Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
fomepizole, Quantity: 1 g/mL
AFT Pharmaceuticals Pty Ltd
fomepizole
Injection
Excipient Ingredients:
Intravenous
1 x 1.5mL vial, 4 x 1.5ml vials
(S4) Prescription Only Medicine
Antizol is indicated for the treatment of ethylene glycol or methanol poisoning. (see DOSAGE AND ADMINISTRATION).
Visual Identification: Clear, colourless to yellow solution, essentially free from particles of foreign matter (visible signs of contamination); Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-12-01
FOMEPIZ-CMI-AU-v5 ANTIZOL _Fomepizole Injection_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about Antizol. It does not contain all the information that is known about Antizol. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you being given Antizol against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ANTIZOL IS USED FOR Antizol belongs to a group of medicines called antidotes. Antizol is used to treat ethylene glycol and methanol poisoning. Antizol helps to restore your blood levels of ethylene glycol and/or methanol to normal. Your doctor may have administered this medicine for another reason. Your doctor will explain why you are being treated with Antizol and tell you what dose you are being 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 Antizol has been administered to you. FOMEPIZ-CMI-AU-v5 Antizol is not addictive. This medicine is available only with a doctor’s prescription BEFORE YOU ARE GIVEN ANTIZOL _WHEN YOU MUST NOT BE GIVEN IT_ _ _ You must not be given Antizol if you have been drinking alcohol excessively. You should not be given Antizol if you have ever experienced an anaphylactic reaction with Antizol or other pyrazoles. ANTIZOL SHOULD NOT BE USED IF THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED. _BEFORE YOU USE IT _ Tell your doctor if you are pregnant or planning to become pregnant The effect of ANTIZOL in pregnant women is not known. Therefore the use of ANTIZOL in pregnant women is not recommended. Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether ANTIZOL passes into breast milk. If you ar Lugege kogu dokumenti
Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION ANTIZOL ® (FOMEPIZOLE) INJECTION 1. NAME OF THE MEDICINE Fomepizole. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1.5 mL (1 g/mL) of fomepizole. It is supplied sterile. Fomepizole injection does not contain any excipients. 3. PHARMACEUTICAL FORM A clear to yellow liquid (or solid) sterile, preservative-free solution for intravenous use. Solidification does not affect the stability of Antizol ® . 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antizol ® (fomepizole) is indicated for the treatment of ethylene glycol or methanol poisoning (see section 4.2 Dosage and method of administration). 4.2 DOSE AND METHOD OF ADMINISTRATION CAUTION: MUST BE DILUTED PRIOR TO USE TREATMENT GUIDELINES: If ethylene glycol or methanol poisoning is left untreated, the natural progression of the poisoning leads to accumulation of toxic metabolites, including glycolic and oxalic acids (ethylene glycol intoxication) and formic acid (methanol intoxication). These metabolites can induce metabolic acidosis, nausea/vomiting, seizures, stupor, coma, calcium oxaluria, acute tubular necrosis, blindness and death. The diagnosis of these poisonings may be difficult because ethylene glycol and methanol concentrations diminish in the blood as they are metabolized to their respective metabolites. Hence, if the fomepizole solution has become a solid in the vial, the solution should be liquefied by running the vial under warm water or by holding in the hand. Solidification does not affect the stability of Antizol ® . TREATMENT WITH FOMEPIZOLE : Begin fomepizole treatment immediately upon suspicion of ethylene glycol or methanol ingestion based on patient history and/or anion gap metabolic acidosis, increased Page 2 of 14 osmolar gap, visual disturbances, or oxalate crystals in the urine, OR a documented serum ethylene glycol or methanol concentration greater than 20 mg/dL (ethylene glycol 3.22 mmol/L, methanol 6.24 mmol/L). DISCONTINUATION OF FOMEPIZOLE TREATMENT: Treatment with f Lugege kogu dokumenti