Aminoven 15% solucion para perfusion

PATIENT INFORMATION LEAFLET

AMINOVEN 15% Solution for Infusion

Amino Acids

Aminoven 15% is an intravenous infusion solution. It is presented in glass bottles of 250 ml, 500 ml, and 1000 ml and in polypropylene bags with an outer bag of 500 ml and 1000 ml.

Aminoven 15% provides nutrition through your circulatory system when you cannot eat normally. It supplies amino acids that your body will use to make proteins (to create and repair muscles, organs, and other bodily structures).

Aminoven 15% is normally mixed with lipids, carbohydrates, salts, and vitamins, which together serve to meet your total nutritional needs.

Do not use Aminoven 15%

• if you are allergic (hypersensitive) to any of the components of Aminoven 15%.

• if you haveprotein or amino acid metabolism disorders
• if you havemetabolic acidosis (your body fluids and tissues have too high levels of acids)
• if you haveuntreated renal insufficiency or other forms of blood filtration
• if you haveadvanced liver insufficiency
• if you havefluid retention
• if you haveshock
• if you havehypoxia (low oxygen levels)
• if you havedecompensated heart failure

Aminoven 15% should not be administered to children or adolescents under 18 years old.

For children under 2 years, pediatric amino acid preparations should be used, which are formulated to meet different metabolic requirements.

Warnings and precautions

Inform your doctor if

• you have low levels of potassium in your blood (hypokalemia)
• you have low levels of sodium in your blood (hyponatremia)
• you have a folate deficiency
• you have heart problems (heart failure)

Your doctor or healthcare staff will check before use that the solution is free of particles.

Use of Aminoven 15% with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Pregnancy and breastfeeding

You must inform your doctor if you are pregnant, think you may be pregnant, or are breastfeeding, your doctor will decide if you should be administered Aminoven 15%.

Driving and operating machinery

Aminoven 15% does not affect your ability to drive or operate machinery.

Follow exactly the administration instructions for Aminoven 15% as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

This medication will be administered by infusion (intravenous drip).

The amount and speed at which the infusion is administered will depend on your needs.

Your doctor will decide what is the correct dose that should be administered to you.

You may be monitored during your treatment.

If you use more Aminoven 15% than you should:

It is very unlikely that you will be administered more infusion than you should be given, as your doctor or healthcare staff will be monitoring you during treatment.

The effects of an overdose may include nausea, vomiting, and chills. If you experience these symptoms or believe you have been given too much Aminoven 15%, inform your doctor or nurse immediately.

If you have used more Aminoven 15% than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

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

Like all medications,this medicationmay cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed when the infusion was administered too quickly:

• Loss of potassium or sodium from the blood
• Folate deficiency

The following adverse effects may appear at the injection site:

• Irritation in the vein
• Thrombophlebitis (formation of a clot) at the venous administration site

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an 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: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.

Your doctor and hospital pharmacist are responsible for the correct conservation, use, and administration of Aminoven 15%.

Do not freeze and store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging.

Dispose of any unused solution.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of unused containers and medications. This will help protect the environment.

Composition of Aminoven 15%

Each 1000 ml of Aminoven 15% contains the following active principles:

Active principlesQuantity (g)

Isoleucine5.20

Leucine8.90

Lysine acetate15.66 (corresponding to 11.1 g of Lysine)

Methionine3.80

Phenylalanine5.50

Threonine8.60

Tryptophan1.60

Valine5.50

Arginine20.00

Histidine7.0

Alanine25.00

Glycine18.50

Proline17.00

Serine9.60

Thyrosine0.40

Taurine2.00

Aminoven 15% also contains glacial acetic acid, injectable water, and maleic acid.

Appearance of the product and contents of the container

Aminoven 15% is available in colourless glass bottles with rubber/ aluminium stopper containing 250 ml, 500 ml or 1000 ml of solution.

Not all container sizes may be marketed.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg v.d.H.

Germany

Manufacturers responsible:

Aminoven in glass bottles is manufactured by:

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

Local Representative:

Fresenius Kabi España SAU

Marina 16-18

08005 Barcelona

Spain

Last review date of this leaflet: November 2017.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Dosage and administration

The daily requirements of amino acids depend on the patient's body weight and metabolic conditions.

The maximum daily dose varies with the patient's clinical condition and may change from day to day.

The recommended perfusion period is to provide continuous perfusion for at least 14 hours to 24 hours, depending on the clinical situation. Bolus administration is not recommended.

The solution will be administered as long as parenteral nutrition is required.

Aminoven 15%

For administration through a central route such as continuous perfusion.

The usual daily dose of Aminoven 15% is 6.7-13.3 ml per kg of body weight equivalent to 1.0 – 2.0 g of amino acids per kg of body weight) e.g. Corresponding to 470-930 ml of Aminoven 15% for a body weight of 70 kg. The maximum perfusion rate is 0.67 ml of Aminoven 15% per kg of body weight per hour (equivalent to 0.1 g of amino acids per kg of body weight and hour).

Maximum daily dose in adults

13.3 ml of Aminoven 15% per kg of body weight/day (equivalent to 2.0 g of amino acids per kg of body weight) e.g. Corresponding to 140 g of amino acids in 70 kg of body weight.

Aminoven 15% is contraindicated in children.

Overdose (symptoms, emergency procedure, antidotes)

Similar to other amino acid solutions, chills, vomiting, nausea, and increased renal losses of amino acids may occur when Aminoven or the perfusion rate is exceeded. In this case, perfusion should be stopped immediately. It may be possible to continue with a reduced dose afterwards.

Too rapid perfusion may also cause fluid overload and electrolyte disturbances.

Emergency procedures should be general supportive measures, with special attention to the respiratory and cardiovascular systems.

Close biochemical monitoring and appropriate treatment of specific abnormalities will be essential.

There is no specific antidote in case of overdose.

Storage

Keep out of the reach and sight of children.

Store the container in the box. Do not store above 25°C. Do not freeze.

Use only if the solution is clear, there are no particles in suspension, and the container remains intact.

Do not use this medicine after the expiry date indicated on the container under the heading CAD. The expiry date is the last day of the month indicated.

Use immediately with a sterile perfusion set once the container is opened. Any remaining mixture should be discarded after perfusion.

Aminoven can be mixed aseptically with other nutrients such as lipid emulsions, carbohydrates, and electrolytes. On request, the manufacturer has available data on the chemical and physical stability of mixtures stored at 4°C for 9 days.

From a microbiological point of view, NPT mixtures prepared in uncontrolled or unvalidated conditions should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should normally not exceed 24 hours at a temperature of 2°C to 8°C, unless the mixture has been prepared in controlled and validated aseptic conditions.