Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
levobupivacaine hydrochloride, Quantity: 0.718 mg; levobupivacine, Quantity: 0.625 mg
Abbvie Pty Ltd
Injection, solution
Excipient Ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections
Epidural
5 x 100mL bags, 24 x 100mL bags, 60 x 100mL bags, 1 x 100 mL bag
(S4) Prescription Only Medicine
Adults - Pain management. Continuous epidural infusion, for post operative and labour analgesia.
Visual Identification: Clear, colourless solution, practically free from visible particulates.; Container Type: Bag; Container Material: Plastic; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2003-09-09
CHIROCAINE PI Version 11 29 April 2019 Page 1 of 30 AUSTRALIAN PI – CHIROCAINE ® LEVOBUPIVACAINE INJECTION 1 NAME OF THE MEDICINE Levobupivacaine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levobupivacaine ampoules contain levobupivacaine hydrochloride equivalent to 2.5 mg/mL, 5.0 mg/mL, and 7.5 mg/mL of levobupivacaine, and the levobupivacaine bags for infusion contain levobupivacaine hydrochloride equivalent to 0.625 mg/mL and 1.25 mg/mL of levobupivacaine. Both presentations contain sodium chloride for isotonicity, and Water for Injections. Sodium hydroxide and/or hydrochloric acid may have been added to adjust pH. 3 PHARMACEUTICAL FORM Levobupivacaine is a sterile, non-pyrogenic, colourless solution (pH 4.0 - 6.5). Levobupivacaine is preservative free and is available in 10 mL single dose injection ampoules and 100 mL and 200 mL injection bag. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AMPOULES 1. Adults Levobupivacaine is indicated in adults for: _SURGICAL ANAESTHESIA _ Major: Epidural (including for caesarean section), intrathecal, peripheral nerve block. Minor: Local infiltration, oral, peribulbar block in ophthalmic surgery. For caesarean section, the 7.5 mg/mL concentration is not recommended, see 4.3 CONTRAINDICATIONS and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. _ _ _ _ CHIROCAINE PI Version 11 29 April 2019 Page 2 of 30 _PAIN MANAGEMENT _ Continuous epidural infusion, single or multiple bolus administration for post-operative, labour or chronic pain. For continuous epidural analgesia, levobupivacaine may be administered in combination with epidural fentanyl, morphine or clonidine. For labour analgesia, the 7.5 mg/mL concentration is not recommended, see 4.3 CONTRAINDICATIONS and 4.4 SPECIAL WARNINGS PRECAUTIONS FOR USE. 2. Children Levobupivacaine is indicated in children greater than 6 months of age, for infiltration analgesia (ilioinguinal/iliohypogastric blocks) see 4.2 DOSE AND METHOD OF ADMINISTRATION. 3. After careful consideration to alternative concentrations, the 7.5 mg/mL conce Прочитајте комплетан документ