Hengsen (micafungin sodium for injection)
micafungin sodium for injection

English Name: Micafungin Sodium for Injection.Chinese Pinyin: Zhusheyong Mikafenjingna.The active pharmaceutical ingredient of this product is micafungin sodium.Chemical name: 5-[(1S, 2S)-2-[(3S, 6S, 9S, 11R, 15S, 18S, 20R, 21R, 24S, 25S, 26S)-3-[(R)-2-carbamoyl-1-hydroxyethyl]-11, 20, 21, 25-tetrahydroxy-15-[(R)-1-hydroxyethyl]-26-methyl-2,5,8,14,17, 23-hexaoxo-18-[4-[5-(4-pentyloxyphenyl)isoxazol-3-yl]benzoylamino]-1,4,7,13,16,22-hexaaza-tricyclo-[22.3.0.09,13]heptacos--6-yl]-1,2-dihydroxyethyl]-2-hydroxyphenylsulphate.


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【Name】

Common Name: Micafungin Sodium for Injection

English Name: Micafungin Sodium for Injection

Chinese Pinyin: Zhusheyong Mikafenjingna

【Ingredient】

The active pharmaceutical ingredient of this product is micafungin sodium.

Chemical name: 5-[(1S, 2S)-2-[(3S, 6S, 9S, 11R, 15S, 18S, 20R, 21R, 24S, 25S, 26S)-3-[(R)-2-carbamoyl-1-hydroxyethyl]-11, 20, 21, 25-tetrahydroxy-15-[(R)-1-hydroxyethyl]-26-methyl-2,5,8,14,17, 23-hexaoxo-18-[4-[5-(4-pentyloxyphenyl)isoxazol-3-yl]benzoylamino]-1,4,7,13,16,22-hexaaza-tricyclo-[22.3.0.09,13]heptacos--6-yl]-1,2-dihydroxyethyl]-2-hydroxyphenylsulphate. 

Chemical Structure: 


Molecular Formula:C56H70N9NaO23S

Molecular Weight:1292.26

Excipients: Dextran 40, sucrose, citric acid, sodium hydroxide.

【Description】

This product is white or off-white powder or cake.

【Indication】

The following infections caused by Aspergillus and Candida: fungalemia, respiratory fungal disease, gastrointestinal fungal disease.

【Strength】

50mgCalculated on C56H71N9O23S

【Dosage and Administration】

 

Aspergillosis:

Adults are usually administrated a single dose of 50-150 mg micafungin sodium daily, intravenous infusion once daily. For patients with acute or refractory aspergillosis, the dose can be increased to 300 mg/day depending on the patient's condition.

Candidiasis:

Adults are usually administrated a single dose of 50 mg micafungin sodium daily, intravenous infusion once daily. For patients with acute or refractory candidiasis, the dose can be increased to 300 mg/day depending on the patient's condition.

When administrating this product through Intravenous infusion, it should be reconstituted in physiological saline, glucose injection or replenisher. If the dose is 75 mg or less, the infusion time is not less than 30 minutes. If the dosage is more than 75 mg , the infusion time is not less than 1 hour. Never use water for injection to reconstitute the product (the solution is non-isotropic).

Note: Since the safety of this product has not been fully established when the dose is increased to 300 mg per day for the treatment of acute or refractory infections, so care must be taken when using this dose, such as close observation of the patient's condition. [In Japan, there is no clinical experience of more than 150 mg per day, and the clinical experience of using 300 mg per day in other countries is very limited]. For patients weighing 50 kg or less, the dose should not exceed 6 mg per kilogram of body weight per day.

Note for preparation: Do not shake the infusion bag vigorously when reconstituting the product, because the product is easy to foam and the foam is difficult to disappear.

Note for administration: Since this product can be slowly decomposed under light, avoid direct sunlight. If it takes more than six hours from the preparation to the end of the infusion, the infusion bag should be shielded from light. (It is not necessary to shield the infusion tube.)

 

Note: Please refer to the product manual for details.