Data Sheet
NAROPIN WITH FENTANYL
(Ropivacaine hydrochloride plus fentanyl citrate)
Presentation
NAROPIN WITH FENTANYL solution is available in 100 and 200 mL Polybags in two strengths; ropivacaine 2 mg/mL with fentanyl 2 µg/mL and ropivacaine 2 mg/mL with fentanyl 4 µg/mL. NAROPIN WITH FENTANYL is a sterile, isotonic solution with nominal osmolality of 288 mOsmol/kg and pH of 4.0 - 6.0.
Uses
Actions
Ropivacaine
Ropivacaine has both anaesthetic and analgesic effects. At high doses it produces surgical anaesthesia with motor block, while at lower doses it produces sensory block (analgesia) with limited and non- progressive motor block.
The duration and intensity of ropivacaine sensory block are not improved by the addition of adrenaline.
Ropivacaine, like other local anaesthetics, causes reversible blockade of impulse propagation along nerve fibres by preventing the inward movement of sodium ions through the cell membrane of the nerve fibres.
Local anaesthetics may have similar effects on other excitable membranes, e.g. in the brain and myocardium. If excessive amounts of medicine reach the systemic circulation, symptoms and signs of toxicity may appear, emanating from the central nervous and cardiovascular systems.
Central nervous system toxicity (see OVERDOSAGE) precedes the cardiovascular effects since it occurs at lower plasma concentrations. Cardiovascular effects measured in vivo in animal studies showed that ropivacaine was consistently well tolerated. Direct effects of local anaesthetics on the heart include slowing of conduction, negative inotropism and, eventually, arrhythmias and cardiac arrest. High intravenous doses of ropivacaine induce similar effects on the heart. Resuscitative measures were highly successful in dogs given large overdoses of ropivacaine. Comparable results to those described were obtained in in vitro heart preparations.
Pregnant ewes showed no greater sensitivity to ropivacaine than non-pregnant ewes.
Healthy volunteers exposed to intravenous infusions tolerated ropivacaine well. The clinical experience with this medicine indicates a good margin of safety.
Indirect cardiovascular effects (hypotension, bradycardia) may occur after epidural administration, depending on the extent of the concomitant sympathetic block.
Fentanyl
Fentanyl is a narcotic analgesic. A dose of 100 µg is approximately equivalent in analgesic activity to 10 mg of morphine or 75 mg of pethidine. The principal actions of therapeutic value are analgesia and sedation. Alterations in respiratory rate and alveolar ventilation associated with narcotic analgesics may last longer than the analgesic effect. As the dose of narcotic is increased, the decrease in pulmonary exchange becomes greater. Large doses may produce apnoea. Fentanyl appears to have less emetic activity than either morphine or pethidine.
Histamine assays and skin wheal testing in man indicate that clinically significant histamine release rarely occurs with fentanyl. Recent assays in man show no clinically significant histamine release at doses up to 50 µg/kg. Fentanyl preserves cardiac stability and blunts stress-related hormonal changes at higher doses.
Fentanyl produces minimal cortical depression and may act by filling receptor sites located in the thalamus, midbrain and spinal cord. A specific morphine antagonist (e.g. nalorphine or naloxone) produces reversal of respiratory, cardiovascular, miotic and motor inco-ordination effects and also produces reversal of analgesia, euphoria and sedation. Rigidity of the diaphragm and intercostal muscles can be eliminated by suxamethonium. Cholinergic effects such as bradycardia are reversed by atropine.
Pharmacokinetics
Ropivacaine
Ropivacaine has a pKa of 8.1 and a distribution ratio of 141 (25°C n-octanol/phosphate buffer pH 7.4).
The plasma concentration of ropivacaine depends upon the dose, the route of administration and the vascularity of the injection site. Ropivacaine follows linear pharmacokinetics and the maximum plasma concentration is proportional to the dose.
Ropivacaine shows complete and biphasic absorption from the epidural space with half-lives of the two phases of the order of 14 minutes and 4 hours. The slow absorption is the rate-limiting factor in the elimination of ropivacaine, which explains why the apparent elimination half-life is longer after epidural than after intravenous administration.
The pharmacokinetic profile of ropivacaine following experimental IV administration is summarised below:
| Plasma clearance | 440 mL/min |
|---|---|
| Unbound plasma clearance | 8 L/min |
| Renal clearance | 1 mL/min |
| Volume of distribution at steady-state | 47 L |
| Unbound volume of distribution at steady-state | 819 L |
| Terminal half-life | 1.8 h |
| Unbound fraction | 0.06 |
| Hepatic extraction ratio | 0.4 |
| Major metabolite | 3-OH-ropivacaine |
Ropivacaine is mainly bound to α1-acid glycoprotein in plasma with an unbound
fraction of about 6%. An increase in total plasma concentrations during
continuous epidural infusion has been observed, related to a postoperative
increase of α1-acid glycoprotein.
Variations in unbound, i.e. pharmacologically active, concentration have been much less than in total plasma concentration.
Ropivacaine readily crosses the placenta and equilibrium in regard to unbound concentration will be rapidly reached. The degree of plasma protein binding in the foetus is less than in the mother, which results in lower total plasma concentrations in the foetus than in the mother.
Ropivacaine is extensively metabolised, predominantly by aromatic hydroxylation. In total 86% of the dose is excreted in the urine after intravenous administration of which only about 1% relates to unchanged medicine. The major metabolite is 3-hydroxyropivacaine, about 37% of which is excreted in the urine, mainly conjugated. Urinary excretion of 4-hydroxyropivacaine, the N-dealkylated metabolite and the 4-hydroxy-dealkylated accounts for 1-3%. Conjugated and unconjugated 3-hydroxyropivacaine shows only detectable concentrations in plasma. 3-hydroxy- and 4-hydroxyropivacaine have a local anaesthetic activity although less than that of ropivacaine.
There is no evidence of in vivo racemisation of ropivacaine.
Fentanyl
The pharmacokinetics of fentanyl can be described by a three-compartment model, with a distribution time of 1.7 minutes, redistribution of 13 minutes and a terminal elimination half-life of 219 minutes. The volume of distribution for fentanyl is 4 L/kg.
Fentanyl plasma protein binding capacity increases with increasing ionisation of the drug. Alterations in pH may affect its distribution between plasma and the central nervous system. It accumulates in skeletal muscle and fat, and is released slowly into the blood.
Fentanyl is primarily transformed in the liver and demonstrates a high first pass clearance with approximately 75% of an intravenous dose excreted in urine, primarily as metabolites with less than 10% representing the unchanged drug. Approximately 9% of the dose is recovered in the faeces, primarily as metabolites.
Pharmacodynamics
As with longer-acting narcotic analgesics, the duration of the respiratory depressant effect of fentanyl may be longer than the analgesic effect. The following observations have been reported concerning altered respiratory response to CO2 stimulation following administration of fentanyl to man:
- Diminished sensitivity to CO2 stimulation may persist longer than depression of respiratory rate. Fentanyl frequently slows the respiratory rate.
- Altered sensitivity to CO2 stimulation has been demonstrated for up to four hours following a single intravenous dose of 600 µg fentanyl to healthy volunteers.
- Duration and degree of respiratory depression is dose related.
- The peak respiratory effect of a single intravenous dose of fentanyl is noted 5 to 15 minutes following injection. (See also WARNINGS AND PRECAUTIONS concerning respiratory depression).
Indications
Acute Pain Management: Continuous epidural infusion e.g. postoperative or labour pain.
Dosage and Administration
The lowest dosage that results in effective analgesia should be used and should be based on the status of the patient and the analgesia required.
Adults
Recommended doses for NAROPIN WITH FENTANYL for injection in the average healthy 70 kg adult for up to 72 hours.
| Epidural administration Continuous infusion | Volume mL/hour |
Dosage | |
|---|---|---|---|
| Ropivacaine | Fentanyl | ||
| Naropin 2 mg/mL + Fentanyl 2 µg/mL | 6-14 | 12-28 mg/hr | 12-28 µg/hr |
| Naropin 2 mg/mL + Fentanyl 4 µg/mL | 6-14 | 12-28 mg/hr | 24-56 µg/hr |
Children
Until further experience has been gained, NAROPIN WITH FENTANYL cannot be recommended for use in children below the age of 12 years.
Elderly or debilitated patients
Debilitated or elderly patients, including those with partial or complete heart conduction block, advanced liver disease or severe renal dysfunction should be given reduced dosage commensurate with their physical condition. (See WARNINGS AND PRECAUTIONS).
Test Dose
For epidural analgesia, a 3-5 mL test dose of a local anaesthetic, preferably containing up to 5 µg of adrenaline (e.g. Xylocaine 2% with Adrenaline 1:200,000), should be administered. Verbal contact and repeated monitoring of the heart rate and blood pressure should be maintained for 5 minutes after the test dose after which, in the absence of signs of subarachnoid or intravascular injection, the main dose may be administered.
Use of a test dose containing adrenaline may have further advantages in that an intravascular injection of adrenaline will be quickly recognised by an increase in heart rate, usually within about 40 seconds. To detect this, the heart rate and rhythm should be monitored with an electrocardiogram. An accidental intrathecal injection may be recognised by signs of spinal block.
Prior to connection to an infusion set, aspiration should be repeated. The infusion rate should be slow, with continual assessment of the patient. If toxic symptoms or signs occur, the infusion should be stopped immediately.
Analgesia
When calculating the dosage for postoperative analgesia, the use of intraoperative local anaesthetics and opioids should be taken into account.
When prolonged blocks are used, either by continuous infusion or repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. Cumulative doses of up to 800 mg ropivacaine for surgery and postoperative analgesia administered over 24 hours were well tolerated, as were postoperative continuous epidural infusions of ropivacaine with 2 µg or 4 µg fentanyl at rates up to 14 mL/hour for 72 hours.
Contraindications
- NAROPIN WITH FENTANYL solutions are contraindicated in patients with known hypersensitivity to local anaesthetics of the amide type or a known tolerance to fentanyl.
- Bronchial asthma. (See also WARNINGS AND PRECAUTIONS).
- Head injuries and increased intracranial pressure - As for any narcotic analgesic, fentanyl should not be used in patients susceptible to respiratory depression, such as comatose patients who may have head injuries or a brain tumour. Fentanyl may obscure the clinical course of patients with head injury.
- Severe and unpredictable potentiation by MAO inhibitors has been reported with narcotic analgesics and the use of fentanyl in patients who have received MAO inhibitors within 14 days is not recommended. (See INTERACTIONS).
Warnings and Precautions
Regional anaesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and medicines necessary for monitoring and emergency resuscitation should be immediately available. Patients receiving major blocks should have an IV line inserted before the blocking procedure. The clinician responsible should be appropriately trained and familiar with diagnosis and treatment of side effects, systemic toxicity and other complications. (See OVERDOSAGE).
Patients in poor general condition due to ageing or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anaesthesia is frequently indicated in these patients. To reduce the risk of potentially serious adverse reactions, attempts should be made to optimise the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly. Patients treated with anti-arrhythmic drugs class III (eg. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.
There have been rare reports of cardiac arrest during the use of NAROPIN for epidural anaesthesia of peripheral nerve blockade, especially after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the possibility of a successful outcome.
Epidural anaesthesia may lead to hypotension and bradycardia. The risk of such effects can be reduced, e.g. by preloading the circulation or by injecting a vasopressor. Hypotension should be treated promptly with, for example, ephedrine 5-10 mg intravenously, repeated as necessary.
Adequate facilities should be available for post-operative monitoring and ventilation. Resuscitative equipment, oxygen and a narcotic antagonist should be readily available to manage apnoea.
NAROPIN WITH FENTANYL should be used with caution in patients with severe impairment of pulmonary function because of the possibility of respiratory depression (e.g. chronic obstructive pulmonary disease, patients with decreased respiratory reserve, or any patient with potentially compromised respiration). In such patients, narcotics may further decrease respiratory drive and increase airway resistance. Respiratory depression caused by narcotic analgesics can be reversed by narcotic antagonists. Consult individual product information (nalorphine or naloxone) before employing narcotic antagonists.
Fentanyl may cause muscle rigidity, particularly involving the muscles of respiration. This effect is related to the dose and speed of injection and may be reduced by slow infusion. It is likely to arise following epidural injection. However, if this effect occurs, it may be managed by the use of assisted or controlled respiration and, if necessary, by administration of a neuromuscular blocking agent compatible with the patient's condition.
As Fentanyl may cause muscle rigidity, NAROPIN WITH FENTANYL should be used with caution in patients with a history of myasthenia gravis.
Fentanyl should be administered with caution to patients with liver and kidney dysfunction because of the importance of these organs in the metabolism and excretion of drugs.
Fentanyl may product bradycardia, which may be treated with atropine; however, it should be used with caution in patients with cardiac bradyarrhythmias.
As has been observed with all narcotic analgesics, episodes suggestive of Sphincter of Oddi Spasm may occur with fentanyl.
NAROPIN is possibly porphyrinogenic and should only be prescribed to patient with acute porphyria when no safer alternative is available. Appropriate precautions should be taken in the case of vulnerable patients.
Pregnancy and Lactation
Pregnancy
Reproduction studies with ropivacaine have been performed in rats and rabbits. No effects on fertility and general reproductive performance were seen in rats over two generations. At the highest dose level increased pup loss was seen during the first three days post partum, which was considered to be secondary to impaired maternal care of the new-born, due to maternal toxicity.
Teratogenicity studies with ropivacaine in rats and rabbits did not show evidence of any adverse effects of ropivacaine on organogenesis or early foetal development. There were no treatment-related effects on late foetal development, parturition, lactation, neonatal viability or growth of the offspring in a perinatal and postnatal study in rats using the maximum tolerated dose.
An additional perinatal and postnatal study in rats, in which ropivacaine was compared with bupivacaine, showed that maternal toxicity was observed at much lower dose levels and at lower unbound plasma concentrations of bupivacaine than of ropivacaine.
There are no clinical studies in pre-term pregnant women on the effects of ropivacaine on the developing foetus. Ropivacaine should be used during pregnancy only if the potential benefit justifies risk to the foetus. The use of ropivacaine at term for obstetric anaesthesia or analgesia is, however, well documented and no negative effects have been observed.
Narcotic analgesics may cause respiratory depression in the newborn infant. These products should only be used during labour after weighing the needs of the mother against the risk to the foetus. The safe use of fentanyl has not been established with respect to possible adverse effects upon foetal development. Therefore it should be used in women of childbearing potential only when in the judgement of the physician the potential benefits outweigh the possible hazards.
Lactation
The excretion of ropivacaine or its metabolites in human milk has not been studied. Based on the milk/plasma concentration ratio in rats, the estimated daily dose to a pup will be about 4% of the dose given to the mother. Assuming that the milk/plasma concentration ratio in humans is of the same order, the total ropivacaine dose to which the baby is exposed by breast feeding is far lower than by exposure in utero in pregnant women at term.
It is not known if fentanyl passes into breast milk.
Effects on Ability to Drive and Use Machines
Depending on the dose, NAROPIN WITH FENTANYL may have a very mild effect on mental function and co-ordination even in the absence of overt CNS toxicity and may temporarily impair locomotion and alertness.
Adverse Effects
Adverse reactions to ropivacaine are rare in the absence of overdosage or inadvertent intravascular injection. Adverse reactions to fentanyl are similar to those observed with other opioid agonist analgesics. The adverse reactions to NAROPIN WITH FENTANYL are similar to those observed with the individual agents.
These adverse reactions are in general dose related and may result from high plasma levels caused by excessive dosage, rapid absorption or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. They should be distinguished from the physiological effects of the nerve block itself e.g. a decrease in blood pressure and bradycardia during epidural anaesthesia.
Pronounced acidosis, hyperkalaemia or hypoxia in the patient may increase the risk and severity of toxic reactions.
The following list of adverse events is based upon experience with the monotherapies in their usual dosage range. These events are considered to be of clinical importance, regardless of causal relationship.
Very Common Events (>10%)
Cardiovascular: Hypotension
Gastrointestinal: Nausea
Common Events (> 1%)
Cardiovascular: Bradycardiaa, hypertension and tachycardia.
Nervous system: Paraesthesia, temperature elevation, rigors (chills), hypoaesthesiaa, headachea, dizziness and anxiety.
Gastrointestinal: Vomitinga.
Other: Urinary retention, back pain, insomnia, chest pain, oliguria, pruritus.
Uncommon Events (< 1%)
Acute systemic toxicity: More serious but less common reactions that reflect acute systemic toxicityb include dysarthria, muscular rigidity, muscle twitching, muscle rigidity with laryngospasm or bronchospasm, unconsciousness, convulsions, hypoxia, hypercapnia, apnoea, respiratory depression, severe hypotension and bradycardia, arrhythmias, cardiac arrest. Indirect cardiovascular effects (hypotension, bradycardia) may occur after epidural administration, depending on the extent of the concomitant sympathetic block.
Vascular: Syncopea
Respiratory, thoracic and mediastinal: Dyspnoeaa
General disorders and administration site conditions: Hypothermiaa
Rare events (≤0.1%)
Cardiac disorders: Cardiac arrest, cardiac arrhythmias
General disorders and administration site conditions: Allergic reactions (anaphylactoid reactions, angioneurotic oedema and urticaria)
a These reactions are more frequent after spinal anaesthesia
b These symptoms usually occur because of inadvertent intravascular injection, overdose or rapid absorption.
Class related adverse drug reactions
This section includes complications related to anaesthestic technique regardless of the local anaesthetic used.
Neurological complications: Neuropathy and spinal cord dysfunctions (eg anterior spinal artery syndrome, arachnoiditis, cauda equine syndrome), have been associated with intrathecal and epidural anaesthesia.
Total spinal block: Total spinal block may occur if an epidural dose is inadvertently administered intrathecally, or if a too large intrathecal dose is administered.
Neurological: Neuropathy and spinal cord dysfunction (e.g. anterior spinal artery syndrome, arachnoiditis, cauda equina syndrome) have been associated with regional anaesthesia, regardless of the local anaesthetic drug used. Convulsions have been observed following unintended intravascular injection of ropivacaine.
Other: Blurred vision, miosis, diaphoresis, post operative mental depression, paradoxical CNS excitation, delirium and spasm of the sphincter of Oddi.
Clinical Trials Using Naropin 2 mg/mL with Fentanyl 2 µg/mL
Clinical trials in patients undergoing epidural infusion for postoperative pain show that the following events were more common in patients receiving NAROPIN WITH FENTANYL than in the group receiving Naropin alone: pruritis, ileus, hypomagnesia, hypoglycaemia, atelectasis, urine abnormalities, laboratory test abnormalities.
The following events were less common in the NAROPIN WITH FENTANYL group than the plain Naropin group: hypothermia, chest pain, vasospasm, coughing.
Interactions
Ropivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics eg certain antiarrhythmics, such as lidocaine and mexiletin, since the toxic effects are additive. Specific interactions studies with ropivacaine and anti-arrhythmic drugs class III (eg. amiodarone) have not been performed, but caution is advised (see WARNINGS AND PRECAUTIONS).
Cytochrome P450
In healthy volunteers ropivacaine clearance was reduced by 77% during co-administration of fluvoxamine, a potent competitive inhibitor of P4501A2. CYP1A2 is involved in the formation of 3-hydroxy-ropivacaine, a major metabolite. Thus strong inhibitors of CYP1A2, such as fluvoxamine and enoxacin, given concomitantly with NAROPIN can cause a metabolic interaction leading to an increased ropivacaine plasma concentration. Prolonged administration of ropivacine should therefore be avoided in patients treated with strong inhibitors of CYP1A2 such as fluvoxamine and enoxacin.
Other CNS Depressants
Other CNS depressant drugs, e.g. barbiturates, neuroleptics, narcotics and general anaesthetics will have additive or potentiating effects with fentanyl. When patients have received such drugs, the dose of NAROPIN WITH FENTANYL required will be less than usual. Likewise, following the administration of fentanyl the dose of other CNS depressant drugs should be reduced.
MAO Inhibitors
Severe and unpredictable potentiation by MAO inhibitors has been reported with narcotic analgesics. Since the safety of fentanyl in this regard has not been established, the use of fentanyl in patients who have received MAO inhibitors within 14 days is not recommended. (See CONTRAINDICATIONS).
Nitrous Oxide
Nitrous oxide has been reported to produce cardiovascular depression when given with high doses of fentanyl.
Amiodarone
Profound bradycardia, sinus arrest and hypotension have occurred when patients receiving amiodarone have been given fentanyl for anaesthesia.
Overdosage
There have been no reports of overdosage in patients receiving NAROPIN WITH FENTANYL. The symptoms of NAROPIN WITH FENTANYL overdosage are expected to reflect those seen with overdosage of the individual drugs. Systemic toxic reactions may involve the central nervous system and the cardiovascular system.
Symptoms
Acute Systemic Toxicity
Systemic toxic reactions primarily involve the central nervous system (CNS) and the cardiovascular system (CVS). Such reactions are caused by high blood concentration of a local anaesthetic, which may appear due to (accidental) intravascular injection, overdose or exceptionally rapid absorption from highly vascularised areas, (see WARNINGS AND PRECAUTIONS). CNS reactions are similar for all amide local anaesthetics, while cardiac reactions are more dependant on the drug, both quantitatively and qualitatively.
Central Nervous System Toxicity is a graded response with symptoms and signs of escalating severity. The first symptoms are usually light-headedness, circumoral paraesthesia, numbness of the tongue, hyperacusis, tinnitus and visual disturbances. Dysarthria, muscular twitching or tremors are more serious and precede the onset of generalised convulsions. These signs must not be mistaken for neurotic behaviour.
Unconsciousness and grand mal convulsions may follow, which may last from a few seconds to several minutes. Hypoxia and hypercarbia occur rapidly during convulsions due to the increased muscular activity, together with the interference with respiration and possible loss of functional airways. In severe cases apnoea may occur. Acidosis, hyperkalaemia, hypocalcaemia and hypoxia increase and extend the toxic effects of local anaesthetics.
Recovery follows the redistribution of the local anaesthetic agent from the central nervous system and subsequent metabolism and excretion. Recovery may be rapid unless large amounts of the agent have been injected.
Cardiovascular Toxicity may be seen in severe case and is generally preceded by signs of toxicity in the central nervous system. In patients under heavy sedation or receiving a general anaesthestic, prodromal CNS symptoms may be absent. Hypotension, bradycardia, arrhythmia and even cardiac arrest may occur as a result of high systemic concentrations of local anaesthetics, but in rare cases cardiac arrest has occurred without prodromal CNS effects.
Overdose due to fentanyl may result in narcosis (which may be preceded by marked skeletal muscle rigidity), cardiorespiratory depression accompanied by cyanosis, followed by a fall in body temperature, circulatory collapse, coma and possibly death.
Treatment
If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately and CNS symptoms (convulsion, CNS depression) must promptly be treated with appropriate airway/respiratory support and the administration of anticonvulsant drugs.
If circulatory arrest should occur, immediate cardiopulmonary resuscitation should be instituted. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.
If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor and or inotropic agents should be considered. Children should be given doses commensurate with their age and weight.
Should cardiac arrest occur, a successful outcome may require prolonged resuscitative efforts.
If depressed respiration is associated with muscular rigidity, an intravenous neuromuscular blocking agent might be required to facilitate assisted or controlled respiration.
The patient should be carefully observed for 24 hours; body warmth and adequate fluid intake should be maintained.
If severe or persistent hypotension occurs, the possibility of hypovolaemia should be considered and managed with appropriate parenteral fluid therapy.
A specific narcotic antagonist, such as nalorphine or naloxone, should be available for use as indicated to manage respiratory depression. This does not preclude the use of more immediate countermeasures. The duration of respiratory depression following overdosage of fentanyl is usually longer than the duration of narcotic antagonist action.
Pharmaceutical Precautions
Storage Conditions
Store below 30°C. Do not freeze.
Shelf-Life
24 months.
Medicine Classification
Controlled Drug B3.
Package Quantities
Naropin 0.2% with Fentanyl 200 µg/100 mL
Naropin 0.2% with Fentanyl 400 µg/100 mL
(Naropin 2 mg with Fentanyl 2 µg/mL)
100 mL & 200 mL Polybag® infusion bags in Sterile AstraZeneca
Theatre PackTM (5's)
Naropin 0.2% with Fentanyl 400 µg/100 mL (Not available in New Zealand)
Naropin 0.2% with Fentanyl 800 µg/200 mL (NOT AVAILABLE IN NEW ZEALAND)
Naropin 2 mg with Fentanyl 4 µg/mL
100 mL & 200 mL Polybag® infusion bags in Sterile AstraZeneca
Theatre PackTM (5's)
Instructions for Use/Handling
NAROPIN WITH FENTANYL injection solutions do not contain a preservative. Each Polybag is intended for single use only, not exceeding 24 hours. Any solution remaining from an opened Polybag should be discarded.
The intact container must not be re-autoclaved. A blistered container should be chosen when a sterile outside is required.
Further Information
Excipients
Sodium chloride
Water for Injection
Hydrochloric acid and sodium hydroxide for pH adjustment.
Name and Address
AstraZeneca Limited
303 Manukau Road, Epsom
P O Box 1301, Auckland
New Zealand
Telephone: (09) 623-6300
Date of Preparation
2 August 2007
(PI: 280507)
Copyright - No part may be reproduced by any process without the prior written permission of AstraZeneca Limited