RINGER LACTATE INTRAVENOUS INFUSION
Product name Ringer Lactate Intravenous Infusion
Main ingredients This is a compound preparation, each 500ml contain: Sodium Lactate 1.55g; Sodium chloride 3.00g; Potassium chloride 0.15g; Calcium chloride (CaCl2•2H2O) 0.10g
Excepient: Water for injection.
Character This product is a colorless clear liquid.
Indications
It is indicated to adjust the equilibrium of humour electrolyte acid and alkali, Used for metabolic acid toxicosis or dehydration caused by metabolic acid toxicosis.
Specification 500ml
Dosage and administration
By phleboclysis. The general dose for the adult is 500-1000ml/time, but the dose can be reduced or increased according to the avoirdupois and the age. The speed of administration is 300~500ml/hour .
Side-effect
(1)for the patients with hepo-calcium ( such as uraemia) , after correcting acid toxicosis the following cases may happen: limb tingling, ache, twitch, dyspnea and so on. The cause is the reduction of concentration of blood serum calcium ion. ( 2 ) cardioacceleration, chest distress, breath lessness, pulmonary edema, heart failure and etc. ( 3 ) blood pressure arise ( 4 ) body weight rise, edema (5) over dose may lead to alkali poisoning ( 6 ) the potassium's concentration decline, sometimes hepopotassaemia may happen .
Contraindication The product is forbidden to use for the following cases: (1)heart failure and acute pulmonary edema(2)cerebral edema (3) lactic acidosis is obvious (4) severe hepatic inadequacy (5) serious renal failure with oliguria or anuria
Attention
Use cautiously if any of the following cases happen:
(1).if the patients with the diabetic is taking caplendus biguanides ( especially Phenformin ), it may inhibit the absorbance of lactic acid of liver, and lactic acid intoxication may happen. (2)the patient with edema companied with Sodium retention trend. (3) blood pressure may arise for the patients with hypertension. (4) cardiac insufficiency (5) the degradation speed of lactate step down for the patients with hepatic inadequacy, it may delay the speed of correcting acidosis. (6)hypoxia and shock , not enough tissue blood-supply , the metabolism of lactate is slow, it may be influential for the speed to correct acidosis.(7)with excessive drinking, Salicylism toxicosis, I type glycogen deposition, lactic acidosis may happen. The product is not appropriate to correct the balance of acid and alkali. (8)with diabetes mellitus ketosis, Acetyl acetic acid, β-hydroxybutyric acid and lactic acid all arise, and may accompany with circulation not good and organ blood-supply not enough, the degradation speed of lactic acid reduce.(9)the patients with renal inadequacy may accompany with water and sodium retention, it may raise the load of heart and blood vessel.
The following items should be examined before use: (1) blood pH or carbon dioxide combining power(2) the concentration of sodium, potassium, and calcium in the serum(3) check the renal function (4)blood pressure (5) cardiorespiratory function state such as edema, breath lessness, cyanosis, bellows rales, jugular engorge, liver-jugular regurgitation and so on. If necessarily, examine the venous pressure or central venous pressure. (6) when the product is administered for the patients with hepatic inadequacy , make careful inspection momentarily.
Osmolality is 240~270mOsmol/kg.
Pregnancy and Lactation
The administration may intensify edema or raise the blood pressure for the gravida have pregnancy toxinosis
Pediatric Use
Calculate the dose according to the age and body weight
Geratology
For the old patients usually have insidious cardiac insufficiency or renal inadequacy, so it is must be used carefully.
Interaction
When administered with other medicine (such as macrolide antibiotic, alkaloid , sulfanilamide group ), pay attention to the incompatibility may happen because of pH value and ionic strength change. Because the product contain Ca+, precipitation may happen when mixed with the blood contain natrium citricum.
Overdose
Overdose may lead to edema or lose balance of ion in body.
Pharmacology and toxicity In the natural case our blood contain a little lactic acid, it is mainly produced by dextrose or hepatin through zymohydrolysis happening in muscle, skin, brain and cell. After the production of lactate, lactic acid will be translated into hepatin or pyruvic acid , or come into tricabroxylic acid circle , be decomposed to water and carbon dioxide. So the last metabolize production is sodium bicarbonate, it can correct metabolizable acid toxicosis. When the product is indicated for hyperpotassaemia following acidosis , sodium lactate can correct acid toxicosis, and make the potassium come into the cell from blood or extracellular fluid. The main viscera that can decompose lactic acid is liver and kidney. When the metabolize of lactic acid is abnormal or out of gear, the curative effect is not very good.
Pharmacokinetics
pH of sodium lactate is 6.5-7.5, it can be absorbed quickly after taking orally , and can be oxidationed by liver in 1-2 hour, with the metabolism products sodium bicarbonate. But it is usually administered by phleboclysis. Using sodium lactate instead of sodium acetate as the buffer for peritoneum dialyszte can reduce the excitation for peritoneum, it can also reduce the influence for depression of cardiac muscle and the resistance of the around blood vessel .
Storage Condition Sealed storage
Package Glass infusion bottle, medicinal halogenated butyl rubber stopper, 500ml/bottle
Polypropylene infusion bottle (including double valve easy folding type), 500ml/bottle
Vertical polypropylene infusion bag (including double valve easy folding type), 500ml/bag
Multi layer co extruded film infusion bag (including double tube type, double valve easy to fold type, and break type), 500ml/bag
Multi layer co extruded film infusion bag [outer bag with double layer sterilization (including double tube type)], 500ml/bag
Expiry date 36months
Drug Marketing Althority Holder
Name:Shijiazhuang No.4 Pharmaceutical Co., Ltd.
Adress: No.518 East Huaian Road, High-tech Industrial Development Zone, Shijiazhuang
Manufacturer
Name:Shijiazhuang No.4 Pharmaceutical Co., Ltd.
Adress: Yangzi Road, Economic & Technological Development Zone, Shijiazhuang(Polypropylene infusion bottle, Vertical polypropylene infusion bag, Multi layer co extruded film infusion bag)
No.518 East Huaian Road, High-tech Industrial Development Zone, Shijiazhuang(Glass infusion bottle)
Postal Code: 052165 050035
Telephone: (0311)67167185 67167186 67167158
Fax: (0311)67167215
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Shijiazhuang No. 4 Pharmaceutical Co., Ltd., as one of the leading manufacturers in Chinese pharmaceutical industry and a well-known brand, has a business history of seventy years. The company principally specializes in R & D, manufacture and sales of wide types of drugs mainly including intravenous infusion.
The production lines have achieved full automation control and information control in the production process and logistics process and reached international advanced level by integrating the world's leading equipment and technology.
With product quality as its life, the Company always organizes production in strict accordance with GMP requirements, establishes and implements superior service concepts and measures and provides guarantee for the health of the majority of patients at home and abroad with excellent quality products and services.
The Company has a powerful R&D team and made a number of achievements in scientific research and undertaken many major scientific and technological innovation projects and industrialization projects by firmly grasping the pulse of pharmaceutical development, increasing new product development investment and accelerating the pace of technological innovation.
Large volume injection is the key products, tablets, capsules, small volume injection and other forms are manufactured also. Recently API has been put into production and sales. There are more than ten international advanced production lines for the large volume injection, its production scale, technology level, brand influence and economic benefit are on the forefront of domestic counterparts, and it has become one of China's top 100 pharmaceutical industry enterprises and China's top 10 chemical and pharmaceutical industry preparation export-oriented excellent enterprise brands for many consecutive years.
The products are radiated to all provinces, autonomous regions and municipalities in China and also exported to many overseas markets, including more than 80 countries in Asia, Americas, Europe, Oceania, Africa and other continents, and it has become one of the main export enterprises of infusion products.