VAMIN 18 WITHOUT ELECTROLYTES SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

VAMIN 18 WITHOUT ELECTROLYTES solution for infusion

Amino Acids

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What VAMIN 18 WITHOUT ELECTROLYTES is and what it is used for
2. What you need to know before you use VAMIN 18 WITHOUT ELECTROLYTES
3. How to use VAMIN 18 WITHOUT ELECTROLYTES
4. Possible side effects
5. Storage of VAMIN 18 WITHOUT ELECTROLYTES
6. Contents of the pack and other information

1. What VAMIN 18 WITHOUT ELECTROLYTES is and what it is used for

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 body structures).

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

2. What you need to know before you use VAMIN 18 WITHOUT ELECTROLYTES

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 kidney function (uremia) and are not undergoing dialysis or any other form of blood filtration treatment

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

Warnings and precautions

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

Before administering this medicine, your doctor should know if you suffer from:

• a situation where your body has problems using proteinsor amino acids
• any kidneyor liverproblems
• alteration of the level of electrolytes and oligoelements

Your doctor will monitor your situation through blood tests.

Your doctor or nurse will check for the absence of particles in the solution being administered to you.

Using VAMIN 18 WITHOUT ELECTROLYTES with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to use VAMIN 18 WITHOUT ELECTROLYTES

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

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

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

Adults and elderly

The usual dose of VAMIN 18 WITHOUT ELECTROLYTES in adults for maintaining 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 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 body weight.

Depending on the patient's requirements, up to 1000 ml of VAMIN 18 WITHOUT ELECTROLYTES can be infused intravenously over 24 hours. In patients with basal amino acid requirements, Vamin 14 without electrolytes can 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 very 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, redness, and sweating.

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

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

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• discomfort
• sweating
• redness

Other side effects include:

• abnormal liver laboratory test results: these results will return to normal after the end of treatment with VAMIN 18 WITHOUT ELECTROLYTES
• vein pain; a clot may form at the injection site
• thrombophlebitis may occur when peripheral veins are used.

Reporting of side effects:

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of VAMIN 18 WITHOUT ELECTROLYTES

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

Do not store above 25°C.

Do not freeze.

Healthcare professionals are responsible for the correct storage, use, and administration of VAMIN 18 WITHOUT ELECTROLYTES.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

Use VAMIN 18 WITHOUT ELECTROLYTES only if the solution is transparent, particle-free, and the container is intact.

Any unused solution should be discarded by healthcare professionals.

6. Contents of the pack and other information

Composition of VAMIN 18 WITHOUT ELECTROLYTES

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

Amino Acids Quantity

L-alanine 16 g

L-arginine 11.3 g

L-aspartic acid 3.4 g

L-cysteine / + L-cystine 0.56 g

L-glutamic acid 5.6 g

L-glycine 7.9 g

L-histidine 6.8 g

L-isoleucine 5.6 g

L-leucine 7.9 g

L-lysine acetate 9.0 g

L-methionine 5.6 g

L-phenylalanine 7.9 g

L-proline 6.8 g

L-serine 4.5 g

L-threonine 5.6 g

L-tryptophan 1.9 g

L-tyrosine 0.23 g

L-valine 7.3 g

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

Appearance of the product and contents of the pack

VAMIN 18 WITHOUT ELECTROLYTES is a clear, colorless or slightly yellow solution of amino acids. It is available in glass bottles with a rubber stopper.

Pack sizes:

500 ml and 1000 ml glass bottles.

Single-use containers.

Not all pack sizes may be marketed.

Marketing authorisation holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005-Barcelona

Manufacturer

FRESENIUS KABI AUSTRIA GMBH

Hafnerstrasse, 36

A-8055 Graz, Austria

Date of last revision of this leaflet: May 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS):

http://www.aemps.gob.es