Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Phytomenadione
CHEPLAPHARM Arzneimittel GmbH
B02BA; B02BA01
Phytomenadione
10 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Vitamin K; phytomenadione
Marketed
1990-04-06
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KONAKION MM AMPOULES 10 MG/ML SOLUTION FOR INJECTION AND ORAL SOLUTION Phytomenadione (vitamin K 1 ) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Konakion MM is and what it is used for 2. What you need to know before you are given Konakion MM 3. How Konakion MM is given 4. Possible side effects 5. How to store Konakion MM 6. Contents of the pack and other information 1. WHAT KONAKION MM IS AND WHAT IT IS USED FOR Konakion MM contains a medicine called phytomenadione. This is a man-made vitamin called vitamin K 1 . Konakion MM is used for the following: • To prevent and treat severe bleeding after the use of certain medicines to thin the blood (called anticoagulants). • To treat children aged 1 year and older normally after advice from a specialist haematologist (blood doctor). Konakion MM works by helping your body make blood clotting factors. These blood clotting factors help stop bleeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KONAKION MM YOU MUST NOT BE GIVEN KONAKION MM IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO PHYTOMENADIONE or any of the other ingredients of Konakion MM (listed in Section 6: Further information). If you are not sure if this applies to you, talk to your doctor or nurse before having Konakion. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before having Konakion MM if: • You have severe problems with your liver. • You have an artificial heart valve. OTHER MEDICINES AND KONAKION MM Tell your doctor or nurse i Soma hati kamili
Health Products Regulatory Authority 10 October 2023 CRN00DR1D Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Konakion MM Ampoules 10 mg/ml Solution for Injection and Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains 10 mg vitamin K1 (phytomenadione) per 1 ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection and oral solution. The solution is clear to slightly opalescent, pale yellow in colour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Konakion is indicated in the treatment of haemorrhage or threatened haemorrhage associated with a low blood level of prothrombin or factor VII. The main indication is: As an antidote to anticoagulant drugs of the coumarin type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Konakion MM ampoules are for intravenous injection or oral use. The ampoule solution should not be diluted or mixed with other parenteral medicines, but may be injected, where appropriate, into the lower part of the infusion set (via Y-site or 3-way tap), during continuous infusion of sodium chloride 0.9% or 5% dextrose. The dosage recommendations detailed in the tables below are provided for therapeutic guidance only. The dose selection for a specific patient should be based not only on the INR value, but various other risk factors and clinical determinants such as patient characteristics, comorbid conditions and concomitant medications should also be appropriately considered. Hence the actual dose selection should be at the discretion of the treating physician. _ADULTS: AS AN ANTIDOTE TO ANTICOAGULANT DRUGS_ Severe or life-threatening haemorrhage, e.g. during anticoagulant therapy: The coumarin anticoagulant should be withdrawn and an intravenous injection of Konakion MM given slowly in a dose of 5-10 mg together with fresh frozen plasma (FFP) or prothrombin complex concentrate (PCC). The dose of vitamin K1can be repeated as needed. The prothrombin level should be estimated three hours later and, if the Soma hati kamili