shanghai raas-九游会旗舰厅

date approved: apr. 02, 2007

date revised: may. 29, 2014

gammaraas - human immunoglobulin (ph4) for intravenous injection

read the package insert carefully and under the instruction of physician

warning

this product is human-plasma-derived. although the screening and testing measures of infectious agents and viral removal and inactivation added in the manufacture process, theoretically, there is still potential risk in the transmission of some known and even unknown infectious agents. the risk-benefit analysis should be taken before administration.

product name

generic name: human immunoglobulin (ph4) for intravenous injection.

ingredients

active ingredients: over 95% of protein is immunoglobulin. derived from human plasma of healthy donors, gammaraas® has been treated with low ph method to inactivate virus, and nanofiltered to remove virus. excipients: sorbitol

characters

gammaraas® is a colorless or pale yellow and clear or slight opalescent liquid preparation.

indications

1.primary immunodeficiency, such as x-linked hypogammaglobuiinemia, common variable immunodeficiency, selective igg subclass deficiency.

2.secondary immunodeficiency, such as severe infections, hematosepsis of newborns.

3.autoimmune diseases, such as ldiopathic thrombocytopenic purpura (ltp), kawasaki syndrome(ks). specifications

1g in 20ml/vial; 2.5g in 50ml/vial; 5g in 100ml/vial;10g in 200ml/vial.the content of igg is 5%.

dosage and administration

administration: gammaraas® shouid be administered intravenously or infused after it is diluted 1-2 times with 5% dextrose injection. for the first infusion of gammaraas®, the initial rate should be at 1.0ml/minute (about 20 drops/minute). lf there is no adverse reaction for the first 15 minutes, the lnfusion rate can be increased, however, the rate should not exceed 3.0ml/minute(about 60 drops/minute).

dosage: the physician shouid prescribe gammaraas®. the recommended dosage is the following:

1.primary immunodeficiency: first dosage:400mg/kg (body weight); maintenance dosage:200-400mg/kg (body weight). the interval time of administration depends on patient's condition and

serum igg ievel, once a month is recommended.

2.idiopathic thrombocytopenic purpura (itp):400mg/kg (body weight)/day for 5 days.maintenance dosage: 400mg/kg (body weight) as a singie infusion. the interval time of administration depends on patient's condition and platelet count, once a week is recommended.

3.severe infections: 200-300mg/kg (bodyweight)/day for 2 to 3 days.

4.kawasaki syndrome: within 10 days of the course of kawasaki syndrome, 2.0g/kg (body weight) may be given as a single fnfusion.

adverse reactions

ln general, the incidence of adverse reaction is rare. symptoms reported include headache, palpitation, and nausea. these reactions are often related to the infusion rate and individuai difference. reactions are often mild and occur within one hour after the infusion, so it is recommended that general conditions and vital signs of the patients should be monitored periodically during the course of the infusion.the infusion should be slowed down or interrupted if necessary, and patients usually can recover by themselves without specific treatments. few patients may have the above adverse reactions after the infusion, and they usually also can recover by themselves within 24 hours.

contraindicatlons

1.gammaraas® is contraindicated in individuals who have an anaphylactic or severe systemic response to immune globulin or have history of other severe allergic reactions.

2.gammaraas® is contraindicated in individuals with selective iga deficiencies who have anti-iga antibody

precautions

1.gammaraas® shouid be administered intravenously only.

2.if necessary, gammaraas® may be diluted with 5% dextrose injection. however, caution should be taken in diabetic patients.

3.the product can not be used if the solution appears to be turbid or contains any sediment or foreign matter, or there is any crack on the bottle, or the product has been expired.

4.aspirated vial must be used for single infusion, and can not be used for other infusion or other patients.

5.caution should be taken in patients with severe acid-alkali metabolicdisorder. 

pregnancy and lactation use

caution should be taken in pregnant women and women who are probably pregnant. if necessary,the course of administration should be instructed and strictly monitored by the physician.

pediatric use

no relevant triais of gammaraas® were performed.

geriatric use

no relevant trials of gammaraas® were performed, and no relevant reference of gammaraas®.

drug interactions

gammaraas® should be infused via a separate intravenous line, and can not be infused with other drugs.

overdose

no relevant trials of gammaraas® were performed, and no reievant reference of gammaraas®.

pharmacology and toxicology

pharmacology: gammaraas® contains a broad spectrum of igg antibodies against bacterial, viral agents, and other pathogens. the idiotype and the anti-idiotype of immunoglobulin constitute a complex immune network. so immunoglobuiin has duplex therapeutic functions, namely immune replacement and immune adjustment. the ievei of igg increases immediately after intravenous infusion, which enhances the capabilities of antiinfection and immune adjustment of human body. toxicology: no relevant trials were performed, and there is no relevant reference.

pharmacokinetics

no relevant experiments of gammaraas® were performed, and no relevant reference of gammaraas®.

storage and shipping

store and ship at 2-8℃, protected from light.

package

glass bottle, one vial per package.

shelf life

currently 36 months.

standard for implementation

volume ⅲ of "pharmacopoeia of the people's republic of china" (2010)

product iicense no.

1g in 20 ml/vial: 国药准字s10980060;

2.5g in 50 mi/vial: 国药准字s10980061;

5g in 100 ml/vial: 国药准字s20013054;

10g in 200 ml/vial: 国药准字s20103006

shanghai raas blood products co.,ltd.

address: no. 2009 wangyuan road, fengxian, shanghai, p. r. china

zip code: 201401

tel: (86-21)-22130888 fax: (86-21)-64626161

service hot line: 400-820-1126

web site: http://www.raas-corp.com