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Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
Safety monitoring procedures; An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial.
The Indonesian Food and Drug Authority (Indonesian: Badan Pengawas Obat dan Makanan, lit. 'Food and Drug Supervisory Agency'), Badan POM/BPOM, or Indonesian FDA is a government agency of Indonesia responsible for protecting public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medication), vaccines, biopharmaceuticals, dietary supplements ...
The development of new techniques for monitoring is an advanced and developing field in smart medicine, biomedical-aided integrative medicine, alternative medicine, self-tailored preventive medicine and predictive medicine that emphasizes monitoring of comprehensive medical data of patients, people at risk and healthy people using advanced ...
Onset of action is the duration of time it takes for a drug's effects to come to prominence upon administration. With oral administration, it typically ranges anywhere from 20 minutes to over an hour, depending on the drug in question.
Modified-release dosage is a mechanism that (in contrast to immediate-release dosage) delivers a drug with a delay after its administration (delayed-release dosage) or for a prolonged period of time (extended-release [ER, XR, XL] dosage) or to a specific target in the body (targeted-release dosage).
Pursuant to article 54 of Council Directive 2001/83/EEC, the full registered name, dosage form, route of administration, posology and warnings of medicine should be incorporated in all drug labelling as regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom. [7]
The main contraindication for ipratropium in any form is hypersensitivity to atropine and related substances. [20] [21]Conditions such as narrow-angle glaucoma, prostatic hyperplasia, or bladder neck obstruction are not necessarily contraindicators, but should be taken into account, particularly if the patient is receiving an anticholinergic by another route.