Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
levobupivacaine hydrochloride, Quantity: 1.436 mg; levobupivacine, Quantity: 1.25 mg
Abbvie Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride; sodium hydroxide
Epidural
12 x 200mL bags
(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 _SOLUTION FOR INJECTION & CONCENTRATED SOLUTION FOR INFUSION_ _levobupivacaine 25mg/10mL, 50mg/10mL, 75 mg/10mL, 62.5mg/100mL*, 125mg/100mL*, 250mg/_ _200mL_ CONSUMER MEDICINE INFORMATION _PLEASE READ THIS INFORMATION CAREFULLY_ WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about this medicine. It does not contain all of the available information. It does not take the place of talking to your doctor. All medicines have benefits and risks. Your doctor has weighed the risks associated with giving you CHIROCAINE against the benefits he/she expects it will have on you. If you have any concerns about taking this medicine, talk to your doctor, pharmacist or nurse. Keep this leaflet while you are being given CHIROCAINE. You may need to read it again. WHAT CHIROCAINE IS USED FOR CHIROCAINE is used to anaesthetise (numb) or make free from pain, specific parts or areas of the body before minor surgery (including surgery to the eye and mouth), and major surgery (including having a baby by caesarean section). CHIROCAINE is also used to help relieve pain during labour and childbirth and after an operation. Your doctor, however, may have prescribed CHIROCAINE for another purpose. Ask your doctor if you have any questions about why CHIROCAINE has been prescribed for you. CHIROCAINE belongs to the group of medicines called local anaesthetics. These medicines work by making an area of the body numb or free from pain. CHIROCAINE is available only with a doctor's prescription. BEFORE YOU ARE GIVEN CHIROCAINE YOU SHOULD NOT BE GIVEN CHIROCAINE IF: You have ever had an allergic reaction to CHIROCAINE or any other anaesthetic. Some of the symptoms of an allergic reaction may include rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty in breathing. BEFORE YOU START TO TAKE OR ARE GIVEN CHIROCAINE YOU MUST TELL YOUR DOCTOR IF 1. You are pregnant or plan to become pregnant. Your doctor will discuss the risks and benefits of rec Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ