VAMIN 14 WITHOUT ELECTROLYTES SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

VAMIN 14 WITHOUT ELECTROLYTES solution for infusion

Amino Acids

Read this package leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this package leaflet, as 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, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What VAMIN 14 WITHOUT ELECTROLYTES is and what it is used for
2. What you need to know before using VAMIN 14 WITHOUT ELECTROLYTES
3. How to use VAMIN 14 WITHOUT ELECTROLYTES
4. Possible side effects
5. Storage of VAMIN 14 WITHOUT ELECTROLYTES
6. Contents of the pack and further information

1. What VAMIN 14 WITHOUT ELECTROLYTES is and what it is used for

VAMIN 14 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 14 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 using VAMIN 14 WITHOUT ELECTROLYTES

Do not use VAMIN 14 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 14 WITHOUT ELECTROLYTES. Inform your healthcare professional so that they do not administer this treatment to you.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Vamin 14 without electrolytes.

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

• a situation in which 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 the absence of particles in the solution that is administered to you.

Using VAMIN 14 WITHOUT ELECTROLYTES with other medicines

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

Pregnancy and breastfeeding

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

Driving and using machines

VAMIN 14 WITHOUT ELECTROLYTES does not affect your ability to drive or use machines.

3. How to use VAMIN 14 WITHOUT ELECTROLYTES

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

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

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

Adults and elderly people

The usual dose of VAMIN 14 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 7-18 ml of VAMIN 14 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 14 WITHOUT ELECTROLYTES can be infused intravenously over 24 hours. In patients with markedly increased amino acid requirements, Vamin 18 without electrolytes can be used.

VAMIN 14 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 14 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 14 WITHOUT ELECTROLYTES, inform your doctor or nurse immediately.

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

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

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

4. Possible side effects

Like all medicines, VAMIN 14 WITHOUT ELECTROLYTES 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
• flushing

Other side effects include:

• abnormal laboratory test results for liver function: these results will return to normal after the end of treatment with VAMIN 14 WITHOUT ELECTROLYTES
• pain in the vein; a clot may form at the injection site
• thrombophlebitis may occur when peripheral veins are used.

Reporting side effects:

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

5. Storage of VAMIN 14 WITHOUT ELECTROLYTES

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

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.

Do not store above 25°C.

Do not freeze.

Healthcare professionals are responsible for the correct storage, use, and administration of VAMIN 14 WITHOUT ELECTROLYTES.

Use VAMIN 14 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 further information

Composition of VAMIN 14 WITHOUT ELECTROLYTES

Each 1000 ml of VAMIN 14 WITHOUT ELECTROLYTES contains the following active substances:

Amino Acids Quantity

L-alanine 12 g

L-arginine 8.4 g

L-aspartic acid 2.5 g

L-cysteine/L-cystine 0.42 g

L-glutamic acid 4.2 g

Glycine 5.9 g

L-histidine 5.1 g

L-isoleucine 4.2 g

L-leucine 5.9 g

L-lysine acetate 6.8 g

L-methionine 4.2 g

L-phenylalanine 5.9 g

L-proline 5.1 g

L-serine 3.4 g

L-threonine 4.2 g

L-tryptophan 1.4 g

L-tyrosine 0.17 g

L-valine 5.5 g

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

Appearance of the product and contents of the pack

VAMIN 14 WITHOUT ELECTROLYTES is a clear, colorless or slightly yellow solution of amino acids. It is available in glass bottles with a rubber stopper.

Container sizes:

500 ml and 1000 ml glass bottles.

Single-use containers

Not all container sizes may be marketed.

Marketing authorization 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 the last revision of this package leaflet: May 2016

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

http://www.aemps.gob.es