INFORMATION FOR HEALTH PROFESSIONALS
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DIPRIVAN is a white, aqueous and isotonic emulsion for intravenous injection containing 10 mg or 20 mg propofol per 1 mL. The vehicle contains soya-bean oil, purified egg phosphatide, disodium edetate, glycerol, sodium hydroxide and water.
DIPRIVAN 1% is available in 20 mL, 50 mL and 100 mL vials and in 50 mL pre-filled syringes.
DIPRIVAN 2% is available in 50 mL pre-filled syringes and 50 mL vials.
Propofol (2, 6-diisopropylphenol) is a short-acting general anaesthetic agent with a rapid onset of action of approximately 30 seconds. Recovery from anaesthesia is usually rapid. The mechanism of action, like all general anaesthetics, is poorly understood. However propofol is thought to produce its sedative/anaesthetic effects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABAA receptors.
In general, falls in mean arterial blood pressure and slight changes in heart rate are observed when DIPRIVAN is administered for induction and maintenance of anaesthesia. However, the haemodynamic parameters normally remain relatively stable during maintenance and the incidence of untoward haemodynamic changes is low.
Although ventilatory depression can occur following administration of DIPRIVAN, any effects are qualitatively similar to those of other intravenous anaesthetic agents and are readily manageable in clinical practice.
DIPRIVAN reduces cerebral blood flow, intracranial pressure and cerebral metabolism. The reduction in intracranial pressure is greater in patients with an elevated baseline intracranial pressure.
Recovery from anaesthesia is usually rapid and clear headed with a low incidence of headache and post-operative nausea and vomiting.
DIPRIVAN at the concentrations likely to occur clinically, does not inhibit the synthesis of adrenocortical hormones.
The decline in propofol concentrations following a bolus dose or following the termination of an infusion can be described by a three compartment open model.
The first phase is characterised by a very rapid distribution (half-life: 2 to 4 minutes) rapid elimination (half-life: 30 to 60 minutes) and a slower final phase, representative of redistribution of propofol from poorly perfused tissue.
Propofol is extensively distributed and rapidly cleared from the body (total body clearance 1.5 to 2 L/min). Clearance occurs by metabolic processes, mainly in the liver, to form inactive conjugates of propofol and its corresponding quinol, which are excreted in urine.
When DIPRIVAN is used to maintain anaesthesia, blood concentrations asymptotically approach the steady-state value for the given administration rate. The pharmacokinetics are linear over the recommended range of infusion rates of DIPRIVAN.
DIPRIVAN is a short-acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia.
DIPRIVAN may also be used for sedation of ventilated patients receiving intensive care.
DIPRIVAN may also be used for monitored anaesthesia care sedation for surgical and diagnostic procedures.
For general anaesthesia or monitored anaesthesia care (MAC) sedation, DIPRIVAN should be administered only by persons trained in the administration of general anaesthesia and not involved in the conduct of the surgical/diagnostic procedure. Patients should be continuously monitored, and facilities for maintenance of a patent airway, artificial ventilation, and oxygen enrichment and circulatory resuscitation must be immediately available.
For sedation of intubated, mechanically ventilated adult patients in the Intensive Care Unit (ICU), DIPRIVAN should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.
For specific guidance relating to the administration of DIPRIVAN using the DIPRIFUSOR target controlled infusion (TCI) system, which incorporates DIPRIFUSOR TCI software, see section E. Such use is restricted to induction and maintenance of anaesthesia, conscious sedation for surgical and diagnostic procedures and for the sedation of ventilated adult patients receiving intensive care. The DIPRIFUSOR TCI system is not recommended for use in ICU sedation or monitored anaesthesia care sedation, or in children.
DIPRIVAN 1% may be used to induce anaesthesia by slow bolus injection or infusion.
DIPRIVAN 2% should be used to induce anaesthesia by infusion and only in those patients who will receive DIPRIVAN 2% for maintenance of anaesthesia.
In unpremedicated and in premedicated patients, it is recommended that DIPRIVAN should be titrated (approximately 40 mg every 10 seconds in an average healthy adult by bolus injection or infusion) against the response of the patient until the clinical signs show the onset of anaesthesia. Most adult patients aged less than 55 years are likely to require 1.5 to 2.5 mg/kg of DIPRIVAN. The total dose required can be reduced by lower rates of administration (20 to 50 mg/min). Over this age, the requirement will generally be less. In patients of ASA Grades 3 and 4, lower rates of administration should be used (approximately 20 mg every 10 seconds).
Anaesthesia can be maintained by administering DIPRIVAN either by continuous infusion or by repeat bolus injections to maintain the depth of anaesthesia required.
Continuous Infusion: DIPRIVAN 1% or DIPRIVAN 2% may be used. The required rate of administration varies considerably between patients but rates in the region of 4 to 12 mg/kg/h usually maintain satisfactory anaesthesia.
Repeat Bolus Injections: It is recommended that only DIPRIVAN 1% is used. If a technique involving repeat bolus injections is used, increments of 25 mg to 50 mg may be given according to clinical need.
Titration to clinical response and daily evaluation of sedation levels are important during use of DIPRIVAN for ICU sedation, especially of long duration.
When used to provide sedation for ventilated adult patients undergoing intensive care, it is recommended that DIPRIVAN be given by continuous infusion. Infusion rates of 0.3 to 4.0 mg/kg/h achieve satisfactory sedation in most adult patients. Administration of DIPRIVAN for ICU sedation in adult patients should not exceed 4mg/k/hour unless the benefit for the patient outweighs the risks (See WARNINGS AND PRECAUTIONS).
To provide sedation for surgical and diagnostic procedures, rates of administration should be individualised and titrated to clinical response.
Most patients will require 0.5 to 1 mg/kg over 1 to 5 minutes for onset of sedation.
Maintenance of sedation may be accomplished by titrating DIPRIVAN infusion to the desired level of sedation - most patients will require 1.5 to 4.5 mg/kg/h.
In addition to the infusion, bolus administration of 10 to 20 mg may be used if a rapid increase in the depth of sedation is required. In patients in ASA grades 3 and 4 the rate of administration and dosage may need to be reduced.
In elderly patients the dose requirement for induction of anaesthesia with DIPRIVAN is reduced. The reduction should take account of the physical status and age of the patient. The reduced dose should be given at a slower rate and titrated against the response. Where DIPRIVAN is used for maintenance of anaesthesia or sedation the rate of infusion or 'target concentration' should also be reduced. Patients of ASA grades 3 & 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in the elderly as this may lead to cardiorespiratory depression.
Administration of DIPRIVAN by a DIPRIFUSOR TCI system is not recommended for any indication in children.
DIPRIVAN is not recommended for use in infants less than 1 month old.
When used to induce anaesthesia in children, it is recommended that DIPRIVAN be given slowly until the clinical signs show the onset of anaesthesia. The dose should be adjusted for age and/or weight. Most patients over 8 years of age are likely to require approximately 2.5 mg/kg of DIPRIVAN for induction of anaesthesia. Between the ages of one month and eight years the requirement may be more. Lower dosage is recommended for children of ASA Grades 3 and 4.
DIPRIVAN is not recommended for use in infants less than 1 month old.
Anaesthesia can be maintained by administering DIPRIVAN by infusion or repeat bolus injection to maintain the depth of anaesthesia required. It is recommended that only DIPRIVAN 1% is used if repeat bolus injections are used. The required rate of administration varies considerably between patients but rates in the region of 9 to 15 mg/kg/h usually achieve satisfactory anaesthesia.
DIPRIVAN is not recommended for sedation in children as safety and efficacy have not been demonstrated.
When used to provide sedation for ventilated paediatric patients undergoing intensive care, it is recommended that DIPRIVAN be given by continuous infusion for not more than 24 hours. The depth of sedation should be regularly monitored and the rate of infusion adjusted to the minimum required to achieve and maintain a satisfactory level of sedation. The rate of administration required varies considerably between patients and with age. Infusion rates in the region of 0.6 to 8 mg/kg/h achieve satisfactory sedation in the majority of paediatric patients. Neonates (aged 0 to 1 month) and adolescents (aged 12 years and above) generally require infusion rates towards the lower end of this range. The dose rates of DIPRIVAN for ICU sedation in paediatric patients should not exceed this guidance unless the benefit for the patient outweighs the risks (See WARNINGS AND PRECAUTIONS).
Children are at particular risk of fat overload. Therefore serum lipids should be monitored in children receiving DIPRIVAN (see WARNINGS AND PRECAUTIONS).
Supplementary analgesic agents are generally required in addition to DIPRIVAN.
Following infusion of DIPRIVAN, discontinuation should be gradual to minimise the risk of withdrawal symptoms.
Administration of DIPRIVAN 2% by bolus injection is not recommended.
Supplementary analgesic agents are generally required in addition to DIPRIVAN.
DIPRIVAN has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular blocking medicines, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered. Lower doses of DIPRIVAN may be required where general anaesthesia is used as an adjunct to regional anaesthetic techniques.
DIPRIVAN can be used for infusion undiluted from plastic syringes or glass infusion bottles or DIPRIVAN pre-filled syringes. When DIPRIVAN is used undiluted to maintain anaesthesia, it is recommended that equipment such as syringe pumps or volumetric infusion pumps should always be used to control infusion rates.
DIPRIVAN 1% may also be used diluted with 5% Dextrose Intravenous Infusion only, in PVC infusion bags or glass infusion bottles. Dilutions, which must not exceed 1 in 5 (2 mg propofol/mL) should be prepared aseptically immediately before administration. The mixture is stable for up to 6 hours.
The dilution may be used with a variety of infusion control techniques but a giving set used alone will not avoid the risk of accidental, uncontrolled infusion of large volumes of diluted DIPRIVAN. A burette, drop counter or volumetric pump must be included in the infusion line. The risk of uncontrolled infusion must be taken into account when deciding the maximum amount of dilution in the burette.
DIPRIVAN may be administered via a Y-piece close to the injection site, into infusions of Dextrose 5% Intravenous Infusion, Sodium Chloride 0.9% Intravenous Infusion or Dextrose 4% with Sodium Chloride 0.18% Intravenous Infusion.
The glass pre-filled syringe (PFS) has a lower frictional resistance than plastic disposable syringes and operates more easily. Therefore, if DIPRIVAN is administered using a hand held pre-filled syringe, the line between the syringe and the patient must not be left open if unattended.
When the pre-filled syringe presentation is used in a syringe pump appropriate compatibility should be ensured. In particular, the pump should be designed to prevent syphoning and should have an occlusion alarm set no greater than 1000 mmHg. If using a programmable or equivalent pump that offers options for use of different syringes then choose only the 'B - D' 50/60 mL 'PLASTIPAK' setting when using the DIPRIVAN pre-filled syringe.
DIPRIVAN 1% may be premixed with alfentanil injection containing 500 µg/mL alfentanil (RAPIFEN; Janssen Pharmaceuticals Ltd.) in the ratio of 20:1 to 50:1 v/v. Mixtures should be prepared using sterile technique and used within 6 hours of preparation.
In order to reduce pain on initial injection, that part of the DIPRIVAN 1% used for induction may be mixed with Lignocaine Injection (See Dilution and Co-administration table below).
DILUTION AND CO-ADMINISTRATION OF DIPRIVAN WITH OTHER MEDICINES OR INFUSION FLUIDS
(See also "Additional Precautions" section)
| Co-Administration Technique |
Additive or Diluent |
Preparation | Precautions |
|---|---|---|---|
| Pre-mixing | Dextrose 5% Intravenous Infusion | Mix 1 part of Diprivan 1% with up to 4 parts of Dextrose 5% Intravenous Infusion in either PVC infusion bags or glass infusion bottles. When diluted in PVC bags it is recommended that the bag should be full and that the dilution be prepared by withdrawing a volume of infusion fluid and replacing it with an equal volume of Diprivan 1%. | prepare aseptically immediately before administration. the mixture is stable for up to 6 hours. |
| Lignocaine Hydrochloride Injection (0.5% or 1% without preservatives). | Mix 20 parts of Diprivan 1% with up to 1 part of either 0.5% or 1% Lignocaine Hydrochloride Injection. | Prepare mixture aseptically immediately prior to administration. Use for induction only. | |
| Alfentanil Injection (500 µg/mL). | Mix Diprivan 1% with Alfentanil injection in a ratio of 20:1 to 50:1 v/v. | Prepare mixture aseptically; use within 6 hours of preparation |
|
| Co-administration via a Y-piece connector | Dextrose 5% Intravenous Infusion. | Co-administer via a Y-piece connector. | Place the Y- piece connector close to the injection site. |
| Sodium Chloride 0.9% Intravenous Infusion. | As above | As above | |
| Dextrose 4% with Sodium Chloride 0.18% Intravenous Infusion. | As above | As above |
Administration of DIPRIVAN by a DIPRIFUSOR TCI system is restricted to induction and maintenance of general anaesthesia, conscious sedation for surgical and diagnostic procedures and for the sedation of ventilated adult patients receiving intensive care. It is not recommended for use in children.
DIPRIVAN may be administered by TCI only with a DIPRIFUSOR TCI system incorporating DIPRIFUSOR TCI software. Such systems will operate only on recognition of electronically tagged pre-filled syringes containing DIPRIVAN 1% or 2% injection. The DIPRIFUSOR TCI system will automatically adjust the infusion rate for the concentration of DIPRIVAN recognised. Users must be familiar with the infusion pump user's manual and with the administration of DIPRIVAN by TCI and with the correct use of the syringe identification system, all of which are set out in the DIPRIFUSOR training manual available from AstraZeneca Limited at the address below.
The system allows the anaesthetist or intensivist to achieve and control a desired speed of induction and depth of anaesthesia or sedation by setting and adjusting target (predicted) blood concentrations of propofol.
The DIPRIFUSOR TCI system assumes that the initial blood propofol concentration in the patient is zero. Therefore, in patients who have received prior propofol, there may be a need to select a lower initial target concentration when commencing Diprifusor TCI. Similarly, the immediate recommencement of DIPRIFUSOR TCI is not recommended if the pump has been switched off.
Guidance on propofol target concentrations is given below. In view of interpatient variability in propofol pharmacokinetics and pharmacodynamics, in both premedicated and unpremedicated patients, the target propofol concentration should be titrated against the response of the patient in order to achieve the depth of anaesthesia or conscious sedation required.
In adult patients under 55 years of age anaesthesia can usually be induced with target propofol concentrations in the region of 4 to 8 µg/mL. An initial target of 4 µg/mL is recommended in premedicated patients and in unpremedicated patients an initial target of 6 µg/mL is advised. Induction time with these targets is generally within the range of 60 to 120 seconds. Higher targets will allow more rapid induction of anaesthesia but may be associated with more pronounced haemodynamic and respiratory depression.
A lower initial target concentration should be used in patients over the age of about 55 years and in patients of ASA grades 3 and 4. The target concentrations can then be increased in steps of 0.5 to 1.0 µg/mL at intervals of 1 minute to achieve a gradual induction of anaesthesia.
Supplementary analgesia will generally be required and the extent to which target concentrations for maintenance of anaesthesia can be reduced will be influenced by the amount of concomitant analgesia administered. Target propofol concentrations in the region of 3 to 6 µg/mL usually maintain satisfactory anaesthesia.
The predicted propofol concentration on waking is generally in the region of 1.0 to 2.0 µg/mL and will be influenced by the amount of analgesia given during maintenance.
Target blood propofol concentration settings in the range of 0.5 to 2.5 µg/mL will generally be required. The target concentration setting should be titrated against the response of the patient to achieve the depth of conscious sedation required.
An initial target concentration towards the upper end of this range will allow more rapid induction of conscious sedation.
An initial target concentration towards the lower end of this range should be used in elderly patients and in patients of ASA grades 3 and 4.
Target blood propofol concentration settings in the range of 0.2 to 2.0 µg/mL will generally be required. Administration should begin at a low target setting which should be titrated against the response of the patient to achieve the depth of sedation required.
If the DIPRIFUSOR TCI system has been used for anaesthesia, it can be continued into the postoperative period to provide sedation during intensive care, with appropriate selection of a target concentration.
DIPRIVAN is contraindicated:
DIPRIVAN should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care). Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. DIPRIVAN should not be administered by the person conducting the diagnostic or surgical procedure.
When DIPRIVAN is administered for monitored anaesthesia care sedation for surgical and diagnostic procedures patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation.
As with other sedative agents, when DIPRIVAN is used for sedation during operative procedures, involuntary movements may occur. During procedures requiring immobility these movements may be hazardous to the operative site.
Special caution should be exercised if infusion rates in prolonged sedation (> 48 hours) exceed 4 mg/kg/h. In severely head injured patients also receiving incremental inotropic support, fatal metabolic acidosis or cardiac failure has been reported in association with propofol infusion rates > 5 mg/kg/h for > 58 hours. No causal relationship with propofol has been established. Review of the sedation regime should be conducted in the presence of unexplained acidosis or cardiovascular compromise.
An adequate period is needed prior to discharge of the patient to ensure full recovery after general anaesthesia. Very rarely the use of DIPRIVAN may be associated with the development of a period of post-operative unconsciousness, which may be accompanied by an increase in muscle tone. This may or may not be preceded by a period of wakefulness. Although recovery is spontaneous, appropriate care of an unconscious patient should be administered.
As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients.
DIPRIVAN lacks vagolytic activity and has been associated with reports of bradycardia (occasionally profound) and also asystole. The intravenous administration of an anticholinergic agent before induction, or during maintenance of anaesthesia should be considered, especially in situations where vagal tone is likely to predominate or when DIPRIVAN is used in conjunction with other agents likely to cause a bradycardia.
When DIPRIVAN is administered to an epileptic patient, there may be an increased risk of convulsion.
Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.
It is recommended that blood lipid levels be monitored should DIPRIVAN be administered to patients thought to be at particular risk of fat overload. Administration of DIPRIVAN should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. If the patient is receiving other intravenous lipid concurrently, a reduction in quantity should be made in order to take account of the amount of lipid infused as part of the DIPRIVAN formulation; 1.0 mL of DIPRIVAN contains approximately 0.1 g of fat.
DIPRIVAN is not recommended for use in neonates for induction and maintenance of anaesthesia. Data from off-label use have indicated that if the paediatric (1 month to 16 years of age) dose regimen is applied to neonates, a relative overdose could occur which may result in cardio-pulmonary depression.
There are no data to support the use of DIPRIVAN for the sedation of premature neonates receiving intensive care.
There are no clinical trials data to support the use of DIPRIVAN for the sedation of children with croup or epiglottitis.
Very rare reports of metabolic acidosis, rhabdomyolysis, hyperkalaemia, and/or cardiac failure, in some cases with a fatal outcome, have been received concerning seriously ill patients receiving DIPRIVAN for ICU sedation. The following appear to be the major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents - vasoconstrictors, steroids, inotropes and/or propofol. All sedative and therapeutic agents used in the ICU (including Diprivan) should be titrated to maintain optimal oxygen delivery and haemodynamic parameters.
EDTA is a chelator of metal ions, including zinc. The need for supplemental zinc should be considered during prolonged administration of DIPRIVAN, particularly in patients who are predisposed to zinc deficiency, such as those with burns, diarrhoea and/or major sepsis.
DIPRIVAN should not be used in pregnancy. DIPRIVAN has been used during termination of pregnancy in the first trimester.
DIPRIVAN crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anaesthesia.
Safety to the neonate following the use of DIPRIVAN in mothers who are breast-feeding has not been established.
Patients should be advised that performance at skilled tasks, such as driving and operating machinery, may be impaired for some time after general anaesthesia.
DIPRIVAN contains no antimicrobial preservatives and supports growth of micro-organisms. When DIPRIVAN is to be aspirated, it must be drawn aseptically into a sterile syringe or giving set immediately after opening the ampoule or breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both DIPRIVAN and the infusion equipment throughout the infusion period. Any medicines or fluids added to the DIPRIVAN line must be administered close to the cannula site. DIPRIVAN must not be administered via a microbiological filter.
DIPRIVAN and any syringe containing DIPRIVAN are for single use in an individual patient. In accordance with established guidelines for other lipid emulsions, a single infusion of DIPRIVAN must not exceed 12 hours. At the end of the procedure or at 12 hours, whichever is the sooner, both the reservoir of DIPRIVAN and the infusion line must be discarded and replaced as appropriate.
Induction of anaesthesia with DIPRIVAN is generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side effects of an anaesthetic agent, such as hypotension. Given the nature of anaesthesia and those patients receiving intensive care, events reported in association with anaesthesia and intensive care may also be related to the procedures being undertaken or the recipient's condition.
| Very common (>1/10) |
General disorders and administration site conditions: | Local pain on induction (1) |
|---|---|---|
| Common (>1/100, <1/10) |
Vascular disorders: | Hypotension (2) |
| Cardiac disorders: | Bradycardia (3) | |
| Respiratory, thoracic and mediastinal disorders: | Transient apnoea during induction | |
| Gastrointestinal disorders: | Nausea and vomiting during recovery phase | |
| Nervous system disorders: | Headache during recovery phase | |
| General disorders and administration site conditions: | Withdrawal symptoms in children (4) | |
| Vascular disorders: | Flushing in children (4) | |
| Uncommon (>1/1000, <1/100) |
Vascular disorders: | Thrombosis and phlebitis |
| Rare (>1/10 000, <1/1000) |
Nervous system: | Epileptiform movements, including convulsions and opisthotonus during induction, maintenance and recovery |
| Very rare (<1/10 000) |
Musculoskeletal and connective tissue disorders: | Rhabdomyolysis (5) |
| Gastrointestinal disorders: | Pancreatitis | |
| Injury, poisoning and procedural complications: | Post-operative fever | |
| Renal and urinary disorders: | Discolouration of urine following prolonged administration | |
| Immune system disorders: | Anaphylaxis - may include angioedema, bronchospasm, erythema and hypotension | |
| Reproductive system and breast: | Sexual disinhibition | |
| Cardiac disorders: | Pulmonary oedema | |
| Nervous system disorders: | Post-operative unconsciousness |
(1) May be minimised by using the larger veins of the forearm and antecubital
fossa. With DIPRIVAN 1% local pain can also be minimised by the
co-administration of lignocaine (see DOSAGE AND ADMINISTRATION, Part D).
(2) Occasionally, hypotension may require use of intravenous fluids and reduction of the administration rate of DIPRIVAN.
(3) Serious bradycardias are rare. There have been isolated reports of progression to asystole.
(4) Following abrupt discontinuations of DIPRIVAN during intensive care.
(5) Very rare reports of rhabdomyolysis have been received where DIPRIVAN has been given at doses of greater than 4 mg/kg/hr for ICU sedation. Also there have been rare reports of metabolic acidosis and cardiac failure associated with Diprivan administered at rates >5 mg/kg/h for >58 hours. A causal relationship has not been established.
Reports from off-label use of DIPRIVAN for induction of anaesthesia in neonates indicates that cardio-respiratory depression may occur if the paediatric dose regimen is applied (see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS).
No pharmacological incompatibility has been encountered.
Accidental overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression would require lowering of the patient's head and, if severe, use of plasma expanders and pressor agents.
Containers should be shaken before use. Any portion of the contents remaining after use should be discarded.
The glass pre-filled syringe (PFS) has a lower frictional resistance than plastic disposable syringes and operates more easily. Therefore, if DIPRIVAN is administered using a hand held pre-filled syringe, the line between the syringe and the patient must not be left open if unattended.
DIPRIVAN should not be mixed prior to administration with injections or infusion fluids with the exception of DIPRIVAN 1% which can be mixed with 5% Dextrose (Intravenous Infusion BP) in PVC bags or glass infusion bottles or lignocaine Injection or alfentanil injection in plastic syringes (see DOSAGE AND ADMINISTRATION).
The neuromuscular blocking agents, atracurium and mivacurium should not be given through the same IV line as DIPRIVAN without prior flushing.
Vials: 36 months.
Pre-filled syringes: 24 months.
The emulsion should be stored between 2°C and 25°C; it must not be frozen.
Prescription Medicine.
20 mL Glass Ampoules (Not available in New Zealand)
20 mL Glass Vials
50 mL Glass Vials
100 mL Glass Vials
20 mL Glass Pre-filled syringes (Not available in New Zealand)
50 mL Glass Pre-filled syringes
10 mL Glass Pre-filled syringes (Not available in New Zealand)
50 mL Glass Pre-filled syringes
50 mL Glass Vials
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12 February 2009
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