RHOGAM ULTRA-FILTERED PLUS (human rho- d immune globulin injection, solution MICRHOGAM ULTRA-FILTERED PLUS (human rho- d immune

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

HUMAN RHO(D) IMMUNE GLOBULIN (UNII: 48W7181FLP) (HUMAN RHO(D) IMMUNE GLOBULIN - UNII:48W7181FLP)

Հասանելի է:

Kedrion Biopharma Inc

INN (Միջազգային անվանումը):

HUMAN RHO IMMUNE GLOBULIN IMMUNE GLOBULIN - UNII:48W7181FLP)

Կազմը:

HUMAN RHO(D) IMMUNE GLOBULIN 300 ug

Կառավարման երթուղին:

INTRAMUSCULAR

Թերապեւտիկ ցուցումներ:

RhoGAM and MICRhoGAM are indicated for administration to Rh-negative women not previously sensitized to the Rho(D) factor, unless the father or baby are conclusively Rh-negative, in case of: - Delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby - Antepartum prophylaxis at 26 to 28 weeks gestation - Antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma - Actual or threatened pregnancy loss at any stage of gestation - Ectopic pregnancy RhoGAM and MICRhoGAM are indicated for prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red blood cells, platelet concentrates, granulocyte concentrates). Pregnancy and other obstetrical conditions In the case of postpartum use, RhoGAM and MICRhoGAM are intended for matern

Ապրանքի ամփոփագիր:

The following presentations of RhoGAM are available: The following presentations of MICRhoGAM are available: Store at 2 to 8°C. Do not store frozen. Do not use after the expiration date printed on the syringe.

Լիազորման կարգավիճակը:

Biologic Licensing Application

Ապրանքի հատկությունները

RHOGAM ULTRA-FILTERED PLUS- HUMAN RHO(D) IMMUNE GLOBULIN INJECTION,
SOLUTION
MICRHOGAM ULTRA-FILTERED PLUS- HUMAN RHO(D) IMMUNE GLOBULIN INJECTION,
SOLUTION
KEDRION BIOPHARMA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RHOGAM ULTRA-FILTERED
PLUS (RHOGAM) AND MICRHOGAM ULTRA-FILTERED PLUS (MICRHOGAM) SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR RHOGAM AND MICRHOGAM.
RHOGAM ULTRA-FILTERED PLUS [RHO(D) IMMUNE GLOBULIN (HUMAN)] (300 ΜG)
(1500 IU),
PREFILLED SYRINGE, FOR INTRAMUSCULAR USE
MICRHOGAM ULTRA-FILTERED PLUS [RH (D) IMMUNE GLOBULIN (HUMAN)] (50
ΜG) (250 IU),
PREFILLED SYRINGE, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1968
RECENT MAJOR CHANGES
Description (11)
12/2022
INDICATIONS AND USAGE
RhoGAM and MICRhoGAM are immune globulins indicated for use in
preventing Rh immunization for:
Pregnancy and other obstetrical conditions in Rh-negative women unless
the father or baby are
conclusively Rh-negative, e.g. delivery of an Rh-positive baby
irrespective of the ABO groups of the
mother and baby, any antepartum fetal-maternal hemorrhage (suspected
or proven), actual or
threatened pregnancy loss at any stage of gestation and ectopic
pregnancy. (1.1)
Prevention of Rh immunization in any Rh-negative person after
incompatible transfusion of Rh-positive
blood or blood products. (1.2)
Limitation of use
_Pregnancy and other obstetrical conditions:_ In the case of
postpartum use, RhoGAM and MICRhoGAM
are intended for maternal administration. Do not inject the newborn
infant. (1.3)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR USE ONLY. (2)
PREGNANCY AND OTHER OBSTETRICAL CONDITIONS (2.1)
DOSE
INDICATION
NOTES
*
RhoGAM
(300 µg)
(1500 IU)
Postpartum (if the newborn is Rh-positive)
Administer within 72 hours of delivery
Additional doses of RhoGAM are
indicated when the patient has been
exposed to > 15 mL of Rh-positive
red blood cells.
Antepartum:
Prophylaxis at 26 to 28 weeks gestation
Administer within 72 hours of suspected or
pr