SPC changes
Abilify
The summary of product characteristics for Abilify (aripipazole; Bristol-Myers
Squibb/Otsuka) now lists QT prolongation, ventricular arrhythmias, sudden
unexplained death, cardiac arrest, torsades de pointes and bradycardia
among the cardiac disorders in the undesirable effects section. See SPC.
Aranesp
The summary of product characteristics for Aranesp (darbepoetin alfa;
Amgen) has been updated. The initial dose for the treatment of symptomatic
anaemia in cancer patients is 500µg given once every three weeks.
The recommendation that the dose should be doubled in patients receiving
Aranesp on a weekly basis (if the increase in haemoglobin is inadequate)
has been removed. See SPC.
Bonefos
The summaries of product characteristics for Bonefos (sodium clodronate;
Schering) now includes additional information about reported cases
of osteonecrosis of the jaw in patients receiving bisphosphonates.
See SPCs.
Doxorubicin
The summaries of product characteristics for Doxorubicin Solution for
Injection (doxorubicin hydrochloride; Pharmacia) and Doxorubicin Rapid
Dissolution have been updated. Information regarding total doxorubicin
dose per cycle, the recommended starting dose, possible toxicity of
doxorubicin in combination with other cytotoxic and cardiotoxic drugs,
the embryotoxic
potential of doxorubicin and its secretion into breastmilk, and the
protective recommendations on the instructions for use or handling
of the product
has been added. Contraindications for intravenous use have been added
and now comprise: persistent myelosuppression, severe hepatic impairment,
severe myocardial insufficiency, recent myocardial infarction, severe
arrhythmias, previous treatment with maximum cumulative doses of doxorubicin,
daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and
anthracenediones. Information has also been added to the special warnings
and precautions for use and undesirable effects sections. Mucositis
has been added as the main gastrointestinal toxic effect of overdosing.
See
SPCs. Keppra
The summary of product characteristics for Keppra (levetiracetam; UCB
Pharma) now includes an indication for use as an adjunctive therapy
in the treatment of primary generalised tonic-clonic seizures in adults
and adolescents over 12 years of age who have idiopathic generalised
epilepsy. The initial dose for this indication is 500mg twice a day.
See SPC.
Neupro
The summaries of product characteristics for Neupro (rotigotine; Schwartz
Pharma) now include an indication for the treatment, in combination with
levodopa, of idiopathic Parkinson’s disease during late stages
of the disease. The initial dose for this indication is 4mg/day. See
SPCs.
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