L-arginine hydrochloride 21% brown, concentrate

Pack size:5 x 20 ml Dosage form:Infusion solution concentrate

L-arginine hydrochloride 21% brown, concentrate. 

Indications: For the treatment of severe metabolic alkalosis (alkali excess or hypoacidity) and in pediatrics (pediatrics) for reducing elevated concentrations of ammonia in the blood (hyperammonemia) caused by severe congenital metabolic disorders.

For risks and side effects, read the package insert and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

L-arginine hydrochloride 21% brown, concentrate for the preparation of an infusion solution
Active ingredient: Arginine hydrochloride

Read the entire package insert carefully before you start using this medicine.

• Keep this leaflet. You may want to read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with anyone else. It may harm others, even if they have the same symptoms as you.
• If any of the side effects listed affect you seriously or if you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains:

1. WHAT IS L-ARGININE HYDROCHLORIDE 21% BROWN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING L&ndash%%%ARGININE&ndash%%%HYDROCHLORIDE 21% BROWN?
3. HOW SHOULD YOU USE L&ndash%%%ARGININE&ndash%%%HYDROCHLORIDE 21% BROWN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD L&ndash%%%ARGININE&ndash%%%HYDROCHLORIDE 21% BROWN BE STORED?
6. MORE INFORMATION

1. WHAT IS L-ARGININE HYDROCHLORIDE 21% BROWN AND WHAT IS IT USED FOR?

L-Arginine Hydrochloride 21% Brown is a solution for correcting acid-base imbalances. It contains arginine hydrochloride, the salt of an amino acid, as its active ingredient. It is used to treat severe metabolic alkalosis (alkali excess or hypoacidity) and in pediatrics (pediatrics) to reduce elevated blood ammonia concentrations (hyperammonemia) caused by severe congenital metabolic disorders.

2. WHAT SHOULD YOU CONSIDER BEFORE USING L-ARGININE HYDROCHLORIDE 21% BROWN?

L-Arginine Hydrochloride 21% Brown should not be used in the following cases:

• Overacidification of the blood (acidosis),
• increased potassium content in the blood (hyperkalemia).

Special care is required when using L-Arginine Hydrochloride 21% Brown in the following cases:

• Amino acid metabolism disorders,
• impaired renal function.

Monitoring of serum electrolyte levels and acid-base balance is necessary. Metabolic alkalosis with concurrently low potassium levels in the blood requires the simultaneous administration of potassium. If chloride levels in the blood are concurrently low, compensation for the chloride deficiency is necessary. In diabetics, blood glucose levels must be monitored. To avoid disturbances in amino acid metabolism, the specified dosage must be adhered to. The doctor will ensure that no infusion solution enters the tissue surrounding the blood vessel into which the cannula has been inserted, in order to avoid tissue damage.

When using L-Arginine Hydrochloride 21% Braun with other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken or used any other medicines, including medicines obtained without a prescription. Interactions with other medicines are not yet known.

Pregnancy and breastfeeding:
Consult your doctor or pharmacist before taking or using any medicines. There are no concerns about use during pregnancy and breastfeeding if indicated.

Ability to drive and operate machinery:
L-Arginine Hydrochloride 21% Brown has no influence on the ability to drive and operate machinery.

3. HOW SHOULD L-ARGININE HYDROCHLORIDE 21% BROWN BE USED?

This medicine will be administered to you by a doctor or medical professional.

Method of administration:
You will receive this medicine as a venous drip (intravenous infusion) after dilution in a suitable infusion solution.

Dosage:
Your doctor will determine the correct dose for you based on the extent of the acid-base balance disturbance. The dose is calculated based on blood tests and your body weight.

If you have received more L-Arginine Hydrochloride 21% Brown than you should:
An overdose can lead to hyperacidity of the blood, disorders in amino acid metabolism (amino acid imbalances), and electrolyte imbalances.

Therapy:
Discontinue the administration of the solution and correct any resulting disturbances.

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

4. POSSIBLE SIDE EFFECTS?

Like all medicines, L-Arginine Hydrochloride 21% Braun can cause side effects, although not everybody experiences them. The following categories are used to estimate the frequency of side effects:

Depending on the dose used and/or speed of administration, the following may occur: Metabolic and nutritional disorders: When larger amounts of arginine hydrochloride are administered, disorders in amino acid metabolism, in diabetics an increase in blood sugar, stomach and intestinal disorders, intolerance reactions, e.g. nausea and vomiting.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly via Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Website: http://www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD L-ARGININE HYDROCHLORIDE 21% BROWN BE STORED?

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the container and carton after "%%%Use by:### or "%%%EXP"%%%. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Use only if the container is undamaged and the solution is clear. Once the ampoule has been opened, the solution must be used immediately. Discard the container and any remaining solution after use.

6. FURTHER INFORMATION

What L-Arginine Hydrochloride 21% Brown contains:
The active ingredient is arginine hydrochloride: 1 ampoule of 20 ml contains 4.214 g arginine hydrochloride: 1 ml contains 1 mmol arginine H+ and 1 mmol Cl-. The other ingredient is: Water for injections.

What L-Arginine Hydrochloride 21% Brown looks like and what's in the pack:
L-Arginine Hydrochloride 21% Brown is a concentrate for infusion solution, meaning it is added to an infusion solution before administration. It is a clear, colorless aqueous solution. It is available in 20 ml glass ampoules, in packs of 5 and 10 ampoules.

Pharmaceutical company:
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen


Manufacturer:
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen

or

B.Braun Medical SA
Carretera deTerrassa 121
08191 Rubi (Barcelona)
Spain

This package leaflet was last revised in July 2025.

Source: Information from the package leaflet.
Version: 07/2025

Areas of application: for the treatment of severe metabolic alkalosis (alkali excess or hypoacidity) and in pediatrics (pediatrics) to reduce elevated concentrations of ammonia in the blood (hyperammonemia) caused by severe congenital metabolic disorders.

To correct acid-base balance disorders