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Nadroparin Calcium Injection Pre Filled Syringe Small Volume Parenteral

Nadroparin Calcium Injection Pre Filled Syringe Small Volume Parenteral

    • Nadroparin Calcium Injection Pre Filled Syringe Small Volume Parenteral
  • Nadroparin Calcium Injection Pre Filled Syringe Small Volume Parenteral

    Product Details:

    Place of Origin: China
    Brand Name: Newlystar
    Certification: GMP
    Model Number: PFS, 0.2 ml/2050IU, 0.3 ml/3075IU, 0.4 ml/4100IU, 0.6 ml/6150IU, 0.8 ml/8200IU

    Payment & Shipping Terms:

    Minimum Order Quantity: 5000boxes
    Price: Negotiation
    Packaging Details: 2’s/box
    Delivery Time: 45days
    Payment Terms: L/C, T/T
    Supply Ability: 20, 000 boxes per day
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    Detailed Product Description
    Product: Nadroparin Calcium Injection Pre-filled Syringe Specification: PFS, 0.2 Ml/2050IU, 0.3 Ml/3075IU, 0.4 Ml/4100IU, 0.6 Ml/6150IU, 0.8 Ml/8200IU
    Standard: In - House Packing: 2’s/box
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    Nadroparin Calcium Injection Pre Filled Syringe Small Volume Parenteral

     

     

    Product : Nadroparin Calcium Injection Pre-filled Syringe

    Specification : PFS, 0.2 ml/2050IU, 0.3 ml/3075IU, 0.4 ml/4100IU, 0.6 ml/6150IU, 0.8 ml/8200IU

    Standard : In - house

    Packing : 2’s/box

     

    Description :

    Nadroparin is a low molecular weight heparin (LMWH) which, when bound to antithrombin III (ATIII), accelerates the inactivation of factor II and factor Xa. Nadroparin halts the coagulation pathway by inhibiting the activation of thrombin (factor IIa) by factor Xa. The amplification of the fibrin clotting cascade is stopped once factors Xa and IIa are inactivated. It is derived from porcine sources and has a mean molecular size of 5000 daltons. Low molecular weight heparins are less effective at inactivating factor IIa due to their shorter length compared to unfractionated heparin.

     

    Indication and dosage

    Nadroparin is used for prophylaxis of thromboembolic disorders and general surgery in orthopedic surgery, treatment of deep vein thrombosis, prevention of clotting during hemodialysis and treatment of unstable angina and non-Q wave myocardial infarction

    Unstable Angina: Adults: The dose is based on body weight. It is usually 86 anti-factor Xa International Units (IU) per kilogram (kg) (39.1 anti-factor Xa IU per pound) of body weight injected under the skin every twelve hours for six days.

    Venous thromboembolism and Pulmonary Embolism:

    Adults: The dose is usually 2850 anti-factor Xa IU injected under the skin once a day beginning two to four hours before surgery and continuing for at least seven days.

     

    Do not use Nadroparin Calcium Injection

    - If you are allergic to nadroparin calcium, heparin or any of the other ingredients of this medicine (listed in section 6).

    - In case of current or history of heparin-related drop in the platelet count (type II thrombocytopenia) or a drop in the platelet count with nadroparin calcium in the medical history

    - In case of organ damage which can be susceptible to bleeding such as:

    o Acute gastrointestinal ulcers

    o Cerebral bleeding

    o Distended vessel (aneurysm) in the brain

    - In case of coagulation disorders (susceptibility to bleeding, coagulation factor deficiency, extensive reduction of platelet count)

    - In case of stroke caused by bleeding in the brain

    - In case of severe, uncontrollable hypertension

    - In case of severe hepatic impairment

    - In case of severe renal impairment (creatinine clearance < 30 ml/min.) except during haemodialysis treatment

    - In case of infectious inflammation of the heart's inner layer (endocarditis)

    - In case of injuries and surgical procedures of the central nervous system, and on the eye and ear

    - In case of bleeding in the eye or other active bleeding processes

    - In case of retinal disorders (retinopathies), vitreous body haemorrhage

    - In case of imminent miscarriage

    - In case of deep vein thrombosis: Regional anaesthesia (spinal or epidural anaesthesia), lumbar puncture

     

    Warnings and precautions

    Talk to your doctor or pharmacist before using Nadroparin Calcium Injection if any of the following apply to you:

    - Thrombocytopenia and platelet function disorders

    - Renal, hepatic, and pancreatic dysfunction

    - Uncontrollable high blood pressure (hypertension)

    - Peptic ulcers in the medical history

    - Suspected malignancies with susceptibility to bleeding

    - Vascular disorders of the eyes

    - In case of recent surgery on the brain, spinal cord or eye

    - Kidney and/or ureteral stones

    - Lumbar puncture

    - Spinal or epidural anaesthesia

    - Simultaneous use of medicines which increase the serum potassium level and with the simultaneous use of (oral) anticoagulants or platelet aggregation inhibitors (e.g.acetylsalicylic acid)

    - High-dose nadroparin calcium treatment in recently operated patients

    - Patients aged 65 years and older

    - Patients aged 18 years and younger

    Nadroparin Calcium Injection should be taken with care and after careful individual risk-benefit analysis in patients with lumbar puncture, spinal or epidural anaesthesia who received preventive treatment with Nadroparin Calcium Injection due to the risk of complications arising from bleeding which may lead to neurological deficits and complete paralysis of the limbs (paraplegia).

    To date no results from randomized, controlled clinical studies are available which prove the safe use of higher doses of Nadroparin Calcium Injection (for example, for deep vein thrombosis prophylaxis in patients with high thromboembolic risk) with the simultaneous use of anaesthetic methods applied close to the spinal cord. Patients must be under careful neurological monitoring after the application of anaesthesia close to the spinal cord, whereby especially persistent sensory and motor deficits must be noted, since Nadroparin Calcium Injection may cause bleeding into the spinal cord at the injection site.

    The platelet count must be checked at regular intervals during treatment with Nadroparin Calcium Injection due to the risk of heparin-induced thrombocytopenia.

    Checks of the platelet count are recommended prior to therapy, on day 1 of therapy, and then at regular intervals of three to four days as well as at the end of therapy.

    Occasionally, mild, temporarily thrombocytopenia (type I) develops at the beginning of therapy (caused by temporary platelet activation) with a platelet count between 100,000/µl and 150,000/µl. Complications generally do not develop in these cases. Therefore, the treatment can be continued.

    Rarely, antibody-induced severe thrombocytopenia (type II) develops with platelet counts of significantly below 100,000/µl or a fast drop to less than 50% of the initial value. The drop in the platelet level primarily starts 6 to 21 days after beginning treatment in non-sensitized patients, in sensitized patients this may occur within hours. The severe form of thrombocytopenia may be accompanied by arterial and venous thrombosis/thromboembolism, disseminated intravascular coagulation, possibly skin necrosis on the injection site, petechial bleeding, purpura, and melena. In these cases, Nadroparin Calcium must be immediately discontinued and a different antithrombotic treatment must be considered. The patient must be informed that s/he must not receive any heparin-containing medicinal products in the future.

    Heparin can suppress the adrenal secretion of aldosterone which can cause hyperkalaemia, especially in patients with elevated plasma potassium level or in patients with a risk of an elevated plasma potassium level such as diabetes mellitus, persistent renal impairment, previously existing metabolic acidosis or the administration of medicinal products which increase the plasma potassium level (e.g.ACE inhibitors, nonsteroidal anti-inflammatory drugs [NSAIDs]). The risk of hyperkalaemia seems to increase with the duration of therapy, but usually is reversible. The plasma potassium level should be checked in risk patients.

    If patients with renal failure (see section 2. Do not use Nadroparin Calcium) are treated due to deep vein thrombosis, the lab parameters should be monitored, preferably by measuring the anti-Xa level (amidolytic assay with chromogenic substrate). Anti-Xa activity can be checked on day 2 and day 4, about 3 hours after subcutaneous application, and should lie within the range of 0.5 to 1.2 I.U. anti-Xa/ml.

    A reduction of the dose should be considered in patients with minor to moderate renal impairment (creatinine clearance ≥ 30 and < 60 ml/min.) (see section 3. How to use Nadroparin Calcium ).

    Note:

    Nadroparin Calcium Injection must not be injected into a muscle (i.m.) or into a vein (i.v.).

    The intramuscular injection of other medicinal products should be avoided during therapy with Nadroparin Calcium Injection due to the risk of hematoma development.

    In very rare cases skin damage was observed, usually on the injection site, which was preceded by reddened (purpura) or painful, inflammatory (erythematous) skin spots. In these cases, treatment should be immediately discontinued.

    Since no compatibility studies are available, the content of the Nadroparin Calcium pre-filled syringe must not be mixed with other preparations.

     

    Children and adolescents

    There are no data on the use of Nadroparin Calcium in children. The use in children is therefore not recommended.

    Elderly patients

    A dose adaptation for elderly patients is not necessary unless in the presence of renal failure. It is recommended to check the kidney function in elderly patients prior to use.

    Other medicines and Nadroparin Calcium Injection

    Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even over-the-counter medicines.

     

    This is particularly important because the simultaneous use of several medicines with Nadroparin Calcium may increase the risk of bleeding:

    - (Oral) anticoagulants

    - Acetylsalicylic acid (or other salicylates)

    - Nonsteroidal anti-inflammatory drugs (NSAIDs)

    - Platelet aggregation inhibitors

    - Systemic adrenocortical hormones ([gluco-] corticosteroids)

    - Dextran

    The interaction of heparin with intravenous nitroglycerin which can reduce the effect of heparin can also not be excluded for Nadroparin Calcium Injection.

    Medicines which increase the serum potassium level must only be used under especially careful medical monitoring during the simultaneous use of Nadroparin Calcium Injection.

    The administration of Nadroparin Calcium Injection in patients who are switched to oral anticoagulants should be continued until a stable INR (International Normalized Ratio) has been achieved within the desired range.

    Please note that this information may also apply to medicinal products you have recently used.

     

    Pregnancy and breast-feeding

    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

    Animal testing showed no signs of a fetotoxic effect. However, only limited clinical data are available in how far the active substance passes into the placenta. Clinical experience about use during pregnancy is limited which show no adverse effects on pregnancy or the health of the foetus/new-born. Use of Nadroparin Calcium Injection is not recommended during pregnancy due to limited clinical experience.

    Only limited information is available whether nadroparin calcium is excreted into the breast milk. For this reason, the use of Nadroparin Calcium Injection is not recommended while breastfeeding.

    Driving and using machines

    No studies on the effects on the ability to drive or use machines have been performed.

     

    Pharmacodynamics

    Nadroparin is a low molecular weight heparin that is composed of a heterogeneous mixture of sulfated polysaccaride glycosaminoglycan chains. Th mean molecular weight is approximately 4300 daltons. The ratio of anti-Xa activity to anti-IIa is 3.5:1 whereas it is about 1:1 for heparin. Its use should be avoided in patients with a creatinine clearance less than 40mL/min. In these patients, unfractionated heparin should only be used. As for monitoring, active partial thromboplastin time (aPTT) will only increase at high doses of low molecular weight heparins (LMWH). Therefore, monitoring aPTT is not recommended. However, anti-Xa activity can be measured to monitor the efficacy of the LMWH.

     

    Mechanism of action

    The mechanism of action for nadroparin is similar to all other LMWHs. Like all LMWHs, nadroparin has a pentasaccharide sequence which binds to ATIII, which potentiates the action of ATIII. This complex greatly accelerates the inactivation of factor Xa and factor IIa. As a result, the coagulation cascade is inhibited.

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    Contact Person: Luke Liu

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