CIPLA ISOPRENALINE isoprenaline hydrochloride 0.2 mg/1 mL injection solution ampoule, Cipla Australia Pty Ltd, CON-922
Product name
CIPLA ISOPRENALINE isoprenaline hydrochloride 0.2 mg/1 mL injection solution ampoule
Sponsor name
Cipla Australia Pty Ltd
Consent start
Consent no.
CON-922
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) carton label does not include a machine readable code; the name
and quantity of all excipients; the name of substances with known effect (sugars
as lactose); the name of the active ingredient as per the AAN; the name of the
medicine on three non-opposing sides of the carton; space for a dispensing
label; name and quantity of the active ingredient are not placed on the same
line immediately underneath the trade name; and the permitted storage conditions
are not stated. Additionally, the ampoule label does not state the name of the
medicine; all relevant warning statements (signal headings); substances
(excipients) with known effect (for lactose and sugars); the name and quantity
of the active ingredient are not placed on the same line immediately underneath
the trade name; and the permitted storage conditions are not stated.
Conditions imposed
1. A 'Dear Healthcare Professional' letter identical to that provided to the
TGA on 29 March 2022 will be supplied with each affected batch.
2. The carton label will be overstickered with Australia-specific information,
as outlined in the communication of 6 April 2022, including the AUST R
number.
Therapeutic product type
Prescription medicines