Baiyu Pharmaceutical Co., Ltd.

Ginkgolide Injection is Baiyu’s exclusive drug with 24 global intellectual properties rights for the treatment of cerebral vascular diseases. The product has been manufactured and marketed in China since 2012 and have entered the health insurance directory smoothly in 2017.

Brand name:  Ginkgolide®

Active ingredients: Bilobalide, Ginkgolide A, Ginkgolide B and Ginkgolide C

Description: A colorless or pale-yellow clear liquid.

Dosage form: liquid injection

Strength: 2ml/ampoule (having 10mg of Ginkgolide)

Storage: Sealed and stored in a cool place free from sunlight.

Packaging: Unopened glass ampoules, 5 ampoules/box, 100 boxes/carton (Can be customized)

Shelf life: 24 months

Indication: Ginkgolide injection indicated for the treatment of mild to moderate cerebral infarction.

Dosage and administration:

Intravenous infusion. 5 ampoules of total 10ml drug is used per time. Prior to use, add into a 250ml of 0.9% sodium chloride injection or 250ml of 5% glucose injection for dilution. The prepared solution should be administrated slowly, once a day and with strictly controlled rate of not more than 40 to 60 drops per minute. The whole duration of treatment lasts 14 days.

Contradiction:

1. People who are allergic or having severe adverse reactions to this product or ginkgo preparations is prohibited from using this drug.

2. This product contains ethanol and glycerol, and should therefore not be used on those having allergic to ethanol and glycerol.

3. Pregnant and breast-feeding women are prohibited from using this drug.

Precautions:

1. Patients' medical and allergic history should be carefully asked before using the drug, and those with allergies should be used with caution.

2. Drugs should be carefully checked before use, as well as the intravenous infusion solution after dilution, those occurs liquid turbidity, precipitation, discoloration, crystallization and other phenomena should not be used.

3. Drug dilution should be performed strictly in accordance with the requirements. The dilution concentration and the amount of diluted solution should not be changed freely. The intravenous infusion solution should be used immediately after being prepared and not be placed for a long time.

4. The injection should be used alone, and combined use or mixed with other injections is prohibited. This product has no safety and efficacy information on combined use with other drugs and therefore should pay attention to combined use.

5. Dosage and administration as well as the treatment period should be controlled strictly. It should be administrated according to the specified recommended dose, dripping rate and the period of treatment on the leaflet. Over-dosage, too fast drip and long-term continuous medication are not allowed. Dripping rate should be not more than 60 drops per minute.

6. This drug should be used in medical institutions add emergency conditions.

7. During the medication period, patients’ reaction should be closely observed, especially within the first 30 minutes. If abnormalities occurs, stop treatment immediately and take active measures. After the end of the medication, patients should be observed at the medical institution for at least 30 minutes.

8. For those having mild vertigo, headache, or local pain after medication, lower the dripping rate and the symptoms may be relieved.

9. This drug should be given with caution on those having a poor ethanol (alcohol) tolerance.

10. If allergic reactions occur after medication, stop treatment and take emergency measures immediately.

11. This drug should be given with caution on those with severe heart, liver and kidney diseases.

12. This drug should be given with caution on those having bleeding tendencies.

13. Existing clinical trials can support only 14 days of medications safety.

14. This product has not been clinically tested in pregnant and lactating women, children, and elderly people over the age of 75. Therefore, the efficacy and safety of medications for pregnant and lactating women, children, and elderly people over 75 years old cannot be determined. More caution should be given for the above groups.

Pharmacology and toxicology:

Non-clinical pharmacodynamics test results show that this product can reduce the stroke score, mortality and cerebral infarct range in a rat model of focal cerebral ischemia induced by a suppository method. It can promote the recovery of electroencephalogram potential amplitude and decrease brain water content in gerbils with cerebral ischemia-reperfusion. It can reduce the brain wet weight, brain index and brain water content in the rat model of four-vessel occlusion cerebral ischemia and reperfusion, and reduce the damage of neurons in hippocampal CA1 area (increasing the density of neurons in this area).