Aminoplasmal b.braun 10% e solucion para perfusion

Label: information for the user

Aminoplasmal B. Braun 10% E solution for infusion

Amino acids and electrolytes

Read this label carefully before starting to use this medication, as it contains important information for you.

- Keep this label. You may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Aminoplasmal B. Braun 10% E is a solution that is administered through a small tube with a cannula that is inserted into a vein (intravenous infusion).

The solution contains amino acids and mineral salts (electrolytes), which are essential for the growth and recovery of the body.

You will receive this medication if you are unable to eat normally and cannot be fed through a tube inserted into your stomach. This solution may be administered to adults, adolescents, and children over 2 years old.

Do not use Aminoplasmal B. Braun 10% E:

• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6)
• if you have a congenital metabolic disorder of amino acids and proteins
• if you have a severe (life-threatening) circulatory disorder (shock)
• if you are receiving insufficient oxygen supply (hypoxia)
• if you have accumulated acidic substances in your blood (metabolic acidosis)
• if you have excessively high levels of any of the mineral salts (electrolytes) contained in the solution

• if you have inadequately controlled heart failure with significant circulatory disorder (decompensated heart failure)
• if you have acute pulmonary edema
• if you have excessive water in your body and your extremities are swollen (hyperhydration)

Your doctor will also consider that solutions with amino acids are generally not to be used:

?if you have severe liver disease (severe hepatic insufficiency)

?if you have severe kidney disorder (severe renal insufficiency) not adequately treated with dialysis or similar treatments

Newborns, infants, and small children under two yearsunder two years

This solution should not be administered to newborns, infants, or small children under two years, as the composition of the solution does not adequately meet the special nutritional needs of this age group.

Warnings and precautions

Consult your doctor before receiving Aminoplasmal B. Braun 10% E

• if you have a metabolic disorder of amino acids caused by a situation other than those listed in the previous section (see section "Do not use Aminoplasmal B. Braun 10% E")
• if you have any liver or kidney function disorder
• if you have a heart function disorder
• if your blood serum is abnormally very concentrated (increased serum osmolality).

Additional precautions taken by your doctor

If your body's water or mineral salt balance is altered, this alteration should be corrected before administering this medication. Examples of this alteration include simultaneous lack ofwater and mineral salts(hypotonic dehydration)or a lack of sodium (hyponatremia) or potassium (hypokalemia)

Your levels of salts and sugar in blood, water balance, acid-base balance, blood proteins, and kidney and liver function will be monitored before and while receiving this medication. Blood samples will be taken and your urine will be collected for analysis.

Generally, you will receive Aminoplasmal B. Braun 10% E as part of an intravenous nutrition regimen, which will also include energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytes, as well as vitamins, liquids, and oligoelements.

Use of Aminoplasmal B. Braun 10% E with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

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

Pregnancy

If you are pregnant, you will only receive this medication if your doctor considers it necessary for your recovery.No data is available on the use of this medication in pregnant women.

Breastfeeding

At therapeutic doses of AminoplasmalB.Braun10%E, no effects are expected on the newborn/infant in the breastfeeding period.However, breastfeeding is not recommended if women need intravenous nutrition at the same time.

Driving and operating machinery

This medication is generally administered to immobile patients in a controlled environment (emergency treatment, acute treatment in a hospital or day center). This excludes driving and operating machinery.

A healthcare professional will administer Aminoplasmal B. Braun 10% E.

The doctor will determine the necessary amount of medication and the duration of treatment for the patients.

The solution will be administered through a small plastic tube that will be inserted into a vein.

Patients with liver or kidney disease

Doses will be adjusted according to individual needs if you have liver or kidney disease.

Duration of administration

This medication can be used as long as intravenous nutrition is needed.

If you have received more Aminoplasmal B. Braun 10% E than you should

It is unlikely that this will happen, as your doctor will determine your daily doses.

However, if you receive an overdose or the solution flows too quickly, you may feel nausea, have to vomit, or experience headaches. Additionally, your blood may contain too much ammonia (hyperammonemia) or you may lose amino acids in your urine. You may also experience excessive fluid in the body (hyperhydration), an imbalance of electrolytes, and water in the lungs (pulmonary edema). If this happens, the infusion should be interrupted and resumed at a lower infusion rate after a certain time.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

These adverse effects are not specifically related to Aminoplasmal B. Braun 10% E, but may occur with any type of intravenous nutrition, especially at the beginning.

The following adverse effects may be serious. If any of the following adverse effects occur, inform your doctor immediately and they will stop administering this medication:

Unknown Frequency(cannot be estimated from available data)

• Allergic Reactions

Other Adverse Effects:

Rare(may affect up to 1 in 100 people)

• Vomiting, Nausea

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You may also report them directly through the national notification system included in Appendix V.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.

Do not use this medication after the expiration date that appears on the labels of the vial and the box. The expiration date is the last day of the month indicated.

Store the vial in the outer packaging to protect it from light.

Do not store at a temperature above 25°C.

Store the solution in cold temperatures, below 15°C, may cause the formation of crystals that can, however, easily dissolve by gentle warming to 25°C until complete dissolution. Gently shake the container to ensure homogeneity. Do not freeze.

After perfusion, no remaining solution should be stored for future use.

Medications should not be disposed of through drains or trash. Dispose of containers and medications that you no longer need at the SIGRE collection point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Composition of Aminoplasmal B. Braun 10% E

The active principles are amino acids and electrolytes.

This medication contains:

The other components are acetylcysteine, citric acid monohydrate (for pH adjustment) and water for injection preparations.

Appearance of the product and contents of the container

This solution should only be used if the stopper of the container is not damaged and the solution is a transparent and colorless solution until a light yellowish color and does not contain particles.

The product is presented in colorless glass bottles of 250 ml, 500 ml and 1,000 ml, closed with rubber stoppers.

The 250 ml and 500 ml bottles are available in boxes of 10 units. The 1,000 ml bottles are presented in boxes of 6 units.

Only some sizes of containers may be marketed.

Marketing authorization holder and responsible manufacturer

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Postal address:

34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

For more information about this medication, please contact the local representative of the marketing authorization holder

B. Braun Medical SA

Ctra. Terrassa, 121

08191 Rubí (Spain)

This medication has been authorized in the member states of the EEA with the following names:

Last review date of this leaflet:02/2021

For detailed information about this medication, please visit 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 only for healthcare professionals:

Administration route

Intravenous.

Only for central venous infusion.

Dosage

Adults and adolescents aged 14 to 17 yearsold

Daily dose:

1.0–2.0g amino acids/kg body weight?10–20ml/kg body weight

?700–1,400ml for a 70kg patient

Maximum infusion rate:

0.1g amino acids/kg body weight/h?1.0ml/kg body weight/h

?1.17ml/min for a 70kg patient

Pediatric population

Newborns, infants and small children under two years old

AminoplasmalB.Braun10%E is contraindicated in newborns, infants and small children under2years old (see section4.3).

Children and adolescents aged 2 to 13 yearsold

The doses for the age groups indicated below are mean values used as a guideline. The exact dose should be adjusted individually according to age, developmental stage and existing diseases.

Daily dose for children aged 2 to 4 years:

1.5g amino acids/kg body weight?15ml/kg body weight

?700–1,400ml for a 10kg patient

Daily dose for children aged 5 to 13 years:

1.0g amino acids/kg body weight?10ml/kg body weight

?700–1,400ml for a 70kg patient

Severely ill children:

For patients who are severely ill, the recommended amino acid intake may be higher (up to 3.0g amino acids/kg body weight per day).

Maximum infusion rate:

0.1g amino acids/kg body weight/h?1.0ml/kg body weight/h

In cases where amino acid requirements are 1.0g per kg body weight per day or more, special attention should be paid to the limitations of fluid intake. In these situations, solutions of amino acids with a higher amino acid content may need to be used to avoid fluid overload.

Renal insufficiency

In patients with renal insufficiency, the dose should be adjusted carefully according to individual needs, the severity of the insufficiency and the type of renal replacement therapy established (hemodialysis, hemofiltration, etc.).

Liver insufficiency

In patients with liver insufficiency, the dose should be adjusted carefully according to individual needs and the severity of the insufficiency.

Handling instructions

Use a sterile administration set for the infusion of Aminoplasmal B. Braun 10% E solution for infusion.

If, in parenteral nutrition, other nutrients need to be added to this medication, such as carbohydrates, lipids, vitamins, electrolytes and oligoelements, the addition should be made under strict aseptic conditions. Mix well after the inclusion of any additive.AminoplasmalB.Braun10%E can only be mixed with other nutrients whose compatibility has been documented. On request, the manufacturer will provide compatibility data for different additives and the corresponding validity period of these mixtures.

Special precautions for storage

Do not use the product if the solution is not transparent and colorless until a light yellowish color or if the container or its stopper is damaged.

Single-use containers. Dispose of the container and any contents after use.

Store the solution in the cold, below 15°C, may cause the formation of crystals that can, however, easily dissolve by gentle warming to 25°C until complete dissolution. Gently shake the container to ensure homogeneity.

Validity period after mixing with additives

Do not refrigerate.

From a microbiological point of view, unless the opening and mixing method prevents the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage conditions and times during use are the responsibility of the user.

For complete information about this medication, please refer to the Product Information or Summary of Product Characteristics.