Page 13 - Laboratory manual for students FAR222 2019 20

FAR 222 Dosage Form II Laboratory Manual

given expiry date aforementioned, the aspect of the sterilisation needs to be considered for a
shorter date such as below:

a) four weeks after first opening of the products for Sterilisation Methods A and C by BPC
1973 (patients must be counselled on this information during dispensing)
b) two weeks after the date of sterilisation (manufacture) for Sterilisation Method B by
BPC 1973 (an exact date must be indicated on the label)

GENERAL LABEL FOR INJECTIONS
This applies to the label on the CONTAINER of any injection having a capacity of more than
10 mL and to the package of ANY injection, e.g. ampoule box.

The label on the package of any medicinal product and the label on any container having a
capacity of more than 10 mL must bear the following details:
a) name of product
b) description of pharmaceutical form - can be omitted on container if container is
enclosed in a package
c) strength - a weight or volume of active ingredient per unit dose
d) official name - if applicable
e) international non-proprietary name - if applicable
f) quantity of product
g) directions for use - if appropriate. Can be omitted from container and package if a
leaflet is contained in package and container and package show that such particulars
are also included in a leaflet
h) contra-indications - if any
i) special handling and storage conditions
j) date of sterilisation
k) expiry date
l) batch reference/number (BN)
m) manufacturer's licence number - if applicable
n) any other details required by licence
o) name of patient - if applicable
p) date of dispensing- if applicable
q) ‘Keep out of reach of children’
r) any warnings or other special requirements

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