Page 14 - Laboratory manual for students FAR222 2019 20

FAR 222 Dosage Form II Laboratory Manual

Example:

Quantity of product
NAME OF INJECTION

Strength of injection (usually weight of active ingredient per suitable dose volume)
Name and concentration of added bactericide
Name and concentration of added stabilising agent
Dose and route of administration
Storage conditions
Auxiliary labels
Date of sterilisation:
Expiry date:
BN:
Name of patient: Date of dispensing:
Keep out of Reach of Children

SCHOOL OF PHARMACEUTICAL SCIENCES,
USM, PENANG

Some injections, e.g. Sodium Chloride Injection BP is not labelled with a dose as it would not
normally be used (when presented in an ampoule) as an injection; it is more likely to be used
as an injection diluent. To comply with the BP monograph, it is labelled with the % w/v and not
with an amount in a suitable dose volume.

A medicinal product contained in an ampoule or other container of 10 mL or lesser capacity,
if enclosed in a package, must be labelled with:

a) name of product
b) strength - as weight or volume of active ingredient per unit dose
c) official name - if applicable
d) international non-proprietary name - if applicable
e) quantity of product
f) route of administration if an ampoule - may be omitted from other dose-forms if the
method of use is immediately apparent to the user
g) date of sterilisation
h) expiry date
i) batch reference
j) any other details required by the licence

Example:

NAME OF INJECTION

Strength of injection (usually weight of active ingredient per suitable dose volume)
Route of administration
Date of sterilisation:
Expiry date:
BN:

SCHOOL OF PHARMACEUTICAL SCIENCES,
USM, PENANG

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