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Immunorho

Immunorho

anti-d immunoglobulins

Manufacturer:

Kedrion

Distributor:

Biogenetech

Marketer:

Biogenetech
Concise Prescribing Info
Contents
Human anti-D Ig
Indications/Uses
Prevention of Rhesus sensitization, Rhesus induced morbus haemolyticus neonatorum in Rh -ve pregnancy w/ Rh +ve husband.
Dosage/Direction for Use
IM Antenatal prophylaxis Dosage range: 50-330 mcg or 250-1,650 IU. Planned antenatal prophylaxis: Administer single dose at 28-30 wk of gestation or 2 doses at 28 & 34 wk. Antenatal prophylaxis following complications of pregnancy: Administer single dose as soon as possible & w/in 72 hr & repeat at 6-12 wk intervals throughout pregnancy. Postnatal prophylaxis Dosage range: 100-300 mcg or 500-1,500 IU administered to mother as soon as possible w/in 72 hr of delivery of Rh +ve (D, Dweak, Dpartial) infant. If >72 hr have elapsed, administer as soon as possible. If lower dose (100 mcg or 500 IU) is administered, perform test to determine extent of fetal-maternal haemorrhage. Large feto-maternal haemorrhage (>4 mL) Additional doses of 10 mcg (50 IU)/0.5 mL fetal RBC.
Contraindications
Hypersensitivity to human Ig, especially in patients w/ IgA Ab.
Special Precautions
Immediately discontinue use if allergic or anaphylactic type reactions are suspected. Not to be administered into a blood vessel. Arterial & venous thromboembolic events including MI, stroke, DVT & pulmonary embolism. Potential risks of hypersensitivity & haemolytic reactions. Possibility of transmitting infective agents. Patients w/ pre-existing risk factors for thrombotic events (eg, HTN, DM & history of vascular disease or thrombotic episodes, patients w/ acquired or inherited thrombophilic disorders, prolonged periods of immobilization, severe hypovolemia, & diseases which increase blood viscosity), especially when prescribed w/ high doses. Clinically monitor biological parameters in patients receiving very high doses. Ensure patients are sufficiently hydrated before use. Inform patients about 1st symptoms of thromboembolic events including dyspnea, pain & swelling of limb, focal neurological deficits & chest pain. Administer in divided doses at different sites if large vol (>2 mL for childn or >5 mL for adults) is required. Consider alternative IV products if IM administration is contraindicated (eg, bleeding disorders); in overwt/obese patients; to achieve adequate plasma levels immediately. Postpone active immunisation w/ live virus vaccines (eg, MMR) for 3 mth after last anti-D Ig administration. Misleading +ve results in serological testing; may interfere w/ serological tests for red cell Ab (eg, Coombs' test) particularly in Rh(D) +ve neonates whose mothers have received antenatal prophylaxis. Childn.
Adverse Reactions
Chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low BP, moderate low back pain. Infusion site swelling, soreness, redness, induration, local heat, itching, bruising & rash.
Drug Interactions
May impair efficacy of live attenuated virus vaccines (eg, MMR).
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BB01 - anti-D (rh) immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Immunorho soln for inj 750 IU/mL
Packing/Price
2 mL x 1's
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