Enoxaparin Sodium Injection, GMP Medicine

• Application: Internal Medicine
• Usage Mode: Inject
• Suitable for: Elderly, Children, Adult
• State: Liquid
• Shape: Injection
• Type: Biological Products
• Model NO.: AMC14084
• Pharmaceutical Technology: Chemical Synthesis
• Transport Package: 2′s/Box 200boxes/CTN
• Specification: 20mg/0.2ml; 40mg/0.4ml; 60mg/0.6ml; 80mg/0.8ml
• Trademark: Medipharm, OEM
• Origin: China
• HS Code: 3004909099
• Production Capacity: 500000 Boxes/Month

Product Description

[Drug Name]
Generic name: Enoxaparin sodium injection
Chinese pinyin: Yinuogansuna Zhusheye
(Active ingredients]
Chemical name: Enoxaparin sodium (Low-Molecular-Weight Heparin Sodium) Stmctural formula:
[indications]
Prophylaxis of venous thromboembolic disease (prevention ofblood clot formation in the veins), in particular those which may be associated with orthopedic or general surgery. Treatment of established deep vein thrombosis, with or without pulmonary embolism, clinical symptoms are not serious, not including pulmonary embolism requires smgery or thrombolytics treatment.
Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrendy with aspirin.
Prevention of thrombus formation in the extra-corporal circulation during hemodialysis.
[Strength] 0.2 ml: 2000 Axa IU; 0.4 ml: 4000 AxalU; 0.6 ml: 6000 Axa IU; 0.8 ml: 8000 Axa IU
[Dosage and Administration]
Enoxaparin sodium can be administered subcutaneously as a single daily iiyection of 150 Axa lU/kg. In patients with complicated thromboembolic disorders, a dose of 100 Axa lU/kg twice daily is recommended. In patients weighing more than 100 kg or less than 40 kg, the dose has not been evaluated. The eflHcacy of enoxaparin sodium may be slightly reduced in patients with weight greater than 100 kg. In patients weighing less than 40 kg, the risk of bleeding may increase. For these patients, special clinical monitoring is required.
Treatment of Deep vein thrombosis:
Unless contraindicated, enoxaparin sodium should be replaced for oral anticoagulants as soon, as possible. The duration of administration should be not more than 10 days, including the time required to achieve a therapeutic oral anticoagulant efiect, unless it is impossible to achieve the goal (see section 4.4 Precautions for Use: platelet monitoring) .Therefore, oral anticoagulant therapy should be used as soon as possible.
[Pregnancy and lactation]
Pregnancy
Animal studies did not show evidence of teratogenicity of enoxaparin. Since there is no teratogenicity in animals, no similar e&ct is expected in humans.
At present, the comparison between the two systems found that teratogenic efiects of substances on the human body proved to have teratogenic efiects on animals.
At present, there is insufficient clinical data available to determine the possible teratogenic or fetal toxicity of enoxq)arin during the injection of theeutic doses during pregnancy.
Currently the ther^)eutic doses of enoxaparin is not recommended as a prophylaxis during pregnancy.
In humans, there is no evidence that enoxaparin sodium crosses the placental barrier. Enox^)arin sodium should be used during pregnancy only if the physician has established a clear need.
Lactation
In principle, the neonatal gastromtestinal absorption of this product can not be carried out, so breast-feeding women using enox^arin treatment is not contraindication. Lactating mothers receiving enoxaparin sodium should be advised to avoid breast-feeding.
[Overdose]
-Accidental overdosage after subcutaneous injection of massive doses of enoxaparin could lead to bleeding complications.
If bleeding, some patients may need to use protamine sulfate treatment, but need to consider the following factors:

• Its curative effect is much lower than that of unfractionated heparin with overdosage.
• Due to adverse reactions (especially anaphylactic shock), the benefitfrisk ratio of protamine sulfate should be assessed in detail before use.

The amount of protamine administered depends on:

• The dose ofhq>arm injected (if the last dose of enoxaparin is administered within 8 hours, 100 anti-heparin units protamine can be used to neutralize the effect of 100 Axa IU low-molecular-weight heparin );

. The time after heparin injection
-If enoxaparin sodium is administered more than 8 hours or protamine injection is required, the protamine 50 anti-heparin unit is administered per 100 Axa IU enoxaparin sodium.
-If enoxaparin is administered more than 12 hours after the injection, no protamine injection, is required.
These recommendations are for patients with normal renal function undergoing repeated dosing.
Neutralization is produced by slow intravenous injection of protamine (sulfete or hydrochloride). However, the anti-Xa activity can not be completely neutralized. Moreover, due to the pharmacokinetic characteristics of low-molecular-weight heparin, the neutralizing effect is transient and therefore the total dose of protamine as calculated may need to be injected multiple times (two to four times) in 24 hours.
-In principle, even high doses of low-molecular-weight heparin will not cause serious consequences (no events are reported) after administration, mainly due to the very low absorption of low-molecular-weight heparin through the gastrointestinal tract.
In case of overdosage or accidental intoxication you must notify to a physician.
[Package] Pre-filled syringe, 2 syringes/pack
[Shelflife] 24 months