FDFs

Zhejiang Hengkang Pharmaceutical Co., Ltd.

浙江恒康药业股份有限公司

Finished Pharmaceutical Products

Product Name	MAH	INDICATIONS AND USAGE	DOSAGE FORMS AND STRENGTHS	DOSAGE AND ADMINISTRATION	WARNINGS AND PRECAUTIONS
Ademetionine1,4-Butanedisulfonate	Hangzhou Brightgem Bio-Technology Co., Ltd.	Cholestasis	Enteric-coated Tablet: 500mg Ademetionine	For the maintenance therapy of intrahepatic cholestasis in patients with pre-cirrhotic or cirrhotic conditions or in those with intrahepatic cholestasis of pregnancy, the recommended dosage of Adenosylmethionine 1,4-Butanedisulfonate Enteric-Coated Tablets is 1.0 g to 2.0 g taken orally once daily.	Refer to the manual.
Amiodarone Hydrochloride	Hangzhou Brightgem Bio-Technology Co., Ltd.	Antiarrhythmic	Tablet: 200mg	Loading Dose: The usual dose is 600 mg per day, which may be administered for 8 to 10 consecutive days. Maintenance Dose: The lowest effective dose should be used. Based on individual patient response, the maintenance dose may be set within the range of 100 mg to 400 mg per day. Owing to the prolonged therapeutic effect of amiodarone, a dosage of 200 mg every other day or 100 mg per day may be adequate.	Refer to the manual.
Baricitinib	Hangzhou Brightgem Bio-Technology Co., Ltd.	Rheumatoid Arthritis/Alopecia Areata	Tablet: 2mg; 4mg	For Rheumatoid Arthritis, the recommended dosage of Baricitinib is 2 mg once daily orally, with or without food. For Alopecia Areata，The recommended dosage of Baricitinib is 2 mg once daily orally, with or without food. Increase to 4 mg once daily if the response to treatment is not adequate.	Refer to the manual.
Beclomethasone Dipropionate	Hangzhou Brightgem Bio-Technology Co., Ltd.	Prophylactic Treatment of Asthma	Suspension for Inhalation: 0.8mg/2 ml	The recommended starting dosage for patients 12 years of age and older who are not on an inhaled corticosteroid is 40 to 80 mcg twice daily, approximately 12 hours apart.	Refer to the manual.
Bilastine	Hangzhou Brightgem Bio-Technology Co., Ltd.	Antihistamines	Tablet: 20mg	The recommended dosage is 20 mg (one tablet) of bilastine once daily to relieve the symptoms of urticaria.	Refer to the manual.
Bilastine	Hangzhou Brightgem Bio-Technology Co., Ltd.	Antihistamines	Oral Solution: 2.5mg/ml		Refer to the manual.
Dotinurad	Hangzhou Brightgem Bio-Technology Co., Ltd.	Hyperuricemia	Tablet: 1mg; 2mg	The dosage should then be gradually increased as needed based on the patient’s serum uric acid levels. The usual maintenance dosage is 2 mg once daily, which may be adjusted according to the patient’s condition. The maximum dosage should not exceed 4 mg once daily.	Refer to the manual.
Eltrombopag Diolamine	Hangzhou Brightgem Bio-Technology Co., Ltd.	Thrombocytopenia	Tablet: 25mg; 50mg	The dose should be adjusted to the lowest dose that achieves and maintains a platelet count of ≥50,000/μL.The recommended starting dose is 25 mg.The dose must not exceed 75 mg per day.	Refer to the manual.
Empagliflozin/Metformin	Hangzhou Brightgem Bio-Technology Co., Ltd.	Diabetes	Tablet: 10mg Empagliflozin/1000mg Metformin	The starting dose should be individualized based on the patient’s current therapeutic regimen. The recommended dose is one tablet of the product containing 10 mg of empagliflozin, taken orally once daily in the morning.	Refer to the manual.
Everolimus	Hangzhou Brightgem Bio-Technology Co., Ltd.	Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)/	Mini-Tablet: 0.5mg; 1mg	Prophylaxis of rejection following organ transplantation.he usual adult dosage is 1.5 mg of everolimus, administered orally in two divided doses per day.The dose should be adjusted individually based on the patient’s condition and trough concentration.	Refer to the manual.
Everolimus	Hangzhou Brightgem Bio-Technology Co., Ltd.	TSC-Associated Partial-Onset Seizures	Mini-Tablet: 0.5mg; 1mg		Refer to the manual.
Everolimus	Hangzhou Brightgem Bio-Technology Co., Ltd.	RCC/BC/NET/TSC/Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer	Tablet: 2.5mg; 5mg	The recommended dosage is 10 mg once daily. It should be taken orally at the same time each day, with or without food.	Refer to the manual.
Mesalazine	Hangzhou Brightgem Bio-Technology Co., Ltd.	Ulcerative Colitis/Crohn’s	Tablet: 500mg; 1000mg	For Ulcerative Colitis Acute Phase: The recommended dosage for adults is 1 g administered four times daily. Maintenance Phase: The recommended dosage for adults is 500 mg administered four times daily. For Crohn’s Disease Both Acute and Maintenance Phases: The recommended dosage for adults is 1 g administered four times daily.	Refer to the manual.
Mesalazine	Hangzhou Brightgem Bio-Technology Co., Ltd.	Ulcerative Colitis/Crohn’s	Suppository: 1000mg	The product is for rectal use. The recommended dose is one 1-gram suppository inserted into the rectum once daily at bedtime.	Refer to the manual.
Rosuvastatin	Hangzhou Brightgem Bio-Technology Co., Ltd.	Hyperlipidemia	Tablet: 5mg; 10mg; 20mg; 40mg	Administer orally. The usual starting dose is 5 mg once daily. The selection of the initial dose should be individualized based on the patient’s baseline cholesterol levels, estimated cardiovascular risk, and potential risk for adverse reactions. The maximum daily dose is 20 mg.	Refer to the manual.
Rosuvastatin	Hangzhou Brightgem Bio-Technology Co., Ltd.	Hyperlipidemia	Tablet: 5mg; 10mg; 20mg; 40mg		Refer to the manual.
Rotigotine	Hangzhou Brightgem Bio-Technology Co., Ltd.	Parkinson’s Disease	Patch:4.5mg/10 cm²; 9mg/20cm²; 13.5mg/30cm²	Apply the patch once daily at approximately the same time each day. The patch should remain on the skin for 24 hours. After removal, apply a new patch to a different area of skin. If the patient forgets to change the patch at the scheduled time or if the patch falls off, a new patch should be applied for the remainder of the same day.	Refer to the manual.
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Sacubitril/Valsartan	Hangzhou Brightgem Bio-Technology Co., Ltd.	Cardiovascular	Tablet: 200mg（97mg Sacubitril/103mg Valsartan）	The recommended starting dose is 100 mg twice daily. Based on patient tolerance, the dose should be doubled every 2 to 4 weeks until the target maintenance dose of 200 mg twice daily is reached.Concomitant use of this product with ACE inhibitors is contraindicated due to the potential risk of angioedema.	Refer to the manual.
Safinamide Mesylate	Hangzhou Brightgem Bio-Technology Co., Ltd.	Idiopathic Parkinson’s Disease	Tablet: 50mg; 100mg	The recommended starting dosage of Safinamide Mesylate is 50 mg administered orally once daily (at the same time of day), without regard to meals. After two weeks, the dosage may be increased to 100 mg once daily, based on individual need and tolerability. If a dose is missed, the next dose should be taken at the same time the next day.	Refer to the manual.
Selexipag	Hangzhou Brightgem Bio-Technology Co., Ltd.	PAH	Tablet: 0.2mg; 0.6mg; 0.8mg	Titrate each patient to their highest tolerated dose (range: 0.2 mg – 1.6 mg twice daily). Begin at 0.2 mg twice daily (~12 hours apart). Increase by 0.2 mg twice daily each week, as tolerated. If intolerance occurs, reduce the dose to the previous, tolerated level.	Refer to the manual.
Sitagliptin/Metformin hydrochloride	Hangzhou Brightgem Bio-Technology Co., Ltd.	Diabetes	Tablet: 50mg Sitagliptin/500mg Metformin	The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin and 500 mg metformin HCl twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.The maximum recommended daily dose is 100 mg of sitagliptin and 2,000 mg of metformin hydrochloride (HCl).	Refer to the manual.
Terbutaline Sulphate	Hangzhou Brightgem Bio-Technology Co., Ltd.	Bronchial Asthma/COPD	Aerosol Solution for Inhalation: 5mg/2 ml	A 5 mg (2 mL) vial should be administered by oral inhalation using a nebulizer, and can be given up to three times daily.	Refer to the manual.
Ticagrelor	Hangzhou Brightgem Bio-Technology Co., Ltd.	Acute Coronary Syndrome	Tablet: 60mg; 90mg	Unless clearly contraindicated, this product should be used in combination with aspirin. The starting dose of Ticagrelor Tablets is a single 180 mg loading dose (administered as two 90 mg tablets), followed by a maintenance dose of one 90 mg tablet twice daily. For patients with a history of myocardial infarction (at least one year prior) who have at least one high-risk factor for atherothrombotic events and require long-term treatment, the recommended dosage is 60 mg twice daily.	Refer to the manual.
Ticagrelor	Hangzhou Brightgem Bio-Technology Co., Ltd.	Acute Coronary Syndrome	Tablet: 60mg; 90mg		Refer to the manual.
Upadacitinib	Hangzhou Brightgem Bio-Technology Co., Ltd.	Rheumatoid Arthritis	Extended-release Tablet: 15mg	15 mg to 30 mg per dose, to be taken one to three times daily, or as directed by the physician.	Refer to the manual.
Vonoprazan Fumarate	Hangzhou Brightgem Bio-Technology Co., Ltd.	GRED	Tablet: 20mg	Administer orally. The recommended dosage for adults is 20 mg once daily. Most patients can experience benefit within 4 weeks of treatment. If the response is inadequate, the treatment course may be extended up to a maximum of 8 weeks.	Refer to the manual.