Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
phenylephrine hydrochloride, Quantity: 0.1 mg/mL
Boucher & Muir Pty Ltd
Injection, solution
Excipient Ingredients: sodium chloride; hydrochloric acid; water for injections
Intravenous
Pack of 10 Ampoules
(S4) Prescription Only Medicine
Phenylephrine hydrochloride is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia. It is also employed to overcome paroxysmal supraventricular tachycardia.
Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-10-04
PHENYLEPHRINE BNM _SOLUTION FOR INJECTION 0.1 MG/ML (0.01 %)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given Phenylephrine BNM. This leaflet answers some common questions about Phenylephrine BNM. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au. 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 Phenylephrine 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 PHENYLEPHRINE BNM IS USED FOR Phenylephrine BNM contains phenylephrine hydrochloride. It works by causing constriction (narrowing) of your blood vessels. It belongs to a group of medicines called vasoconstrictors. Phenylephrine BNM is used to help increase your blood pressure and slow down your heart, for example, during surgery. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Phenylephrine BNM is only available with a doctor's prescription. Phenylephrine BNM is not addictive. BEFORE YOU ARE GIVEN PHENYLEPHRINE BNM Phenylephrine BNM is not suitable for everyone. _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN PHENYLEPHRINE BNM IF YOU ARE ALLERGIC TO: • Phenylephrine • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. You must not be given Phenylephrine BNM if you have: • very high blood pressure • a very fast heart beat (palpitations). DO NOT USE IT AFTER THE Pročitajte cijeli dokument
Phenylephrine BNM 1 AUSTRALIAN PRODUCT INFORMATION PHENYLEPHRINE BNM PHENYLEPHRINE HYDROCHLORIDE 0.1 MG/ML (0.01 %) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE phenylephrine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL solution of phenylephrine hydrochloride injection 0.1 mg/mL (0.01 %) contains 0.1 mg phenylephrine hydrochloride. Each 5 mL ampoule contains 0.5 mg phenylephrine hydrochloride as well as 45 mg sodium chloride (equivalent to 17.7 mg sodium). For the full list of excipients, see Section 6.1 List of excipients. The solution is preservative free and sulfite free. 3 PHARMACEUTICAL FORM Phenylephrine BNM is a clear, colourless, aqueous solution, free from visible particulates, in sterile form for parenteral injection. pH 3.0 - 5.0; Osmolarity: 270 to 300 mOsm/L. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Phenylephrine hydrochloride is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia. It is also employed to overcome paroxysmal supraventricular tachycardia. 4.2 DOSE AND METHOD OF ADMINISTRATION Phenylephrine BNM solution for injection 0.1 mg/mL (0.01 %) is for slow intravenous injection. Phenylephrine BNM is NOT for subcutaneous or intramuscular administration. Phenylephrine BNM contains no antimicrobial preservative. It is for use in one patient on one occasion only. Discard any residue. Phenylephrine BNM 2 It should only be administered by healthcare professionals with appropriate training and relevant experience. The dose should be adjusted according to the pressor response. _ _ _MILD OR MODERATE HYPOTENSION: _ _Intravenously: _ Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg. Injections should not be repeated more often than every 10 to 15 minutes. A 0.5 mg intravenous dose should elevate blood pressure for about 15 minutes. _SPINAL ANAESTHESIA - HYPOTENSION: _ Phenylephrine BNM solution for injection 0.1 mg/mL (0.01 %) is NOT for subcutaneous or intramuscular administrati Pročitajte cijeli dokument