Phenobarbital sodium 10 mg/mL oral solution

Clear colourless solution.

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Barbiturate antiepileptic/sedative.
Active-drug context from another product’s labelling; it does not establish stability or dosing of this compounded preparation.

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Clear and colourless. Reject if yellowing or precipitation occurs.

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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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Glycerol is miscible with water. This does not establish product microbiological stability.

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Glycerol is hygroscopic; limit raw-material exposure to moisture.

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For the finished product the source specifies:
Amber plastic bottle, ≤25 °C. Do not refrigerate: precipitation risk.

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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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Glycerol: hazardous reaction with strong oxidising agents.

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Glycerol: Glycerol is hygroscopic; limit raw-material exposure to moisture.
These are selected facts for identified ingredients; relevant sensitivities and incompatibilities are detailed in the corresponding fields. This is not a complete SDS for every material.

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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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A complete formula-specific hazard classification is not established. Assess potency, dust/aerosol, allergens, solvents, microbial risk and cross-contamination using the actual materials and process. Absence of a flag does not establish absence of hazard.

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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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7 days, as revised on 11 February 2025.
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. Selection/qualification is defined locally.

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Weigh sodium salt, wet with glycerol and add water progressively. Transfer quantitatively, make to 40 mL, mix and package.

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Use phenobarbital sodium powder, not phenobarbital free acid or tablets. Water must meet the source therapeutic-use specification and applicable local quality requirements.

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Amber plastic bottle as specified by the sheet.

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Clear and colourless. Reject if yellowing or precipitation occurs.

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Amber plastic bottle, ≤25 °C. Do not refrigerate: precipitation risk.

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Do not refrigerate. Do not use if yellow colour or precipitate develops. Use powdered sodium salt.

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Phenobarbital sodium 10 mg/mL oral solution
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Από του στόματος / Oral use
Dose/directions: __________
Storage: Amber plastic bottle, ≤25 °C. Do not refrigerate: precipitation risk.
Do not refrigerate. Do not use if yellow colour or precipitate develops. Use powdered sodium salt.

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