Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
phenylephrine hydrochloride, Quantity: 10 mg
Accord Healthcare Pty Ltd
Injection, solution
Excipient Ingredients: hydrochloric acid; sodium hydroxide; sodium citrate dihydrate; water for injections; citric acid monohydrate; sodium metabisulfite; sodium chloride
Intramuscular, Intravenous, Subcutaneous
10, 25
(S4) Prescription Only Medicine
For the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia and for the treatment of vascular failure in shock, shock-like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anaesthesia, and as a vasoconstrictor in regional analgesia
Visual Identification: A clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-11-16
Version 1.0 Page 1 of 3 PHENYLEPHRINE ACCORD _Phenylephrine Hydrochloride Injection 10 mg/1 mL _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Phenylephrine Accord. It does not contain all of the available information. It 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 Accord against the benefits they expect it will have for 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 Phenylephrine Accord. You may need to read it again. WHAT PHENYLEPHRINE ACCORD IS USED FOR Phenylephrine Accord is used to help increase your blood pressure and slow down your heart, for example, during surgery or in states of shock. It does this by causing constriction (narrowing) of your blood vessels. It belongs to a group of medicines called vasoconstrictors. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PHENYLEPHRINE ACCORD HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN PHENYLEPHRINE ACCORD _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU MUST NOT BE GIVEN PHENYLEPHRINE ACCORD IF YOU ARE ALLERGIC TO: • PHENYLEPHRINE • SODIUM METABISULFITE • 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 Accord if you have: • very high blood pressure. • a very fast heartbeat (palpitations) IF YOU ARE NOT SURE WHETHER YOU SHOULD START TAKING THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU ARE GIVEN IT. _ Tell your doctor if you have, or have had, any medical conditions, Pročitajte cijeli dokument
Page 1 of 7 AUSTRALIAN PRODUCT INFORMATION PHENYLEPHRINE ACCORD (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Phenylephrine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial of 1 mL contains 10 mg of phenylephrine hydrochloride. EXCIPIENT WITH KNOWN EFFECT: • Sodium metabisulfite For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Solution for injection. Phenylephrine Accord is a vasoconstrictor and pressor drug chemically related to adrenaline and ephedrine. Phenylephrine Accord is a clear, colourless, aqueous solution, free from visible particulates, in sterile form for parenteral injection. Phenylephrine Accord contains no antimicrobial preservative. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Phenylephrine hydrochloride is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia and for the treatment of vascular failure in shock, shock-like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anaesthesia, and as a vasoconstrictor in regional analgesia. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE MILD OR MODERATE HYPOTENSION: _Subcutaneously or Intramuscularly: _ Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg. _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 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the pressure for about 15 minutes. SEVERE HYPOTENSION AND SHOCK - INCLUDING MEDICINE-RELATED HYPOTENSION: Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intra-aortic pressures must be maintained to prevent cerebral or coronary arter Pročitajte cijeli dokument