Microsoft word - replagal pi ireland april 2012 final.doc
Replagal (agalsidase alfa) Prescribing
0/7 male patients tested positive for IgG
information: Please consult the Summary
of Product Characteristics (SmPC) before
Presentation:
patient receiving Replagal. Extensive renal
solution for IV infusion. 1ml of concentrate
agalsidase alfa. Indication: Long-term
enzyme replacement therapy in patients with
a confirmed diagnosis of Fabry disease (-
galactosidase A deficiency). Dosage and
intracellular α-galactosidase activity. Side administration: Replagal 0.2mg/kg body effects: Most reported adverse effects have
been mild to moderate. Very common
other week. No dosage regimen in children
(>1/10 patients): headache, flushes, nausea,
(0-6 years) can presently be recommended
rigors, pyrexia, pain/discomfort, fatigue;
as safety and efficacy have not yet been
common (>1/100, <1/10 patients): peripheral
oedema, dizziness, dysgeusia, neuropathic
unexpected safety issues were encountered
pain, tremor, hypersomnia, hypoesthesia,
paraesthesia, increased lacrimation, tinnitus,
regimen is suggested for children between
7-18 years of age. Contraindications:
Hypersensitivity to the active substance or
any of the excipients. Warnings and
throat secretion, rhinorrhoea, diarrhoea,
precautions: 13.7% of adult patients
vomiting, abdominal pain/discomfort, acne,
receiving Replagal in clinical trials had
erythema, pruritus, rash, livedo reticularis,
idiosyncratic infusion-related reactions
musculoskeletal discomfort, myalgia, back
(generally within 2–4 months of starting
treatment although later onset [after 1 year]
arthralgia, joint swelling, aggravated fatigue,
feeling hot, feeling cold, asthenia, chest
paediatric patients >7 years of age and 3 of
pain, chest tightness, influenza-like illness,
8 paediatric patients <7 years experienced
at least one infusion reaction over a period
corneal reflex; uncommon (>1/1000, <1/100 patients): parosmia, angioneurotic oedema,
effects have decreased with time. If mild or
urticaria, sensation of heaviness, decreased
moderate acute infusion reactions occur,
oxygen saturation. Not known (since derived
from post-marketing spontaneous reports):
infusion can be temporarily interrupted (for
cardiac arrhythmias (atrial fibrillation,
5–10 minutes) until symptoms subside. If
ventricular extrasystoles, tachyarrhythmia),
hypotension, hyperhidrosis. Infusion related
reactions reported in the post marketing
setting may also include cardiac events such
as cardiac arrhythmias (atrial fibrillation,
ventricular extrasystoles, tachyarrhythmia),
triggering cardiac events in patients with
myocardial ischemia, and heart failure in
pre-existing cardiac manifestations of Fabry
patients with Fabry disease involving the
heart structures. Infusion-related symptoms
antibodies to the protein. A low titre antibody
may include dizziness, hyperhidrosis, and
response was seen in approximately 24% of
hypotension. The most frequent were mild
male patients; the remaining 76% remained
antibody negative throughout. In paediatric
included rigors, pyrexia, flushing, headache,
patients >7 yrs of age, 1/16 male patients
nausea, and dyspnoea. Package quantity:
tested positive for IgG anti-agalsidase alfa
Vials of 5ml (containing 3.5ml concentrate)
antibodies. No increase in the incidence of
in a pack size of 1 vial. Pharmaceutical precautions: Store in a refrigerator (2°C–
patient. In paediatric patients <7 yrs of age,
Marketing authorisation number and holder: EU/1/01/189/001-006. Shire Human
(SmPC), or on request from the marketing
Genetic Therapies AB, Svärdvägen 11D, SE
authorisation holder. Date of preparation:
182 33 Danderyd, Sweden. Legal category: Item code:
POM. Further information is available in the
Adverse events should be reported to the Pharmacovigilance Unit at the Irish Medicines Board (IMB) (imbpharmacovigilance@imb.ie). Information about adverse event reporting can be found on the IMB website (www.imb.ie). Adverse events should also be reported to Shire Human Genetic Therapies on +44 (0)1256 894000 or faxed on +44 (0)1256 894715 or emailed to Globalpharmacovigilance@shire.com
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Medication Recall / Fungal Meningitis from Injection Investigation NOTE: All new and/or updated information is noted with asterisks (**). • The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), in partnership with state health departments are investigating a cluster of clinical meningitis cases following spinal injections. • Most patients received e