Medicine name
Australian name of the medicine, incorporating Australian Tall Man Lettering for look-alike and sound-alike medicine names.
Synonyms: Internationally accepted equivalent names of the medicine that are not the Australian name of the medicine. Represented as “Also known as…”.
Trade name: The registered product names of the medicine that are available in Australia at the time of publication.
Special Access Scheme medicines: Products that are not registered for use in Australia are imported and/or supplied under the Therapeutic Goods Administration’s Special Access Scheme (SAS). The trade name of imported medicines is unpredictable and the information in SAS medicine monographs applies to the specified product only.
Presentation and preparation
The strength of liquid preparations in vials, ampoules and bags are expressed as the amount of drug per mL, e.g. 100 mg/mL. Prefilled syringes are expressed as the amount of drug per total volume in the syringe, e.g. 40 mg/0.8 mL. Dry powder preparations are expressed as the total amount of drug per unit (vial or ampoule), e.g. 500 mg.
Powder volume: The powder volume, or displacement volume, is the volume the drug powder contributes to the volume of the drug solution after reconstitution, e.g. (0.7 mL). The powder volume should be considered when reconstituting the powder to a specific concentration. The powder volume is particularly important in paediatrics where part vials are used and a definite concentration is needed to accurately calculate the amount of drug to be administered.
Volume: The volume of liquid preparation in the unit (vial or ampoule), e.g. [1 mL].
Reconstitution: Use the specified diluent for reconstituting dry powder preparations. Other diluents not listed may also be suitable; consult with product information. If reconstituting with alternative solutions, preservative-free products should be used. If reconstituted solutions appear discoloured or appears to contain particulate matter other than what the specific monograph states, it should not be used and should be discarded. This guideline lists the recommended volumes and concentrations for the reconstitution of medicines.
IV administration:
Information for the administration of the medicine as an IV injection or infusion. The RCH uses smart infusion pump technology with dose error reduction software (DERS) for medicine infusions. This guideline reflects this practice.
Dilution: Use a compatible IV fluid to dilute to the concentration specified. If no concentration is specified, and dilution is advised, dilute to a convenient volume to enable administration of the medicine over the time indicated. The concentrations used in paediatrics may be higher than those used in the adult patient population so as to reduce the volume of fluid administered. The maximum concentration if necessary is intended for use in fluid restricted patients.
RCH standard concentrations: This refers to dosing units and standardised concentrations for IV infusions used at RCH. Concentrations are expressed as the amount of drug per total volume, e.g. 50 mg/50 mL, followed by the concentration, e.g. (1 mg/mL). Specific cohorts and weight classes where relevant, are also specified, e.g. NICU, fluid restricted etc. Refer to relevant local guidelines for more detailed administration information.
CoPAT administration: Reconstitution and stability information for preparing community-based parenteral antimicrobial therapy (CoPAT). This information is intended to guide users on the preparation of a continuous infusion via delivery devices FOLFusor SV5 or FOLFusor LV10, immediately before administration. CoPAT medicines are diluted with sodium chloride 0.9% and are expected to have a shelf life of 24 hours from manufacture in its chosen delivery device, unless otherwise stated. For preparations made in advance of administration, please refer to Pharmacy Sterile Compounding manufacturer or relevant local guideline.
Storage and temperature are important factors that could affect stability of CoPAT devices during administration. Research indicates that significant temperature fluctuations may occur in practice, and that preparations left out of the fridge in hot climates or placed close to the patient’s body during infusion often reach high temperatures (up to 35°C). Medicines that have only been tested for stability up to 25°C will require extra storage precautions; an ice pack should be supplied with each infusion and placed with the infusor in the bumbag during administration. The ice pack should be frequently replaced over the course of the infusion duration in order to maintain lower temperatures.
This information is not intended to replace local protocols, refer to local guidelines for best practice.
Other routes of administration:
IM: Intramuscular administration instructions. If the volume of the IM injection exceeds 1 mL, consider dividing the dose among multiple injection sites to minimise pain. Specific IM reconstitution instructions are provided when necessary. Use undiluted preparation for IM injection, unless otherwise stated. Medicines given IM may need to be injected into specific sites and the site of injection may need to be rotated when administered frequently. Do not inject near an artery or nerve. Refer to local medicines information resources.
SC: Subcutaneous administration instructions. SC administration guidance in palliative care has been included if the information is available and appropriate; however, this guidance is not comprehensive and local palliative care guidelines and resources should be used. Rotate site of SC injections.
Other routes of administration, other than IV, IM or SC, are listed when necessary and appropriate. Intrathecal, intraventricular, spinal and epidural are not within the scope of this guideline and are not included.
Compatible IV fluids
Medicines are compatible with the listed fluids for the administration time and concentration stated in the IV administration section, unless otherwise stated. Medicines should be prepared and diluted for use immediately before use and not stored. Continuous infusions are stable for 24 hours, unless otherwise stated. Medicines compatible with sodium chloride 0.9% are considered to be compatible with lower concentrations of sodium chloride. If there is no information in these guidelines regarding compatibility or incompatibility of a medicine with a particular fluid, further information may be obtained from the pharmacy department. If no further information is available, the combination should be avoided.
Plasma-Lyte 148 is listed for Y-site administration only. Potassium chloride 20 mmol/L is listed for Y-site administration only as an additive to a compatible fluid. Medicines are not to be diluted in potassium chloride-containing fluids or Plasma-Lyte 148.
This guideline does not attempt to consider drug-drug compatibilities. Refer to specialist texts and consider concentrations used in paediatrics when interpreting drug compatibility information.
Additional information
This information must be considered before administration.
Only adverse effects related to parenteral administration are included in this guideline.
Extravasation risk: A potential complication of IV medicine administration is extravasation of the medicine. Medicines that have been reported to cause tissue damage if extravasated are identified in this guideline. Specific instructions for the management of extravasation of medicines are not provided. Refer to local extravasation management guidelines.
Cytotoxic medication: Medicines that are toxic to cells and pose an occupational hazard to the person preparing and giving the medicine. Special handling is required. Refer to relevant local guideline.
Potentially hazardous medication: Medicines that may pose an occupational hazard to the person preparing and giving the medicine. Special handling may be required. Refer to relevant local guideline.
Benzyl alcohol: Medicines that contain benzyl alcohol should be used with caution in neonates as benzyl alcohol has been linked with ‘gasping syndrome’.
IV aminoglycoside antibiotics are inactivated by IV cephalosporins, penicillins and teicoplanin: The inactivation is dependent on concentration, temperature and time of exposure. It is preferable to separate doses by 1 hour. If it is not possible to separate doses by 1 hour, flush the line well with a compatible fluid before and after giving each medicine.
- Aminoglycoside antibiotics included in this guideline are amikacin, gentamicin and tobramycin.
- Cephalosporins included in this guideline are cefazolin, cefepime, cefotaxime, cefoxitin, ceftazidime, ceftazidime + avibactam and ceftriaxone.
- Penicillins included in this guideline are amoxicillin, amoxicillin + clavulanic acid, ampicillin, benzylpenicillin, flucloxacillin, and piperacillin + tazobactam.
Refrigerate, do not freeze: Store between 2 to 8°C. Bring refrigerated medicines to room temperature before administration.
Vial stability: Vials are stable for 24 hours after opening or reconstitution, when refrigerated, unless otherwise stated. Bring any refrigerated vials to room temperature before use. Solutions should be clear and colourless unless otherwise stated in the relevant monograph.
Protect from light: Some medicines degrade when exposed to light. Medicines that require protection from light during storage are identified in this guideline and should be stored in their original packaging or in a closed drawer or cupboard until use. Medicines that require protection from light during administration are identified in this guideline and specific administration instructions are provided in the relevant monograph.