Glycerine fructose sodium chloride injection

Approval date: 14 November 2006

Modification date: September 30, 2010

October 1st, 2012

Instructions for glycerine fructose sodium chloride injection

Please read the instructions carefully and use them under the guidance of your physician.

[name of drug]

General name: glycerol fructose sodium chloride injection

English name: Glycerol Fructose and Sodium Chloride Injection

Chinese pinyin: Ganyou Guotang Luhuana Zhusheye

[ingredients] this product is a compound injection, containing 10g glycerin, 5g fructose and 0.9g sodium chloride per 100ml.

The auxiliary material is sodium chloride.

[properties] this product is a colorless and clear liquid.

[indications] used for cerebrovascular disease, brain trauma, brain tumor, intracranial inflammation and other causes of acute and chronic intracranial pressure increase, brain edema and other diseases.

[specification] 250ml

[usage and dosage] intravenous infusion, usually 250 ~ 500ml once for adults, 1 ~ 2 times a day, each 500ml infusion needs 2 ~ 3 hours, 250ml infusion needs 1 ~ 1.5 hours. According to age, symptoms can be appropriate increase or decrease.

[adverse reactions] generally, there are no adverse reactions with occasional itching, rash, headache, nausea, thirst and hemolysis.

Literature shows that the following adverse reactions can occur with the application of this product:

1. Acidosis (incidence unknown) : lactic acidosis may occur, sodium bicarbonate injection should be given.

2. Other adverse reactions:

Adverse reactions

0.1% < incidence < 5%

Incidence < 0.1%

Urinary system

Occult blood, hemoglobinuria, hematuria, frequency of urination

The gastrointestinal tract

nausea

vomiting

Metabolic disorders

hypokalemia

Hypernatremia, diabetic hyperosmolar nonketoid coma, hyperglycemia

other

Headache, thirst

Arm pain, elevated blood pressure, discomfort

【 taboo 】

1. It should be contraindicated in patients with hereditary fructose intolerance.

2. Allergic to any of the ingredients.

3. Hypernatremia, anuria and severe dehydration.

[precautions]

1. Use with caution in patients with severe circulatory dysfunction, renal dysfunction, diabetes insipidus, and hemolytic anemia.

2. Patients with severe active intracranial hemorrhage should be cautious in the absence of surgical conditions.

3. This product contains 0.9% sodium chloride, and patients should pay attention to the intake of salt.

4. In case of suspected acute subdural or epidural hematoma, the source of bleeding should be first treated and confirmed that there is no more bleeding before application of this product.

5. Rapid infusion may cause hemolysis and hemoglobinuria.

6. In patients with severe renal insufficiency, the product accumulates in the body due to the reduction of excretion, which can significantly increase the blood volume, aggravate the heart load, induce or aggravate heart failure.

7. Before use, the product should be visually inspected under natural light (avoid direct sunlight). If there is any visible foreign matter, it shall not be used. If the bottle is found to have cracks, loose seal, air leakage, solution discoloration, turbidity, mildew or cotton-like mycelium group is strictly prohibited to use.

8. When the external temperature is low, heat the product to the body temperature before using.

[medication for pregnant and lactating women] is not clear.

[medication for children] is not clear.

[geriatric medication] the physiological function of elderly patients is usually decreased, and elderly patients with abnormal water and electrolyte levels should be careful to use this product.

[drug interactions] are unclear.

[drug overdose] is unclear.

【 pharmacology and toxicology 】 glycerin fructose sodium chloride injection is a hypertonic preparation, through high permeability dehydration, can reduce the brain water content, reduce intracranial pressure. The effect of reducing intracranial pressure is slow and lasts for a long time.

[pharmacokinetics] this product enters the whole body tissue through the blood, its distribution reaches the equilibrium within about 2 ~ 3 hours. Enter cerebrospinal fluid and brain tissue slowly, clearance is also slow. Most metabolism of this product is CO2 and water elimination.

[storage] keep airtight (10 ~ 30℃).

[packaging] infusion glass bottle, each bottle is 250ml.

[validity period] 18 months

[executive standard] the first supplement of Chinese pharmacopoeia 2010 edition

[approval document no.] Chinese medicine approval number H20054813

[production enterprise]

Company name: guangdong peidi pharmaceutical co., LTD

Production address: 66 peidi avenue, yueshan town, kaiping city, guangdong province

Zip: 529331

Telephone number: 0750-2789285, 2789348

400-8899-328 (national service telephone number)

Fax number: 0750-2789285, 2789348

Web site: http://www.pdpharm.com