PROSPECTO: INFORMATION FOR THE USER

GLAMIN

Solution for Infusion

GLAMIN provides direct parenteral nutrition 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, electrolytes, and vitamins.

Do not use Glamin:

- If you have a rare congenital alteration in which your body cannot break down (metabolize) amino acids (for example, phenylketonuria)

- If you have liver insufficiency or kidney insufficiency

- If you have serious disorders of blood circulation

- If you present unstable hemodynamic conditions that put your life at risk (shock)

- If you present metabolic acidosis (a state in which the blood pH is low)

- If you have oxygen insufficiency in the body

- If you present a known alteration called hyperhydration in which there is too much water in the body

- If you present low sodium levels (hyponatremia)

- If you present low potassium levels (hypokalemia)

- If you present high levels of lactic acid in the body (hyperlactemia)

- If you present changes in your blood profile

- If you present fluid in the lungs (pulmonary edema)

- If you have a cardiac alteration known as decompensated heart failure in which your heart does not pump blood through the body quickly enough

- If you are allergic (hypersensitive) to any of the active principles 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 undergo 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 taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

No data is 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 operating machines

This is not applicable as this medication is used in the hospital.

You will receive your medication through intravenous infusion (drop by drop through a vein). Your doctor will decide on the appropriate dose you should receive based on your needs.

The usual dose of Glamin in adults is 7-14 ml per kilogram 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 highly unlikely that you will receive more medication than you should because 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 adverse effects have been observed when the infusion is administered too quickly:

-nausea and vomiting

-sweating

-headaches

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in the package insert. 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 about the safety of this medication.

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 at a temperature 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 must be transparent and colorless. Do not administer otherwise.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Glamin

The active principles arein 1000 ml

Alanine16.00 g

Arginine11.30 g

Aspartic acid3.40 g

Glutamic acid5.60 g

Glycyl-Glutamine H2O30.27 g

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

Glycyl-Tyrosine 2H2O3.45 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 container

Glamin is a clear, colorless or slightly yellowish solution of amino acids and dipeptides. It is presented in glass bottles of 250, 500 and 1,000 ml, closed with butyl rubber stoppers.

Not all types of containers may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Fresenius Kabi España, S.A.U.

c/ Marina 16-18

08005 Barcelona

SPAIN

Responsible for manufacturing:

Fresenius Kabi Austria GmbH,

Haffnerstrasse 36,

A-8055 Graz,

Austria.

This medicinal product 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 leaflet has been revised in: January 2015

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