Seventy seven percent of respondents reported the numbers of patients treated for broad indications, labeled as infection (44%), cancer (19%) or other conditions (37%) (Table 2).
She perceived her illness to be very serious and suspected it might be a cancer (consequence and also an indirect indication of label).
Using the CDF to routinely finance treatments that are outside their licensed indication ('off-label') and outside the NHS exceptionality processes or trial settings, may result in ethical concerns.
Rates of caesarean section, proportion of small for gestational age babies, and gestational age at birth were not significantly different between interventions so no indication of labelling or other harmful effects was found for these outcomes.
You can find out about the oil's contra-indications by reading the label.
This includes the approval of new drugs, identification of new indications, official labeling (to prevent unwarranted claims), surveillance of adverse drug reactions, and approval of methods of manufacture.
If rFVIIa is administered, the patient's next of kin should be informed that rFVIIa is being used outside the currently approved indications (off-label use), especially because the use of rFVIIa may increase the risk of thromboembolic complications [ 319].
If rFVIIa is administered, the patient's next of kin should be informed that rFVIIa is being used outside the currently approved indications (off-label use), especially since the use of rFVIIa may increase the risk of thromboembolic complications [ 516].
However, neither of these last two sources takes advantage of the scientific literature, in which drug-induced phenomena are documented in a variety of settings, such as in vitro and in vivo methods, across species, for approved indications, off-label uses and for drugs in development.
Sandro Scarpelini and Sandro Rizoli We understand the clinical scenario and debate question as whether one should administer a drug outside its licensed indications (off-label) to treat a condition (upper gastrointestinal bleeding) without any evidence for the drug's efficacy and safety.
