SPC changes
Aricept
The summary of product characteristics for Aricept (donepezil hydrochloride;
Pfizer/Eisai) has been updated. It now states that there are no adequate
data to support the use of Aricept in pregnant women and that patients
with hereditary problems of galactose intolerance, Lapp lactase deficiency
or glucose-galactose malabsorption should not take Aricept. See SPC.
Gonal-F
The summaries of product characteristics for Gonal-F (follitropin alfa;
Serono) now include details of additional warnings, precautions and
adverse events. The special warnings and precautions section now states
that patients with porphyria or a family history of porphyria should
be closely monitored during treatment with Gonal-F and deterioration
or a first appearance of this condition may require cessation of treatment.They
also state that, very rarely, severe ovarian hyperstimulation syndrome
may be complicated by pulmonary embolism, ischaemic stroke and myocardial
infarction.
Urticaria, oedema, breathing difficulties, serious cases of allergic
reaction (including anaphylactic reaction) and exacerbation of asthma
have been added to the list of very rare adverse events for women. Varicocele
has been added to the list of common adverse events for men and mild
to severe injection site reaction (pain, redness, bruising, swelling
and/or irritation at the site of injection) has been added to the list
of very common adverse events for men. See SPCs.
Kineret
The summary of product characteristics for Kineret (anakinra; Amgen)
now includes information relating to immunogenicity and the needle
cover containing dry natural rubber (a derivative of latex). See SPC.
Rapilysin
The summary of product characteristics for Rapilysin (reteplase; Roche)
has been updated. It now states that the most commonly reported adverse
drug reaction associated with reteplase treatment is haemorrhage, predominantly
at the injection site and that local reactions at injection site can
also occur. The SPC also now says that, as with other thrombolytic
agents, recurrent ischaemia and angina, hypotension, heart failure
and pulmonary oedema have been reported frequently as sequelae of myocardial
infarction or thrombolytic administration. See SPC.
Taxotere
The summary of product characteristics for Taxotere (docetaxel; sanofi-aventis)
now includes an additional indication, in combination with cisplatin
and 5-fluorouracil, for the treatment of patients with metastatic gastric
adenocarcinoma, including adenocarcinoma of the gastroesophageal junction,
who have not received prior chemotherapy for metastatic disease. The
recommended dose of docetaxel is 75mg/m2 as a one-hour infusion, followed
by cisplatin 75mg/m2, as a one- to three-hour infusion (both on day
1 only), followed by
5-fluorouracil 750mg/m2 per day given as a 24-hour continuous infusion
for five days, starting at the end of the cisplatin infusion. Treatment
is repeated every three weeks. Patients must receive premedication with
antiemetics and appropriate hydration for cisplatin administration. Prophylactic
granulocyte colony-stimulating factor treatment should be used to mitigate
the risk of hematological toxicities. Information about dosage adjustments
during treatment for this indication and treatment of elderly patients
and those with liver impairment has also been added. See SPC.
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