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  药店国别: 法国药房
产地国家: 法国
所属类别: 神经系统药物->麻醉药
处方药:处方药
包装规格: 50支/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
Septodont Inc.
生产厂家英文名:
Septodont Inc.
该药品相关信息网址1:
http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?id=699&type=display
原产地英文商品名:
SCANDONEST 3% PLAIN INJECTION 50vials/box
原产地英文药品名:
MEPIVACAINE HCl
中文参考商品译名:
SCANDONEST 3% PLAIN注射剂 50支/盒
中文参考药品译名:
盐酸甲哌卡因
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Anesthesia
英文适应病症2:
Oral and dental treatment in the local anesthesia
临床试验期:
完成
中文适应病症参考翻译1:
麻醉
中文适应病症参考翻译2:
口腔及牙科治疗中的局部浸润麻醉
药品信息:

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 详细处方信息以本药内容附件PDF文件(201161220214334.pdf、201161220221710.pdf)的“原文Priscribing Information”为准
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部分中文甲哌卡因处方资料(仅供参考)

[通用名]盐酸甲哌卡因

[英文名]Mepivacaine Hydrochloride

[药理毒理]
药理作用:
盐酸甲哌卡因盐酸盐是一种新型的氨基类局部麻醉剂。它作用于感觉及运动神经纤维,见效快,药效持续时间长,能有效阻碍神经传导。
在麻醉剂中加入肾上腺素可减缓盐酸甲哌卡因在人体内的运行速度,以确保麻醉时间和效果,并在一定程度上减小了用量。
毒理研究:
盐酸甲哌卡因对人体的半数致死毒量为5~10μg/ml,与利多卡因和普鲁卡因相比毒性更小。
尚无动物实验研究资料以确定其致癌性、致突变性和生殖毒性。也无有关人的资料表明本品可能具有致癌性、致突变性和生殖毒性。

[药代动力学]
当作用于外围神经传导阻滞,盐酸甲哌卡因在注射2~4分钟后开始见效。其在体内的分布率为0.8,与血浆蛋白的结合率为60~78%(主要与氧—糖蛋白),本身的pKa值为7.6。
通常600mg盐酸甲哌卡因在血浆中的半衰期为2~3小时,而对肝病和糖尿病患者而言,半衰期将延长。
盐酸甲哌卡因在人体的代谢主要由肝来完成。其绝大多数被胆汁分解,而经常吸收通过尿液排出(尿液的PH值可能因此受影响)。对于盐酸甲哌卡因放射性标记的病例,10%的放射性元素将以CO2的形式由肺排出。
对成人而言,最终排泄物中未经分解的盐酸甲哌卡因只占其总量的2.8~3.2%,而这个百分比对新生幼儿而言为43.3%。

[适应症]
主要用于口腔及牙科治疗中的局部浸润麻醉(神经传导阻滞型)。

[用法用量]
用法:区域注射,不得静脉注射。
剂量:成人每次治疗限用1~3剂。具体情况视麻醉范围及所用麻醉技术而定。
推注速度:应不超过每分钟1ml。
儿童、老人用药见[儿童用药]、[老年患者用药]项的详细描述。

[不良反应]
● 盐酸甲哌卡因
中枢神经系统:可能受盐酸甲哌卡因抑制或亢奋,产生眼球不自主运动、妄语、头疼、恶心等症状。
呼吸系统:呼吸困难,甚至呼吸暂停。
心血管系统:心动过缓,低血压等。可能导致室性期外收缩、室颤,甚至心跳停止。
过敏反应:荨麻疹,浮肿等。这些症状出现的可能性很小。

[禁忌症]
● 对氨基类麻醉剂或同类药品有过敏反应者。
● 患有以下心血管疾病者:高血压、心律失常、冠状动脉或风心病等心瓣膜疾病。
● 服用复方三环抗抑郁药及进行单胺氧化酶治疗的病人。

[注意事项]
对同一患者,一个疗程只能使用一次,而且针剂一经开封必须即时使用。
● 肝肾功能不良者尽可能避免使用本麻醉剂。
● 避免对患者已受感染或红肿的部位进行麻醉。
● 注射要缓慢进行,而且必须回抽以确保针头不在血管内。
● 本药品中含血管收缩剂,因此不能在同一区域重复使用,以免引起该区组织坏死。

[孕妇及哺乳期妇女用药]
孕妇及哺乳期妇女慎用。如需使用,应在有经验的麻醉意识指导下使用

[儿童用药]
●对3周岁以下儿童严禁使用本药。
●对儿童的用药剂量视患儿年龄、体重计所用具体治疗方式而定。
一般,儿童使用本麻醉剂的剂量为每公斤体重0.025ml(0.5mg盐酸甲哌卡因),但一次不能超过一剂。限定儿童一次可摄入盐酸甲哌卡因盐酸盐的最高限量为:
儿童体重(公斤)×1.33

[老年患者用药]
临床研究显示老年患者用药应减量。本品及其代谢物主要通过肾脏排除,而其毒性对肾功能损伤患者会有所增加,由于老年患者肾功能会有下降,因此应特别注意剂量的选择,并且及时监测肾脏功能。

[药物相互作用]
●本产品与复方三环抗抑郁药及单胺氧化酶有不良反应。
●本产品与以下药品也可能发生不良反应:
吩噻嗪、高血压药品、抗心律失常药、甲氰米胍,其他区域麻醉剂、镇静剂。

[药物过量]
过量或在静脉注射本药品都会使药物在血液中含量过高而引起严重后果。会出现痉挛和血压下降。一旦发生过量反应,应立即进行紧急抢救,若抢救不及时,会引起患者缺氧、体内酸中毒、心动过环、心律不齐甚至心跳停止。

[有效期] 二年。

[贮藏] 25℃以下避光保存,注意防潮。

[提示] 请在医生指导下使用。

Scandonest® 3% plain Mepivacaine HCl. 3% Injection, USP
Indications
Local dental anesthesia by infiltration or nerve block in adults and pediatric patients.
Local or loco-regional dental anesthesia (and chiropody procedures).

Features & Benefits
• Formulation without vaso-constrictor for specific medical situations.
• No-methylparaben formulation to avoid allergic reactions on sensitive patients.
• Terminal sterilization of product/cartridges for safe use.
• Latex-free plungers and seals.

Clinical Pharmacology
SCANDONEST stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia.

SCANDONEST is rapidly metabolized, with only a small percentage of the anesthetic (5 to 10 percent) being excreted unchanged in the urine. SCANDONEST, because of its amide structure, is not detoxified by the circulating plasma esterases. The liver is the principal site of metabolism, with over 50 percent of the administered dose being excreted into the bile as metabolites. Most of the metabolized mepivacaine is probably resorbed in the intestine and then excreted into the urine since only a small percentage is found in the feces. The principal route of excretion is via the kidney. Most of the anesthetic and its metabolites are eliminated within 30 hours. It has been shown that hydroxylation and N-demethylation, which are detoxification reactions, play important roles in the metabolism of the anesthetic. Three metabolites of mepivacaine have been identified from adult humans : two phenols, which are excreted almost exclusively as their glucuronide conjugates, and the N-demethylated compound (2', 6'-pipecoloxylidide).

The onset of action is rapid (30 to 120 seconds in the upper jaw ; 1 to 4 minutes in the lower jaw) and SCANDONEST 3% PLAIN will ordinarily provide operating anesthesia of 20 minutes in the upper jaw and 40 minutes in the lower jaw.

SCANDONEST 2% L with levonordefrin 1:20,000 provides anesthesia of longer duration for more prolonged procedures, 1 hour to 2.5 hours in the upper jaw and 2.5 hours to 5.5 hours in the lower jaw.

SCANDONEST does not ordinarily produce irritation or tissue damage.

Levonordefrin is a sympathomimetic amine used as a vasoconstrictor in local anesthetic solutions. It has pharmacologic activity similar to that of epinephrine but it is more stable than epinephrine. In equal concentrations, levonordefrin is less potent than epinephrine in raising blood pressure, and as a vasoconstrictor.

Indications and usage
SCANDONEST is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and children.

Contraindications
Mepivacaine is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.

Warnings
RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE. (See ADVERSE REACTIONS).

Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity.

Fatalities may occur with use of local anesthetics in the head and neck region as the result of retrograde arterial flow to vital CNS areas even when maximum recommended doses are observed. The practitioner should be alert to early evidences of alteration in sensorium or vital signs.

The solution which contains a vasoconstrictor (SCANDONEST 2% L) should be used with extreme caution for patients whose medical history and physical evaluation suggest the existence of hypertension, arteriosclerotic heart disease, cerebral vascular insufficiency, heart block, thyrotoxicosis and diabetes. etc.

The solution which contains a vasoconstrictor (SCANDONEST 2% L) also contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

SCANDONEST 3% PLAIN is sulfite free.

Precautions
The safety and effectiveness of mepivacaine depend upon proper dosage, correct technique, adequate precautions, and readiness for emergencies.

The lowest dose that results in effective anesthesia should be used to avoid high plasma levels and possible adverse effects. Injection of repeated doses of mepivacaine may cause significant increase in blood levels with each repeated dose due to slow accumulation of the drug or its metabolites, or due to slower metabolic degradation than normal.

Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their weight and physical status.

Mepivacaine should be used with caution in patients with a history of severe disturbances of cardiac rhythm or heart block.

INJECTIONS SHOULD ALWAYS BE MADE SLOWLY WITH ASPIRATION TO AVOID INTRAVASCULAR INJECTION AND THEREFORE SYSTEMIC REACTION TO BOTH LOCAL ANESTHETIC AND VASOCONSTRICTOR.

If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Young children should be given minimal doses of each agent.

Changes in sensorium such as excitation, disorientation, drowsiness, may be early indications of a high blood level of the drug and may occur following inadvertent intravascular administration or rapid absorption of mepivacaine.

Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.

Information for Patients
The patient should be cautioned against loss of sensation and possibility of biting trauma should the patient attempt to eat or chew gum prior to return of sensation.

Clinically Significant Drug Interactions
The administration of local anesthetic solutions containing vasopressors, such as levonordefrin, epinephrine or norepinephrine, to patients receiving tricyclic antidepressants or monoamine oxidase inhibitors may produce severe prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.

Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.

Solutions containing a vasoconstrictor should be used cautiously in the presence of diseases which may adversely affect the patient's cardiovascular system. Serious cardiac arrhythmias may occur if preparations containing a vasoconstrictor are employed in patients during or following the administration of potent inhalation anesthetics.

Mepivacaine SHOULD BE USED WITH CAUTION IN PATIENTS WITH KNOWN DRUG ALLERGIES AND SENSITIVITIES. A thorough history of the patient's prior experience with mepivacaine or other local anesthetics as well as concomitant or recent drug use should be taken (see CONTRAINDICATIONS). Patients allergic to methylparaben or paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, ect.) have not shown cross-sensitivity to agents of the amide type such as mepivacaine. Since mepivacaine is metabolized in the liver and excreted by the kidneys, it should be used cautiously in patients with liver and renal disease.

Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies of mepivacaine hydrochloride in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy
Teratogenic effects
Pregnancy Category C
Animal reproduction studies have not been conducted with this solution. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this solution, is administered to a nursing woman.

Pediatric Use
Great care must be exercised in adhering to safe concentrations and dosages for pedodontic administration (see DOSAGE AND ADMINISTRATION).

Adverse reactions
Systemic adverse reactions involving the central nervous system and the cardiovascular system usually result from high plasma levels due to excessive dosage, rapid absorption, or inadvertent intravascular injection.

A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance to normal dosage on the part of the patient.

Reactions involving the central nervous system are characterized by excitation and/or depression. Nervousness, dizziness, blurred vision, or tremors may occur followed by drowsiness, convulsions, unconsciousness, and possibly respiratory arrest. Since excitement may be transient or absent, the first manifestations may be drowsiness merging into unconsciousness and respiratory arrest.

Cardiovascular reactions are depressant. They may be the result of direct drug effect or more commonly in dental practice, the result of vasovagal reaction, particularly if the patient is in the sitting position. Failure to recognize premonitory signs such as sweating, feeling of faintness, changes in pulse or sensorium may result in progressive cerebral hypoxia and seizure or serious cardiovascular catastrophe. Management consists of placing the patient in the recumbent position and administration of oxygen. Vasoactive drugs such as ephedrine or methoxamine may be administered intravenously.

Allergic reactions are rare and may occur as a result of sensitivity to the local anesthetic and are characterized by cutaneous lesions of delayed onset or urticaria, edema and other manifestations of allergy. The detection of sensitivity by skin testing is of limited value. As with other local anesthetics, anaphylactoid reactions to mepivacaine have occurred rarely. The reactions may be abrupt and severe and are not usually dose related. Localized puffiness and swelling may occur.

Overdosage
Treatment of a patient with toxic manifestations consists of assuring and maintaining a patent airway and supporting ventilation (respiration) as required. This usually will be sufficient in the management of most reactions. Should a convulsion persist despite ventilatory therapy, small increments of anticonvulsive agents may be given intravenously, such as benzodiazepine (e.g . diazepam) or ultrashort-acting barbiturates (e.g. thiopental, or thiamylal) or short-acting barbiturates (e.g. pentobarbital or secobarbital). Cardiovascular depression may require circulatory assistance with intravenous fluids and/or vasopressor (e.g. ephedrine) as dictated by the clinical situation. Allergic reactions should be managed by conventional means.

Intravenous and subcutaneous LD50's in mice for mepivacaine hydrochloride 3% are 33 and 258 mg/kg, respectively. The acute IV and SC LD50's in mice for mepivacaine hydrochloride 2% with levonordefrin 1:20,000 are 30 and 184 mg/kg, respectively.

Dosage and administration
As with all local anesthetics the dose varies and depends upon the area to be anesthetized, the vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dose needed to provide effective anesthesia should be administered. For specific techniques and procedures refer to standard dental manuals and textbooks.

For infiltration and block injections in the upper or lower jaw, the average dose of 1 cartridge will usually suffice.

Each cartridge contains 1.7 mL (34 mg of 2% or 51 mg of 3%).

5.3 cartridges (180 mg of the 2% solution or 270 mg of the 3% solution) are usually adequate to effect anesthesia of the entire oral cavity. Whenever a larger dose seems to be necessary for an extensive procedure, the maximum dose should be calculated accordlng to the patient's weight. A dose of up to 3 mg per pound of body weight may be administered. At any single dental sitting the total dose for all injected sites should not exceed 400 mg in adults.

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 详细处方信息以本药内容附件PDF文件(201161220214334.pdf、201161220221710.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2011-6-13
附件:




201161220221710.pdf    

201161220214334.PDF    

 
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