Plasma Derived Product of Human Fibrinogen

• Storage: 2-8 Centigrade
• Dosage Form: Freeze Dried Powder
• Transport Package: Carton
• Specification: 0.5g/vial
• Trademark: PAFC
• Origin: China
• HS Code: 3002120099
• Production Capacity: More Than 1000000 Bottles

Product Description

Package Insert of Human Fibrinogen
	[Drug Name]	[Generic Name]		Human Fibrinogen
		[English Name]		Human Fibrinogen
		[Excipients]		Sucrose
	[Appearance]		The product looks like a greyish-white or light yellow crisp cake. The reconstituted product shall be a clear liquid. Slight opalescence may occur.
	[Indications]		30-min dry heat virus deactivation process under 100°C is newly added for the manufacture of the product, likely to cause a decrease of in vivo biological activity of human fibrinogen and change of immunogenicity, so it is recommended to use the product when there are no other effective therapies and it is required to supplement fibrinogen, and after weighing the pros and cons.  Congenital fibrinogenopenia or afibrinogenemia;  Acquired fibrinogenopenia, severe liver impairment, liver cirrhosis; disseminated intravascular coagulation; and blood coagulation disorders due to afibrinogenemia caused by postpartum hemorrhage, major surgery, trauma, and internal hemorrhage.
	[Specification]		0.5g/vial
	[Administration and Dosage]		Administration: Before use, pre-heat the product and sterile water for injection to 30~37°C, inject pre-heated water for injection as per the stated value indicated on the vial label, put in a 30~37°C water bath, and gently shake it till full dissolution (do not shake with force, to avoid albuminous degeneration). Inject by intravenous drip with the infusion set with filter device. Keep the dripping speed of usually 60 drops per minute.  Dosage: The dose shall be determined according to the medical condition and clinical test results of the patient, including coagulation test results, fibrinogen level, etc., usually 1-2g for the first dose, and if necessary, further doses shall be administered according to the doctor's advice.
	[Adverse Reactions]		Usually, no adverse reaction may occur, few patients of allergic constitution may present allergic reaction, and for those with serious reaction, emergent measures shall be taken.
	[Contraindications]		Those allergic to the product are not allowed to use the product.
	[Precautions]		1.      This product is only used for intravenous infusion.  2.      The product is clear solution with slight opalescence after dissolution, allowed to contain small amount of tiny protein grains, so the infusion set shall be provided with filter device, but the product shall not be used when large quantities of or large insoluble substances are found in it.  3.      When the product is dissolved in cold seasons or at low temperature when taken out from a cold place, due care shall be taken to raise the temperature of the product and solution to 30-37°C before dissolution. Too low temperature will often cause difficulty in dissolution of the product or albuminous degeneration.  4.       Use up the product after opening it at one time, and do not split for transfusion or use by a second patient.  5.       For treatment of consumptive coagulopathy, coagulation factor replacement therapy can be effective only when heparin protection and antithrombin III are normal.  6.       It should be used within the validity period. Do not use the product when loss of vacuum is found in the preparation bottle upon preparation.  7.       During use of the product, the coagulation indexes and fibrinogen level of the patient shall be closely monitored, and the dose shall be adjusted according to the monitoring results.  8.       Due to the limitations of in vitro enzyme activity assay, the activity of fibrinogens from different manufacturers may not be totally the same, so the dose shall be adjusted upon mutual substitution.
	[Pregnancy and Lactation]		The product shall be used with caution for pregnant or lactating women, only deemed necessary after weighing the pros and cons for the patient, and under the guidance and close observation of the physician.
	[Pharmacology and Toxicology]		Pharmacology: In the coagulation process, fibrinogen is enzymolyzed by thrombin to become fibrous protein, and form the solid fibrous protein through the action of fibrin-stabilizing factor (FXIII), providing the effective hemostasis effect.  Toxicology: No test conducted or reliable reference on this item.
	[Pharmacokinetics]		According to relevant literature, the half life of fibrinogen not processed with 30-min dry heat process under 100°C is 3-4 days. The product is fibrinogen processed with 30-min dry heat process under 100°C, and no pharmacokinetic study has been conducted.
	[Storage]		Keep from sunlight under 2-8°C for storage and transport.
	[Package]		1 vial (freeze drying)/pack, injection vial made of molded neutral borosilicate glass
	[Shelf Life]		36 months
	[Applicable Standard]		Drug Registration Specification YBS00032008 and meeting the requirements of Chinese Pharmacopoeia (2020 Edition, Volume III).
	[Approval No.]		GYZZ S20013014