Vamin 18 without electrolytes solution for infusion: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VAMIN 18 WITHOUT ELECTROLYTES infusion solution

Amino acids

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

Keep this leaflet as you may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
If you experience any adverse reactions, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

What VAMIN 18 WITHOUT ELECTROLYTES is and what it is used for
What you need to know before using VAMIN 18 WITHOUT ELECTROLYTES
How to use VAMIN 18 WITHOUT ELECTROLYTES
Possible side effects
How to store VAMIN 18 WITHOUT ELECTROLYTES
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 the bloodstream when you are unable to eat normally. It supplies amino acids, which your body uses to form proteins (to build 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 requirements for complete nutrition.

2. What you need to know before starting to 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 impaired liver function
if you have or have had impaired kidney function (uremia) and are not undergoing dialysis or any other form of blood filtration treatment

If you have any of the conditions mentioned above, VAMIN 18 WITHOUT ELECTROLYTES must not be administered to you. Inform your healthcare professional so that this treatment is not given to you.

Warnings and precautions

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

Before this medicine is administered, your doctor must know if you have:

any condition in which your body has difficulty utilizing proteins or amino acids
any renal or hepatic problems
disturbances in electrolyte or trace element levels

Your doctor will monitor your condition through blood tests.

Your doctor or nurse will check that there are no particles present in the solution to be administered.

Use of VAMIN 18 WITHOUT ELECTROLYTES with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 operate machinery.

3. How to use VAMIN 18 WITHOUT ELECTROLYTES

This medicine will be administered by intravenous infusion (intravenous drip) into a vein.

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

Your doctor will determine the correct dose you should receive.

Adults and elderly patients

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

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 dosage 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 estimated ideal body 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 basal amino acid requirements, Vamin 14 without electrolytes may be used.

VAMIN 18 WITHOUT ELECTROLYTES must 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 than the correct dose, 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.

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

If symptoms of overdose occur, the infusion should be slowed or stopped.

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everybody will experience them.

The following adverse effects may occur if the infusion is administered too rapidly:

malaise
sweating
flushing

Other adverse effects include:

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

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 proper 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 refers to the last day of the month indicated.

Use VAMIN 18 WITHOUT ELECTROLYTES only if the solution is clear, free from particles, and the container is intact.

Any unused solution remaining must 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 - Amount

L-alanine 16 g

L-arginine 11.3 g

L-aspartic acid 3.4 g

L-cysteine / + 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 injections.

Appearance of the product and contents of the container

VAMIN 18 WITHOUT ELECTROLYTES is a clear, colourless or slightly yellow amino acid solution. It is available in glass bottles with rubber stoppers.

Container sizes:

Glass bottles of 500 ml and 1000 ml.

Single-use containers.

Only certain 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 most recent review of this leaflet: May 2016

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

http://www.aemps.gob.es