Label: Information for the User

VAMIN 18 WITHOUT ELECTROLYTES solution for infusion

Amino Acids

Read this label carefully before starting to use this medication because it contains important information for you.

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

VAMIN 18 WITHOUT ELECTROLYTES provides nutrients through your bloodstream when you cannot eat normally. It provides amino acids, which in your body will be used to form proteins (to create and repair muscles, organs, and other bodily structures).

VAMIN 18 WITHOUT ELECTROLYTES is normally mixed with salts, fats, carbohydrates, and vitamins, which together provide the needs for complete nutrition.

Do not use VAMIN 18 WITHOUT ELECTROLYTES:

- if you have congenital defects in amino acid metabolism

- if you have or have had severely decreased liver function

- if you have or have had decreased renal function (uremia) and are not undergoing dialysis or any other form of blood filtration treatment

If you have any of the situations mentioned above, do not administer VAMIN 18 WITHOUT ELECTROLYTES. Inform your healthcare professional, so they do not administer this treatment.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Vamin 18 without electrolytes.

Before administering this medication, your doctor must know if you suffer from:

• a situation in which your body has problems usingproteinsoramino acids
• any renal or hepatic problem
• alteration of the level of electrolytes and oligoelements

Your doctor will monitor your situation through blood tests.

Your doctor or nurse will monitor the absence of particles in the solution they administer to you.

Use of VAMIN 18 WITHOUT ELECTROLYTES with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

VAMIN 18 WITHOUT ELECTROLYTES does not affect your ability to drive or operate machines.

This medication will be administered to you through a drip (intravenous infusion) in a vein.

The amount and rate of infusion will depend on your needs.

Your doctor will decide on the correct dose that you should receive.

Adults and elderly people

The usual dose of VAMIN 18 WITHOUT ELECTROLYTES in adults for the maintenance of body protein mass depends on the patient's clinical situation (nutritional status and degree of metabolic stress).

The requirements are 0.10-0.15 g nitrogen/kg body weight/day (without metabolic stress or with mild metabolic stress and normal nutritional status), 0.15-0.20 g nitrogen/kg body weight/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25 g nitrogen/kg body weight/day (severe catabolism such as in burns, sepsis and trauma). The dose range of 0.10-0.25 g nitrogen/kg body weight/day corresponds to 5-14 ml of VAMIN 18 WITHOUT ELECTROLYTES/kg body weight/day. In obese patients, the dose should be based on the estimated ideal weight.

Depending on the patient's requirements, up to 1000 ml of VAMIN 18 WITHOUT ELECTROLYTES may be infused intravenously over 24 hours. In patients with basic amino acid requirements, Vamin 14 without electrolytes may be used.

VAMIN 18 WITHOUT ELECTROLYTES should be infused slowly, at a rate not exceeding 1000 ml in 8 hours, corresponding to approximately 2 ml per minute.

If you use more VAMIN 18 WITHOUT ELECTROLYTES than you should

It is highly unlikely that you will receive more doses than you should, as your doctor or nurse will monitor you during treatment. However, if you think you have received too much VAMIN 18 WITHOUT ELECTROLYTES, inform your doctor or nurse immediately.

The effects of an overdose may include nausea, vomiting, flushing and sweating.

If symptoms of overdose appear, the infusion should be slower or interrupted.

In case of overdose or accidental ingestion, consult immediately with your doctor or the Toxicology Information Service. Phone (91) 562 04 20.

If you have any other questions 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.

The following adverse effects may be observed if the infusion is administered too quickly:

• Discomfort
• Sweating
• Redness

Other adverse effects include:

• Abnormal results from liver function laboratory tests: these results will be normal again after completion of treatment with VAMIN 18 WITHOUT ELECTROLYTES
• Pain in the vein; a clot may form at the injection site
• Tromboflebitis may occur when using peripheral veins.

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 about the safety of this medication.

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

Do not store at a temperature above 25°C

Do not freeze

The healthcare personnel is responsible for the correct conservation, use, and administration of VAMIN 18 WITHOUT ELECTROLYTES.

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

Use VAMIN 18 WITHOUT ELECTROLYTES only if the solution is transparent, free of particles, and with the intact packaging.

Any remaining solution not used must be discarded by healthcare professionals

VAMIN 18 WITHOUT ELECTROLYTES Composition

Each 1000 ml of VAMIN 18 WITHOUT ELECTROLYTES contains the following active principles.

Amino AcidsQuantity

L-alanine16 g

L-arginine11.3 g

L-aspartic acid3.4 g

L-cysteine / + L-cystine0.56 g

L-glutamic acid5.6 g

L-glycine7.9 g

L-histidine6.8 g

L-isoleucine5.6 g

L-leucine7.9 g

L-lysine acetate9.0 g

L-methionine5.6 g

L-phenylalanine7.9 g

L-proline6.8 g

L-serine4.5 g

L-threonine5.6 g

L-tryptophan1.9 g

L-tyrosine0.23 g

L-valine7.3 g

The other components are: glacial acetic acid and water for injectable preparations.

Appearance of the product and contents of the package

VAMIN 18 WITHOUT ELECTROLYTES is a transparent, colorless or slightly yellowish solution of amino acids. It is available in glass bottles with rubber stoppers.

Package sizes:

500 ml and 1000 ml glass bottles.

Single-use containers

Only some package sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi España S.A.U

C/ Marina 16-18

08005-Barcelona

Responsible for manufacturing

FRESENIUS KABI AUSTRIA GMBH

Hafnerstrasse, 36

A-8055 Graz, Austria

Last review date of this leaflet: May 2016

More detailed and updated information on this medication is available on the website of

the Spanish Agency for Medicines and Medical Devices (AEMPS):

http://www.aemps.gob.es