Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Phytomenadione
Roche Products Pty Ltd
Medicine Registered
KONAKION ® MM _PRONOUNCED KOE-NAK-EE-ON_ _contains the active ingredient phytomenadione (also called Vitamin K1)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about KONAKION MM. It does not contain all 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 of you receiving KONAKION MM against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT KONAKION MM IS USED FOR KONAKION MM contains the active ingredient phytomenadione. KONAKION MM is used to treat excessive bleeding problems. KONAKION MM belongs to a group of medicines called Vitamin K. Vitamin K substances are used to treat excessive bleeding problems and work by reversing some of the causes of excessive bleeding. This risk of bleeding is usually caused by the use of too much medication to prevent blood clots (also known as anticoagulant medication). There are many different types of medicines used to treat bleeding disorders. KONAKION MM belongs to one of these groups. Your doctor, however, may have prescribed KONAKION MM for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY KONAKION MM HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU RECEIVE KONAKION MM _WHEN YOU MUST NOT HAVE IT_ DO NOT HAVE KONAKION MM IF: 1. YOU HAVE HAD AN ALLERGIC REACTION TO KONAKION MM, ANY OTHER TYPE OF VITAMIN K OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some 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 skinIf you use this medicine after the expiry date has passed it may not work as well 2. YOU ARE PREGNANT OR PLAN TO BECOME PREGNANT. 3. THE AMPOULE IS DAMAGED OR Read the complete document
r Konakion ® PI 100604 1 of 6 ISPI 2.0 NAME OF THE MEDICINE KONAKION ® Phytomenadione (Vitamin K 1 ) _CAS-84-80-0 _ CH CH CH = C CH CH CH CH CH 2 2 2 2 3 3 CH 3 CH 3 O O 3 DESCRIPTION KONAKION contains as the active ingredient phytomenadione (Vitamin K 1 ) which is 2-methyl-3-phytyl- 1,4-naphthaquinone. Phytomenadione is a clear, yellow, very viscous, odourless or nearly odourless oil with a molecular weight of 450.7. It is insoluble in water, soluble 1 in 70 in alcohol, more soluble in dehydrated alcohol; soluble in benzene, chloroform, ether and vegetable oils. It is stable in air but decomposes on exposure to light. KONAKION is available in ampoules. The ampoule contains the active ingredient phytomenadione 10mg/mL in a mixed micelles (MM) solution (the micelles are composed of glycocholic acid and lecithin in an aqueous solution). The MM ampoule also contains sodium hydroxide, hydrochloric acid and water for injection. PHARMACOLOGY PHARMACODYNAMICS As a component of an enzyme system, Vitamin K 1 promotes the formation in the liver of coagulation factors II (prothrombin), VII, IX and X and of the coagulation inhibitors protein C and protein S, within the body. Anticoagulants of the coumarin and indandione series cause a reversible displacement of Vitamin K 1 from this enzyme system, thereby inhibiting the synthesis of these factors. Since this is a competitive displacement, KONAKION is a specific antagonist for warfarin and similar anticoagulants. It is not capable, however, of terminating the action of heparin; for this purpose a salt of protamine should be used. Vitamin K 1 administration, which promotes synthesis of the abovementione Read the complete document