Common name: Human Fibrinogen
English name: Human Fibrinogen
Phonetic Script (Haniu Pinyin): Ren Jianwidanbayuan
[Ingredients] Human fibrinogen. Auxiliary ingredients are mannitol, arginine hydrochloride and sodium citrate.
[Character] Gray white or light yellow loose body, it should be a clean solution with a slight incontinence after reconstruction.
- Congenital fibrinogen deficiency or deficiency.
- Associated fibrinogen reduction: severe liver damage; Cirrhosis; Dispersing intravascular clots; Postpartum hemorrhage and coagulopathy are caused by major surgical, traumatic or internal bleeding caused by fibrinogen deficiency.
[Specification] 0.5 g / bottle, volume 25 ml after reconstitution.
[Usage and Dosage]
Usage: Preparation bottle with human fibrinogen and sterile water is provided for injection 30 ～ 37 to (open the aluminum-plastic combination cap to leak the rubber stopper and sterilize the exposed part of the rubber stopper with a sterilizer). Discard and then inject pre-warmed sterile water for injection as indicated on the bottle label (25 ml), leave the instant empty, bathe in a 30-37 degree centigrade water and gently rotate the bottle until the product is completely dissolved in the body ( (Do not vibrate strongly to avoid protein isolation)) and then use a blood circulation device with a filter device for intravenous drip dri drip rate is usually 60 drops per minute.
Dosage: The dose should be determined according to the test results and the results of conditional tests, including the accumulation of fibrinogen levels. In general, the first dose is 1 to 2 grams, if necessary, follow the doctor's orders.
[Reactive reactions] A large number of patients with allergies should take emergency measures in people with allergic reactions, rare fever, runny nose, chest discomfort, palpitations and severe reactions. This product does not contain more than 3% arginine hydrochloride as a stabilizer.
[Contraindications] People who are allergic to these products and foreigners are prohibited.
- This product is designed for intrauterine infusion.
- This product has a clear and somewhat smooth texture after it has been dissolved. For this purpose, the transfusion set used for the infusion should be equipped with a filter device, but it should not be used if a large or large soluble substance is found.
- In the winter season, when the product is melted or the temperature of the product is removed from the cooling place, the temperature of the product should be 30 ~ 37 to before it melts and weak oo too low temperature often makes it difficult to dissolve and causes protein isolation.
- It should be used within the validity period If you notice that the vacuum in the preparation bottle has been lost during preparation, do not use it. Once this product has dissolved, it should be used as soon as possible.
- The infusion rate is very fast, cyanosis, polyposis or thrombosis can cause intervascular clots, so pay attention to the infusion rate. This. During use of this product, patients should closely monitor the coagulation index and fibrinogen levels and adjust the dose of this product according to the results.
- In vitro enzyme activity Due to the limitations of the detection method, the fibrinogen activity produced by different enterprises may not be the same.
- This product is a product of human blood A Although it has been screened for viruses and treated for virus inactivation, it still cannot safely rule out the possibility of transmission of blood-borne diseases due to unknown pathogens such as viruses.
- This product is reconstituted according to the prescribed amount and does not contain more than 3% arginine hydrochloride as stabilizer Adjust large doses or stop using this product Patients who already have metabolic disorders should use this product with caution.
[Ication for pregnant and lactating women]
The test has not been performed and there are no reliable sources. Pregnant It should be used with caution in pregnant and lactating women. It should be used only when necessary after considering the patient's advantages and disadvantages.
[Children's Medicine] The trial was not conducted and there is no reliable reference.
[Medicine for the Elderly] The trial was not performed and there is no reliable reference.
[Drug Interactions] Do not use it in combination with other drugs.
[Drug overdose] Risk of thrombosis.
[Pharmacology and Toxicology]
What is the effect of pharmacology: During fibrinogen coagulation in fibrin by the enzyme thrombin, the fibrin-stabilizing factor (F. blower) acts to form a solid fibrin to play an effective role in hemostasis.
Toxicology Study: The test was not performed and there is no reliable reference.
Under normal circumstances, the half-life of human fibrinogen, which is not dried at 100 at C for 30 minutes, is 3-4 days.
[Storage] Store and transport at 2-8 degrees Celsius protected from light.
[Packaging] 1 bottle per box, including sterile water bottle of injection (25 ml) as weak.
[Validity period] 48 months.
[Executive Standards] Chinese Pharmacopoeia 2015 Third Edition, YBS00182017
[Number of approvals] Synoform Standard S20170007