Flucytosine 50 mg/mL oral suspension

Homogeneous whitish suspension.

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Antifungal.

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pH 4–5; assay 90–110%. Before rotor/stator treatment, source reports 95% of particles at 56–224 μm. Check the original for remaining uniformity/particle-size tests.

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For the finished product the source specifies:
Amber type II glass with suitable closure, 15–25 °C, protected from light.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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For the finished product the source specifies:
Amber type II glass with suitable closure, 15–25 °C, protected from light.

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Specification of this preparation, not a demonstrated stability range:
pH 4–5; assay 90–110%. Before rotor/stator treatment, source reports 95% of particles at 56–224 μm. Check the original for remaining uniformity/particle-size tests.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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Complete formula-specific PPE is not specified. Select gloves, eye protection and exposure controls using the exact materials’ SDS and the local risk assessment.
Supplementary AEMPS framework: clean long-sleeved laboratory clothing, hair covering and dedicated footwear/overshoes. Powder handling requires suitable eye/respiratory protection; change gloves with activity or damage. Select the exact type/material using SDS and risk assessment.

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SPECIAL FACILITY: source requires an isolator or suitable unidirectional airflow in a grade D environment and dedicated equipment. It identifies reproductive toxicity category 1B (H360). Assess operator/environmental protection. This is a non-sterile oral product.
The source’s specialist conditions are prerequisites; a general weighing sheet or ordinary compounding bench is insufficient.

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Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment.

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Source reports 90 days under its own preparation and study conditions.
The source period applies to its exact composition, method and packaging. It is not this batch’s expiry date and cannot be transferred to another vehicle/strength. Calculate the actual date in the blank batch record.

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No separate base is identified in the dependency register. Check any commercial vehicles/compound excipients listed in the formula.

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Indicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials, Mortar and pestle. Selection/qualification is defined locally.

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After qualifying the required specialist facility, preferably within one day: triturate three flucytosine 500 mg tablets using dedicated mortar/pestle to powder <226 µm under the source exposure controls. Transfer to a preferably sterile single-use container. Add Ora-Blend to a final volume of 30 mL. Homogenise with a suitable disperser such as rotor/stator. Pack in an amber type II glass bottle with a tamper-evident screw cap. Final-product sterility is not established.

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SPECIAL FACILITY: source requires an isolator or suitable unidirectional airflow in a grade D environment and dedicated equipment. It identifies reproductive toxicity category 1B (H360). Assess operator/environmental protection. This is a non-sterile oral product.

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Amber type II glass bottle with a tamper-evident screw cap.

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pH 4–5; assay 90–110%. Theoretical osmolality 1790–2423 mOsm/kg, not an actual batch result. Before dispersion, 95% of particles 56–224 µm. Content uniformity by Ph. Eur. 2.9.6 test B and an appropriate USP method; full chapters are required.

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Amber type II glass with suitable closure, 15–25 °C, protected from light.

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No additional special directions are established beyond the source route, storage and notes. Complete patient details, dose and directions from the prescription.

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Flucytosine 50 mg/mL oral suspension
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Από του στόματος / Oral use
Dose/directions: __________
Storage: Amber type II glass with suitable closure, 15–25 °C, protected from light.
Shake before use.
DRAFT — not a release label.

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