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Phytovigilance & Supplements
Acute cholestatic hepatitis associated with turmeric products
IntroductionSince 2002, the Italian National Institute of Health (ISS) has coordinated the national phyto-vigilance system.1 This system is based on the collection and evaluation of spontaneous reports of suspected adverse reactions that have occurred after taking food supplements, vitamins,...
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Phytovigilance & Supplements
The use of alternative and complementary medicines in breastfeeding: the HaBIT study
In recent years there has been an increase in the use of complementary and alternative medicines (CAM) in the general population, in paediatrics and also during pregnancy and lactation. This phenomenon is largely due to the fact that complementary medicine practices and even more natural products...
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Drugs & Children
Treating Children’s Pain in the Emergency Room
Preventing, detecting and treating pain is today an ethical imperative that strongly involves the paediatric world1,2. In hospital the measurement of pain should have the same relevance as that of the essential vital parameters and be constantly monitored at all the stages of hospital treatment....
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Drugs & Pregnancy
Antiepileptic drugs in pregnancy: what are the risks for foetal development?
In an article that appeared in Focus Pharmacovigilance in 2014 the main adverse effects of antiepileptic drugs were discussed.1 In this article it was emphasised that the use of these drugs during pregnancy may lead to an increased risk of foetal malformations and how the extent of this risk varies...
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Drugs & Elderly
Enoxaparin and kidney failure
Drug Indications Enoxaparin is a low molecular weight heparin (LMWH) that is widely used in clinical practice. The treatment indications are: treatment of deep vein thrombosis (DVT) in the presence or absence of pulmonary embolism; treatment of coronary diseases: unstable angina, non-Q...
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Drugs & Children
Inflammatory bowel disease and biosimilars
Over the last 20 years, biological drugs have changed the therapeutic prospect for chronic inflammatory bowel diseases both in the adult and in the child.1 Infliximab was the first drug that, when its patent expired, had biosimilars authorised by EMA, CT-P13 and SB2 respectively in 2013 and 2016.2...
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Drugs & Elderly
Anticholinergic drugs in the elderly patients
Focus Farmacovigilanza 2017;97(6):1
Many drugs commonly used in the clinical practice have an anticholinergic activity. These are mostly psychotropic drugs like tricyclic antidepressants and antipsychotics, but also drugs that target other organs and apparatus, like for example first generation antihistaminics or furosemide (see...
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Drugs & Pregnancy
The quality of the information in the Summary of the Product Characteristics
Focus Farmacovigilanza 2017;96(3):1
The Summary of the Product Characteristics (SPC) represents the source of official and legitimate drug information for the healthcare professionals within the European Union. Specific information concerning the use in pregnancy, breastfeeding and fertile age, besides the effects on fertility, are...
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Phytovigilance & Supplements
Safety of Ganoderma lucidum supplements
Focus Farmacovigilanza 2016;95(11):11
The use of natural products is a growing phenomenon both in Italy and in the rest of the world. Some mushrooms have been used by the Eastern traditional medicine for centuries to improve the general health, increase the immune defenses and as adjuvant for the treatment of chronic diseases. The...
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Drugs & Children
NSAIDs, pneumonia and empyema: an ongoing confrontation
Focus Farmacovigilanza 2016;94(9):2
Over the past twenty years, the worldwide increase in cases of pleural empyema and complicated pneumonia by Streptococcus pneumoniae in children has attracted much epidemiological and clinical attention.1 In fact, particularly invasive and/or pathogenic serotypes have emerged – especially serotypes...
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