Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1284
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Sufentanil Citrate (Injection)
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The dosage of sufentanil should
be individualized in each case according to body weight, physical status, underlying
pathological condition, use of other drugs, and type of surgical procedure and
anesthesia. In obese patients (more than 20% above ideal total body weight), the
dosage of sufentanil should be determined on the basis of lean body weight. Dosage
should be reduced in elderly and debilitated patients . Vital signs should be monitored
routinely. Because the clearance of
sufentanil is reduced in neonates, especially those with cardiovascular disease, the
dose of sufentanil should be reduced accordingly .<br/>Intravenous Use: Sufentanil citrate may be
administered intravenously by slow injection or infusion 1) in doses up to 8 mcg/kg as an analgesic adjunct to general
anesthesia and 2) in doses���8 mcg/kg as a
primary anesthetic agent for induction and maintenance of anesthesia (seeDosage Range Chart).
If benzodiazepines, barbiturates, inhalation agents, other opioids or other
central nervous system depressants are used concomitantly, the dose of sufentanil
and/or these agents should be reduced . In all
cases, dosage should be titrated to individual patient response.<br/>Usage In Children: For induction and
maintenance of anesthesia in pediatric patients less than 12 years of age
undergoing cardiovascular surgery, an anesthetic dose of 10-25 mcg/kg
administered with 100% oxygen is generally recommended. Supplemental dosages
of up to 25-50 mcg are recommended for maintenance, based on response to
initial dose and as determined by changes in vital signs indicating surgical
stress or lightening of anesthesia.<br/>Premedication: The selection of
preanesthetic medications should be based upon the needs of the individual
patient.<br/>Neuromuscular Blocking Agents: The neuromuscular
blocking agent selected should be compatible with the patient's condition,
taking into account the hemodynamic effects of a particular muscle relaxant
and the degree of skeletal muscle relaxation required (see CLINICAL
PHARMACOLOGY, WARNINGS andPRECAUTIONS). In patients
administered high doses of sufentanil, it is essential that quali���ed personnel
and adequate facilities are available for the management of postoperative
respiratory depression. Also see WARNINGS andPRECAUTIONS
sections. For purposes of
administering small volumes of Sufentanil Citrate Injection accurately, the
use of a tuberculin syringe or equivalent is recommended. Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration,
whenever solution and container permit.
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Sufentanil Citrate Injection,
USP is a sterile, nonpyrogenic, aqueous solution for intravenous and epidural
injection. Each mL contains sufentanil citrate equivalent to 50 mcg (0.05 mg) of
sufentanil in Water for Injection. pH 3.5���6.0; citric acid added, if needed, for pH
adjustment. Contains no preservative. Sufentanil Citrate is a potent opioid analgesic
chemically designated as
N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide
2-hydroxy-1,2,3-propanetricarboxylate (1:1) with the following structural formula:
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Pharmacology: Sufentanil is an opioid
analgesic. When used in balanced general anesthesia, sufentanil has been reported
to be as much as 10 times as potent as fentanyl. When administered intravenously
as a primary anesthetic agent with 100% oxygen, sufentanil is approximately 5 to 7
times as potent as fentanyl. Assays of histamine in
patients administered sufentanil citrate have shown no elevation in plasma
histamine levels and no indication of histamine release. (See dosage chart for more
complete information on the intravenous use of Sufentanil Citrate
Injection.)<br/>Pharmacodynamics:<br/>Intravenous Use: At intravenous doses up
to 8 mcg/kg, sufentanil is an analgesic component of general anesthesia; at
intravenous doses���8 mcg/kg, sufentanil produces a deep level of anesthesia.
Sufentanil produces a dose-related attenuation of catecholamine release,
particularly norepinephrine. At intravenous dosages���8 mcg/kg, sufentanil produces hypnosis and anesthesia without the use of
additional anesthetic agents. A deep level of anesthesia is maintained at
these dosages, as demonstrated by EEG patterns. Dosages of up to 25 mcg/kg
attenuate the sympathetic response to surgical stress. The catecholamine
response, particularly norepinephrine, is further attenuated at doses of
sufentanil of 25-30 mcg/kg, with hemodynamic stability and preservation of
favorable myocardial oxygen balance. Sufentanil has an
immediate onset of action with relatively limited accumulation. Rapid
elimination from tissue storage sites allows for relatively more rapid
recovery as compared with equipotent dosages of fentanyl. At dosages of 1-2
mcg/kg, recovery times are comparable to those observed with fentanyl; at
dosages>2-6 mcg/kg, recovery times are comparable to en���urane,
iso���urane and fentanyl. Within the anesthetic dosage range of 8-30 mcg/kg of
sufentanil, recovery times are more rapid compared to equipotent fentanyl
dosages. The vagolytic effects
of pancuronium may produce a dose-dependent elevation in heart rate during
sufentanil-oxygen anesthesia. Moderate doses of pancuronium or of a less
vagolytic neuromuscular blocking agent may be used to maintain a stable lower
heart rate and blood pressure during sufentanil-oxygen anesthesia. The
vagolytic effects of pancuronium may be reduced in patients administered
nitrous oxide with sufentanil. Preliminary data
suggest that in patients administered high doses of sufentanil, initial dosage
requirements for neuromuscular blocking agents are generally lower as compared
to patients given fentanyl or halothane, and comparable to patients given
en���urane. Bradycardia is
infrequently seen in patients administered sufentanil-oxygen anesthesia. The
use of nitrous oxide with high doses of sufentanil may decrease mean arterial
pressure, heart rate and cardiac output. Sufentanil at 20 mcg/kg
has been shown to provide more adequate reduction in intracranial volume than
equivalent doses of fentanyl, based upon requirements for furosemide and
anesthesia supplementation in one study of patients undergoing craniotomy.
During carotid endarterectomy, sufentanil-nitrous oxide/oxygen produced
reductions in cerebral blood���ow comparable to those of en���urane-nitrous
oxide/oxygen. During cardiovascular surgery, sufentanil-oxygen produced EEG
patterns similar to fentanyl-oxygen; these EEG changes were judged to be
compatible with adequate general anesthesia. The intraoperative use
of sufentanil at anesthetic dosages maintains cardiac output, with a slight
reduction in systemic vascular resistance during the initial postoperative
period. The incidence of postoperative hypertension, need for vasoactive
agents and requirements for postoperative analgesics are generally reduced in
patients administered moderate or high doses of sufentanil as compared to
patients given inhalation agents. Skeletal muscle
rigidity is related to the dose and speed of administration of sufentanil.
This muscular rigidity may occur unless preventative measures are taken . Decreased respiratory
drive and increased airway resistance occur with sufentanil. The duration and
degree of respiratory depression are dose related when sufentanil is used at
sub-anesthetic dosages. At high doses, a pronounced decrease in pulmonary
exchange and apnea may be produced.<br/>Epidural Use In Labor And
Delivery: Onset of analgesic
effect occurs within approximately 10 minutes of administration of epidural
doses of sufentanil and bupivacaine. Duration of analgesia following a single
epidural injection of 10-15 mcg sufentanil and bupivacaine 0.125% averaged 1.7
hours. During labor and
vaginal delivery, the addition of 10-15 mcg sufentanil to 10 mL 0.125%
bupivacaine provides an increase in the duration of analgesia compared to
bupivacaine without an opioid. Analgesia from 15 mcg sufentanil plus 10 mL
0.125% bupivacaine is comparable to analgesia from 10 mL of 0.25% bupivacaine
alone. Apgar scores of neonates following epidural administration of both
drugs to women in labor were comparable to neonates whose mothers received
bupivacaine without an opioid epidurally.<br/>Pharmacokinetics:<br/>Intravenous Use: The pharmacokinetics of
intravenous sufentanil can be described as a three-compartment model with a distribution time of 1.4 minutes, redistribution of 17.1 minutes and an
elimination half-life of 164 minutes in adults. The elimination half-life of
sufentanil is shorter (e.g. 97��42 minutes) in infants and children, and
longer in neonates (e.g. 434��160 minutes) compared to that of adolescents
and adults. The liver and small intestine are the major sites of
biotransformation. Approximately 80% of the administered dose is excreted
within 24 hours and only 2% of the dose is eliminated as unchanged drug.
Plasma protein binding of sufentanil, related to the alphaacid
glycoprotein concentration, was approximately 93% in healthy males, 91% in
mothers and 79% in neonates.<br/>Epidural Use In Labor And
Delivery: After epidural
administration of incremental doses totaling 5-40 mcg sufentanil during labor
and delivery, maternal and neonatal sufentanil plasma concentrations were at
or near the 0.05-0.1 ng/mL limit of detection, and were slightly higher in
mothers than in their infants.<br/>Clinical Studies:<br/>Epidural Use In Labor And
Delivery: Epidural sufentanil was
tested in 340 patients in two (one single-center and one multi-center)
double-blind, parallel studies. Doses ranged from 10 to 15 mcg sufentanil and
were delivered in a 10 mL volume of 0.125% bupivacaine with and without
epinephrine 1:200,000. In all cases, sufentanil was administered following a
dose of local anesthetic to test proper catheter placement. Since epidural
opioids and local anesthetics potentiate each other, these results may not
re���ect the dose or ef���cacy of epidural sufentanil by itself. Individual doses of
10-15 mcg sufentanil plus bupivacaine 0.125% with epinephrine provided
analgesia during the���rst stage of labor with a duration of 1-2 hours. Onset
was rapid (within 10 minutes). Subsequent doses (equal dose) tended to have
shorter duration. Analgesia was profound (complete pain relief) in 80% to 100%
of patients and a 25% incidence of pruritus was observed. The duration of
initial doses of sufentanil plus bupivacaine with epinephrine is approximately
95 minutes, and of subsequent doses, 70 minutes. There are insuf���cient
data to critically evaluate neonatal neuromuscular and adaptive capacity
following recommended doses of maternally administered epidural sufentanil
with bupivacaine. However, if larger than recommended doses are used for
combined local and systemic analgesia, e.g., after administration of a single
dose of 50 mcg epidural sufentanil during delivery, then impaired neonatal
adaption to sound and light can be detected for 1 to 4 hours and if a dose of
80 mcg is used, impaired neuromuscular coordination can be detected for more
than 4 hours.
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Sufentanil Citrate Injection is
contraindicated in patients with known hypersensitivity to the drug or known
intolerance to other opioid agonists.
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Sufentanil Citrate Injection,
USP, equivalent to 50 mcg (0.05 mg) sufentanil per mL, is available in the following: 1 mL (50 mcg) DOSETTE ampuls
packaged in 10s (NDC 10019-050-43) 2 mL (100 mcg) DOSETTE ampuls
packaged in 10s (NDC 10019-050-21) 5 mL (250 mcg) DOSETTE ampuls
packaged in 10s (NDC 10019-050-06)<br/>Storage: PROTECT FROM LIGHT: Keep covered in carton until time of
use. Store at 20��-25��C (68��-77��F), excursions permitted to
15��-30��C (59��-86��F) [see USP Controlled Room Temperature]. Baxter and Dosette are
trademarks of Baxter International Inc., or its subsidiaries. Manufactured by Baxter Healthcare Corporation Deerfield, IL 60015 USA For Product Inquiry 1 800
ANA DRUG (1-800-262-3784) MLT-7/1.0
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General: The initial dose of
sufentanil should be appropriately reduced in elderly and debilitated patients.
The effect of the initial dose should be considered in determining supplemental
doses. Vital signs should be
monitored routinely. Nitrous oxide may produce
cardiovascular depression when given with high doses of sufentanil (see CLINICAL
PHARMACOLOGY). Bradycardia has been
reported infrequently with sufentanil-oxygen anesthesia and has been responsive to
atropine. Respiratory depression
caused by opioid analgesics can be reversed by opioid antagonists such as
naloxone. Because the duration of respiratory depression produced by sufentanil
may last longer than the duration of the opioid antagonist action, appropriate
surveillance should be maintained. As with all potent opioids, profound analgesia
is accompanied by respiratory depression and diminished sensitivity to
COstimulation which may persist into or recur in the postoperative
period. Respiratory depression may be enhanced when sufentanil is administered in
combination with volatile inhalational agents and/or other central nervous system
depressants such as barbiturates, tranquilizers and other opioids. Appropriate
postoperative monitoring should be employed to ensure that adequate spontaneous
breathing is established and maintained prior to discharging the patient from the
recovery area. Respiration should be closely monitored following each
administration of an epidural injection of sufentanil. Proper placement of the
needle or catheter in the epidural space should be veri���ed before sufentanil is
injected to assure that unintentional intravascular or intrathecal administration
does not occur. Unintentional intravascular injection of sufentanil could result
in a potentially serious overdose, including acute truncal muscular rigidity and
apnea. Unintentional intrathecal injection of the full sufentanil/bupivacaine
epidural doses and volume could produce effects of high spinal anesthesia
including prolonged paralysis and delayed recovery. If analgesia is inadequate,
the placement and integrity of the catheter should be veri���ed prior to the
administration of any additional epidural medications. Sufentanil should be
administered epidurally by slow injection.<br/>Neuromuscular Blocking Agents: The hemodynamic effects
and degree of skeletal muscle relaxation required should be considered in the
selection of a neuromuscular blocking agent. High doses of pancuronium may
produce increases in heart rate during sufentanil-oxygen anesthesia.
Bradycardia and hypotension have been reported with other muscle relaxants
during sufentanil-oxygen anesthesia; this effect may be more pronounced in the
presence of calcium channel and/or beta blockers. Muscle relaxants with no
clinically signi���cant effect on heart rate (at recommended doses) would not
counteract the vagotonic effect of sufentanil; therefore, a lower heart rate
would be expected. Rare reports of bradycardia associated with the concomitant
use of succinylcholine and sufentanil have been reported.<br/>Interaction With Calcium
Channel And Beta Blockers: The incidence and
degree of bradycardia and hypotension during induction with sufentanil may be
greater in patients on chronic calcium channel and beta blocker therapy. (SeeNeuromuscular Blocking
Agents.)<br/>Interaction With Other
Central Nervous System Depressants: Both the magnitude and
duration of central nervous system and cardiovascular effects may be enhanced
when sufentanil is administered to patients receiving barbiturates,
tranquilizers, other opioids, general anesthetics or other CNS depressants. In
such cases of combined treatment, the dose of sufentanil and/or these agents
should be reduced. The use of
benzodiazepines with sufentanil during induction may result in a decrease in
mean arterial pressure and systemic vascular resistance.<br/>Head Injuries: Sufentanil may obscure
the clinical course of patients with head injuries.<br/>Impaired Respiration: Sufentanil should be
used with caution in patients with pulmonary disease, decreased respiratory
reserve or potentially compromised respiration. In such patients, opioids may
additionally decrease respiratory drive and increase airway resistance. During
anesthesia, this can be managed by assisted or controlled
respiration.<br/>Impaired Hepatic Or Renal
Function: In patients with liver
or kidney dysfunction, sufentanil citrate should be administered with caution
due to the importance of these organs in the metabolism and excretion of
sufentanil.<br/>Carcinogenesis, Mutagenesis,
Impairment Of Fertility: No long-term animal
studies of sufentanil have been performed to evaluate carcinogenic potential.
The micronucleus test in female rats revealed that single intravenous doses of
sufentanil as high as 80 mcg/kg (approximately 2.5 times the upper human
intravenous dose) produced no structural chromosome mutations. The AmesSalmonella typhimurium metabolic
activating test also revealed no mutagenic activity. See Animal
Toxicology for reproduction studies in rats and
rabbits.<br/>Pregnancy:<br/>Teratogenic Effects���Pregnancy
Category C.: Sufentanil has been
shown to have an embryocidal effect in rats and rabbits when given in doses
2.5 times the upper human intravenous dose for a period of 10 days to over 30
days. These effects were most probably due to maternal toxicity (decreased
food consumption with increased mortality) following prolonged administration
of the drug. No evidence of
teratogenic effects have been observed after administration of sufentanil
citrate in rats or rabbits.<br/>Labor and Delivery: The use of epidurally
administered sufentanil in combination with bupivacaine 0.125% with or without
epinephrine is indicated for labor and delivery. (See INDICATIONS AND
USAGE and DOSAGE AND
ADMINISTRATION.) Sufentanil is not recommended for intravenous use or
for use of larger epidural doses during labor and delivery because of potential
risks to the newborn infant after delivery. In clinical trials, one case of severe
fetal bradycardia associated with maternal hypotension was reported within 8
minutes of maternal administration of sufentanil 15 mcg plus bupivacaine 0.125%
(10 mL total volume).<br/>Nursing Mothers: It is not known whether
sufentanil is excreted in human milk. Because fentanyl analogs are excreted in
human milk, caution should be exercised when sufentanil citrate is administered to
a nursing woman.<br/>Pediatric Use: The safety and ef���cacy of
intravenous sufentanil in pediatric patients as young as 1 day old undergoing
cardiovascular surgery have been documented in a limited number of cases. The
clearance of sufentanil in healthy neonates is approximately one-half that in
adults and children. The clearance rate of sufentanil can be further reduced by up
to a third in neonates with cardiovascular disease, resulting in an increase in
the elimination half-life of the drug.<br/>Animal Toxicology: The intravenous
LDof sufentanil is 16.8 to 18.0 mg/kg in mice, 11.8 to 13.0 mg/kg in
guinea pigs and 10.1 to 19.5 mg/kg in dogs. Reproduction studies performed in rats
and rabbits given doses up to 2.5 times the upper human intravenous dose for a
period of 10 to over 30 days revealed high maternal mortality rates due to
decreased food consumption and anoxia, which preclude any meaningful
interpretation of the results. Epidural and intrathecal injections of sufentanil
in dogs and epidural injections in rats were not associated with
neurotoxicity.
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Overdosage is manifested by an
extension of the pharmacological actions of sufentanil
as with other potent opioid analgesics. The most serious and significant effect of
overdose for both intravenous and epidural administration of sufentanil is respiratory
depression. Intravenous administration of an opioid antagonist such as naloxone should
be employed as a speci���c antidote to manage respiratory depression. The duration of
respiratory depression following overdosage with sufentanil may be longer than the
duration of action of the opioid antagonist. Administration of an opioid antagonist
should not preclude more immediate countermeasures. In the event of overdosage, oxygen
should be administered and ventilation assisted or controlled as indicated for
hypoventilation or apnea. A patent airway must be maintained, and a nasopharyngeal
airway or endotracheal tube may be indicated. If depressed respiration is associated
with muscular rigidity, a neuromuscular blocking agent may be required to facilitate
assisted or controlled respiration. Intravenous���uids and vasopressors for the
treatment of hypotension and other supportive measures may be employed.
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Sufentanil Citrate
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Sufentanil Citrate (Injection)
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The most common adverse
reactions of opioids are respiratory depression and skeletal muscle rigidity,
particularly of the truncal muscles. Sufentanil may produce muscular rigidity that
involves the skeletal muscles of the neck and extremities. See CLINICAL PHARMACOLOGY,WARNINGS and PRECAUTIONS on the
management of respiratory depression and skeletal muscle rigidity. Urinary retention
has been associated with the use of epidural opioids but was not reported in the
clinical trials of epidurally administered sufentanil due to the use of indwelling
catheters. The incidence of urinary retention in patients without urinary catheters
receiving epidural sufentanil is unknown; return of normal bladder activity may be
delayed. The following adverse reaction
information is derived from controlled clinical trials in 320 patients who received
intravenous sufentanil during surgical anesthesia and in 340 patients who received
epidural sufentanil plus bupivacaine 0.125% for analgesia during labor. Based on the
observed frequency, none of the reactions occurring with an incidence less than 1%
were observed during clinical trials of epidural sufentanil used during labor and
delivery (N=340). In general, cardiovascular and
musculoskeletal adverse experiences were not observed in clinical trials of epidural
sufentanil. Hypotension was observed 7 times more frequently in intravenous trials
than in epidural trials. The incidence of central nervous system, dermatological and
gastrointestinal adverse experiences was approximately 4 to 25 times higher in studies
of epidural use in labor and delivery. Probably Causally Related: Incidence greater than 1%���Derived from clinical trials (See preceding paragraph) Cardiovascular���bradycardia*,
hypertension*, hypotension* Musculoskeletal���chest wall
rigidity* Central Nervous System���somnolence* Dermatological���pruritus (25%) Gastrointestinal���nausea*,
vomiting* *Incidence 3% to 9% Probably Causally Related: Incidence less than 1%���Derived
from clinical trials (Adverse events reported in
post-marketing surveillance, not seen in clinical trials, are italicized) Body as a whole���anaphylaxis Cardiovascular���arrhythmia*,
tachycardia*, cardiac arrest Central Nervous System���chills* Dermatological���erythema* Musculoskeletal���skeletal muscle rigidity of neck and extremities Respiratory���apnea*,
bronchospasm*, postoperative respiratory depression* Miscellaneous���intraoperative
muscle movement* *Incidence 0.3 to
1%
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SUFENTANIL CITRATE INJECTION
SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF INTRAVENOUS
AND EPIDURAL ANESTHETICS AND MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS. AN OPIOID ANTAGONIST,
RESUSCITATIVE AND INTUBATION EQUIPMENT AND OXYGEN SHOULD BE READILY AVAILABLE. PRIOR TO CATHETER INSERTION,
THE PHYSICIAN SHOULD BE FAMILIAR WITH PATIENT CONDITIONS (SUCH AS INFECTION AT THE
INJECTION SITE, BLEEDING DIATHESIS, ANTICOAGULANT THERAPY, ETC.) WHICH CALL FOR
SPECIAL EVALUATION OF THE BENEFIT VERSUS RISK POTENTIAL.<br/>Intravenous Use: Intravenous administration
or unintentional intravascular injection during epidural administration of
sufentanil citrate may cause skeletal muscle rigidity, particularly of the truncal
muscles. The incidence and severity of muscle rigidity is dose related.
Administration of sufentanil may produce muscular rigidity with a more rapid onset
of action than that seen with fentanyl. Sufentanil may produce muscular rigidity
that involves the skeletal muscles of the neck and extremities. As with fentanyl,
muscular rigidity has been reported to occur or recur infrequently in the extended
postoperative period. The incidence of muscular rigidity associated with
intravenous sufentanil can be reduced by: 1)
administration of up to 1/4 of the full paralyzing dose of a non-depolarizing
neuromuscular blocking agent just prior to administration of sufentanil at dosages
up to 8 mcg/kg, 2) administration of a full
paralyzing dose of a neuromuscular blocking agent following loss of consciousness
when sufentanil is used in anesthetic dosages (above 8 mcg/kg) titrated by slow
intravenous infusion or 3) simultaneous
administration of sufentanil and a full paralyzing dose of a neuromuscular
blocking agent when sufentanil is used in rapidly administered anesthetic dosages
(above 8 mcg/kg). The neuromuscular blocking
agents used should be compatible with the patient's cardiovascular status.
Adequate facilities should be available for postoperative monitoring and
ventilation of patients administered sufentanil. It is essential that these facilities be fully equipped to handle all degrees of respiratory
depression.
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Sufentanil Citrate Injection is
indicated for intravenous administration in adults and pediatric patients: ���as an analgesic adjunct in
the maintenance of balanced general anesthesia in patients who are intubated and
ventilated. ���as a primary anesthetic agent
for the induction and maintenance of anesthesia with 100% oxygen in patients
undergoing major surgical procedures; in patients who are intubated and ventilated,
such as cardiovascular surgery or neurosurgical procedures in the sitting position; to
provide favorable myocardial and cerebral oxygen balance or when extended
postoperative ventilation is anticipated. Sufentanil Citrate Injection is
indicated for epidural administration as an analgesic combined with low dose
bupivacaine, usually 12.5 mg per administration, during labor and vaginal delivery. SEE DOSAGE AND
ADMINISTRATION SECTION FOR MORE COMPLETE INFORMATION ON THE USE OF
SUFENTANIL.
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Sufentanil Citrate
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