| 单词 | recombinant | ||||||
| 释义 | recombinantre·com·bi·nantR0086900 (rē-kŏm′bə-nənt)recombinant(riːˈkɒmbɪnənt) geneticsre•com•bi•nant(riˈkɒm bə nənt)adj.
recombinantrecombinantGeneticsrecombinant[rē′käm·bə·nənt]recombinantrecombinant[re-kom´bĭ-nant]This process has had great impact in the field of medicine. It has revolutionized the manufacture of pharmaceutical products, where it is used to manufacture a variety of proteins used in the treatment of disease, including hormones, vaccines, and interferons. alteplase (tissue plasminogen activator, recombinant)Pharmacologic class: Plasminogen activator Therapeutic class: Thrombolytic Pregnancy risk category C ActionConverts plasminogen to plasmin, which in turn breaks down fibrin and fibrinogen, thereby dissolving thrombus AvailabilityInjection: 2-mg single-patient vials; 50-mg, 100-mg vials Indications and dosages➣ Lysis of thrombi obstructing coronary arteries in acute myocardial infarction (MI) 3-hour infusion- Adults: 100 mg I.V. over 3 hours as follows: 60 mg over first hour (give 6 to 10 mg as bolus over first 1 to 2 minutes), then 20 mg I.V. over second hour, then 20 mg I.V. over third hour Adults weighing less than 65 kg (143 lb): 1.25 mg/kg I.V. in divided doses over 3 hours, not to exceed 100 mg Accelerated infusion- Adults weighing more than 67 kg (147 lb): Give total dosage of 100 mg as follows: 15 mg I.V. bolus over 1 to 2 minutes, then 50 mg I.V. over next 30 minutes, then 35 mg I.V. over next 60 minutes. Adults weighing 67 kg (147 lb) or less: 15 mg I.V. bolus over 1 to 2 minutes, followed by 0.75 mg/kg I.V. over next 30 minutes (not to exceed 50 mg), followed by 0.5 mg/kg I.V. over next hour, not to exceed 35 mg ➣ Acute ischemic cerebrovascular accident (CVA) Adults: 0.9 mg/kg I.V. over 1 hour, to a maximum dosage of 90 mg, with 10% of total dosage given as I.V. bolus within first minute ➣ Acute massive pulmonary embolism Adults: 100 mg I.V. over 2 hours, followed by heparin ➣ Restoration of function of central venous access device Adults weighing 30 kg (66 lb) or more: Cathflo Activase-2 mg/2-ml concentration instilled in dysfunctional catheter. If catheter function isn't restored in 120 minutes after first dose, may give second dose. Adults weighing 10 kg (22 lb) to less than 30 kg: Cathflo Activase-Use 110% of catheter lumen volume not to exceed 2 mg/2-ml concentration instilled in dysfunctional catheter. If catheter function isn't restored in 120 minutes after first dose, may give second dose. Off-label uses• Small-vessel occlusion by microthrombi • Peripheral arterial thromboembolism Contraindications• Hypersensitivity to drug or its components (Cathflo Activase) • Seizures, stroke, aneurysm, intracranial neoplasm, bleeding diathesis PrecautionsUse cautiously in: • hypersensitivity to anistreplase or streptokinase • GI or genitourinary bleeding, ophthalmic hemorrhage, organ biopsy, severe hepatic or renal disease • elderly patients • pregnant or breastfeeding patients • children. AdministrationSee Be aware that intracranial hemorrhage must be ruled out before therapy begins. See To treat acute ischemic CVA, give within 3 hours of initial signs or symptoms. See If uncontrolled bleeding occurs, stop infusion and notify prescriber immediately. • Give I.V. only, using controlled-infusion pump. • Reconstitute with unpreserved sterile water for injection. May be further diluted with normal saline solution or D5W.  Adverse reactionsCNS: cerebral hemorrhage, cerebral edema, CVA (with accelerated infusion) CV: hypotension, bradycardia, recurrent ischemia, pericardial effusion, pericarditis, mitral regurgitation, electromechanical dissociation, arrhythmias, cardiogenic shock, heart failure, cardiac arrest, cardiac tamponade, myocardial rupture, embolization, venous thrombosis GI: nausea, vomiting, GI bleeding GU: GU tract bleeding Hematologic: spontaneous bleeding, bone marrow depression Musculoskeletal: musculoskeletal pain Respiratory: pulmonary edema Skin: bruising, flushing Other: fever, edema, phlebitis or bleeding at I.V. site, hypersensitivity reaction (including rash, anaphylactic reaction, laryngeal edema), sepsis InteractionsDrug-drug. Aspirin, drugs affecting platelet activity (such as abciximab, heparin, dipyridamole, oral anticoagulants, vitamin K antagonists): increased risk of bleeding Drug-diagnostic tests. Blood urea nitrogen: elevated level Patient monitoring• Monitor vital signs, ECG, and neurologic status. • Maintain strict bed rest. • Watch for signs and symptoms of bleeding tendency and hemorrhage. • Monitor patient on Cathflo Activase for GI bleeding, venous thrombosis, and sepsis. • Evaluate results of clotting studies. Patient teaching• As appropriate, explain therapy and monitoring to patient and family. coagulation factor VIIa (recombinant)Pharmacologic class: Coagulation factor VIIa Therapeutic class: Antihemophilic agent Pregnancy risk category C FDA Box Warning• Arterial and venous thrombotic and thromboembolic events following administration of NovoSeven RT have been reported during postmarketing surveillance. Clinical studies have shown an increased risk of arterial thromboembolic adverse events with NovoSeven RT when administered outside the current approved indications. Fatal and nonfatal thrombotic events have been reported. • Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven RT. • Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis. • Safety and efficacy of NovoSeven RT haven't been established outside the approved indications. ActionPromotes hemostasis by activating intrinsic pathway of coagulation cascade to form fibrin AvailabilityLyophilized powder for injection: 1 mg/vial, 2 mg/vial, 5 mg/vial Indications and dosages➣ Bleeding episodes in patients with hemophilia A or B who have inhibitors to factor VIII or IX and in patients with acquired hemophilia Adults: For hemostatic dosing, 90 mcg/kg I.V. bolus q 2 hours until hemostasis occurs or therapy is deemed ineffective. For posthemostatic dosing, appropriate dosing duration hasn't been determined. For severe bleeds, continue dosing at 3- to 6-hour intervals after hemostasis is achieved, to maintain hemostatic plug. ➣ Prevention of bleeding in surgical interventions or invasive procedures in patients with hemophilia A or B who have inhibitors to factor VIII or IX and in patients with acquired hemophilia Adults: Initially, 90 mcg/kg I.V. immediately before intervention and repeated at 2-hour intervals for duration of surgery. For minor surgery, administer postsurgical doses by I.V. bolus injection at 2-hour intervals for first 48 hours and then at 2- to 6-hour intervals until healing has occurred. For major surgery, administer postsurgical doses by I.V. injection at 2-hour intervals for 5 days, followed by 4-hour intervals until healing has occurred. Administer additional bolus doses, if required. ➣ Bleeding episodes or prevention of bleeding in surgical intervention or invasive procedures in patients with congenital factor VII deficiency Adults: 15 to 30 mcg/kg I.V. q 4 to 6 hours until hemostasis is achieved. Effective treatment has been achieved with dosages as low as 10 mcg/kg. ➣ Bleeding episodes or surgery in patients with acquired hemophilia Adults: 70 to 90 mcg/kg I.V., repeated q 2 to 3 hours until hemostasis is achieved ContraindicationsNone PrecautionsUse cautiously in: • hypersensitivity to drug, its components, or mouse, hamster, or bovine products • prolonged use of drug • concomitant use of activated or non-activated prothrombin complex concentrates (avoid use) • patients with increased risk of thromboembolic complications (including advanced atherosclerotic disease, crush injury, septicemia, history of coronary heart disease, liver disease, disseminated intravascular coagulation, postoperative immobilization, elderly patients and neonates) • pregnant or breastfeeding patients • children. Administration• Monitor factor VII-deficient patients for prothrombin time and factor VII coagulant activity before administering drug. See Give by I.V. bolus only over 2 to 5 minutes, depending on dosage. • Reconstitute only with specified volume of diluent supplied. See Don't mix with sterile water for injection or infusion solutions. See Don't inject diluent directly on the powder. • Administer within 3 hours of reconstituting. If line needs to be flushed before or after administering drug, use normal saline solution.  Adverse reactionsCNS: headache, cerebral artery occlusion, cerebrovascular accident CV: hypertension, hypotension, bradycardia, angina, superficial thrombophlebitis, thrombophlebitis, deep vein thrombosis, coagulation disorder, disseminated intravascular coagulation (DIC), increased fibrinolysis, purpura GI: nausea, vomiting GU: renal dysfunction Hematologic: purpura, hemorrhage, hemarthrosis, disseminated intravascular coagulation, coagulation disorders, decreased fibrinogen plasma, thrombosis Musculoskeletal: arthrosis, arthralgia Respiratory: pneumonia, pulmonary embolism Skin: pruritus, rash, urticaria Other: fever, edema, pain, redness or reaction at injection site, hypersensitivity reaction InteractionsDrug-drug. Activated prothrombin complex concentrates, prothrombin complex concentrates: risk of potential interaction (though not evaluated) Patient monitoringSee Monitor for signs and symptoms of coagulation activation or thrombosis. If DIC or thrombosis is confirmed, reduce dosage or discontinue drug, depending on patient's symptoms. • Monitor factor VII-deficient patients for prothrombin time and factor VII coagulant activity before and after administering drug. If factor VIIa activity fails to reach expected level, prothrombin time isn't corrected, or bleeding isn't controlled after treatment with recommended dosages, antibody formation may be suspected and analysis for antibodies should be performed. • Be aware that laboratory coagulation parameters may be used as adjunct to clinical evaluation of hemostasis to monitor drug efficacy and treatment schedule. However, these parameters lack direct correlation with achievement of hemostasis. • Monitor renal function tests. Patient teachingSee Instruct patient to immediately report signs and symptoms of hypersensitivity reactions (including hives, urticaria, chest tightness, or wheezing) and thrombosis (including new-onset swelling and pain in limbs or abdomen, new-onset chest pain, shortness of breath, loss of sensation, or altered consciousness or speech). • Instruct patient to report swelling, pain, burning, or itching at infusion site. • Tell patient to inform prescriber if she's pregnant or intends to become pregnant. • As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above. factor IX (human)factor IX (recombinant)factor IX complexPharmacologic class: Blood modifier Therapeutic class: Antihemophilic Pregnancy risk category C ActionConverts fibrinogen to fibrin, increasing levels of clotting factors AvailabilityPowder for injection: Various strengths; units specified on label Indications and dosages➣ Factor IX deficiency (hemophilia B or Christmas disease); anticoagulant overdose Adults and children: Dosage individualized; drug administered I.V. Use following equations to calculate approximate units needed: Human product-1 unit/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal Recombinant product-1.2 units/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal Proplex T-0.5 unit/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal Off-label uses• Hepatic dysfunction • Esophagitis • Unspecified GI hemorrhage (human product) Contraindications• Hypersensitivity to mouse or hamster protein (with BeneFix) • Fibrinolysis PrecautionsUse cautiously in: • recent surgery • pregnant patients • children younger than age 6 (safety and efficacy not established). AdministrationSee Give by slow I.V. infusion. Average infusion rate is 100 units (2 to 3 ml)/minute; don't exceed 10 ml/minute. • If prescribed, administer hepatitis B vaccine before giving factor IX. • Know that dosage is highly individualized according to degree of factor IX deficiency, patient's weight, and bleeding severity. • Don't use glass syringe. Don't shake reconstituted solution or mix with other I.V. solutions.  Adverse reactionsCNS: light-headedness, paresthesia, headache CV: blood pressure changes, thromboembolic reactions, myocardial infarction (MI) EENT: allergic rhinitis GI: nausea, vomiting Hematologic: disseminated intravascular coagulation (DIC) Respiratory: pulmonary embolism Skin: rash, flushing, diaphoresis, pruritus, urticaria Other: altered taste, fever, chills, burning sensation in jaw and skull, pain at I.V. injection site, hypersensitivity reactions including anaphylaxis InteractionsDrug-drug. Aminocaproic acid: increased risk of thrombosis Patient monitoring• Be aware that factor IX complex may transmit hepatitis. • Closely monitor vital signs during infusion. See Observe for hemolytic reaction. If it occurs, stop infusion, flush line with saline solution, and notify prescriber immediately. • Monitor I.V. injection site closely. See Monitor coagulation studies closely. Know that drug may cause thromboembolic disorders, including MI and DIC. Patient teaching• Inform patient that drug may transmit diseases. See Tell patient to immediately report signs and symptoms of hypersensitivity reaction, including rash, hives, tightness in chest, wheezing, shortness of breath, and swelling of throat or lips. See Advise patient to immediately report unusual bleeding or bruising. • Caution patient to avoid activities that can cause injury. • Tell patient to wear medical identification stating that he has a blood-clotting disorder. • Instruct patient to notify surgeon or dentist of his blood-clotting disorder before surgery or invasive dental procedures. • As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above. teriparatide (recombinant)Pharmacologic class: Biosynthetic fragment of human parathyroid hormone Therapeutic class: Parathyroid hormone Pregnancy risk category C FDA Box WarningIn male and female rats, drug increased incidence of osteosarcoma (malignant bone tumor). Because of uncertain relevance of this finding to humans, use drug only in patients for whom potential benefits outweigh potential risk. Don't administer to patient at increased baseline risk for osteosarcoma. ActionStimulates new bone growth by binding to specific high-affinity cell-surface receptors AvailabilityInjection: Multidose prefilled delivery device (pen) with 28 daily doses of 20 mcg/dose (600 mcg/2.4 ml) Indications and dosages➣ Osteoporosis in patients at high risk for bone fracture Adults: 20 mcg/day subcutaneously for up to 2 years Contraindications• Hypersensitivity to drug • Conditions that increase osteosarcoma risk (such as Paget's disease, unexplained alkaline phosphatase elevation, open epiphyses, skeletal radiation therapy) • Bone cancer metastases or history of bone cancer • Metabolic bone disease other than osteoporosis • Hypercalcemia PrecautionsUse cautiously in: • urolithiasis, hypotension • concurrent use of cardiac glycosides • pregnant or breastfeeding patients. Administration• Inject subcutaneously into thigh or abdominal wall, with patient lying down. • Know that prefilled injection pen delivers 20 mcg of drug per actuation and may be reused for up to 28 days after first injection. Discard pen in protected container after 28 days, even if it's not empty.  Adverse reactionsCNS: dizziness, headache, insomnia, depression, vertigo, asthenia CV: hypertension, angina, syncope EENT: rhinitis, pharyngitis GI: nausea, vomiting, diarrhea, dyspepsia, anorexia Metabolic: hyperuricemia Musculoskeletal: joint pain, cramps Respiratory: cough, dyspnea, pneumonia Skin: rash, sweating Other: pain InteractionsDrug-drug. Digoxin: increased digoxin toxicity Drug-diagnostic tests. Calcium: increased level Patient monitoring• Monitor respiratory and neurologic status and assess patient's mood. • Monitor bone mineral density tests and calcium level. Patient teaching• Instruct patient to promptly report such adverse reactions as cough and difficulty breathing. • Tell patient that prefilled injection pen delivers 20 mcg of drug per actuation. Inform him that he may reuse it for up to 28 days after first injection, and should then discard it in appropriate receptacle, even if it's not empty. • Advise patient to establish effective bedtime routine to minimize insomnia. • Caution patient to avoid driving and other hazardous activities until he knows how drug affects strength and balance. • As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above. re·com·bi·nant(rē-kom'bi-nănt),recombinant(rē-kŏm′bə-nənt)recombinantadjective Referring to a structural rearrangement or shuffling of genetic material that:(1) Occurs normally during meiosis; or (2) Is deliberately generated under controlled experimental conditions, as in recombinant DNA. noun An organism with a combination of alleles from either parent due to crossing over or independent assortment of chromosomes during meiosis. recombinantadjective Referring to a structural rearrangement or 'shuffling' of genetic material thatre·com·bi·nant(rē-kom'bi-nănt)recombinantPertaining to an organism, chromosome or segment of DNA produced by genetic material from more than one source.re·com·bi·nant(rē-kom'bi-nănt)recombinant
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