SuperAmp (Solvent) Instructions for Use

Marketing Authorization Holder

Corgem Pharmaceuticals Pvt. Ltd. (India)

Manufactured By

Claris Lifesciences, Ltd. (India)

ATC Code

V07AB (Solvents and diluents, including irrigation solutions)

Active Substance

Water for injections (Ph.Eur. European Pharmacopoeia)

Dosage Form

SuperAmp

Solvent for preparation of injectable dosage forms: 5 ml or 10 ml amp. 50 pcs.

Dosage Form, Packaging, and Composition

Solvent for preparation of injectable dosage forms transparent, colorless.

5 ml – plastic ampoules (50) – cardboard packs.
10 ml – plastic ampoules (50) – cardboard packs.

Clinical-Pharmacological Group

Solvent for the preparation of injectable dosage forms

Pharmacotherapeutic Group

Solvent

Pharmacological Action

Water for injections does not possess pharmacological activity. It is used as a solvent intended for the preparation of infusion and injection solutions, ensuring optimal conditions for the compatibility and efficacy of substrates and water.

Water is the basis of various transfusion preparations, biological tissues and fluids (blood, lymph, cell plasma, etc.), and is necessary for metabolic processes.

Under normal conditions, water is excreted in urine, feces, sweat, and through respiration. Fluid loss through sweat, respiration, and feces occurs regardless of fluid intake. Maintaining adequate hydration requires 30-45 ml/kg/day of water in adults; in children – 45-100 ml/kg, and in infants – 100-165 ml/kg.

Pharmacokinetics

When alternating water and electrolytes are administered, homeostasis is maintained by the kidneys.

Indications

Dissolution and dilution of medicinal products for their parenteral (injection/infusion) administration immediately before use.

Used for the preparation of sterile infusion and injection solutions from powders, lyophilisates, and concentrates.

ICD codes

Dosage Regimen

Determine the required volume of SuperAmp (Water for Injections) by consulting the prescribing information for the specific drug to be reconstituted or diluted.

Select the appropriate ampoule size (5 ml or 10 ml) to accommodate the final volume of the prepared solution.

Perform all preparation steps under strict aseptic conditions. Cleanse hands and work surface with a suitable disinfectant prior to initiating the procedure.

Inspect the plastic ampoule for integrity. Do not use if the ampoule is damaged, the tamper-evident seal is broken, or the solution is cloudy or contains visible particulate matter.

Open the ampoule immediately before use. Snap the ampoule tip at the pre-scored break point, ensuring a clean break to avoid glass or plastic fragments.

Withdraw the entire contents using a sterile syringe and needle of appropriate size. Do not store the opened ampoule for future use; it is for single use only.

Transfer the solvent to the vial containing the powder, lyophilisate, or concentrate. Direct the stream of solvent against the inner wall of the vial to minimize foaming.

Gently agitate or roll the vial until the drug is completely dissolved. Do not shake vigorously unless specified in the drug’s instructions.

Inspect the resulting solution visually for particulate matter and discoloration prior to administration. Do not use if the solution is not clear or if any precipitates are observed.

Administer the prepared solution immediately or within the time frame specified by the reconstituted drug’s stability data. Adhere strictly to the recommended infusion rate or injection speed for the final drug product.

Discard any unused portion of the solvent and the prepared drug solution according to standard procedures for hazardous medical waste.

Adverse Reactions

Determined by the side effects of the drug for which the water for injections was used for dissolution or dilution.

Contraindications

Water for injections is not used for the dissolution and dilution of drugs for which another solvent is specified as mandatory.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is determined by the instructions for use of the drug for which the water for injections will be used for dilution.

Special Precautions

Water for injections should not be mixed with oil-based injection solutions.

Medicinal products whose concentration must be within certain limits should be diluted with water for injections strictly within the specified limits.

Special control over the amount of administered solutions prepared using water for injections is required in newborns and young children, in whom even the administration of small volumes can lead to disturbances in water-electrolyte balance.

If the packaging integrity is compromised or the contents are cloudy, the water for injections should not be used.

Effect on ability to drive vehicles and operate machinery

The effect on the ability to perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions is determined by the properties of the drug for which the water for injections was used for dissolution or dilution.

Drug Interactions

When mixing with other drugs (infusion solutions, concentrates for preparation of infusion solutions, injection solutions, powders, dry substances for preparation of injection solutions), visual control for compatibility is necessary (pharmaceutical incompatibility may occur).

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.