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CIPLA ISOPRENALINE; ISOCIP; ISOCIPRALINE (Cipla Australia Pty Ltd)
Product name
CIPLA ISOPRENALINE; ISOCIP; ISOCIPRALINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
160 (255 working days)
Active ingredients
isoprenaline hydrochloride
Registration type
New generic medicine
Indication
CIPLA ISOPRENALINE; ISOCIP; ISOCIPRALINE (solution for injection) is indicated:
- For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
- For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation) (see section 4.3 Contraindications).
- For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available (see section 4.3 Contraindications).
- For bronchospasm occurring during anaesthesia.
- As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolaemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure and cardiogenic shock (see section 4.4 Special warnings and precautions for use).