VAMIN 14 WITHOUT ELECTROLYTES SOLUTION FOR INFUSION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VAMIN 14 WITHOUT ELECTROLYTES infusion solution

Amino acids

Read the entire 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the 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. How to store VAMIN 14 WITHOUT ELECTROLYTES
6. Contents of the pack and other information

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

VAMIN 14 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 14 WITHOUT ELECTROLYTES is typically 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 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 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 14 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 14 WITHOUT ELECTROLYTES.

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

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

Your doctor will monitor your condition through blood tests.

Your doctor or nurse will check that the solution to be administered contains no particles.

Use of VAMIN 14 WITHOUT ELECTROLYTES with other medicines

Tell your doctor or pharmacist if you are currently 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 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 operate machinery.

3. How to use VAMIN 14 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 14 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 7–18 ml of VAMIN 14 WITHOUT ELECTROLYTES/kg body weight/day. In obese patients, the dose should be based on estimated ideal body weight.

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

VAMIN 14 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 14 WITHOUT ELECTROLYTES than you should

It is highly unlikely that you will receive more than the intended dose, 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.

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

If you have any doubts about using this product, ask your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, VAMIN 14 WITHOUT ELECTROLYTES may cause adverse effects, although not everybody experiences 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 14 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 type of adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 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 proper storage, handling, and administration of VAMIN 14 WITHOUT ELECTROLYTES.

Use VAMIN 14 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 14 WITHOUT ELECTROLYTES

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

Amino acids 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