shanghai raas-九游会旗舰厅

date approved: apr. 02, 2007

date revised: nov. 15, 2013

fibingluraas - fibrin sealant (human)

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: fibrin sealant (human)

trade name: fibinglueaas®

ingredients

active lngredients: fibingluraas® is a kit of fibrin sealant (human), contains two components of plasma protein,namely lyophilized fibrinogen (human) and lyophilized thrombin (human), enclosed one vial of sterile water for injection and one vial of calcium chloride solution for reconstitution, and one sterile medical materiais package used for preparation and application.

excipients: 1. excipient for thrombin: glycine, tris (hydroxymethyl)aminomethane

2. excipients for fibrinogen: sodium chloride; sodium citrate; sucrose

characteristics

lyophilized fibrimogen (human): gray-white or slight yellow powder. after reconstitution it shall be clear or slight opalescent. a few small protein particles may occasionally exist.

lyophilized thrombin (human): white or yellowish powder without signs of thawing. after reconstitution it should be colorless or light yellow solution with slight opalescent. a few small protein particles may occasionally exist.

indications

fibingluraas® is a topical hemostasis drug. it is used in the treatment of surface of burn, abdomen incision of general surgery, oozing of blood in live operation and blood vessel surgery.

specifications

2 ml.

dosage and administration

preparation of components

1.disnfect the rubber stoppers and all instruments to be used with routine method. preparation of solution should also keep sterile. lyophilized fibrinogen should be reconstituted in sterile water for injection, and lyophilized thrombin should be reconstituted in calcium choride solution. during the course of application, the above two solution are mixed to form solution of sealant, and it looks like white viscous colloid.

2.preparation of fibrinogen solution: warm the vial of lyophilized fibrinogen and the vial of sterile water for injection in a water-bath at 30-37ºc for a few minutes. then transfer 2ml sterile water for injection lnto the vial of lyophilized fibrinogen using a syringe. return the vial of lyophilized fibrinogen to the water-bath, gently agitate the vial but avoid excessive frothing. take out the vial 10-15 minutes later, visually inspect the vial in the light to confirm whether the fibrinogen is fully reconstituted or not. complete reconstitution solution should be clear and have no undissolved particles. if undissolved protein is found, return and keep vial in water-bath for more time.

3.preparation of thrombin solution: warm the vial of thrombin and the vial of calcium chloride solution to room tempreature prior to preparation. then transfer 2ml calcium chloride solution into the vial of lyophilized thrombin using a syringe. gently agitate the vial to dissolve thrombin.

note: application needle and syringe used for the reconstitution of thrombin should be strictly distinguished from those used for the reconstitution of fibrinogen to aviod the solution prematurely solidifying.

methods of application

1.simultaneous application using connected mixing system.

the sterile connected mixing system consists of a clip for two indentical disposable syringes and a common plunger which ensures that equal volumes of the two components are fed through a common jioning piece before being mixed in the application needle and ejected.

1)place the syringes filled with fibrinogen and thrombin solution respectively into the clip. both syrings should be filled with equal volumes, carefully fix the syringes to aviod any solution flowing out of the syringes.

2)connect the nozzles of the two syringes to the jioning piece and make sure that it is firmly fixed, and then fasten them to the clip.

3)fit the one of application needles or spray heads in the medical materials package onto the joining piece.

spray heads provided in the medical materials package can be used in the management of extensive wound areas. to glue two separate surfaces, thin and even coating sprayed one of surfaces is acceptable. 

note: if application of the two components with the connected mixing system and application needle is interrupted then replace one new needle. 1 spare needle and 1 spare spray head come with the medical materials package. if the jioning piece is blocked, replace a new one. direct coating through the joining piece without application needle or spare spray head is also acceptable.

2.sequential application

apply fibrinogen solution to administration location,then apply high concentration thrombin solution immediately. fix or hold the glued parts with continuous gentle pressure in the desired position for a few minutes to ensure that the setting sealant adheres firmly to the sorrounding tissue.

dosage

the required dose of mixed sealant solution depends on the size of the surface to be sealed or coated or on the size of the defect to be packed. it is also dependent on the application method chosen and skills. as a guideline for the gluing of surfaces 2 ml mixed sealant solution will be sufficient for 20 cm2 area. the sealant solution can be applied by connected mixing system with application needle or spray head. to avoid that the solidified fibrin sealant does not be absorbed for long time, only a thin layer of the sealant solution should be applied.

to make fibrin sealant solidified rapidly, it is important to choose proper concentration of thrombin solution. how to choose the concentration of thrombin solution depends on the actual situations. if 500iu/ml thrombin solution is applied, solidification only takes a few seconds. if more clotting time is expected, the thrombin solution can be propery diluted with 40mmol/l calcium chloride solution.

adverse reactions

no adverse reactions occur during the coures of clinical trial. it is reported that after repeated administration, allergic or anaphylactic reactions may occur.

contraindications

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

2.massive haemorrhage of arteries or veins should be treated with other methods.

warnings: fibingluraas® is a topical drug, and must not be injected into blood vessel. there is no report on thrombosis caused by fibrin sealant oversea during the course of clinical use so far. if it is used via vein carelessly, severe thrombosis complication may occur.

precautions

general precautions

1.the enclosed needles, syringes and connected mixing system are all once-used, and should be dealt with as biological waste after application. repeated use is forbidden.

2.the product should be used immediately after open. discard any unused contents, do not leave for next use. the two components, fibrinogen (human) and thrombin (human), should be applied within 4 hours after preparation.

3.keep the administration location dry as possible, before spreading the colloid, the surface of wound should be dried. the colloid will solidify within 10 seconds. do not dry or press the wound within at least 60 seconds after spreading the colloid.

precautions during the course of preparation and application

1.use the provided syringes and needles to dissolve and imbibe the solution of lyophilized fibrinogen and the solution of lyophilized thrombin respectively.

2.instruments used to prepare the solution of lyophilized fibrinogen must not be confused with those used to prepare the solution of lyophilized thrombin so as to prevent clotting previously.

3.warm lyophilized fibrinogen and the diluent to 30-37ºc prior to reconstitution, leave the vial for1-2minutes after infusing the diluent, gently rotate the vial to dissolve the lyophilized product completely and avoid foaming.

4.firmly connect 2 syringes and needles with the joining pieces.

5.if the needles or the spread heads are blocked during the preparation, please replace a new needle or spread head.

6.once the colloid is transported, the plunger must not be pulled back, otherwise the colloid will return to the y-type joint, which will block the tip of the applicator, please replace a new y-type joint.

pregnancy and lactation

safety and efficacy of administration to pregnancy and lactation women are unknown. caution should be taken.

pediatric use

safety and efficacy of administration to children are unknown.

geriatric use

safety and efficacy of administration to children are unknown, please count the advantages and disadvantages before administration.

drug interactions

to avoid denaturing protein after the product touch alcohol, iodine and heavy metal in the disinfector, all impurities on the surface of the wound should be removed.

overdose

during the course of clinical use of fibrin sealant oversea,there are no adverse reactions due to overdosage. the excessive drugs will be hydrolyzed and absorbed rapidly by fibrinolysin within 15 days.

clinical pharmacology

fibingluraas® consists of fibrinogen and thrombin

prepared from human plasma. mixture of two components

simulates the last phase of blood coagulation, activation

of fibrinogen by thrombin and crosslinking of fibrin

monomers to fibrin polymers leads to hemostasis before

or after surgery and tissue glue.

pharmacokinetics

none of pharmacokinetics data on human body.

storage and shipping

store and ship at 2-8ºc in a dry place, protected from light, do not freeze.

package

single package of fibingluraas® contains: one vial of lyophilized fibrinogen (human); one vial of lyophilized thrombin (human); one vial of sterile water for injection; one vial of calcium chloride solution; one sterile medical materials package used for preparation and application.the medical materials package has been singly sterilized and contains: one clip, one plunger, two syringes of 2ml specification, two joining pieces (also called y-type joint), two spray heads, two application needles, and two normal needles. keep two syringes of 2ml specification for future use.

shelf life

currently 36 months.

standard for implementation

ybs00142003

product license no.

国药准字s20030070

shanghai raas blood products co., ltd.

address: no.2009 wang yuan 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