Sodium chloride B. braun (Solvent) Instructions for Use

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

ATC Code

V07AB (Solvents and diluents, including irrigation solutions)

Active Substance

Sodium chloride (Ph.Eur. European Pharmacopoeia)

Dosage Form

Sodium chloride B. braun

Solvent for preparation of dosage forms for injections 0.9%: 5 ml, 10 ml or 20 ml amp. 20 pcs.

Dosage Form, Packaging, and Composition

5 ml – ampoules (20) – carton packs.
10 ml – ampoules (20) – carton packs.
20 ml – ampoules (20) – carton packs.

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Rehydrating agent

Pharmacological Action

A 0.9% sodium chloride solution is identical to human blood plasma. In small volumes, it is used as a solvent for the preparation of injectable drug solutions.

Pharmacokinetics

It is excreted by the kidneys.

Indications

• Dissolution and dilution of medicinal products for parenteral administration.

Use exclusively as a solvent for drugs compatible with a 0.9% sodium chloride solution. Always consult the instructions for the primary drug to confirm compatibility before preparation.

ICD codes

Dosage Regimen

Administer subcutaneously, intramuscularly, or intravenously only after the complete dissolution or dilution of the primary medicinal product.

Perform all preparation steps under strict aseptic conditions, including the opening of ampoules and the filling of syringes or infusion containers.

The required volume of solvent is determined by the instructions for use of the specific drug to be reconstituted or as directed by the prescribing physician.

Adverse Reactions

The adverse reaction profile is primarily determined by the pharmacological properties of the drug being dissolved or diluted.

Local reactions at the injection site, such as irritation or phlebitis, may occur. Systemic effects related to the sodium chloride itself are unlikely when used in small volumes as a solvent.

Drug Interactions

Visually inspect the mixture for any signs of physical incompatibility, such as precipitation, haze, or gas formation, upon combining with another drug.

Be aware that therapeutic or chemical incompatibility may not be visible. Always refer to specific compatibility data for the drug being mixed.

Contraindications

• Do not use for the dissolution or dilution of drugs for which the manufacturer explicitly specifies a different, mandatory solvent.
• Avoid use with medications known to be chemically or physically incompatible with a 0.9% sodium chloride solution.

Hypersensitivity to sodium chloride or any of the excipients is a contraindication.

Overdose

Overdose in the context of use as a solvent is improbable due to the small volumes administered. Any toxic effects would be attributable to the active drug being reconstituted.

In the event of administration of an excessive volume of the solution itself, monitor for hypernatremia and fluid overload, particularly in patients with compromised cardiac or renal function.

Use in Pregnancy and Lactation

The possibility of use during pregnancy and breastfeeding is determined by the instructions for use of the drug for which the 0.9% sodium chloride solution will be used for dilution.

Special Precautions

Before dissolving/diluting a drug, read the instructions for use of the drug.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.