You are in browse mode. You must login to use MEMORY

level: level 2

Questions and Answers List

level questions: level 2

Question	Answer
occurs by introduction of the immunoglobulin produced in another individual (human or animal) into the host, who is not involved in their production It can also be classified as natural or artificial, just like active immunity.	Passive acquired immunity
occurs by placental transmission of immunoglobulin gamma (IgG) from the mother to the fetus.	Naturally acquired passive immunity
include several biologic products containing immunoglobulins. These are limited to provision of temporary prophylaxis to susceptible individuals. Notable in this category are the anti-venins for the treatment of snakebite and spiders	Artificially acquired passive immunity
1 Biologics are produced by manufacturers licensed to do so in accordance with the terms of the federal __ 2 Each product must meet specified standard as administered by the	1 Public Health Service Act approved July 1, 1944 2 Center for Biologics Evaluation and Research of the FDA
Provisions generally applicable to biologic products include tests for:	1 PYROGENS 2 Potency 3 General safety 4 Sterility 5 Purity 6 Water (residual moisture) 7 Identity 8 Constituent materials (preservatives, diluents, adjuvants) 9 Additional safety tests on live vaccines
The label of a biologic product must include:	1 Title or Proper Name 2 Name, address, and license number of the manufacturer 3 Expiration date 4 Recommended individual dose for multiple-dose containers 5 Number of Preservative/s used and the amount of containers (if more than one) 6 Amount of product in the container 7 Recommended storage temperature 8 Auxiliary statements (e.g. freezing is to be avoided) 9 Other information as FDA regulations may require to ensure safe and effective use of the product.
1 Most biologics are stored in a refrigerator w/ temperature __	1 (2C to 8C) and freezing is to be avoided.
Diluents packaged with biologics should not be frozen. Beside the biologic substance that is harmed by freezing, the container may be broken due to the expansion of an aqueous vehicle resulting in loss of product. The expiration date for biologic products varies with the product and the storage temperature. Most biologic products have an expiration date of a year or longer after the date of manufacture or issue.	.
Can decrease their potency and dramatically reduce the effectiveness of Biologics	Extreme temperatures, and Exposure to heat or Freezing
Biologics are expensive and can add significantly to one’s inventory costs.	.
The overriding theme for the pharmacist in storage, handling, and shipping of biologic products is to maintain the __	Cold Chain. If this cold chain is to be maintained, the pharmacist can be assured that the quality of the product will not be diminished
1 For small-volume biologics, a __should be used for storage 2 __ should be used because ice buildup interferes with the freezer’s ability to maintain very low temperatures. Defrosting	1 standard refrigerator-freezer 2 Frost-free freezers
A separate refrigerator dedicated to biologics is preferable to minimize the time the refrigerator door is opened. The WHO recommends that the door not be opened more frequently than __	four times per day.
1 can be used to store diluents or bottles of water. This helps provide insulation and a thermal reserve. 2 Insulated containers	1 door shelving 2 Thermal packs, blue ice packs, chemical packs
Refrigerator temperatures should range between __, and freezers should stay well below 0°C. Usually, an optimal temperature is __	2°C and 8°C, -15°C
- twice daily monitoring and recording - temp log should be kept for 3 years	National Immunization Program (NIP)
Store containers of the same vaccine together. To avoid selecting the wrong product or one having a similar sounding name or packaging, separate the product. (Pediatric and Adult dosage forms )	.