shanghai raas-九游会旗舰厅

date approved: apr. 02, 2007

date revised: nov. 08, 2013

hemoraas -human coagulation factor viii

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 coagulation factor ⅷ 

ingredients

active ingredients: human coagulation factorⅷ. derived from human plasma of healthy donors, hemoraas® has been treated with a mixture of trin‑butyl-phosphate (tnbp) and polysorbate 80 (tween 80), and the final product has been virus inactivated by dry heat treatment at 100℃ for 30 minutes.

excipients: sodium citrate, glycine, tween 80, calcium chloride, sodium hydroxide, hydrochloric acid.

characters

hemoraas® is a white loose powder. after reconstitution, the solution is clear or with slight opalescence. 

indications

hemoraas® is indicated for correcting the disorder of coagulation due to deficiency of human coagulation factor ⅷ , mainly for prevention andcontrol of bleeding in patients with hemophilia a or acquired factor ⅷ deficiency, and for treatment of bleeding caused by operation of these patients. 

specifications

100 iu, 200 iu, 250 iu, 300 iu, 400 iu, 500 iu and 1000 iu

dosage and administration

administration: hemoraas® should be administered intravenously only, and the course of administration should be strictly monitored by the physician. if the product is just brought out from the refrigerator or at the low temperature in winters, it must be warmed up to 25 - 37 ℃ for dissolution.

otherwise, precipitation will likely appear. sterile water for injection or 5% dextrose should be

infused into the vial at the label-indicated volume. then the vial should be swirled gently to dissolve the product and avoid any foam. after that, atransfusion syringe with filter is used for intravenous injection. the infusion usually is conducted at a rate of 60 drops per minute. after dissolution, the product should be used out within one hour without any delay. do not refrigerate the reconstituted solution. discard all administration equipment after use.

dosage: the dosage must be determined according to the need of individual patient based on such factors as the body weight, presence of inhibitors, and severity of hemorrhage. the folowing formula provides a guide for dosage calculation:human coagulation factor ⅷ unites required (iu) = 0.5 body weight (kg) desired factor viii increase (% of normal) 

example: factor viii unites required (iu) = 0.5 × 50 (kg) × 30 (%) = 750 iu

the following general dosages are recommended:

1.mild to moderate hemorrhages: usually be treated with a single dosage of human coagulation factor ⅷ 10-15 iu per kg to raise the factor ⅷ to 20-30% of normal level.

2.severe hemorrhage or in minor surgery: the plasma factor ⅷ level of patients should be raised to 30-50% of normal level. the initial dosage is 15-25 iu per kg. the maintaining dosage 10-15 iu per kg is given at 8-12 hour intervals if required.

3.massive hemorrhage: the life-threatening bleeding such as the mouth bleeding,urinary tract bleeding and central nervous system bleeding or hemorrhage near vital areas, such as neck, throat, retroperitoneal space and iliopsoas sheath; should be treated with 40 iu per kg initially and repeated every 8-12 hours of the maintaining dosage 20-25 iu per kg. physicians should determine the extent of the therapy course.

4.surgery: elective surgery should only be considered if the inhibitor level is within normal limits. factor ⅷ level should be achieved within the normal range (60-120%) at the beginning of surgery. usually 30-40 units per kg is given prior to surgery. after surgery, level of factor ⅷ should be maintained at 60% of normal for 4 day and reduce to 40% for the next 4 days.

5.development of acquired factor ⅷ inhibitors: large doses of factor ⅷ (human) are required. the dosage is usually more than twice of the requirement for the treatment of hemophilia a patients.

adverse reactions

adverse reactions may include chills, nausea, dizziness or headache. these symptoms are usually transitory. the possibility of allergic reactions exists.

contraindications

hemoraas® is contraindicated in individuals who have an anaphylactic response to it.

precautions

1.when large doses are repeatedly administered, the possibilities of allergic reaction, hemolysis and pulmonary edema should be noted, especially for the patients with cardiac diseases.

2.the product, after reconstitution is usually a clear solution, or with slight opalescence, and a few small protein particles may occasionally exist. if large insoluble particles are present do not use the product.

3.hemoraas® is not indicated for hemophilia b caused by the deficiency of factor ⅸ or hemophilia c caused by the deficiency of factor ⅺ . a correct diagnosis must be made before administration of the product.

4.administer only by the intravenous route.

5.administer immediately after reconstitution within one hour. discard any unused contents.

6.do not use the expired product. do not use if the preparation vial is not in vacuum condition.

pregnancy and lactation

animal reproduction studies have not been conducted with factor ⅷ (human). it is also unknown whether factor ⅷ (human) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. factor ⅷ (human) should be given to a pregnant woman only if clearly needed.

pediatric use

caution should be taken in children.

geriatric use

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

drug interactions

hemoraas® should be infused singly, and can not be administered with other drugs.

overdose

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

pharmacology and toxicology

pharmacology: in intrinsic coagulation pathway, in the present of ca2 and phospholipid, activated factor ⅷ act as a cofactor of activated factor ⅸ to convert factor ⅹ to activated factor ⅹ , which activates prothrombin into thrombin to initiate normal coagulation process. each unit of factor ⅷ per kg of body weight infused will increase the circulatory level of factor ⅷ by 2.0 to 2.5%. 

toxicology: no relevant trials were performed, and there is no relevant reference.

pharmacokinetics

the biological half-life of factor ⅷ is about 8-12 hours.

storage and shipping

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

package

glass bottle, one vial per package.

shelf life

currently 24 months.

standard for implementation

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

product license no.

100 iu: 国药准字s10950029;

200 iu: 国药准字s10950028;

250 iu: 国药准字s10980062;

300 iu: 国药准字s10950030;

400 iu: 国药准字s10950037;

500 iu: 国药准字s10980063;

1000 iu: 国药准字s10980064;

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