Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
anti-D Rho immunoglobulin, Quantity: 250 IU; anti-D Rho immunoglobulin, Quantity: 10 mg/mL
CSL Behring Australia Pty Ltd
anti-D Rho immunoglobulin
Injection, solution
Excipient Ingredients: glycine; water for injections; human immunoglobulin A
Intramuscular
1 x 3mL vial
(S4) Prescription Only Medicine
Rh(D) Immunoglobulin is indicated for the prevention of Rh sensitisation in Rh(D)negative females at or below child bearing age.
Visual Identification: A clear to slightly opalescent, colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2000-11-13
Rh(D) Immunoglobulin-VF AU CMI 14.00 Page 1 of 3 RH(D) IMMUNOGLOBULIN-VF Human Anti-D Rh o Immunoglobulin, solution for intramuscular injection. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Rh(D) Immunoglobulin-VF. It does not contain complete information about Rh(D) Immunoglobulin-VF. It does not take the place of talking to your doctor. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR. FOLLOW YOUR DOCTOR’S ADVICE EVEN IF IT IS DIFFERENT FROM WHAT THIS LEAFLET SAYS. PLEASE READ THIS LEAFLET CAREFULLY AND KEEP IT FOR FUTURE REFERENCE. The information in this leaflet is subject to change. Please check with your doctor whether there is any new information about this medicine that you should know since you were last treated. WHAT RH(D) IMMUNOGLOBULIN-VF IS USED FOR Rh(D) Immunoglobulin-VF is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. Rh(D) Immunoglobulin-VF contains protein substances called antibodies which are an important component of the body’s natural defence system. If a pregnant woman has an Rh(D) negative blood group and her baby is Rh(D) positive, the baby’s blood is incompatible with the mother’s and this could cause Haemolytic Disease of the Newborn (HDN). HDN may lead to serious complications such as severe anaemia, brain damage and even death of the baby in rare cases. The antibodies in Rh(D) Immunoglobulin-VF can prevent HDN from developing. Rh(D) Immunoglobulin-VF is also given to a woman who has an Rh(D) negative blood group after she has given birth to an Rh(D) positive baby to prevent HDN from occurring during the next pregnancy. Sometimes it is given on other occasions when a woman of child-bearing age may become exposed to Rh(D) positive blood: for example, after blood transfusion, amniocentesis (taking a sample of the fluid surrounding the unborn baby), miscarriage or stillbirth. Ask your doctor if you have any questions about why Rh(D) Immunoglobu Read the complete document
Rh(D) Immunoglobulin-VF AU PI 15.00 Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION RH(D) IMMUNOGLOBULIN-VF ( HUMAN ANTI-D RH O IMMUNOGLOBULIN ) – SOLUTION FOR INTRAMUSCULAR INJECTION 1 NAME OF THE MEDICINE Human Anti-D Rh o Immunoglobulin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Rh(D) Immunoglobulin-VF is a sterile, preservative-free solution containing human plasma protein of which at least 98% is immunoglobulin (mainly IgG), with an anti-D (Rh o ) antibody content of 625 IU per vial/ ≥10 mg/mL human plasma proteins or 250 IU per vial/ ≥10 mg/mL human plasma proteins. The pH value of the ready-to-use solution is 6.6. Rh(D) Immunoglobulin-VF is manufactured from human plasma collected by Australian Red Cross Lifeblood. Rh(D) Immunoglobulin-VF contains 22.5 mg/mL glycine. 3 PHARMACEUTICAL FORM Solution for intramuscular injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Rh(D) Immunoglobulin-VF is indicated for the prevention of Rh sensitisation in Rh(D) negative females at or below child bearing age. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _SENSITISING EVENTS IN PREGNANCY (unless the blood type of the foetus is confirmed to be _ _Rh(D) negative) _ The recommended dose of anti-D immunoglobulin is: • 250 IU after sensitising events in the first trimester of pregnancy and • 625 IU after sensitising events beyond the first trimester. Rh(D) Immunoglobulin-VF AU PI 15.00 Page 2 of 10 If the gestational age is not known with certainty and the possibility exists that the gestational age is 13 weeks or more, 625 IU should be given. In twin and multiple pregnancies in the first trimester, 625 IU should be given. The dose should be given as soon as possible and within 72 hours of the event. Sensitising events include normal delivery, miscarriage, termination of pregnancy, ectopic pregnancy, chorionic villus sampling, amniocentesis, cordocentesis, abdominal trauma considered sufficient to cause foeto-maternal haemorrhage, antepartum haemorrhage and external cephalic version. Since evidence of the ef Read the complete document