1: Parenteralia

Question 1

parenteral articles must meet requirements for

Answer 1

sterility
pyrogens
particulate matter
other contaminants
inhibitors of microorganism growth

Question 2

parenteral route is used when

Answer 2

rapid action
oral dose can’t be used
when something is not effective except as an injection

Question 3

rate these from fastest to slowest peak

-IM, IV, SC

Answer 3

IV, SC, IM

Question 4

T or F: IV is only small volumes

Answer 4

F- can also be large volumes

Question 5

SC and intracutaneous is _____ amounts for ____ and ____

Answer 5

small amounts only

diagnostic and immunization

Question 6

4 advantages to parenteral admin

Answer 6

alternative to poorly absorbed drugs
fast and predictable
for uncooperative, unconscious, or can’t take it orally
for localized drug therapy

Question 7

disadvantages of parenteral

Answer 7

Expensive
Must be sterile
Administration requires skilled or trained personnel
May be difficult to remove if adverse or toxic reaction
Thrombus (clot) or embolism (blocking vessel)

Question 8

5 categories of injections

Answer 8

Solutions ready for injection
Dry, soluble products ready to be combined with solvents
Suspensions ready for injection
Dry, insoluble products ready to be combined with solvents
Emulsions

Question 9

Official types of injections

Answer 9

1. Solutions of meds (injection)
2. Dry solids (for injection)
3. Emulsion (injectable emulsion)
4. Suspensions (injectable suspension)
5. Dry solids (for injectable SUSPENSION)

Question 10

can suspensions be given IV

Answer 10

no- interferes with clotting system

Question 11

Aqueous vehicles must meet requirements for _____ or ______, whichever is specified

Answer 11

Pyrogen test or Bacterial Endotoxin Test

Question 12

what to add to IV to make isotonic

Answer 12

NaCl

Question 13

who can’t use bacteriostatic water for injection

Answer 13

neonates

Question 14

nonaqueous injection vehicles are

Answer 14

fixed oils of vegetable origin only

Question 15

requirements for fixed oils

Answer 15

liquid at room temp
clear at 10C
antioxidants
free of acids
odourless
non-irritating, active, or toxic
non-pharmacologically active/ interacting

Question 16

Use caution for __ addition of added substances to IVs

Answer 16

> 5mL

Question 17

Maximums for added substances:
____ for agents containing mercury and cationic, surface active compounds
_____for chlorobutanol, cresol, phenol, and similar
_____ for sulfur dioxide or equivalent amount of sulfite, bisulfite, or metabisulfite of potassium or sodium

Answer 17

0. 01%
1. 5%
2. 2%

Question 18

substance(s) to prevent growth of microorganisms must be added for______________, regardless of method of sterilization

Answer 18

multiple dose containers

Question 19

when do multiple dose containers not require addition of anti-microbials

Answer 19

different directions in individual monograph
substance contains radionuclide with physical half life of <24h
active ingredients themselves are antimicrobial

Question 20

list 3 types of solutes

Answer 20

Drugs
Isotonic agents like NaCl, dextrose, and other materials to adjust tonicity
Buffer agents to prevent chemical degradation
Antimicrobial agents like thiomersal, benzoyl alcohol
Antioxidants like sodium bisulfate or ascorbic acid (both aq)
Preservatives
Solubilizers
Thickeners

Question 21

______: hermetic container with sterile drug intended for single dose
- give an example

Answer 21

Single dose

Ex- ampoules sealed by fusion

Question 22

___________: hermetic container that permits withdrawal of successive portions of the contents without changing strength, quality, or purity of remaining portion
- give an example

Answer 22

Multiple dose

Ex- vial with elastomer seal

Question 23

multiple dose products should not see change in ___, ____, or ____ of remaining portion

Answer 23

strength, purity, quality

Question 24

Sufficient area of container must remain uncovered for _____ or _______ to permit inspection of contents

Answer 24

full length or circumference