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Citicoline sodium chloride injection

Product description
Approved date: November 14, 2006
 
Date of revision: October 17, 2011
 
          November 24, 2014
 
          November 30, 2015
 
Citicoline sodium chloride injection instructions
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Common name: citicoline sodium chloride injection
 
Product Name: Pi Diming
 
English name: Citicoline Sodium and Sodium Chloride Injection
 
Pinyin: Baolindanjianna Lühuana Zhusheye
 
[Ingredients] The main component of this product is citicoline sodium, and its chemical name is: the monosodium salt of choline cytidine diphosphate.
 
 
 
Molecular formula: C14H25N4NaO11P2
 
Molecular weight: 51.31
 
The auxiliary material is: sodium chloride.
 
【Properties】 This product is a colorless and clear liquid.
 
[Indications] for acute craniocerebral trauma and disturbance of consciousness after brain surgery.
 
[Specifications] (1) 250ml: citrulline sodium 0.25g and sodium chloride 2.25g; (2) 100ml: citicoline sodium 0.5g and sodium chloride 0.9g
 
[Usage and Dosage] Intravenous infusion: 0.25 ~ 0.5g each time, once a day, slow infusion. 5 to 10 days is a course of treatment.
 
【Adverse reactions】
 
Whole body: occasionally fever, burnout, allergic reactions, severe cases of anaphylactic shock.
 
Cardiovascular system: Occasionally temporary blood pressure drop, bradycardia and tachycardia.
 
Digestive system: Occasionally nausea, vomiting, loss of appetite, stomach pain, burning of the stomach, diarrhea and abnormal liver function.
 
Respiratory system: reports of allergic asthma, severe cases of dyspnea and laryngeal edema.
 
Nervous system: Occasionally dizziness, tremors, headache, insomnia, excitement, irritability, and paralysis.
 
Skin facial features: occasional rash and transient diplopia.
 
[Contraindications] Disabled for allergic to this product.
 
【Precautions】
 
1. Patients with a history of drug allergy should be used with caution;
 
2. Use with caution in patients with severe acute craniocerebral injury with cerebral hemorrhage, cerebral edema and increased intracranial pressure;
 
3. Patients with epilepsy and hypotension should be used with caution;
 
4. This product is a sodium-containing preparation. Please pay attention when applying low sodium.
 
5. Before using this product, it should be visually inspected under natural light (avoid direct sunlight). If visible foreign matter is present, it should not be used. If it is found that there are cracks in the bottle mouth, loose seal, gas leakage, discoloration of the solution, turbidity, mildew or cotton-like hyphae, it is strictly prohibited.
 
6. The osmolality of this product is: 260 ~ 320mOsmol / kg.
 
[Pregnant women and lactating women] The safety and efficacy of medication for pregnant women and lactating women has not been established. Pregnant women and lactating women should be used with caution.
 
[Child medication] Adjust the dose according to the condition and age.
 
[Geriatric Use] Adjust the dose according to the condition and age.
 
[Drug interaction] When this product is used in patients with tremor paralysis, it should not be combined with levodopa, otherwise it may cause deterioration of muscle stiffness. In combination with brain peptides, it has a synergistic effect on improving brain function.
 
[Drug overdose] If the dosage is too large, there may be symptoms such as nausea, vomiting, loss of appetite, headache, insomnia, excitement, convulsions, etc., which can be reduced and treated with symptoms.
 
[Pharmacology and Toxicology] Citicoline is a nucleoside derivative that enhances the function of the brainstem network structure, especially the upstream network structure activation system closely related to consciousness; enhances the function of the cone system and improves motor paralysis; Improve brain circulation, increase brain blood flow resistance, increase brain blood flow and promote brain metabolism, which has a certain effect on promoting brain function recovery and promoting recovery. The acute toxicity of this product in intravenous administration in mice and rats showed that LD50mice=4600mg/kg and LD50rats=4150mg/kg. A six-month long-term toxicity study using Beagle dogs as model animals showed no toxic side effects in the normal concentration range.
 
[Pharmacokinetics] After the injection of this product, the blood drug concentration decreased rapidly, and it decreased to 1/3 of the injection time in 30 minutes. The 1-2 hours was basically stable, and the distribution was the most in the liver, accounting for 10%. It is metabolized to free choline and cytidine diphosphate in the liver, mainly through the kidney and lung. The half-life of the original drug is 3.5 hours, and the half-life of the main metabolite choline is 2 hours. This product is difficult to pass the blood-brain barrier, the drug into the brain is very small, only 0.1%, but the drug stays in the brain for a long time, the drug concentration peaks within 3 hours after injection, and remains unchanged within 24 hours. Moreover, the cerebral choline content of the injured brain is significantly higher than that of the normal brain and the damaged hemisphere.
 
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
 
[Package] Sodium calcium glass infusion bottle, 250ml per bottle; 100ml per bottle.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval number] (1) National medicine standard word H20020319 (250ml: citicoline sodium 0.25g and sodium chloride 2.25g)
 
(2) National medicine quasi-word H20030352 (100ml: citicoline sodium 0.5g and sodium chloride 0.9g)
 
【manufacturer】
 
Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
Postal code: 529331
 
Phone number: (0750) 2789348
 
400-8899-328 (National Service Phone)
 
Fax number: (0750) 2789348
 
Website: http://www.pdpharm.com
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