24肝素钠

基本信息 anticoagulation. Caution is necessary when using the 10 unit/mL concentration in premature infants who weigh less than 1 kg who are receiving
frequent flushes since a therapeutic heparin dose may be given to the infant in a 24-hour period. HEP-LOCK U/P(单体保护剂肝素冲洗液)是
正压、有效、安全的封管。
S=Saline A=Administer medications S=Saline H=Heparin(if using)
S=生理盐水 A=输注药物 S=生理盐水 H=肝素盐水
关于儿童封管，很多的说法，此处我把美国FDA批准的百特的封管液的原文放在幻灯片上了，后面的是原文的中文翻译。注
对新生儿外周短期导管使用肝素封管液或0.9%不含防腐剂的 盐水封管液没有特殊推荐。尚欠缺能做出特殊推荐的资料。
O条款，翻译上最难的条款：中心血管通路导管，一些研究显示肝素和盐水封管的结果类似，另一些则报道盐水封管有巨大
间歇性短暂封管 的并发症。由于中心血管置管的风险和价值，每次使用的短暂间隙首选10u/ml的肝素溶液封管。
数据库（1990 ～2009.12），查找比较生理盐水与肝素钠封管的“随机对照 试验” 进行分析。 共纳入9 个临床研究，合计1770 例患者
对“③ 在平均留置时间上，两者差异有统计学意义，肝素钠封管优于生理盐水封管”解释一下；在这些纳入统计学分析的实验
中生理盐水是最安全的，是作为空白对照组；肝素钠封管的静脉炎发生率和盐水一样，是说引起静脉炎的可能性很小，肝素

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Lovenox safely and effectively. See full prescribing information for Lovenox.Lovenox® (enoxaparin sodium injection) for subcutaneous and intravenous useInitial U.S. Approval: 1993WARNING : SPINAL/EPIDURAL HEMATOMASee full prescribing information for complete boxed warning . • Enoxaparin use in patients undergoing spinal/epidural anesthesia or spinal puncture increases the risk of spinal or epidural hematoma, which may cause long-term or permanent paralysis (5.5) • Risk is increased by:o Indwelling epidural catheters for analgesia (5.5) o Drugs affecting hemostasis [e.g., nonsteroidal anti-inflammatory drugs, platelet inhibitors, anticoagulants] (5.5, 7)o Traumatic or repeated spinal or epidural puncture (5.5)-----------------------RECENT MAJOR CHANGES ------------------Indications and Usage (1.4), 5/2007 Dosage and Administration (2) 5/2007ST-segment Elevation Myocardial Infarction Warnings and Precautions (5.2) 5/2007 Percutaneous coronary revascularization procedures------------------INDICATIONS AND USAGE -------------------Lovenox is a low molecular weight heparin [LMWH] indicated for:• Prophylaxis of deep vein thrombosis (DVT) in abdominalsurgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1)• Inpatient treatment of acute DVT with or without pulmonaryembolism (1.2)• Outpatient treatment of acute DVT without pulmonaryembolism. (1.2)• Prophylaxis of ischemic complications of unstable angina andnon-Q-wave myocardial infarction [MI] (1.3)• Treatment of acute ST-segment elevation myocardialinfarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI] (1.4)-------------------DOSAGE AND ADMINISTRATION--------------Indication Standard Regimen (2.1, 2.3) Severe RenalImpairment (2.2)DVT prophylaxis in abdominal surgery 40 mg SC once daily 30 mg SC once daily DVT prophylaxis in knee replacement surgery30 mg SC every 12 hours 30 mg SC once daily DVT prophylaxis in hip replacement surgery 30 mg SC every 12 hours or 40 mg SConce daily30 mg SC once daily DVT prophylaxis in medical patients 40 mg SC once daily 30 mg SC once daily Inpatient treatment of acute DVT with or without pulmonary embolism 1 mg/kg SC every 12 hours or 1.5 mg/kg SC once daily (with warfarin)1 mg/kg SC once daily Outpatient treatment acute DVT without of hours (with warfarin) g SC oncedaily pulmonary embolism 1 mg/kg SC every 12 1 mg/k Unstable angina and g SC once non-Q-wave MI 1 mg/kg SC every 12hours (with aspirin) 1 mg/k daily Acute STEMI in patients <75 years of CI, see 1)] hours with aspirin) by g SC once daily age[For dosing insubsequent P Dosage andAdministration (2.30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg SC every 12 30-mg single IV bolus plus a 1 mg/kgSC dose followed 1 mg/k Acute STEMI in patients ≥75 years of 12 hours (no bolus) daily (no bolus) age0.75 mg/kg SC every 1 mg/kg SC once Do not use as intramuscular injection.For subcutaneous use, do not mix with other injections or fusions. --------------------DOSAGE FORMS AND STRENGTHS-------- • 60 mg/0.6 mL, 80 mg/0.8AINDICATIONS ----------------- i-platelet) oval5.3) arin or other LMWHs (5.6)notMultiple-dose formulations contain benzyl alcohol (5.8) --- adverse reactions (>1%) were bleeding, anemia, rombocytopenia, elevation of serum aminotransferase, diarrhea, ADVERSE REACTIONS, contact nofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or /medwatch. in--100mg/mL concentration (3.1):• Prefilled syringes: 30 mg/0.3 mL, 40 mg/0.4 mLGraduated prefilled syringes:mL,100 mg/1 mL• Multiple-dose vial: 300 mg/3 mL 150mg/mL concentration (3.2):• Graduated prefilled syringes: 120 mg/0.8 mL, 150 mg/1 mL------------------------------CONTR• Active major bleeding (4.1)Thrombocytopenia with a positive in vitro test for ant • antibody in the presence of enoxaparin sodium (4.2 Hypersensitivity to enoxaparin sodium (4.3)•• Hypersensitivity to heparin or pork products (4.4)-----------------------WARNINGS AND PRECAUTIONS ----------• Use caution in conditions with increased risk of hemorrhage(5.1)• Obtain hemostasis at the puncture site before sheath rem after percutaneous coronary revascularisation (5.2)• Use caution with concomitant medical conditions (• Use caution in case of history of heparin-inducedthrombocytopenia (5.4)• Monitor thrombocytopenia of any degree closely (5.5) •Do not exchange with hep • Pregnant women with mechanical prosthetic heart valves adequately studied (5.7)•• Periodic blood counts recommended (5.9)-----------------------------ADVERSE REACTIONS ----------------Most common th and nauseaTo report SUSPECTED sa w-----------------------------DRUG INTERACTIONS ----- hich may enhance hemorrhage risk prior to itiation of Lovenox or conduct close clinical and laboratory --------------Discontinue agents w in monitoring (5.9, 7).----------------USE IN SPECIFIC POP ------ULATIONS ------------ patients with• Hepatic Impairment (8.8)• Low-weight patients: Observe for signs of bleeding (8.9)• Severe renal impairment: Adjust dose for creatinine clearance <30 mL/min (2.2)See 17 for PATIENT COUNSELING INFORMATIONRevised: [m/year]WARNIN 1 INDIC ction)2 NGTHSon 4 5 ures ty with Other Heparinswith Mechanical Prosthetic Heart7 CTIONS8 USE IN SPECIFIC POPULATIONS8.1 Pregnancyical Prosthetic Heart Valves ent 11 12 LOGY13 OLOGYlity 14 Acute ardialections or subsections omitted from the full prescribing ation are not listedFULL PRESCRIBING INFORMATION: CONTENTS* G - SPINAL / EPIDURAL HEMATOMAS ATIONS AND USAGEProphylaxis of deep vein thrombosis in patients1.1 undergoing surgery and in medical patients with severely restricted mobility during acute illness Treatment of acute deep vein thrombosis1.2 1.3 Prophylaxis of ischemic complications of unstableangina and non-Q-wave myocardial infar 1.4 Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI DOSAGE AND ADMINISTRATION2.1 Adult dosage 2.2 Renal impairment2.3 Geriatric patients with acute STEMI 2.4 Administration3 3.1 100-mg/mL concentrati DOSAGE FORMS AND STRE 3.2 150-mg/mL concentration CONTRAINDICATIONSWARNINGS AND PRECAUTIONS5.1 Increased risk of Hemorrhage5.2 Percutaneous coronary revascularization proced 5.3 Use of Lovenox with Concomitant Medical Conditions 5.4 History of heparin-induced thrombocytopenia 5.5 ThrombocytopeniaInterchan 5.6 geabili 5.7 Pregnant Women Valves5.8 Benzyl alcohol 5.9 Laboratory tests6 6.1 Clinical StudiesADVERSE REACTIONS6.2 Post-marketing experience DRUG INTERA 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use8.6 Patients with Mechan 8.7 Renal impairment 8.8 Hepatic impairm 8.9 Low-weight Patients 10 OVERDOSAGE DESCRIPTIONCLINICAL PHARMACO 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 PharmacokineticsNONCLINICAL TOXIC 13.1 Carcinogenesis, Mutagenesis, Impairment of Ferti 13.2 Animal ToxicologyICAL TRIALS EX CLIN PERIENCE14.1 Prophylaxis of deep vein thrombosis followingabdominal surgery14.2 Prophylaxis of deep vein thrombosis following Hip orKnee Replacement surgeryProphylaxis of deep vein thr 14.3 ombosis in MedicalPatients with Severely Restricted Mobility during Illness14.4 Treatment of acute deep vein thrombosis with orwithout pulmonary embolism14.5 Prophylaxis of ischemic complications in unstableangina and non-Q-wave myocardial infarction14.6 Treatment of acute ST-segment Elevation Myoc Infarction (STEMI)16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUSELING INFORMATION*S inform12FULL PRESCRIBING INFORMATIONWARNING: SPINAL / EPIDURAL HEMATOMAS3When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, 4patients anticoagulated or scheduled to be anticoagulated with low molecular weight 5heparins or heparinoids for prevention of thromboembolic complications are at risk of 6developing an epidural or spinal hematoma which can result in long-term or permanent 7paralysis.89The risk of these events is increased by the use of indwelling epidural catheters for 10administration of analgesia or by the concomitant use of drugs affecting hemostasis such as 11non steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other 12anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or 13spinal puncture.1415Monitor patients for signs and symptoms of neurological impairment. If neurologic 16compromise is noted, urgent treatment is necessary.1718Consider the potential benefit versus risk before neuraxial intervention in patients 19anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and 20Precautions (5.1) and Drug Interactions (7)].2122232425262728293031323334353637383940414243 1 INDICATIONS AND USAGE1.1Prophylaxis of deep vein thrombosisLovenox is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism:•in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Trials Experience 14.1].•in patients undergoing hip replacement surgery, during and following hospitalization.•in patients undergoing knee replacement surgery.•in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.1.2Treatment of Acute Deep Vein ThrombosisLovenox is indicated for:•the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium;•the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.1.3Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-wave Myocardial InfarctionLovenox is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 1.4 Treatment of acute ST- segment Elevation Myocardial Infarction (STEMI)Lovenox has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute STEMI receiving thrombolysis and being managed medically or with Percutaneous Coronary Intervention (PCI).2 DOSAGE AND ADMINISTRATIONAll patients should be evaluated for a bleeding disorder before administration of Lovenox, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring Lovenox activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].For subcutaneous use, Lovenox should not be mixed with other injections or infusions. For intravenous use (i.e., for treatment of acute STEMI), Lovenox can be mixed with normal saline solution (0.9%) or 5% dextrose in water.Lovenox is not intended for intramuscular administration.2.1 Adult DosageAbdominal Surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of Lovenox is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials. 65 66 67 68 69 70Hip or Knee Replacement Surgery: In patients undergoing hip or knee replacement surgery, the recommended dose of Lovenox is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with Lovenox 40 mg once a day is administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials. 71 72 73 74 75 76 77 78 79 80Medical Patients During Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of Lovenox is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of Lovenox has been administered in the controlled clinical trial. 81 82 83 84 85 86Treatment of Deep Vein Thrombosis With or Without Pulmonary Embolism: In outpatient treatment , patients with acute deep vein thrombosis without pulmonary embolism who can be 87 88treated at home, the recommended dose of Lovenox is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment , patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of Lovenox is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of Lovenox). Lovenox should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of Lovenox administration has been administered in controlled clinical trials. 89 90 91 92 93 94 95 96 97 98 99 100Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of Lovenox is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with Lovenox should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of Lovenox has been administered in clinical trials. [See Warnings and Precautions (5.2) and Clinical Trials Experience (14.5)]. 101 102 103 104 105 106 107 108Treatment of acute ST-segment Elevation Myocardial Infarction: In patients with acute ST-segment Elevation Myocardial Infarction, the recommended dose of Lovenox is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), Lovenox should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated. In the pivotal clinical study, the Lovenox treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.For patients managed with Percutaneous Coronary Intervention (PCI): If the last Lovenox SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last Lovenox SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of Lovenox should be administered [see Warnings and Precautions (5.2)].2.2 Renal ImpairmentAlthough no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.133 134 135 136 137 The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in SpecificPopulations (8.6) and Clinical Pharmacology (12.3)].Table 1Dosage Regimens for Patients with Severe Renal Impairment(creatinine clearance <30mL/minute)Indication DosageRegimen Prophylaxis in abdominal surgery 30 mg administered SC once dailyProphylaxis in hip or knee replacement surgery 30 mg administered SC once dailyProphylaxis in medical patients during acute illness 30 mg administered SC once dailyInpatient treatment of acute deep vein thrombosis withor without pulmonary embolism, when administered inconjunction with warfarin sodium1 mg/kg administered SC once dailyOutpatient treatment of acute deep vein thrombosiswithout pulmonary embolism, when administered inconjunction with warfarin sodium1 mg/kg administered SC once dailyProphylaxis of ischemic complications of unstableangina and non-Q-wave myocardial infarction, whenconcurrently administered with aspirin1 mg/kg administered SC once dailyTreatment of acute ST-segment Elevation MyocardialInfarction in patients <75 years of age30 mg single IV bolus plus a 1 mg/kgSC dose followed by 1 mg/kgadministered SC once daily.Treatment of acute ST-segment Elevation MyocardialInfarction in geriatric patients ≥75 years of age1 mg/kg administered SC once daily(no initial bolus)138 139140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 2.3 Geriatric patients with acute ST-Elevation Myocardial InfarctionFor treatment of acute ST-segment Elevation Myocardial Infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses)[see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].2.4 AdministrationLovenox is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.The use of a tuberculin syringe or equivalent is recommended when using Lovenox multiple-dose vials to assure withdrawal of the appropriate volume of drug.156157 158 159 160 161 162 163 Lovenox must not be administered by intramuscular injection. Lovenox is intended for use under the guidance of a physician.For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided. Subcutaneous Injection Technique: Patients should be lying down and Lovenox administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.164 165 166 167 168 169 170171 172 173 174 175 176 177 178 Lovenox prefilled syringes and graduated prefilled syringes are available with a system that shields the needle after injection.1. Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient.Figure A179 180181 182 183 184 2. Inject using standard technique, pushing the plunger to the bottom of the syringe (see FigureB).Figure B185 186187 188 3. Remove the syringe from the injection site keeping your finger on the plunger rod (see FigureC).189Figure C190 191 192 193 194 195 196198199 200 201 2024. Orient the needle away from you and others, and activate the safety system by firmly pushing the plunger rod. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see Figure D).Figure D1975. Immediately dispose of the syringe in the nearest sharps container (see Figure E).Figure E203 204 205 206 207 208 209 210 211 212 213NOTE:• The safety system can only be activated once the syringe has been emptied.• Activation of the safety system must be done only after removing the needle from the patient’s skin.• Do not replace the needle shield after injection. • The safety system should not be sterilized.Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.Intravenous (Bolus) Injection Technique: For intravenous injection, the multiple-dose vial should be used. Lovenox should be administered through an intravenous line. Lovenox should not be mixed or co-administered with other medications. To avoid the possible mixture of Lovenox with other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of Lovenox to clear the port of drug. Lovenox may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.214 215 216 217 218 219 220 221222223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 3 DOSAGE FORMS AND STRENGTHSLovenox is available in two concentrations:3.1 100 mg per mL-Prefilled Syringes 30 mg / 0.3 mL, 40 mg / 0.4 mL-Graduated Prefilled Syringes 60 mg / 0.6 mL, 80 mg / 0.8 mL, 100 mg / 1 mL-Multiple-Dose Vials 300 mg / 3 mL3.2 150 mg per mL-Graduated Prefilled Syringes 120 mg / 0.8 mL, 150 mg / 1 mL4 CONTRAINDICATIONS•Active major bleeding.•Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium.•Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactoid reactions) [see Adverse Reactions (6.2)].•Known hypersensitivity to heparin or pork products.•Known hypersensitivity to benzyl alcohol (which is in only the multi-dose formulation of Lovenox).5 WARNINGS AND PRECAUTIONS5.1 Increased Risk of HemorrhageCases of epidural or spinal hematomas have been reported with the associated use of Lovenox and spinal/epidural anesthesia or spinal puncture resulting in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative indwelling epidural catheters or by the concomitant use of additional drugs affecting hemostasis such as NSAIDs[see boxed Warning, Adverse Reactions (6.2) and Drug Interactions (7)].Lovenox should be used with extreme caution in conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophthalmological surgery, or in patients treated concomitantly with platelet inhibitors.Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal.Bleeding can occur at any site during therapy with Lovenox. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site.5.2Percutaneous coronary revascularization proceduresTo minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, non-Q-wave myocardial infarction and acute ST-segment elevation myocardial267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 infarction, adhere precisely to the intervals recommended between Lovenox doses. It is important to achieve hemostasis at the puncture site after PCI. In case a closure device is used, the sheath can be removed immediately. If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC Lovenox. If the treatment with enoxaparin sodium is to be continued, the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal. The site of the procedure should be observed for signs of bleeding or hematoma formation [see Dosage and Administration (2.1)].5.3 Use of Lovenox with Concomitant Medical ConditionsLovenox should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, and hemorrhage.5.4 History of Heparin-induced ThrombocytopeniaLovenox should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia.5.5ThrombocytopeniaThrombocytopenia can occur with the administration of Lovenox.Moderate thrombocytopenia (platelet counts between 100,000/mm3 and 50,000/mm3) occurred at a rate of1.3% in patients given Lovenox, 1.2% in patients given heparin, and 0.7% in patients given placebo in clinical trials.Platelet counts less than 50,000/mm3 occurred at a rate of 0.1% in patients given Lovenox, in 0.2% of patients given heparin, and 0.4% of patients given placebo in the same trials. Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3, Lovenox should be discontinued. Cases of heparin-induced thrombocytopenia with thrombosis have also been observed in clinical practice. Some of these cases were complicated by organ infarction, limb ischemia, or death [see Warnings and Precautions (5.4)].5.6 Interchangeability with Other HeparinsLovenox cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage. Each of these medicines has its own instructions for use.5.7 Pregnant Women with Mechanical Prosthetic Heart ValvesThe use of Lovenox for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been adequately studied. In a clinical study of pregnant women with mechanical prosthetic heart valves given enoxaparin (1 mg/kg twice daily) to reduce the risk of thromboembolism, 2 of 8 women developed clots resulting in blockage of the valve and leading to maternal and fetal death. Although a causal relationship has not been established these deaths may have been due to therapeutic failure or inadequate anticoagulation. No patients in the。

核磁共振内标法定量分析肝素钠中多硫酸软骨素高照明;张玉冰;于永良【摘要】@@ 1 引言rn肝素钠是一种由葡萄糖胺,L-艾杜糖醛苷、N-乙酰葡萄糖胺和D-葡萄糖醛酸交替组成的黏多糖硫酸脂钠盐,是临床大量应用的抗凝血药.研究证明,肝素钠还具有抗炎、抗过敏、抗病毒,抗癌等多种生物学功能.2008年初,欧美各国发生了肝索钠注射液事件,致使81人死亡.随后,美国FDA应用核磁共振方法在肝素钠原料药中定性查出杂质多硫酸软骨素(OSCS),并认为OSCS是引起用药异常的杂质.肝素与OSCS均属于黏多糖硫酸脂聚合物,分子量分布都有一定宽度,且结构及性质相似,因此,常规的化学和生物检测方法很难区分[2].%The quantitative analysis of Oversulfated Chondroitin Sulfate by 1 H-NMR internal standard method has been developed in this paper. The optimum experimental conditions have been described. The linear range of the method was found to be 0. 1％-5 ％. The regression equation derived was y＝2. 7929x-0.0317(r＝0. 9994). The limit of detection was 0. 1％. The average recovery rate was shown to be 98. 1％(n＝6), and the RSD was 0.35 ％(n＝6). The results showed that 1 H-NMR can be used for the quantitative determination of contaminants in heparin.【期刊名称】《分析化学》【年(卷),期】2011(039)004【总页数】2页(P601-602)【作者】高照明;张玉冰;于永良【作者单位】生态化工教育部重点实验室,青岛科技大学化工学院,青岛,266042;生态化工教育部重点实验室,青岛科技大学化工学院,青岛,266042;生态化工教育部重点实验室,青岛科技大学化工学院,青岛,266042【正文语种】中文肝素钠是一种由葡萄糖胺,L-艾杜糖醛苷、N-乙酰葡萄糖胺和D-葡萄糖醛酸交替组成的黏多糖硫酸脂钠盐,是临床大量应用的抗凝血药。

低分子量肝素钠注射液以下内容仅供参考，请以药品包装盒中的说明书为准。

妊娠：C哺乳：L2，产后出血者禁用低分子量肝素钠注射液说明书【警告】对本品过敏者，急性细菌性心内膜炎，血小板减少症，事故性脑血管出血禁用【药品名称】低分子量肝素钠注射液【英文名】Low Molecular Weight Heparin Sodium Injection 【汉语拼音】Di fen zi liang Gan su na Zhu she ye【成份】本品主要成份为:重均分子量低于8000的硫酸氨基葡聚糖的钠盐。

辅料为亚硫酸氢钠、氯化钠。

【性状】本品为无色至淡黄色的澄明液体。

【适应症】抗凝血、抗血栓形成药，用于血液透析或血液过滤时，防止体外循环过程中血液凝固及预防血栓形成。

【规格】0.5ml：5000IU【用法用量】用法：皮下注射和静脉注射。

用量：剂量单位以抗Xa因子活性单位（anti-XaIU）计算，血液透析、血液灌流。

1、单次剂量：常规治疗病人，静脉快速注射70～80anti-XaIU/公斤体重。

2、连续剂量：初次急性病人，开始前静脉快速注射30～40anti-XaIU/公斤体重，继以静脉输注每小时10～15anti-XaIU/公斤体重。

3、有出血危险的危重病人，开始前静脉快速注射10～15anti-XaIU/公斤体重，继以静脉输注每小时5anti-XaIU/公斤体重。

4、特殊情况（如体重＞60公斤，病人体重减轻/增加或血液状态改变）剂量应根据需要个体化调整。

【不良反应】偶见异常皮肤粘膜出血、牙龈出血、皮疹及皮肤瘙痒等轻度过敏反应。

【禁忌】对本品过敏者，急性细菌性心内膜炎，血小板减少症，事故性脑血管出血禁用。

【注意事项】1、不能用于肌肉注射（肌注可致局部血肿）。

硬膜外麻醉方式者术前2至4小时慎用。

2、下列情况慎用：有过敏史者；有出血倾向及凝血机制障碍者包括胃、十二指肠溃疡，中风，严重肝、肾疾病，严重高血压，视网膜血管性病变。