![]() Diphtheria ToxoidĬ.04.160 Liquid diphtheria toxoid shall be sterile, formalized, detoxified diphtheria toxin and shall not contain more than 0.02 per cent free formaldehyde.Ĭ.04.161 Diphtheria toxoid alum precipitated shall be prepared from diphtheria toxoid, and shall not contain more than 15 milligrams of alum per human dose.Ĭ.04.162 The alum used in the preparation of diphtheria toxoid alum precipitated shall contain not less than 99.5 per cent pure potassium alum, Al K(SO 4) 2,12H 2O.Ĭ.04.163 No fabricator shall use a culture medium for the production of diphtheria toxin that contains horse protein or Witte peptone or that has not been freed as far as possible from any other allergenic ingredient.Ĭ.04.168 No person shall sell diphtheria toxoid that contains phenol.Ĭ.04.169 No person shall sell diphtheria toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization.Ĭ.04.170 The expiration date of diphtheria toxoid shall be not later than two years after the date of manufacture or the date of issue. ![]() (b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/100 of one test dose must not cause, and 1/50 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.Ĭ.04.145 The human test dose for the Schick control shall give a negative Schick reaction when injected intracutaneously into normal guinea pigs.Ĭ.04.146 No person shall sell diphtheria toxin for Schick test unless both the inner and the outer labels carry a statement of the number of human test doses it contains together with the name of any stabilizer.Ĭ.04.147 The expiration date of Schick test reagents for the diagnosis of susceptibility to diphtheria shall be not later than 12 months after the date of manufacture or the date of issue. (a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction, but mixed with 1/1,500 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction” and (b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/50 of one test dose must not cause, and 1/25 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.Ĭ.04.144 The human test dose of diphtheria toxin for Schick test, when fresh toxin containing no preservative is used, shall be determined by (a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction but mixed with 1/1,250 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction” and (b) sterile diphtheria toxin heated at a temperature of 95☌ for five minutes.Ĭ.04.143 The human test dose of diphtheria toxin for Schick test, when aged toxin containing a preservative is used, shall be determined by ![]() (c) diphtheria toxin for Schick test with control.Ĭ.04.141 Diphtheria toxin for Schick test shall be sterile diluted diphtheria toxin stabilized by an acceptable method.Ĭ.04.142 Schick control shall be suitably diluted Toxins, Toxoids Schick Test ReagentsĬ.04.140 Schick test reagents for the diagnosis of susceptibility to diphtheria shall be ![]() ![]() PART C Drugs (continued) DIVISION 4 (continued) Poliomyelitis VaccineĬ.04.122 Poliomyelitis vaccine shall be an aqueous suspension of killed poliomyelitis viruses, Types I, II, and III.Ĭ.04.123 Poliomyelitis vaccine shall be prepared in acceptable tissue culture medium from strains of poliomyelitis virus proven capable of producing vaccine of acceptable potency.Ĭ.04.124 Poliomyelitis vaccine in its final form shall contain not more than 0.35 milligram per millilitre of total nitrogen, nor more than one part per million of animal serum.Ĭ.04.125 No person shall sell poliomyelitis vaccine unless it has been tested by an acceptable method for potency and safety and when so tested it shall be safe and of acceptable potency.Ĭ.04.126 The outer label shall carry a statement of any antibiotic present in the vaccine.Ĭ.04.127 The expiration date of the poliomyelitis vaccine shall be not later than 12 months after the date of the last satisfactory potency test unless evidence, satisfactory to the Minister, is presented that a longer period is appropriate.Ĭ.04.137 Bacteriophage shall be a virus preparation with specific lytic action against micro-organisms actually or potentially pathogenic.Ĭ.04.138 The expiration date of bacteriophage shall be not later than 12 months after the date of manufacture or the date of issue. ![]()
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