Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Bupivacaine hydrochloride monohydrate 5.28 mg/mL equivalent to bupivacaine hydrochloride 5mg/mL
Boucher & Muir (New Zealand) Limited t/a BNM Group
0.5% w/v
Solution for injection
Active: Bupivacaine hydrochloride monohydrate 5.28 mg/mL equivalent to bupivacaine hydrochloride 5mg/mL Excipient: Glucose monohydrate Sodium hydroxide Water for injection
Prescription
Bupivacaine spinal heavy BNM is indicated for · intrathecal (subarachnoid, spinal) anaesthesia for surgical and obstetrical procedures · lower abdominal surgery (including caesarean section), urological and lower limb, including hip surgery, lasting 1.5 to 3 hours.
Package - Contents - Shelf Life: Ampoule, glass, Clear Type I glass ampoule, 4mL deliverable volume - 10 dose units - 36 months from date of manufacture stored at or below 25°C
2019-02-21
1 BUPIVACAINE SPINAL HEAVY BNM Consumer Medicine Information BUPIVACAINE SPINAL HEAVY BNM Bupivacaine hydrochloride 20 mg/4 mL (0.5%) Solution for intrathecal injection WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given Bupivacaine spinal heavy BNM. This leaflet answers some common questions about Bupivacaine spinal heavy BNM. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.medsafe.govt.nz. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks associated with giving you Bupivacaine spinal heavy BNM against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR, PHARMACIST OR NURSE. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT BUPIVACAINE SPINAL HEAVY BNM IS USED FOR Bupivacaine spinal heavy BNM contains bupivacaine hydrochloride monohydrate. Bupivacaine spinal heavy BNM is used to prevent or relieve pain before surgery of the lower abdomen and lower limbs. They will not put you to sleep. Bupivacaine spinal heavy BNM can also be used to make childbirth less painful. Bupivacaine spinal heavy BNM belongs to a group of medicines called spinal local anaesthetics. They are injected into the spinal fluid where they make the nerves unable to pass messages to the brain. Depending on the amount used, Bupivacaine spinal heavy BNM will either totally stop pain or will cause a partial loss of feeling. Your doctor will have explained why you are being treated with Bupivacaine spinal heavy BNM and told you what dose you will be given. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR CAREFULLY. They may differ from the information contained in this leaflet. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Bupivacaine spinal heavy BNM is only available with a doctor's prescription. B Přečtěte si celý dokument
1 BUPIVACAINE SPINAL HEAVY BNM BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION 0.5% W/V NEW ZEALAND DATA SHEET 1 PRODUCT NAME BUPIVACAINE SPINAL HEAVY BNM 0.5% w/v Injection, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bupivacaine spinal heavy BNM solution for injection is a sterile, hyperbaric, isotonic aqueous solution containing bupivacaine hydrochloride monohydrate equivalent to bupivacaine hydrochloride 5 mg/mL (0.5%w/v) in water for injections. It also contains glucose monohydrate equivalent to glucose 80 mg per mL of solution (8% w/v). It has a specific gravity of 1.03 g/mL at 20°C. The pH of the solution is adjusted with sodium hydroxide to remain between 4.0 and 6.0 during the approved shelf-life. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Bupivacaine spinal heavy BNM is a clear and colourless solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bupivacaine spinal heavy BNM is indicated for • intrathecal (subarachnoid, spinal) anaesthesia for surgical and obstetrical procedures • lower abdominal surgery (including caesarean section), urological and lower limb, including hip surgery, lasting 1.5 to 3 hours. 4.2 DOSE AND METHOD OF ADMINISTRATION The following dosage recommendations should be regarded as a guide for use in the average adult. The patient’s physical status and concomitant medication should be considered when deciding the dose, and the lowest dose required for adequate anaesthesia should be used. Duration varies with dose, while segmental spread may be difficult to predict. 2 BUPIVACAINE SPINAL HEAVY BNM BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION 0.5% W/V The dose should be reduced in the elderly and in patients in the late stages of pregnancy. DOSE _SPINAL ANAESTHESIA FOR SURGERY _ The spread of anaesthesia obtained is dependent on several factors, the most important being volume of solution injected, position of patient and rate of injection. • 1.5 - 4 mL Bupivacaine spinal heavy BNM (7.5-20 mg bupivacaine hydrochloride). Přečtěte si celý dokument