shanghai raas-九游会旗舰厅

date approved: apr. 02, 2007

date revised: nov.8, 2013

fibroraas®-human fibrinogen

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 fibrinogen 

active ingredients: human fibrinogen. it is made from human plasma of healthy donors by separation and purification, followed by s/d treatment and heat treated at 100°c for 30 minutes for 2 steps virus inactivation.

excipients: glycine, arginine hydrochloride, sodium citrate.

characteristics

fibroraas® is gray-white or slight yellow powder. after reconstitution, the solution is clear or slight opalescent.

indications

1 .congenital hypofibrinogenaemia or fibrinogenaemia.

2. acquired hypofibrinogenaemia: severe liver damage, cirrhosis, disseminated intravascular coagulation, disorder of blood coagulation due to fibrinogenaemia caused by obstetric hemorrhage, big surgical, trauma or internal haemorrhage.

this product has been heat treated at 100°c for 30 minutes during manufacturing as an additional vims inactivation step. the heat treatment might cause immunogenicity changes, and reduce bioactivity in vivo. it is suggested that the physician should evaluate the benefits and risks before use, when administration of this product is indeed necessary. 

specifications

0.5g/vial, after reconstitution, the volume shall be 25ml/vial.

dosage and administration

administration: warm fibroraas® and sterile water for injection to 30-37°c prior to reconstitution. sterile water for injection(25ml as indicated on label) should be drawn completely into product vial. gently rotate the vial to dissolve the lyophilized product completely. do not vigorously shake to avoid foaming and denaturing protein. administration by drip infusion with a filter transfusion set. the infusion rate is usually adjusted to 60 drops per minute.

dosage: according to patient’s condition and results of clinical laboratory test for hematological examination, include blood coagulation test and fibrinogen level in plasma. generally, 1-2 grams may be given in the first treatment. to continue the subsequent  treatments as prescribed by the physician.

adverse reactions

clinical data for adverse reactions are not available yet. refer to literature, fever and anaphylactic reactions may occur in few patients .emergency treatment should be taken in patients with severe reactions.

contraindications

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

precautions

1. fibroraas® should always be administered by intravenous injection.

2. after reconstitution, fibroraas® is a clear solution with slight opalesence. a few small protein particles may occasionally exist. so a transfusion set with filter must be used in administration. the product should not be used if large insoluble particles are present.

3.if fibroraas® is reconstituted in cold season or it is just taken from cold place, warm fibroraas® and the diluent to 30-37'c prior to reconstitution.

too low temperature may result in difficulties of reconstitution which may cause protein denaturation.

4.once reconstituted, the preparation should be used immediately.

5.in the teatment of consumption coagulopathy, it should be noticed that replacement therapy of clotting factors is only effcetive if there is heparin protection and antithrambin lll(at-lll) level is in the normal range.

6.use before the expiration date. do not use if the preparation vial is not in a vacuum condition.

7.the patient’s state of thrombosis and themostasis should be controlled and adjust the dosage by results of clinical laboratory test for blood coagulation test and fibrinogen level in plasma.

8.due to the limits of the methods of bioactivity test in vitro, the bioactivity of products may vary from different manufacturers. so the dosage should be adjusted when the products are replaced one another.

9.after reconstitution, the product contains less than 3% of arginine hydrochloride as excipient. the large dosage may result in hyperchloremic metabolic acidosis. it is suggested that electrolyte level should be monitored before and during administration, and based on the results to adjust the dosage or even discontinue the administration. caution should be taken in the patients with metabolic dysfunction.

pregnancy and lactation 

caution should be taken in pregnancy and lactation women. the physician must guide administration after the evaluation of benefits and risks.

pediatric patients

no relevant trials of fibroraas® were preformed , and no relevant reference of fibroraas®

geriatric patients 

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

drug interactions

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

overdose

there is risk of causing thrombosis when overdose. 

pharmacology and toxicology

during the course of blood coagulation, fibrinogen is converted into fibrin by thrombin, and forms stable fibrin in the present of activated coagulation factor xiii to have effective hemostasis functions. 

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

pharmacokinetics

as the reference, the biological half-life of no heat- treated (100℃ for 30 minutes) fibrinogen is about 3- 4 days. this product has been heat-treated(100℃ for 30 minutes) and no relevant pharmacokinetics studies were performed, and there is no relevant reference.

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), drug standard

registration no. ybs00332007.

product license no.

国药准字s10950031;

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

400-820-1126(toll-free)

web site: www.raas-corp.com