HYPERRHO S/D FULL DOSE (rho(d) immune globulin- human solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

Human Rho(d) Immune Globulin (UNII: 48W7181FLP) (Human Rho(d) Immune Globulin - UNII:48W7181FLP)

Διαθέσιμο από:

GRIFOLS USA, LLC

INN (Διεθνής Όνομα):

Human Rho Immune Globulin Immune Globulin - UNII:48W7181FLP)

Σύνθεση:

Human Rho(d) Immune Globulin 1500 [iU]

Οδός χορήγησης:

INTRAMUSCULAR

Θεραπευτικές ενδείξεις:

HyperRHO S/D Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho (D) negative mother within 72 hours after birth of an Rho (D) positive infant,(12) providing the following criteria are met: - The mother must be Rho (D) negative and must not already be sensitized to the Rho (D) factor. The mother must be Rho (D) negative and must not already be sensitized to the Rho (D) factor. - Her child must be Rho (D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS). Her child must be Rho (D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS). If HyperRHO S/D Full Dose is administered antepartum, it is essential that the mother receive another dose of HyperRHO S/D Full Dose after delivery of an Rho (D) positive infant. If the father can be determined to be Rho (D) negative, HyperRHO S/D Full Dose need not be given. HyperRHO S/D Full Dose should be administered within 72 hours to all nonimmuni

Περίληψη προϊόντος:

HyperRHO S/D Full Dose is available in a single dose syringe with attached needle. HyperRHO S/D Full Dose is packaged as 1 syringe per carton, and as 10 cartons, each with a single dose disposable syringe. HyperRHO S/D Full Dose is preservative-free, in a latex-free delivery system.

Καθεστώς αδειοδότησης:

Biologic Licensing Application

Αρχείο Π.Χ.Π.

HYPERRHO S/D FULL DOSE- RHO(D) IMMUNE GLOBULIN (HUMAN) SOLUTION
GRIFOLS USA, LLC
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RH (D) IMMUNE GLOBULIN (HUMAN)
HYPERRHO S/D FULL DOSE
SOLVENT/DETERGENT TREATED
DESCRIPTION
Rh (D) Immune Globulin (Human) — HyperRHO
S/D Full Dose treated with
solvent/detergent is a colorless to pale yellow or pink sterile
solution of immune globulin
containing antibodies to Rh (D) for intramuscular administration; it
is preservative-free,
in a latex-free delivery system. HyperRHO S/D Full Dose is prepared by
cold ethanol
fractionation from human plasma. The immune globulin is isolated from
solubilized Cohn
fraction II. The fraction II solution is adjusted to a final
concentration of 0.3% tri-n-butyl
phosphate (TNBP) and 0.2% sodium cholate. After the addition of
solvent (TNBP) and
detergent (sodium cholate), the solution is heated to 30°C and
maintained at that
temperature for not less than 6 hours. After the viral inactivation
step, the reactants are
removed by precipitation, filtration and finally ultrafiltration and
diafiltration. HyperRHO
S/D Full Dose is formulated as a 15–18% protein solution at a pH of
6.4–7.2 in 0.21–0.32
M glycine. HyperRHO S/D Full Dose is then incubated in the final
container for 21–28
days at 20–27°C.
The potency is equal to or greater than 1500 IU (300 mcg). Each single
dose syringe
contains sufficient anti-Rh (D) to effectively suppress the immunizing
potential of 15 mL
of Rh (D) positive red blood cells.(2-4)
The removal and inactivation of spiked model enveloped and
non-enveloped viruses
during the manufacturing process for HyperRHO S/D Full Dose has been
validated in
laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was
chosen as the
relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV)
was chosen to
model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model
Human Herpes
viruses and other large enveloped DNA viruses; and Reo virus type 3
(Reo) was chosen
to model non-enveloped viruses and for its resistance to physical and
chemica