SPC changes
Accupro
The summary of product characteristics for Accupro (quinapril hydrochloride;
Pfizer) tablets now includes additional information about the use of
Accupro in children and adolescents. See SPC.
APO-go
The summary of product characteristics for APO-go (apomorphine hydrochloride;
Forum) ampoules 10mg/ml has been updated. Pregnancy and lactation have
been removed as contraindications. A statement recommending caution
when prescribing APO-go to pregnant women and women of childbearing
age has been added. See SPC. However, the SPC for APO-go 5mg/ml has
not been updated and, until it is, Forum says it will continue to treat
pregnancy and lactation as contraindications for APO-go.
Fungilin
The summary of product characteristics for Fungilin (Amphotericin; Bristol-Myers
Squibb) now includes updated information in the section describing
adverse effects following oral administration.
See SPC.
Herceptin
The summary of product characteristic for Herceptin (trastuzumab; Roche)
has been updated to include an additional indication for the treatment
of patients with HER2-positive early breast cancer following surgery,
chemotherapy (neoadjuvant or adjuvant) and radiotherapy. The SPC states
that Herceptin should only be used in patients whose tumours have either
HER2 overexpression or HER2 gene amplification as determined by an
accurate and validated assay. See SPC.
Provigil
The summary of product characteristics for Provigil (modafinil; Cephalon)
has been updated to define better the patient population for which
Provigil is licensed.The SPC now states that Provigil is indicated
for the symptomatic relief of excessive sleepiness associated with
narcolepsy, obstructive sleep apnoea/hypopnoea syndrome or moderate
to severe chronic shift- work sleep disorder. Definitions of excessive
sleepiness, moderate sleepiness and severe sleepiness have been added.
Additional clarification has been given to the prescriber in making
the diagnosis of shift-work sleep disorder. The SPC also now states
that effort should be made to treat the underlying condition before
initiating treatment with Provigil and that appropriate steps to ensure
adequate sleep should be taken before determining the requirement for
Provigil in patients with moderate to severe shift-work sleep disorder.
It also now includes information on the use of Provigil by sexually
active women. See SPC.
Back to Top
|
The
Pharmaceutical Journal