GMP Certified / Pentoxifylline Injection 5ml: 0.1g

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 0.1g/5ml
• Model NO.: injection
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Pentoxifylline Injection
Strength	5ml:0.1g
Packing	5 amps/box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Pentoxifylline Injection

Character:
This product is a colorless clear liquid.

Indications:
(1) Cerebral blood circulation disorders such as transient ischemic attack, stroke sequelae, brain dysfunction caused by cerebral ischemia;
(2) Peripheral blood circulation disorders such as chronic embolic vasculitis.

Adverse reactions:
(1) Common adverse reactions are: nausea, dizziness, headache, anorexia, abdominal distension, vomiting, etc., the incidence of more than 5%, up to about 30%.
(2) The less common adverse reactions are:  cardiovascular system: decreased blood pressure, irregular breathing, edema; Nervous system: anxiety, depression, convulsions; Digestive system: anorexia, constipation, dry mouth, thirst; Skin: angioedema, rash, nail shine; Others: blurred vision, conjunctivitis, central blind spot enlargement; As well as decreased taste, increased saliva, decreased white blood cells, muscle soreness, swollen neck glands and weight change.
(3) Occasional adverse reactions include angina pectoris and arrhythmia; Jaundice, hepatitis, abnormal liver function, low blood fibrinogen, hypoplastic anemia and leukemia.

Pharmacology and toxicology
Pharmacological action:
Pentoxifylline and its metabolites improve hemorrheology by reducing blood viscosity, the exact mechanism of action has not been determined. Pentoxifylline can reduce blood viscosity, increase red blood cell deformability, improve the hemorheological characteristics of white blood cells in a dose-dependent manner, and inhibit the adhesion and activation of neutrophils. In patients with chronic peripheral artery disease, this product can increase blood flow, improve microcirculation and increase oxygen supply to the tissues.
Toxicological studies:
Genotoxicity: Micronucleus test in mice, multiple Salmonella mutagenicity test (Ames test), and mammalian cell culture test (extra-programmed DNA synthesis test) were negative.
Reproductive toxicity: Oral administration of 576 mg/kg in rats and 264mg/kg in rabbits (24 and 11 times the maximum recommended daily dose for humans in terms of body weight, respectively); In terms of body surface area, 4.2 and 3.5 times the maximum recommended daily dose for humans, respectively), no fetal malformations were found. In the 576mg/kg rats, reabsorption was increased. There are no adequate and rigorously controlled studies in pregnant women. During pregnancy, pentoxifylline should only be used if the benefits outweigh the risks. Pentoxifylline and its metabolites can be secreted into milk. Because this product can cause tumor development in rats, after considering the importance of breastfeeding women, it is determined to stop breastfeeding or discontinue the drug.
Carcinogenicity: Rats were given this product for 18 months at a dose of 450mg/kg(in terms of body weight, about 19 times the maximum recommended daily dose for humans; By body surface area, about 3.3 times the maximum recommended daily dose for humans) and then given at a non-exposure dose for 6 months, pentoxifylline significantly increased the occurrence of benign breast fibroadenoma in female mice. The relevance of this finding to human use is unclear. No abnormalities were found in long-term carcinogenesis tests in mice at the same dose.

Storage:
Keep in dark and airtight.