Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
thiamine hydrochloride, Quantity: 100 mg/mL
Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies
Thiamine hydrochloride
Injection
Excipient Ingredients: disodium edetate; benzyl alcohol; water for injections
Intramuscular, Intravenous
Pack of 1 vial, Pack of 10 vials, Pack of 5 vials, Pack of 6 vials
Not scheduled. Not considered by committee
Thiamine Hydrochloride Injection is used for the prevention and treatment of vitamin B1 deficiency.
Visual Identification: A clear and colourless solution contained in an amber glass vial, sealed with a grey chlorobutyl rubber stopper and aluminium seal with red polypropylene flip-off insert; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-09-25
Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL Injection 1 BIOLOGICAL THERAPIES THIAMINE HYDROCHLORIDE 100 MG IN 1 ML INJECTION CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I BEING GIVEN THIS MEDICINE? This medicine contains the active ingredient thiamine hydrochloride. It is used for the prevention and treatment of vitamin B1 deficiency. For more information, see Section 1. Why am I being given this medicine? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN THIS MEDICINE? Do not use if you have ever had an allergic reaction to this medicine or any of the ingredients listed at the end of the CMI. This medicine must not be given to a child under 2 years. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I am given this medicine? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Thiamine Hydrochloride 100 mg in 1 mL Injection and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS THIS MEDICINE GIVEN TO ME? This medicine is given as an injection into a vein or a muscle. This medicine must only be given by a doctor or nurse. The usual dose is 5 mg to 100 mg under normal circumstances or much higher amounts in critically ill patients. More instructions can be found in Section 4. How is this medicine given to me? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING GIVEN THIS MEDICINE? THINGS YOU MUST DO • Remind or tell any doctor, surgeon, anaesthetist, dentist or pharmacist you visit that you are being treated with Thiamine Hydrochloride Injection. • Tell your doctor if you feel that giving this medicine is not helping your condition. • Keep all of your doctor’s appointments Citiți documentul complet
AUSTRALIAN PRODUCT INFORMATION BIOLOGICAL THERAPIES THIAMINE HYDROCHLORIDE 100 MG IN 1 ML INJECTION _Biological Therapies _ _Page 1 of 7 _ _Version ID: pi119s2110 _ AUST R: 218622 1. NAME OF THE MEDICINE Thiamine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL Injection contains 100 mg of thiamine hydrochloride. For the full list of excipients, see Section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Injection for Intravenous or Intramuscular use. The injection is a clear and colourless solution. The pH of the solution is 2.5 to 3.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Thiamine Hydrochloride 100 mg in 1 mL Injection is used for the prevention and treatment of vitamin B 1 deficiency. 4.2 DOSE AND METHOD OF ADMINISTRATION Use in one patient on one occasion only and discard any residue. Thiamine Hydrochloride 100 mg in 1 mL Injection is administered by IM injection or slow IV injection over a period of at least 10 minutes. Due to the potential for serious anaphylactic reactions, parenteral administration of thiamine is only indicated when oral administration of thiamine is not acceptable or possible. Facilities for treating anaphylaxis should be available when administering Thiamine Injection. If the thiamine hydrochloride solution is cloudy or contains visually detectable particles, please contact the Quality Assurance Manager at Biological Therapies. Thiamine Deficiency Simple thiamine deficiency is rare and as a result multiple vitamin deficiencies should be suspected either in those patients exhibiting signs consistent with thiamine deficiency, or those considered to be at risk of developing thiamine deficiency. Consideration should be given to administering other water soluble vitamins in conjunction with thiamine. In critically ill thiamine deficient adults and in patients with malabsorption syndromes, the usual IM or IV dosage of thiamine hydrochloride is 5 to 100 mg three times daily. In patients with beriberi, the dose should then be reduced according to response and fo Citiți documentul complet