Sodium acetate 1M Fresenius Kabi concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Acetate sodium 1M Fresenius Kabi concentrate for solution for infusion

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What ACETATE SODIUM 1M FRESENIUS KABI is and what it is used for
2. What you need to know before using ACETATE SODIUM 1M FRESENIUS KABI
3. How to use ACETATE SODIUM 1M FRESENIUS KABI
4. Possible adverse effects
5. How to store ACETATE SODIUM 1M FRESENIUS KABI
6. Contents of the pack and other information

1. What ACETATO SÓDICO 1M FRESENIUS KABI is and what it is used for

ACETATO SÓDICO 1M FRESENIUS KABI belongs to a group of intravenous medicinal products known as additive and/or concentrated intravenous solutions.

ACETATO SÓDICO 1M FRESENIUS KABI is indicated for:

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

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

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 conditions in which edema (fluid retention) and/or sodium retention coexist.

• if you have problems with urine production.

Warnings and precautions

Sodium acetate must always be administered slowly to avoid sodium overload and fluid retention. It should be used with great caution in patients with disorders such as metabolic or respiratory alkalosis, as well as in conditions associated with elevated acetate levels or impaired ability to utilize acetate, such as severe hepatic insufficiency.

Intravenous administration may lead to fluid overload and/or solute overload.

Care must be taken when administering fluids, especially with other solutions containing sodium.

Consult your doctor, even if any of the above-mentioned conditions have occurred to you in the past.

Use of other medicines:

Inform 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 operate machinery.

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

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

Your doctor will determine the most appropriate dose for your needs and instruct healthcare personnel accordingly. The usual dose in parenteral nutrition is up to 160 mmol/day of sodium acetate.

Your doctor will indicate how long your treatment with ACETATE SODIUM 1M FRESENIUS KABI should last. Please do not stop the treatment prematurely.

Use in children

The usual 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:

Symptoms of overdose are summarized in the section describing high blood sodium levels, under the following heading “POSSIBLE ADVERSE EFFECTS”. Your doctor will take appropriate measures to correct the metabolic imbalance along with providing vital supportive measures.

4. Possible adverse effects

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

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

With chronic administration, fluid retention may occur, causing swollen feet, weight gain, and oedema.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ACETATE SODIUM 1M FRESENIUS KABI

This medicine does not require any special storage temperature. Do not refrigerate. Keep in the original packaging to protect from light.

Keep out of the reach and sight of children.

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

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

6. PACKAGE CONTENTS AND ADDITIONAL INFORMATION

Composition of Acetate Sódico 1M Fresenius Kabi

• The active substance 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 injections.

Appearance of the product and package contents

Acetate Sódico 1M Fresenius Kabi is a solution for intravenous infusion, transparent, colourless and free from visible particles, contained in 10 ml glass ampoules.

The package may contain either 10 or 100 ampoules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer

Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal

This summary of product characteristics was last revised in April 2015

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended exclusively for physicians or healthcare professionals:

Sodium acetate solution must be administered by intravenous infusion after dilution in at least 50 ml of a compatible intravenous solution. In addition to the recommended doses, serum sodium levels should be monitored when repeated administrations are required.

Use only if the solution is clear. If not used entirely, any remaining contents must be discarded.

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