FINAL PT 2 Flashcards
immunizing agents as referred to by the Food and Drug Administration.
biologics, biologicals
refers to a substance produced by a living source and includes antibiotics, hormones, and vitamins, among others.
biologicals
immunizing agents as referred to by the Advisory Committee on Immunization Practices (ACIP).
immunologicals
any virus, therapeutic serum, toxin, antitoxin or analogous product which is employed for the prevention, treatment, or cure of diseases in humans according to the Code of Federal Regulations (CFR)
biological products
defined as the natural or acquired resistance to disease.
immunity
Among human races there are differences in susceptibility to common infections (yellow fever, pneumonia, tuberculosis).
racial immunity
Some individuals also demonstrate decreased capacity to resist skin disorders, common colds, and other familiar diseases. The natural resistance of the same individual may vary from time to time.
individual immunity
this type develops within an individual response to the introduction of antigenic substances into his/her body.
active immunity
this may occur by natural means, as by injection.
naturally acquired active immunity
it may be developed in response to the administration of a specific vaccine or toxoid
artificially acquired active immunity
occurs by the introduction of the immunoglobulins produced in other individual (human or lower animals).
passive acquired immunity
occurs by placental transmission of immunoglobulin G (IgG) from the mother to the fetus, the infant may have passive immunity to diphtheria, tetanus, measles, mumps, and other infections for the first 4 to 6 months of life.
naturally acquired passive immunity
are administered primarily for prophylactic action in the development of active immunity (acquired).
naturally acquired passive immunity
composed of killed whole bacteria or viruses or
substructures of these.
activated vaccine
contain live but weakened microorganisms
attenuated vaccine
bacterial toxins modified and detoxified by the use of moderate heat and chemical treatment so that the antigenic properties remain while the substance is rendered nontoxic
toxoids
it do not cause diseases, however, exposure of immune competent patients may result in antibody production that will protect the patient against disease caused by the naturally occurring toxin.
toxoids
Biologicals for Active Immunity
bacterial vaccines
viral vaccines
cancer vaccines
toxoids
Types of Biologicals for Passive Immunity
Human Immune Sera and Globulins (Homologous Sera)
Animal Immune Sera (Heterologous Sera)
Biologics are sensitive to extreme temperatures, and exposure to heat or freezing can decrease their potency and dramatically reduce their effectiveness.
pharmaceutical dosage forms and drug delivery systems applied topically to the eye include solutions, suspensions, gels, ointments, and drug-impregnated inserts.
ophthalmic preparations
most preparations are intended for intranasal use contain adrenergic agents and are employed for their decongestant activity on the nasal mucosa
nasal preparations
Most of these preparations are in solution form and are administered as nose drops or spray, however, a few are available as jellies.
nasal preparations
are sometimes referred to as ear or aural preparations.
otic preparations
a radioactive pharmaceutical agent or drug that is used for diagnostic or therapeutic procedures.
radiopharmaceuticals
used to diagnose diseases or evaluate the progression of disease following specific therapy intervention.
radiopharmaceuticals
are useful to evaluate a patient’s response to drug therapy and surgery. These agents can detect early changes in physiologic function that come before morphologic or biochemical end points.
radiopharmaceuticals
allows the physician to secure a patient image that is essentially a low-resolution “autoradiograph” showing the regional concentration of a positron-emitting nuclide inside the living body.
positron emission tomography
It is a method for quantitative imaging of regional function and chemical reactions within various organs of the living human body.
positron emission tomography
used to treat glaucoma through its diuretic action has been shown to increase cerebral blood flow following its IV administration.
azetazolamide
used to help diagnose renovascular hypertension.
captopril
reduces the volume and concentration of stomach acids.
cimetidine
used as an alternative to a treadmill stress test prior to cardiac imaging.
dipyridamole
ideal agent used in combination with myocardial perfusion imaging agents.
adenosine
a loop diuretic is administered to help confirm or rule out mechanical renal obstruction during renal scintigraphy when there is a significant retention of radioactivity noted in the renal pelvis.
furosemide
schilling test determines a patient’s capability to absorb radioactive vitamin B12 from the intestine.
vitamin b12
encompasses any technique that uses living organisms (microorganisms) in the production of modification of products.
biotechnology
encompasses the use of tissue culture, living cells, or cell enzymes to make a defined product.
biotechnology
has been called “the substance of life”. It is DNA that constitutes genes, allowing cells to reproduce and maintain life.
recombinant DNA
when a “foreign” body or antigen molecule enters the body, an immune response is initiated.
monoclonal antibodies
a biotechnological process whereby there is substantial amplification (over 100,000- fold) or a target nucleic acid sequence (a gene).
polymerase chain reaction
is process in which exogenous genetic material is transferred into somatic cells to correct an inherited or acquired gene defect.
gene therapy
involves the screening for polypeptide molecules that can mimic larger proteins.
peptide technology
it focuses upon the study of function of specific proteins and intracellular expression.
nucleotide blockade/antisense
The sequence of a nucleotide chain that contains the information for protein synthesis
sense sequence
The nucleotide chain that is complementary to the sense sequence
antisense sequence
recognize and bind to the nucleotide sense sequence of specific mRNA molecules, preventing the synthesis of unwanted proteins and actually destroying the sense molecules in the process.
antisense drugs
is the transport of drugs through the skin using ultrasound.
phonophoresis
It is a combination of ultrasound therapy with topical drug therapy to achieve therapeutic drug concentrations at selected sites in the skin.
phonophoresis
an electrochemical method that enhances the transport of some solute molecules by creating a potential gradient through the skin tissue with an applied electrical current or voltage.
iontophoresis
a dosage form suitable for delivering active pharmaceutical ingredients to the skin.
tapes
a bullet-sized red “lollipop” that is used to relax a patient and block pain; it is used as a preoperative sedative indicated for sedation/analgesia prior to diagnostic or therapeutic procedures in hospital settings.
fentanyl lollipops
is a thin, flexible sheet of material, usually composed of a polymer material that is actually used in various routes of administration for administration in a rapid dissolving form.
film
designed to adhere to the gum or inner cheek to provide a controlled and sustained release testosterone through the buccal mucosa.
mucoadhesive system
a semisolid confection that is designed to be chewed rather than swallowed. it release their active ingredients into the saliva and can deliver therapeutic agents for both local action or for systemic action.
medicated gums
the original “fast-dissolving tablets” are the molded tablets for sublingual use.
rapid-dissolving tablets
numerous drug delivery devices now use osmosis as the driving force.
osmotic pump
is used in research laboratories to provide constant-rate delivery and preprogrammed delivery of a drug. It consists of a flexible impermeable diaphragm surrounded by a sealed layer containing an osmotic agent that is enclosed within a semi- permeable membrane.
alzet (alza osmotic minipump)
vaginal administration of drugs, especially hormones, has several advantages, including self-insertion and removal, continuous drug administration at an effective dose level, and good patient compliance.
intravaginal drug delivery system
the device may slowly release an average of 60 μ of progesterone per day for a period of 1 year after insertion. The continuous release of progesterone into the uterine cavity provides a local rather than a systemic action.
intrauterine progesterone delivery system
a thick, flat, rectangular polymeric slab enclosed in a pouch of knitted polyester retrieval system. The buff-colored semi-transparent polymeric hydrogel slab contains 10 mg of dinoprostone.
dinoprostone vaginal insert
a unique method of administering estradiol using the estradiol vaginal ring.
estring
another type of vaginal product with extended action which contains micronized progesterone and the polymer polycarbophil in an oil-in- water emulsion system.
crinone gel
is a single-use, medicated transurethral system for the delivery of alprostadil to the male urethra. It is indicated for the treatment of erectile dysfunction.
alprostadil urethral microsuppositories
is a rod-shaped water-soluble
form of hydroxypropyl cellulose.
lacrisert
available in a membrane-controlled reservoir system that is used in the treatment of glaucoma, called the Ocusert.
pilocarpine insert
are composed of small vesicles of a bilayer of phospholipid encapsulating an aqueous space ranging from about 0.03 to 10 mm in diameter.
liposomes
long-acting dosage forms that provide continuous release of the drug, often for periods of months to years.
implants
a sterile biodegradable product containing Goserelin acetate, equivalent to 3.5 mg of drug, designed for subcutaneous injection with continuous release over a 28 days period.
goserelin
a sterile non- biodegradable, osmotically driven miniaturized implant designed to deliver Leuprolide acetate for 12 months at a controlled rate.
viadur implant
DAD (Medtronic) is a sophisticated implant delivery device than can be programmed from outside the body. It consists of titanium housing an electronic control module, a battery and a peristaltic drive pump.
implanted pumps
Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose/s
medical devices
It can be used either alone or in combination with any accessory, consumable or other piece of medical equipment. Medical equipment excludes implantable, disposable or single-use medical devices. (WHO, 2014).
medical devices
are subject to the least regulatory control and are not intended to help support or sustain life or be substantially important in preventing impairment to human
health, and may not present an unreasonable risk of illness or injury.
class I devices
are subject to special labeling requirements, mandatory performance standards and post market surveillance.
class II devices
are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury and require premarket approval.
class III devices
includes medical imaging machines, used to aid in diagnosis.
Examples: ultrasound and MRI machines, PET and CT scanners, and x-ray machines
diagnostic equipment
includes infusion pumps, medical lasers and LASIK surgical machines.
treatment equipment
used to maintain a patient’s bodily function.
Examples: medical ventilators, incubators, anesthetic machines, heart-lung machines, ECMO, and dialysis machines.
life support equipment
allow medical staff to measure a patient’s medical state. Monitors may measure patient vital signs and other parameters including ECG, EEG, and blood pressure.
medical monitors
automates or helps analyze blood, urine, genes, and dissolved gases in the blood
medical laboratory equipment
may also be used in the home for certain purposes, e.g. for the control of diabetes mellitus.
diagnostic medical equipment
like continuous passive range of motion (CPM) machines.
therapeutic: physical therapy machines
