Shinepharm Cardiovascular Remedy: Creatine Phosphate Sodium Injection

• Application: Internal Medicine
• Usage Mode: for Injection
• Suitable for: Elderly, Children, Adult
• State: Solid
• Shape: Powder
• Type: Biological Products
• Model NO.: AMC13037-01
• Pharmaceutical Technology: Chemical Synthesis
• Transport Package: 1′s/Box
• Specification: 1G/10ML
• Trademark: Shinepharm
• Origin: China
• HS Code: 3004909099
• Production Capacity: 1000000 Boxes/Month

Product Description

Product Description

Indicatios:
Nifedipine tablets are indicated for the treatment of hypertension and the prophylaxis of chronic stable angina pectoris.
Dosage and administration:
Posology:
The recommended starting dose of Nifedipine is 10 mg every 12 hours swallowed with water with subsequent titration of the dosage according to response. Nifedipine permit titration of initial dosage, which may be adjusted upwards to 40 mg every 12 hours, to a maximum daily dose of 80 mg.
Method of administration
Oral use.
As a rule, tablets must be swallowed whole with a little liquid, either with or without food. Nifedipine tablets should not be taken with grapefruit juice.
The tablets should not be crushed, chewed, divided or dissolved.
Contraindications:
Nifedipine must not be administered to patients with known hypersensitivity to nifedipine or to other dihydropyridines because of the theoretical risk of cross-reactivity, or to any of the excipients.
Nifedipine must not be used in cardiogenic shock, clinically significant aortic stenosis, unstable angina, or during or within 4 weeks of a myocardial infarction.
Nifedipine should not be used for the treatment of acute attacks of angina.
The safety of Nifedipine in malignant hypertension has not been established.
Nifedipine should not be used for the secondary prevention of myocardial infarction.
Nifedipine should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction.
Storage:
Store at or below 25°C protected from light.
Nifedipine Tablet Specifications:

 

Product Description

Indications:
As a drug to protect myocardial, Creatine Phosphate Sodium has better curative effect and reliable safety, which leads huge usage of this product all over the world. In cardio-surgery, it can be added into cardiopulmonary byass to protect myocardium. It also can be used to treat my ocardial metabolic abnormalities because of ischemia.
Dosage and Administration:
1.0g each time, 1-2 times every day by intravenous injection within 30-45 minutes. It is added into cardiopulmonary byass to protect myocardium and cardiopulmonary byass concentration is 10 mmol/L.
Precautions & Warning:
Blood pressure might decrease if more than 1.0g creatine phosphate is administered by intravenous injection at rapid injection speed. Large dose of this drug 5-10g/ day can cause high intake of phosphate sodium, which might affect calcium metabolism and secretion of stable state hormones.
This drug can't be used for patients who is allergic to creatine phosphate. Large dose of this drug 5-10g/ day can't be used for patients with chronic renal insufficiency.
Contra-indications:
There are no contraindications to the administration of creatine phosphate sodium.
Storage instructions:
Keep protected from light, stored in cool and dry condition (not more than 20°C). Keep out of the reach of children.

Testing terms	Standards	Results
Characteristic	White or almost white powder or crystalline powder	White crystalline powder
pH	8.0~9.0	8.4
Solubility	Meet the requirements	Complies
Clarity and Colour of Solution	Meet the requirements	Complies
Related substance	Creatine≤0.75% Creatinine≤0.75% Other single impurity≤0.5% Total impurities≤2.0%	0.095% 0.0077% 0.08% 0.25%
Water	Should be 20.0%-25.0%	24.0%
Sterility	Should be sterile	Sterile
Bacterial Endotoxin	<0.15  EU/mg	<0.15 EU/mg
Particulate Matters	≥10μm:≤6000/vial ≥25μm:≤600/vial	97/ vial 28/vial
Assay	90.0%-110.0%	101.4%

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