SPC changes
Simulect injection
The summary of product characteristics for Simulect (basiliximab) injection
now states that it may be used in children and adolescents from one
to 17 years of age (Novartis). The warning “Simulect must not
be administered unless it is absolutely certain that the patient will
receive the graft and concomitant immunosuppression” applies
to children and adolescents as well as adults. Additional clinical
data have been included throughout the product summary. See SPC.
Danol capsules
The summary of product characteristics for Danol (danazol) capsules
has been revised (Sanofi-Synthelabo). Danazol is now restricted to
second
line therapy in endometriosis and benign fibrocystic breast disease
only. The conditions under which it may be used for these indications
have
also been updated. The drug is no longer indicated for gynaecomastia,
pre-operative thinning of the endometrium, dysfunctional uterine bleeding,
or the control of benign, multiple or recurrent breast cysts. In addition
the duration of therapy should normally be limited to no more than
six months. See SPC.
Motilium
The summary of product characteristics for Motilium (domperidone) 10mg
tablets, 1mg/ml suspension and 30mg suppositories has been updated
(Sanofi-Synthelabo). The indications now include the relief of the
symptoms of nausea and vomiting, epigastric sense of fullness, upper
abdominal discomfort and regulation of gastric content in adults, and
the relief of the symptoms of nausea and vomiting in children. Corresponding
changes have been made to the sections on posology and administration,
and special warnings and precautions for use. Motilium is now contraindicated
in prolactin-releasing pituitary tumour, and should not be used when
stimulation of gastric motility could be harmful. Amendments have also
been made to the sections on interactions,
pregnancy and lactation, driving and using machines, undesirable effects,
overdose and pharmacodynamics. See SPC for full details.
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