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SPC changes: August 2013

24 August 2013


Alfentanil (alfentanil hydrochloride; Hameln) solution for injection 500µg/ml is now indicated for use in neonates, infants and children as an opioid in association with a hypnotic to induce anaesthesia and as a narcotic analgesic in association with general anaesthesia for both short and long surgical procedures. Extensive changes to the summary of product characteristics reflect this new indication.


The summary of product characteristics for Alimemazine (alimemazine tartrate; Zentiva) has been updated to advise that the recommended dose must not be exceeded. Overdose can result in neuroleptic malignant syndrome, symptoms of which include a combination of hyperthermia, muscle rigidity, altered mental status and autonomic instability. Because the syndrome is potentially fatal, alimemazine must be immediately discontinued, and intensive clinical monitoring and symptomatic treatment must be initiated.


Mood changes and depression have been added as common side effects to the summary of product characteristics for Gonapeptyl Depot (triptorelin acetate; Ferring).


The dosage of Sytron (sodium feredetate; Archimedes) for the treatment of iron-deficiency anaemia in all paediatric age groups should be 3 to 6mg/kg per day (maximum 200mg) in two or three divided doses. For prophylaxis in babies and children, a daily dose of between 5mg and 60mg depending on the age of the child is required, according to the updated summary of product characteristics.


Pneumocystis jiroveci pneumonia has been added as a rare adverse effect of treatment with Torisel (temsirolimus; Pfizer), now known as Torisel Injection 30mg. According to the updated summary of product characteristics, prophylaxis of Pneumocystis jiroveci pneumonia should be considered for patients who require concomitant use of corticosteroids or other immunosuppressive agents based upon current standard of care.


Tyverb (lapatinib; GlaxoSmithKline) is now indicated in combination with trastuzumab for adult patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy. There have been further changes to the summary of product characteristics because of this additional indication.


Velcade in combination with dexamethasone, or with dexamethasone and thalidomide, is now indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Further updates to the summary of product characteristics reflect this addition. Headache and hypocalcaemia have also been as common adverse reactions.


Myopathy and rhabdomyolosis have been added to the list of uncommon side effects of Zytiga (abiraterone acetate; Janssen) in the summary of product characteristics, and caution is now recommended in patients concomitantly treated with drugs known to be associated with myopathy or rhabdomyolysis. Diarrhoea has been added to the list of very common side effects. 

10 August 2013


Autoimmune disorders such as Grave’s disease have been reported to occur in the setting of immune reactivation. These events can occur many months after initiation of treatment with Fuzeon (enfuvirtide; Roche), according to the updated summary of product characteristics.


Glivec (imatinib; Novartis) is now licensed for use in paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia.


The summary of product characteristics for Jakavi (ruxolitinib; Novartis) now states that progressive multifocal leukoencephalopathy has been reported after treatment for myelofibrosis. Patients should be monitored and referral to a neurologist considered if symptoms occur and further dosing of Jakavi should be suspended until PML has been ruled out. 


Serum liver tests are now recommended before starting treating with Votrient (pazopanib; GlaxoSmithKline) and at three weeks, five weeks, seven weeks and nine weeks afterwards, according to the summary of product characteristics.  


Reports of renal failure and fatal cases of hepatitis have been added to the summary of product characteristics for Xenical (orlistat; Roche). Additionally, reduced efficacy of antidepressants or antipsychotics has been reported and Xenical should therefore be used with caution in these patients. 





Citation: The Pharmaceutical Journal URI: 20065403

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