部份中文枸橼酸芬太尼处方资料（仅供参考）
【药理毒理】
本品为人工合成的强效麻醉性镇痛药。镇痛作用机制与吗啡相似，为阿片受体激动剂，作用强度为吗啡的60～80倍。与吗啡和哌替啶相比，本品作用迅速，维持时间短，不释放组胺、对心血管功能影响小，能抑制气管插管时的应激反应。本品对呼吸的抑制作用弱于吗啡，但静脉注射过快则易抑制呼吸。有成瘾性。纳洛酮等能拮抗本品的呼吸抑制和镇痛作用。急性毒性LD50（mg/kg）：小鼠，皮下62；静脉11.2。　　
【药代动力学】
口服经胃肠道吸收，但临床一般采用注射给药。静脉注射1分钟即起效，4分钟达高峰，维持30～60分钟。肌内注射时约7～8分钟发生镇痛作用，可维持1～2小时。肌内注射生物利用度67%，蛋白结合率80%，消除T1/2约3.7小时。本品主要在肝脏代谢，代谢产物与约10%的原形药由肾脏排出。　　
【适应症】
本品为强效镇痛药，适用于麻醉前、中、后的镇静与镇痛，是目前复合全麻中常用的药物。
1. 用于麻醉前给药及诱导麻醉，并作为辅助用药与全麻及局麻药合用于各种手术。与氟哌利多(Droperidol)2.5mg和本品0.05mg的混合液，麻醉前给药，能使病人安静，对外界环境漠不关心，但仍能合作。
2. 用于手术前、后及术中等各种剧烈疼痛。　　
【用法用量】
1. 成人静脉注射；全麻时初量
① 小手术按体重0.001～0.002mg/kg（以芬太尼计，下同）；
② 大手术按体重0.002～0.004mg/kg；
③体外循环心脏手术时按体重0.02～0.03mg/kg计算全量，维持量可每隔30～60分钟给予初量的一半或连续静滴，一般每小时按体重0.001～0.002mg/kg；
④全麻同时吸入氧化亚氮按体重0.001～0.002mg/kg；
⑤局麻镇痛不全．作为辅助用药按体重0.0015～0.002mg/kg。
2. 成人麻醉前用药或手术后镇痛：按体重肌内或静脉注射0.0007～0.0015mg/kg。
3．小儿镇痛：2岁以下无规定，2～12岁按体重0.002～0.003mg/kg。
4．成人手术后镇痛：硬膜外给药，初量 0.1mg，加氯化钠注射液稀释到8ml，每2～4小时可重复，维持量每次为初量的一半。　　
【不良反应】
1. 一般不良反应为眩晕、视物模糊、恶心、呕吐、低血压、胆道括约肌痉挛、喉痉挛及出汗等。偶有肌肉抽搐。
2. 严重副反应为呼吸抑制、窒息、肌肉僵直及心动过缓，如不及时治疗，可发生呼吸停止、循环抑制及心脏停搏等。
3. 本品有成瘾性，但较哌替啶轻。　　
【禁忌症】 支气管哮喘、呼吸抑制、对本品特别敏感的病人以及重症肌无力病人禁用。禁止与单胺氧化酶抑制剂（如苯乙肼、帕吉林等）合用。 　　
【注意事项】
1．本品为国家特殊管理的麻醉药品，务必严格遵守国家对麻醉药品的管理条例，医院和病室的贮药处均应加锁，处方颜色应与其他药处方区别开。各级负责保管人员均应遵守交接班制度，不可稍有疏忽。
2．本品务必在单胺氧化酶抑制药（如呋喃唑酮、丙卡巴肼）停用14天以上方可给药，而且应先试用小剂量（1/4常用量），否则会发生难以预料的、严重的并发症，临床表现为多汗、肌肉僵直、血压先升高后剧降、呼吸抑制、发绀、昏迷、高热、惊厥，终致循环虚脱而死亡。
3. 心律失常、肝、肾、功能能不良、慢性梗阻性肺部疾患，呼吸储备力降低及脑外伤昏迷、颅内压增高、脑肿瘤等易陷入呼吸抑制的病人慎用。
4．本品药液有一定的刺激性，不得误入气管支气管，也不得涂敷于皮肤和黏膜。
5. 硬膜外注入本品镇痛时，一般4～10分钟起效，20分钟脑脊液的药浓度达到峰值，同时可有全身瘙痒，作用时效3.3～6.7小时，而且仍有呼吸频率减慢和潮气量减小的可能，处理应及时。
6．本品决非静脉全麻药．虽然大量快速静脉注射能使神智消失，但病人的应激反应依然存在，常伴有术中知晓。
7．快速推注本品可引起胸壁、腹壁肌肉僵硬而影响通气。　　
【孕妇及哺乳期妇女用药】 孕期用药的安全性尚难肯定，慎用。　　
【老年患者用药】
年老、体弱的病人首次剂量应适当减量，由首次剂量的效果考虑确定剂量的增加量。　　
【药物相互作用】
1．本品与哌替啶因化学结构有相似之处，两药可有交叉敏感。
2．本品与中枢抑制药，如催眠镇静药（巴比妥类、地西泮等）、抗精神病药（如吩噻嗪类）、其他麻醉性镇痛药以及全麻药等有协同作用，合用时应慎重并适当调整剂量。
3．本品与80%氧化亚氮合用，可诱发心率减慢、心肌收缩减弱、心排血量减少，左室功能欠佳者尤其明显。
4. 肌松药的用量可因本品的使用而相应减少，肌松药能解除本品的肌肉僵直，遇有呼吸暂停，持续的时间又长，应识别这是中枢性的（系本品使用所致），还是外周性的（由于肌松药作用于神经肌接头处N2受体）。
5．中枢抑制剂如巴比妥类、安定药、麻醉剂，有加强本品的作用，如联合应用，本品的剂量应减少1/4～1/3。　　
【药物过量】
大剂量快速静注可引起颈、胸、腹壁肌强直， 胸顺应性降低影响通气功能。偶可出现心率减慢、血压下降、瞳孔极度缩小等，最后可致呼吸停止、循环抑制或心停搏。中毒解救：出现肌肉强直者，可用肌松药或吗啡拮抗剂(如纳洛酮、丙烯吗啡等)对抗。呼吸抑制时立即采用吸氧、人工呼吸等急救措施，必要时亦可用吗啡特效拮抗药，静脉注射纳洛酮0.005～0.01mg/kg、成人0.4mg。心动过缓者可用阿托品治疗。本品与氟哌利多合用产生的低血压，可用输液、扩容等措施处理，无效时可采用升压药，当禁用肾上腺素。
Fentanyl 50 microgram/ml Injection
1. Name of the medicinal product
Fentanyl 50 microgram/ml Injection
2. Qualitative and quantitative composition
Fentanyl citrate 78.5 micrograms equivalent to 50 micrograms per ml fentanyl.
Each 2ml ampoule contains 100 micrograms of fentanyl as fentanyl citrate.
Each 10ml ampoule contains 500 micrograms of fentanyl as fentanyl citrate.
Each 50ml vial contains 2500 micrograms of fentanyl as fentanyl citrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Clear, colourless solution
4. Clinical particulars
4.1 Therapeutic indications
Fentanyl is a short acting opioid used
- as an analgesic component in general or local anaesthesia
- to provide analgesia during short surgical procedures
- as an analgesic/respiratory depressant in patients who need assisted ventilation
- in combination with a neuroleptic drug as part of the technique of neuroleptanalgesia
4.2 Posology and method of administration
Route of administration
Fentanyl should be given only in an environment where the airway can be controlled and by personnel who can control the airway (see section 4.4).
Intravenous administration either as a bolus or by infusion.
Intramuscular administration.
Fentanyl, by the intravenous route, can be administered to both adults and children. The dose of fentanyl should be individualised according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anaesthesia.
Adults
The usual dosage regimen in adults is as follows:

Initial	Supplemental
Spontaneous Respiration	50-200 mcg	50 mcg
Assisted Ventilation	300-3500 mcg	100-200 mcg

Doses in excess of 200 mcg are for use in anaesthesia only. As a premedicant, 1-2 ml fentanyl may be given intramuscularly 45 minutes before induction of anaesthesia.
After intravenous administration in unpremedicated adult patients, 2 ml fentanyl may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity. 10 ml fentanyl injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50 mcg/kg fentanyl will provide intense analgesia for some four to six hours, for intensely stimulating surgery.
Fentanyl may also be given as an infusion. In ventilated patients, a loading dose of fentanyl may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes followed by an infusion of approximately 0.1 mcg/kg/min. Alternatively the loading dose of fentanyl may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate. Unless it is planned to ventilate post-operatively, the infusion should be terminated at about 40 minutes before the end of surgery.
Lower infusion rates, e.g. 0.05-0.08 mcg/kg/minute are necessary if spontaneous ventilation is to be maintained. Higher infusion rates (up to 3 mcg/kg/minute) have been used in cardiac surgery.
Fentanyl is chemically incompatible with the induction agents thiopentone and methohexitone because of wide differences in pH.
Paediatric population
Children aged 12 to 17 years old:
Follow adult dosage.
Children aged 2 to 11 years old:
The usual dosage regimen in children is as follows:

	Age	Initial	Supplemental
Spontaneous Respiration	2-11 yrs	1-3 mcg/kg	1-1.25 mcg/kg
Assisted Ventilation	2-11 yrs	1-3 mcg/kg	1-1.25 mcg/kg

Use in children:
Analgesia during operation, enhancement of anaesthesia with spontaneous respiration
Techniques that involve analgesia in a spontaneous breathing child should only be used as part of an anaesthetic technique, or given as part of a sedation/ analgesia technique with experienced personnel in an environment that can manage sudden chest wall rigidity requiring intubation, or apnoea requiring airway support (see section 4.4).
Use in elderly and debilitated patients:
The initial dose should be reduced in the elderly and debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses.
4.3 Contraindications
Fentanyl should not be used in patients with
- known hypersensitivity to fentanyl citrate, other morphinomimetics or muscle relaxants.
- obstructive airways disease or any respiratory depression.
- concurrent administration with monoamine oxidase inhibitors or within 2 weeks of their discontinuation.
- brain trauma.
4.4 Special warnings and precautions for use
Fentanyl should be given only in an environment where the airway can be controlled and by personnel who can control the airway. Resuscitation equipment and opioid antagonists should be readily available.
In common with other narcotic analgesics, the most common serious adverse reactions with fentanyl are respiratory depression, bradycardia and skeletal muscle rigidity.
Significant respiratory depression will occur following the administration of fentanyl in doses in excess of 200 micrograms. This, and the other pharmacological effects of fentanyl, can be reversed by specific narcotic antagonists (eg naloxone). Additional doses of the latter may be necessary because the respiratory depression may last longer than the duration of action of the opioid antagonist.
Bradycardia and possible asystole can occur in non-atropinised patients , and can be antagonised by atropine.
Rigidity, which may also involve the thoracic muscles, can be avoided by the following methods:
-slow IV injection (usually sufficient for lower doses)
-premedication with benzodiazepines
-use of muscle relaxants
As with all narcotic analgesics, care should be observed when administering Fentanyl Injection to patients with myasthenia gravis.
Caution is required when fentanyl is used in patients with increased intracranial pressure.
Reduced dosage in elderly or debilitated patients should be considered. Carefully titrate dose and monitor closely in patients with hypothyroidism, pulmonary disease, decreased respiratory reserve, alcoholism and hepatic or renal impairment.
Patients on chronic opioid therapy or with a history of opioid abuse may require higher doses.
Administration in labour may cause respiratory depression in the new-born infant.
As with all potent opioids, profound analgesia is accompanied by marked respiratory depression, which may persist into or recur in the early post-operative period. It is imperative to ensure that adequate spontaneous breathing has been established and maintained before discharge from the recovery area whenever large doses of infusions of Fentanyl Injection have been administered. Hyperventilation during anaesthesia may alter the patient's response to CO2, thus affecting respiration post-operatively. Opioid pre-medication may potentiate or prolong depressant effects of fentanyl citrate.
A transient fall in blood pressure may occur following intravenous administration of fentanyl citrate injection, especially in hypovolaemic patients. Appropriate measures to maintain a stable arterial pressure should be taken.
Repeated use of fentanyl may result in the development of tolerance and dependence.
After fentanyl administration an increase of the bile duct pressure can be observed, in isolated cases a spasm of the Sphincter of Oddi may occur: This has to be taken into account during intraoperative diagnostic procedure in bile duct surgery and in pain management of intensive care patients.
As all other opioids, fentanyl can have an inhibitory effect on intestinal motility. This should be considered in the pain management of intensive care patients with inflammatory or obstructive intestinal diseases.
Serotonin Syndrome
Caution is advised when fentanyl is coadministered with drugs that affect the serotonergic neurotransmitter systems.
The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]). This may occur within the recommended dose.
Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperoreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
If serotonin syndrome is suspected, rapid discontinuation of fentanyl should be considered.
Paediatric population
Techniques that involve analgesia in a spontaneously breathing child should only be used as part of an anaesthetic technique, or given as part of a sedation / analgesia technique, with experienced personnel in an environment that can manage sudden chest wall rigidity requiring intubation, or apnoea requiring airway support.
4.5 Interaction with other medicinal products and other forms of interaction
CNS depressants: In patients concurrently receiving other central nervous system depressants (including sedatives, hypnotics, general anaesthetics, phenothiazines, other tranquillisers and alcohol) fentanyl should be used with caution and in reduced dosage because of the risk of respiratory depression, hypotension and profound sedation or coma. The pharmacological effects of fentanyl citrate can be reversed by naloxone.
Monoamine oxidase inhibitors: In patients with preceding medication with MAO inhibitors within the last 14 days before opioid administration life-threatening interactions with pethidine on the central nervous system (i.e. agitation, muscle rigidity, hyperpyrexia, convulsions), and the respiratory and circulatory system (i.e. circulatory depression, hypotension, haemodynamic instability and coma) have been observed and cannot be ruled out with fentanyl.
Clonidine: Co-administration of clonidine may enhance fentanyl effects and especially prolong fentanyl-induced respiratory depression.
Muscle relaxants: Vecuronium can cause haemodynamic depression when combined with fentanyl.
CYP3A4 inhibitors: Fentanyl, a high clearance drug, is rapidly and extensively metabolised mainly by CYP3A4. Potent CYP3A4 inhibitors (e.g. itraconazole, ritonavir, cimetidine) may inhibit the metabolism of fentanyl.
Prior administration of cimetidine may lead to increased plasma levels of fentanyl.
Oral ritonavir (one of the most potent CYP3A4 inhibitors), reduced the clearance of IV fentanyl by two thirds; however peak plasma concentrations after a single dose of fentanyl were not affected.
Similarly, itraconazole (a potent CYP3A4 inhibitor) at 200 mg/day given orally for 4 days had no significant effect on the pharmacokinetics of a single dose of intravenous fentanyl 3 micrograms/kg in ten healthy volunteers.
Co-administration of fluconazole or voriconazole (moderate CYP3A4 inhibitors) and fentanyl may result in an increased exposure to fentanyl.
When fentanyl is used in a single dose, the concomitant use of potent CYP3A4 inhibitors such as ritonavir requires special patient care and observation. With continuous treatment, dose reduction of fentanyl may be required to avoid accumulation of fentanyl, which may increase the risk of prolonged or delayed respiratory depression.
Droperidol: The concomitant use of droperidol can result in a higher incidence of hypotension.
Serotonergic drugs: Coadministration of fentanyl with a serotonergic agent, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition
Effect of fentanyl on other drugs
Following the administration of fentanyl, the dose of other CNS depressant drugs should be reduced.
The total plasma clearance and volume of distribution of etomidate is decreased by a factor 2 to 3 without a change in half-life when administered with fentanyl.
Simultaneous administration of fentanyl and intravenous midazolam results in an increase in the terminal plasma half-life and a reduction in the plasma clearance of midazolam. When these drugs are co-administered with fentanyl their dose may need to be reduced.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of fentanyl in pregnant women. Fentanyl can cross the placenta in early pregnancy. Studies in animals have shown some reproductive toxicity (see Section 5.3, Preclinical safety data). The potential risk for humans is unknown.
Administration during childbirth (including Caesarean section) is not recommended because fentanyl crosses the placenta and the foetal respiratory centre is particularly sensitive to opioids. If fentanyl is nevertheless administered, an antidote for the child should always be at hand.
Breast-feeding
Fentanyl is excreted into human milk. It is therefore recommended that breast-feeding is not initiated within 24 hours of treatment. The risk/benefit of breast-feeding following fentanyl administration should be considered.
4.7 Effects on ability to drive and use machines
Where early discharge (from clinical care) is envisaged, patients should be advised not to drive or to operate machinery for 24 hours after administration.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called 'statutory defence') if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
o It was not affecting your ability to drive safely
4.8 Undesirable effects
The safety of fentanyl IV was evaluated in 376 subjects who participated in 20 clinical trials evaluating fentanyl IV as an anaesthetic. These subjects took at least 1 dose of fentanyl IV and provided safety data. Based on pooled safety data from these clinical trials, the most commonly reported (≥5% incidence) Adverse Drug Reactions (ADRs) were (with % incidence): nausea (26.1); vomiting (18.6); muscle rigidity (10.4); hypotension (8.8); hypertension (8.8); bradycardia (6.1); and sedation (5.3).
Including the above-mentioned ADRs, Table 1 displays ADRs that have been reported with the use of fentanyl IV from either clinical trials or post-marketing experience.
The displayed frequency categories use the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data).
Table 1: Adverse Drug Reactions

System Organ Class	Adverse Drug Reactions
	Frequency Category
	Very Common (≥ 1/10)	Common (≥ 1/100 to < 1/10)	Uncommon (≥ 1/1,000 to < 1/100)	Not Known
Immune System Disorders				Hypersensitivity (such as anaphylactic shock, anaphylactic reaction, urticaria)
Psychiatric Disorders		Agitation	Euphoric mood
Nervous System Disorders		Dyskinesia; Sedation; Dizziness	Headache	Convulsions; Loss of consciousness; Myoclonus
Eye Disorders		Visual disturbance
Cardiac Disorders		Bradycardia; Tachycardia; Arrhythmia		Cardiac arrest
Vascular Disorders		Hypotension; Hypertension; Venous pain	Phlebitis; Blood pressure fluctuation
Respiratory, Thoracic and Mediastinal Disorders		Laryngospasm; Bronchospasm; Apnoea	Hyperventilation; Hiccups	Respiratory depression
Gastrointestinal Disorders	Nausea; Vomiting
Skin and Subcutaneous Tissue Disorders		Allergic dermatitis		Pruritus
Musculoskeletal, connective tissue and bone disorders	Muscle rigidity (which may also involve the thoracic muscles)
General Disorders and Administration Site Conditions			Chills; Hypothermia
Injury, Poisoning and Procedural Complications		Postoperative confusion	Airway complication of anaesthesia

When a neuroleptic is used with fentanyl, the following adverse reactions may be observed: chills and/or shivering, restlessness, postoperative hallucinatory episodes and extrapyramidal symptoms (see Section 4.4).
The opioid specific effect on smooth muscles may lead to increased muscle tone of the ureter resulting in urinary retention, especially in patients with prostatic hypertrophy.
Other adverse events (frequency unknown) include spasm of the sphincter of Oddi, constipation, increased sweating and coughing.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the MHRA website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
As with other narcotic analgesics the possible manifestations of fentanyl overdosage include respiratory depression and hypotension, with circulatory failure and deepening coma.
Intensive supportive therapy may be required to correct respiratory failure and shock. A patent airway must be maintained and assisted respiration may be required. The specific narcotic antagonist naloxone hydrochloride is used to counteract respiratory depression and coma. A dose of 0.4 to 2 mg is given intravenously and may be repeated at intervals of 2 to 3 minutes if necessary, up to 10 mg. The duration of respiratory depression following overdosage with fentanyl may exceed the duration of narcotic antagonist action. Muscle rigidity may be treated with intravenous neuromuscular blocking agent.
The patient should be carefully observed; body warmth and adequate fluid intake should be maintained. If hypotension is severe or if it persists, the possibility of hypovolaemia should be considered and, if present, it should be controlled with appropriate parenteral fluid administration.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Phenylpiperidine derivatives, Opioids
ATC code: N02AB
Fentanyl citrate is a potent narcotic analgesic
The principal actions of therapeutic value are analgesia and sedation. When used with a neuroleptic agent it can induce a state of neuroleptanalgesia. As with other narcotic analgesics, fentanyl depresses respiration and this effect increases as the dose is increased.
Following intravenous injection fentanyl has rapid onset of action, although the maximal analgesic and respiratory depressant effect may not occur for several minutes.
Fentanyl Injection is usually given by the intravenous route.
5.2 Pharmacokinetic properties
After intravenous injection the fentanyl plasma concentrations decrease rapidly. The disposition of fentanyl is triphasic with half-lifes of about 1 minute, 15 minutes and 6 hours. Fentanyl has a volume of distribution of the central compartment of about 15 litres and a total volume of distribution of about 400 litres.
Especially in elderly patients or after repeated administration, half-lifes may be prolonged. Secondary peak plasma levels may occur.
Fentanyl is 80 – 85 % bound to plasma proteins. Fentanyl is metabolised rapidly, mainly in the liver, mainly by oxidative N-desalkylation. The clearance is about 0.5 l/hour/kg. About 75 % of the administered dose is eliminated within 24 hours. Only 10 % of the dose is excreted as intact substance.
5.3 Preclinical safety data
In vitro fentanyl showed, like other opioid analgesics, mutagenic effects in a mammalian cell culture assay, only at cytotoxic concentrations and along with metabolic activation. Fentanyl showed no evidence of mutagenicity when tested in in vivo rodent studies and bacterial assays. In a two-year rat bioassay, fentanyl was not carcinogenic.
Some tests on female rats showed reduced fertility as well as embryo mortality. These findings were related to maternal toxicity and not a direct effect of the drug on the developing embryo. There was no evidence of teratogenic effects.)
6. Pharmaceutical particulars
6.1 List of excipients
Sodium chloride, Water for Injections, hydrochloric acid or sodium hydroxide for pH adjustment.
6.2 Incompatibilities
Fentanyl citrate is reportedly physically incompatible with pentobarbital sodium, methohexital sodium, thiopental sodium and nafcilline.
6.3 Shelf life
Shelf-life of the product as package for sale:
3 years (36 months)
Shelf-life after dilution:
24 hours
Shelf-life after first opening: use immediately.
6.4 Special precautions for storage
Keep the vial/ ampoules in the outer carton
Chemical and physical in-use stability has been demonstrated for 24 hours at 20-25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled validated aseptic conditions.
6.5 Nature and contents of container
2 ml or 10 ml clear glass ampoules, glass type I Ph. Eur., packed in cardboard cartons and containing 5 x 2 ml/10 ml ampoules or 10 x 2 ml/10 ml ampoules.
50 ml clear glass vial, glass type I Ph. Eur., closed with bromobutyl rubber stopper packed in a cardboard carton containing one vial.
6.6 Special precautions for disposal and other handling
Use finger protection when opening an ampoule.
The injection (both ampoules and vials) is for single patient use and should be used immediately after opening. The injection should not be used if particles are present. Any unused portion should be discarded.
The product can be used either undiluted or diluted. Dilution ranges tested with 0.9 % sodium chloride and 5 % glucose solutions are 1:1 and 1:25. Hence the maximal dilution must not exceed 1 part fentanyl with 25 parts 0.9 % sodium chloride or 5 % glucose solutions.
7. Marketing authorisation holder
hameln pharmaceuticals ltd.
Nexus
Gloucester Business Park
Gloucester
GL3 4AG
UK
8. Marketing authorisation number(s)
PL 01502/0062
9. Date of first authorisation/renewal of the authorisation
10/01/2011
10. Date of revision of the text
07/09/2014
提示：本品属管制（麻醉药品）药品，不供个人使用！另外;需要其他的厂家以咨询为准。
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产地国家: 美国
原产地英文商品名:
Fentanyl injection 100mcg/2mL(0.05mg/mL)/Box
原产地英文药品名:
Fentanyl Citrate
中文参考商品译名:
Fentanyl注射液 100微克/2毫升（0.05毫克/毫升）/瓶  25瓶/盒
中文参考药品译名:
枸橼酸芬太尼
生产厂家中文参考译名:
West-ward Pharmaceutical Corp
生产厂家英文名:
West-ward Pharmaceutical Corp

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产地国家: 美国
原产地英文商品名:
Fentanyl injection 250mcg/5mL(0.05mg/mL)/Box
原产地英文药品名:
Fentanyl Citrate
中文参考商品译名:
Fentanyl注射液 250微克/2毫升（0.05毫克/毫升）/瓶  25瓶/盒
中文参考药品译名:
枸橼酸芬太尼
生产厂家中文参考译名:
West-ward Pharmaceutical Corp
生产厂家英文名:
West-ward Pharmaceutical Corp

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产地国家: 美国
原产地英文商品名:
Fentanyl injection 2500mcg/50mL(0.05mg/mL)/Box
原产地英文药品名:
Fentanyl Citrate
中文参考商品译名:
Fentanyl注射液 2500微克/50毫升（0.05毫克/毫升）/瓶  25瓶/盒
中文参考药品译名:
枸橼酸芬太尼
生产厂家中文参考译名:
West-ward Pharmaceutical Corp
生产厂家英文名:
West-ward Pharmaceutical Corp