Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
desflurane, Quantity: 1 mL/mL
Sandoz Pty Ltd
Inhalation
Excipient Ingredients:
Inhalation
1
(S4) Prescription Only Medicine
DESFLURANE SANDOZ is indicated as an inhalation agent for maintenance of anaesthesia. DESFLURANE SANDOZ is not recommended for mask induction of anaesthesia because of a high incidence of moderate to severe upper airway adverse events.
Visual Identification: Clear, colourless liquid inside a 250 mL amber plastic coated glass bottle, sealed with a valve assembly and aluminium ferrule, and secured with PET sealing film; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-03-12
Page 1 of 5 DESFLURANE SANDOZ ® _Desflurane _ CONSUMER MEDICINE INFORMATION DESFLURANE SANDOZ ® WHAT IS IN THIS LEAFLET What is DESFLURANE SANDOZ ® ? What DESFLURANE SANDOZ ® is used for Before you receive DESFLURANE SANDOZ ® • before you are due to receive it • when you must not receive it Using DESFLURANE SANDOZ ® Side Effects Product Description How Can I Obtain More Facts About DESFLURANE SANDOZ ® ? Manufacturer WHAT IS DESFLURANE SANDOZ ® DESFLURANE SANDOZ ® is one of a family of drugs called halogenated methylethlyethers which are administered by inhalation by an anaesthetist when you go for surgery. It is a colourless fluid supplied in an amber coloured glass bottle. It is given by your anaesthetist using a vaporiser specifically designed for use with DESFLURANE SANDOZ ® . WHAT DESFLURANE SANDOZ ® IS USED FOR DESFLURANE SANDOZ ® is a special mixture of anaesthetic drug used for maintaining heavy sleep during surgery. It is administered by inhalation by your anaesthetist. The medication produces anaesthesia, a loss of consciousness and pain sensations during the surgery. DESFLURANE SANDOZ ® is washed out quickly from the body via the lungs so that recovery from the anaesthetic is rapid once the drug has been stopped. Your doctor will help you understand the benefits of taking DESFLURANE SANDOZ ® during Page 2 of 5 DESFLURANE SANDOZ ® _Desflurane _ CONSUMER MEDICINE INFORMATION surgery in your case. BEFORE YOU RECEIVE DESFLURANE SANDOZ ® BEFORE YOU ARE DUE TO RECEIVE IT YOU MUST TELL YOUR DOCTOR IF: • You had previously had any problems with a general anaesthetic. • You, or anyone in your family, have had malignant hyperthermia, during or shortly after receiving an anaesthetic (see Side Effects) • You have allergies to: o DESFLURANE SANDOZ ® (if you have had this anaesthetic before and experienced an allergic reaction). o Halogenated anaesthetic agents which are breathed in to induce anaesthesia. • You have the following medical conditions: o heart disease; for example coronary a Đọc toàn bộ tài liệu
200706-desflurane-sandoz-pi Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION DESFLURANE SANDOZ (DESFLURANE) 1. NAME OF THE MEDICINE Desflurane 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Desflurane Sandoz contains 1 mL/mL desflurane. There are no excipients present in this product. 3. PHARMACEUTICAL FORM Liquid for inhalation. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Desflurane Sandoz is indicated as an inhalation agent for maintenance of anaesthesia. Desflurane Sandoz is not recommended for mask induction of anaesthesia because of a high incidence of moderate to severe upper airway adverse events. 4.2. D OSE AND METHOD OF ADMINISTRATION Desflurane Sandoz is administered by inhalation. The concentration of Desflurane Sandoz should be administered by persons trained in the administration of general anaesthesia and delivered from a vaporiser specifically designed and designated for use with desflurane (see Section 4.4 Special warnings and precautions for use). The vapour pressure of Desflurane Sandoz at room temperature (about 700 mm Hg) precludes its use in commonly-used agent-specific vaporisers as such vaporisers cannot provide a stable and predictable delivered concentration. Unlike agent-specific vaporisers, Desflurane Sandoz requires a vaporiser which utilises a heated sump (enclosure containing liquid desflurane) to prevent condensation, which could occur should the temperature in the sump fall below 22.8⁰C at 1 atmosphere pressure (desflurane boiling point). To power the heating elements, the vaporiser must be connected to an electrical source. A vaporiser designed for use with Desflurane Sandoz must also include a filling port compatible with the valve on the Desflurane Sandoz bottle. _PREMEDICATION_ The premedication should be chosen to suit the individual requirements of the patient. Studies to date with patients scheduled to be anaesthetised have frequently received IV premedication such as opioids and/or benzodiazepines, and these have not shown an effect of premedication on respiratory tract Đọc toàn bộ tài liệu