GLAMIN SOLUTION FOR INFUSION

Introduction

PROSPECT: INFORMATION FOR THE USER

GLAMIN

Solution for infusion

Contents of the prospectus:

1. What is GLAMIN and what is it used for
2. What you need to know before starting to use GLAMIN
3. How to use GLAMIN
4. Possible side effects
5. Storage of GLAMIN
6. Contents of the package and additional information

1. What is GLAMIN and what is it used for

Glamin provides parenteral nutrition directly to your bloodstream when you cannot eat normally, for example after an operation or illness. Glamin provides amino acids that your body will convert into proteins (to create and repair muscles, organs, and other body structures).

It is usually used as part of a balanced intravenous diet, along with lipids, carbohydrates, salts, and vitamins.

2. What you need to know before starting to use GLAMIN

Do not use Glamin:

• If you have a rare congenital disorder in which the body cannot break down (metabolize) amino acids (e.g., phenylketonuria)
• If you have liver or kidney failure
• If you have serious blood circulation disorders
• If you have life-threatening hemodynamic instability (shock)
• If you have metabolic acidosis (a state in which the blood pH is low)
• If you have oxygen deficiency in the body
• If you have a condition known as hyperhydration, in which there is too much water in the body

• If you have low sodium levels (hyponatremia)
• If you have low potassium levels (hypokalemia)
• If you have high lactic acid levels in the body (hyperlactatemia)
• If you have changes in your blood profile
• If you have fluid in the lungs (pulmonary edema)
• If you have a cardiac disorder known as decompensated heart failure, in which your heart does not pump blood from the body quickly enough

• If you are allergic (hypersensitive) to any of the active ingredients or to any of the excipients of this medication (listed in section 6).

Your doctor or nurse will review this before using Glamin.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Glamin.

Your doctor may request that you have regular blood tests to check your condition.

The doctor or nurse will check that the solution does not contain particles before use.

Children

Glamin is not recommended for use in children.

Use of other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Pregnancy and breastfeeding

There are no data available in humans on the use of Glamin during pregnancy and breastfeeding. The use of Glamin during pregnancy and breastfeeding should be subject to the evaluation of the benefit-risk ratio by your doctor.

Consult your doctor or pharmacist before using this medication if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant. Your doctor will decide if you should use Glamin.

Driving and using machines

This does not apply, as this medication is used in the hospital.

3. How to use GLAMIN

You will receive your medication through intravenous infusion (drop by drop through a vein). Your doctor will decide what dose is suitable for you according to your needs.

The usual dose of Glamin in adults is 7-14 ml per kg of body weight per day. If you have liver or kidney problems, your doctor may need to adjust the dose.

Use in children:

Glamin is not recommended for use in children.

If you use more GLAMIN than you should:

It is very unlikely that you will receive more medication than you should, as this medication will be administered by your doctor or nurse, who will monitor you during treatment. However, if you think you have received too much Glamin, inform your doctor or nurse immediately.

The following side effects have been observed when the infusion is administered too quickly:

• nausea and vomiting
• sweating
• flushing

In cases of overdose or accidental ingestion, consult the Toxicology Information Service, Phone: 91-5620420

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Glamin is not expected to cause side effects if used as directed.

Reporting side effects

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

5. Storage of GLAMIN

Keep this medication out of the sight and reach of children.

Your doctor and hospital pharmacist are responsible for the correct storage, use, and disposal of Glamin.

Do not store above 25°C.

Do not use this medication after the expiration date indicated on the label. The expiration date is the last day of the month indicated.

The solution should be clear and colorless. Do not administer otherwise.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the package and additional information

Composition of Glamin

The active ingredients are in 1000 ml

Alanine 16.00 g

Arginine 11.30 g

Aspartic acid 3.40 g

Glutamic acid 5.60 g

Glycyl-Glutamine H2O 30.27 g

(equiv. Glycine 10.27 g; equiv. Glutamine 20.0 g)

Glycyl-Tyrosine 2H2O 3.45 g (equiv. Glycine 0.94 g; equiv. Tyrosine 2.28 g)

The other components are citric acid and water for injectable preparations.

Appearance of the product and contents of the package

Glamin is a clear, colorless, or slightly yellow solution of amino acids and dipeptides. It is presented in glass vials of 250, 500, and 1000 ml, closed with butyl rubber stoppers.

Not all types of packaging may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi España, S.A.U.

c/ Marina 16-18

08005 Barcelona

SPAIN

Manufacturer:

Fresenius Kabi Austria GmbH,

Haffnerstrasse 36,

A-8055 Graz,

Austria.

This medication is authorized in the Member States of the European Economic Area with the following names:

Austria: Glavamin Infusionslösung

Belgium: Glavamin infusionlösung

Glavamin oplossing voor infusiue

Glavamin solution pour infusion

Denmark: Glavamin

Finland: Glavamin

Germany: Glamin

Glavamin

Italy: Glamin

Luxembourg: Glavamin

Netherlands: Glamin

Norway: Glavamin 22,4 g N/l infusjonsvæske, oppløsning

Portugal: Glamin, solução para perfusão

Slovenia: Glamin 134 mg/ml raztopina za infundiranje

Spain: GLAMIN Solución para perfusión

Sweden: Glavamin, infusionsvätska, lösning

This prospectus was revised in: January 2015

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