SODIUM ACETATE 1M FRESENIUS KABI CONCENTRATE FOR PERFUSION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Acetate 1M Fresenius Kabi concentrated solution for infusion

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even

if it is not listed in this leaflet. See section 4.

Contents of the pack:

1. What Sodium Acetate 1M Fresenius Kabi is and what it is used for
2. What you need to know before you use Sodium Acetate 1M Fresenius Kabi
3. How to use Sodium Acetate 1M Fresenius Kabi
4. Possible side effects
5. Storage of Sodium Acetate 1M Fresenius Kabi
6. Contents of the pack and other information

1. What Sodium Acetate 1M Fresenius Kabi is and what it is used for

Sodium Acetate 1M Fresenius Kabi belongs to a group of intravenous medicines called intravenous additive and/or concentrated solutions.

Sodium Acetate 1M Fresenius Kabi is indicated for:

• Treatment of electrolyte replacement in parenteral nutrition
• Correction of hyponatremia (low sodium levels in the blood)
• Correction of severe acidosis

2. WHAT YOU NEED TO KNOW BEFORE YOU USE SODIUM ACETATE 1M FRESENIUS KABI

Do not use Sodium Acetate 1M Fresenius Kabi:

• if you are allergic (hypersensitive) to sodium acetate or any of the other ingredients 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 conditions where edema (fluid retention) and/or sodium retention coexist.
• if you have problems with urine production.

Warnings and precautions

Sodium acetate should always be administered slowly to avoid sodium overload and fluid retention. It should be used with caution in patients with disorders such as metabolic or respiratory alkalosis, as well as in situations with elevated acetate levels or difficulties in its use, such as severe liver failure.

Its intravenous administration may lead to fluid overload and/or solute overload.

Caution should be exercised when administering fluids, especially with other solutions that contain sodium.

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

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Sodium Acetate 1M Fresenius Kabi does not affect the ability to drive or use machines.

3. HOW TO USE SODIUM ACETATE 1M FRESENIUS KABI:

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

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

Your doctor will indicate the duration of your treatment with SODIUM ACETATE 1M FRESENIUS KABI. Please do not stop treatment.

Use in children

The normal dose in newborns under 32 weeks of gestation is 3 mmol/kg/day.

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

The symptoms in case of overdose are summarized in the table of excess sodium in the blood described in the following section "POSSIBLE SIDE EFFECTS". Your doctor will take the necessary measures to correct the metabolic situation along with vital support measures.

4. Possible side effects

Like all medicines, SODIUM ACETATE 1M FRESENIUS KABI can cause side effects, although not everybody gets them.

The main side effects, due to excessive administration, would consist of an excess of sodium in the blood, manifested by nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivary and lacrimal secretion, excessive sweating, fever, tachycardia, hypertension, renal failure, pulmonary and peripheral edema, respiratory arrest, headache, dizziness, restlessness, weakness, muscle tremor and stiffness, convulsions, coma, and death.

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

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, talk to your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of SODIUM ACETATE 1M FRESENIUS KABI

This medicine does not require any special storage temperature. Do not refrigerate. Keep 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 rest.

Do not use Sodium Acetate 1M Fresenius Kabi after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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).

Other ingredients are: water for injections.

Appearance of the product and contents of the pack

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

The pack contents may be 10 or 100 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Labesfal – Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

This leaflet was last revised in April 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

The sodium acetate solution should be administered by intravenous infusion, previously diluted to a minimum of 50 ml of a compatible intravenous solution, and subject to the indicated doses, the evolution of serum sodium levels should be taken into account for successive administrations.

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

The concomitant 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.