국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 320 mg
CSL Behring Australia Pty Ltd
Injection, solution
Excipient Ingredients: glycine; human immunoglobulin A
Intramuscular
2mL x 1
(S4) Prescription Only Medicine
Normal Immunoglobulin-VF is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. It may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. In susceptible contacts of hepatitis A, measles and poliomyelitis, Normal Immunoglobulin-VF may be of value in preventing or modifying the disease. In general, the earlier in the incubation period of these diseases Normal Immunoglobulin-VF is given, the greater its effectiveness. Hepatitis A-Routine passive protection is recommended in persons exposed less than one week previously for the following categories of individuals, Household contacts of an index case, who have not already had hepatitis A or have no serological evidence of immunity to the virus. Common source exposures. When a vehicle such as food or water is identified as a common source of infection for multiple hepatitis cases, administration of Normal Immunoglobulin-VF should be considered for all those exposed to the source. Institutional contacts. Staff in institutions where hepatitis is endemic. Routine prophylaxis is not recommended for school, office, factory or hospital contacts. Rubella, Although Normal Immunoglobulin-VF can prevent or modify the clinical disease in susceptible rubella contacts if given within 72 hours of exposure, it does not prevent viraemia in such patients. It should, therefore, not be relied upon to prevent congenital malformations due to rubella if given to susceptible pregnant women during the first trimester. Measles (Morbilli), Normal Immunoglobulin-VF is indicated for protection against measles in persons exposed less than one week previously. It is recommended in children under six months of age whose mothers have not had the disease, in children between six months and three years of age who have not been actively immunised and in immunosuppressed contacts of the index case. Poliomyelitis, Normal Immunoglobulin-VF is recommended for susceptible contacts who have not been immunised against poliomyelitis.
Visual Identification: Clear to opalescent, colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1998-10-21
Normal Immunoglobulin-VF AU CMI 10.00 Page 1 of 3 NORMAL IMMUNOGLOBULIN-VF Human Normal Immunoglobulin, solution for intramuscular injection. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Normal Immunoglobulin-VF. It does not contain complete information about Normal 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 NORMAL IMMUNOGLOBULIN-VF IS USED FOR Normal Immunoglobulin-VF is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. Normal Immunoglobulin-VF contains protein substances called antibodies which can provide protection against some infectious diseases. It can prevent infection if given to people with low levels of antibodies. Normal Immunoglobulin-VF is used to treat conditions where low antibody levels in the blood are inherited, and in other diseases where a lack of antibody may cause frequent infections. It is also used to prevent infection by viruses such as poliomyelitis, hepatitis A, and measles in those coming in contact with a source of infection, such as family members. Ask your doctor if you have any questions about why Normal Immunoglobulin-VF has been prescribed for you. Your doctor will have assessed the risks and benefits associated with the use of this medicine for you. BEFORE YOU ARE GIVEN NORMAL IMMUNOGLOBULIN-VF Normal Immunoglobulin-VF must not be used if you have a history of allergy to this medicine. Tell your doctor if you have allergies to any other medicines, or if you have ever had an allergic reaction to an injection. TELL YOUR DOCTOR 전체 문서 읽기
Normal Immunoglobulin-VF AU PI 11.00 Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION NORMAL IMMUNOGLOBULIN-VF ( HUMAN NORMAL IMMUNOGLOBULIN ) 1 NAME OF THE MEDICINE Human Normal Immunoglobulin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Normal Immunoglobulin-VF is a sterile, preservative-free solution containing 160 mg/mL human plasma proteins and 22.5 mg/mL glycine. At least 98% of the protein is immunoglobulins (mainly IgG). Normal Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A (IgA). Normal Immunoglobulin-VF is manufactured from human plasma collected by Australian Red Cross Lifeblood. 3 PHARMACEUTICAL FORM Solution for intramuscular injection. The solution has a pH of 6.6. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Normal Immunoglobulin-VF is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. It may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. In susceptible contacts of hepatitis A, measles and poliomyelitis, Normal Immunoglobulin-VF may be of value in preventing or modifying the disease. In general, the earlier in the incubation period of these diseases Normal Immunoglobulin-VF is given, the greater its effectiveness. HEPATITIS A Routine passive protection is recommended in persons exposed less than one week previously for the following categories of individuals: • Household contacts of an index case, who have not already had hepatitis A or have no serological evidence of immunity to the virus. Normal Immunoglobulin-VF AU PI 11.00 Page 2 of 10 • Common source exposures. When a vehicle such as food or water is identified as a common source of infection for multiple hepatitis cases, administration of Normal Immunoglobulin-VF should be considered for all those exposed to the source. • Institutional contacts. • Staff in institutions where hepatitis is endemic. Routine prophylaxis is not recommended 전체 문서 읽기