If not all of the contents are used, discard the remainder.

Do not use Sodium Acetate 1M Fresenius Kabi after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Sodium Acetate 1M Fresenius Kabi

−The active ingredient is: sodium acetate. Each ml of solution contains 136.1 mg of sodium acetate (electrolytes: sodium: 1 mEq, acetate: 1 mEq).

−The other components are: water for injectable preparations.

Appearance of the product and content of the container

Sodium Acetate 1M Fresenius Kabi is an intravenous infusion solution, transparent, colorless and without visible particles, contained in 10 ml glass ampoules.

The content of the container may be 10 or 100 ampoules.

Holder of the marketing authorization and responsible for manufacturing Holder of the marketing authorization

Fresenius Kabi España S.A.U Marina 16-18. 08005 – Barcelona

Responsible for manufacturing

Labesfal – Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

This leaflet has been reviewed in April 2015

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

The sodium acetate solution should be administered in i.v. infusion after dilution in a minimum of 50 ml of a compatible I.V. solution and, in the absence of the indicated doses, the evolution of serum sodium levels should be taken into account for subsequent administrations.

Use only if the solution is clear. If not all the contents are used, discard the remainder.

The concurrent administration, in the same syringe, of sodium acetate, is compatible with cimetidine, for 48 hours at room temperature, as well as with enalapril, esmolol, labetalol and ondansetron.