Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Phytomenadione
CHEPLAPHARM Arzneimittel GmbH
B02BA; B02BA01
Phytomenadione
2/0.2 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Vitamin K; phytomenadione
Marketed
1995-04-20
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KONAKION MM PAEDIATRIC AMPOULES 2 MG/0.2 ML ORAL SOLUTION OR SOLUTION FOR INJECTION Phytomenadione (vitamin K 1 ) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR BABY OR CHILD IS GIVEN THIS MEDICINE, OR BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask the doctor, nurse or midwife. • This medicine has been prescribed for you or your child 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 or your child get any side effects, talk to your doctor, nurse or midwife. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Konakion MM Paediatric is and what it is used for 2. What you need to know before you or your child is given Konakion MM Paediatric 3. How Konakion MM Paediatric is given 4. Possible side effects 5. How to store Konakion MM Paediatric 6. Contents of the pack and other information 1. WHAT KONAKION MM PAEDIATRIC IS AND WHAT IT IS USED FOR Konakion MM Paediatric contains a medicine called phytomenadione. This is a man-made vitamin called vitamin K 1 . Konakion MM Paediatric is most commonly used for the following: • Babies who do not have enough vitamin K in their bodies. Giving Konakion MM Paediatric PREVENTS and TREATS bleeding caused by a lack of vitamin K. This is called ‘vitamin K deficiency bleeding’ (VKDB). This is a serious, but rare condition. All newborn babies are given vitamin K 1 with their parent’s permission. Konakion MM Paediatric may also be used in adults and older children when small amounts of vitamin K are required, for the following: • To prevent and treat 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 Paediatric Lestu allt skjalið
Health Products Regulatory Authority 10 October 2023 CRN00DR1D Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Konakion MM Paediatric Ampoules 2 mg/ 0.2 ml oral solution or solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains 2 mg phytomenadione in 0.2 ml. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral solution or solution for injection. A clear to slightly opalescent pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Konakion MM Paediatric is indicated for the prophylaxis and treatment of vitamin K deficiency bleeding (VKDB) in neonates and infants. Konakion MM Paediatric is further indicated for the treatment of overdoses with anticoagulants of the coumarin type in adults and older children (1 to 18 years) where small quantities of vitamin K are required. This may also include the treatment of haemorrhage or threatened haemorrhage, associated with a low blood level of prothrombin or factor VII. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION PREVENTION AND TREATMENT OF VITAMIN K DEFICIENCY BLEEDING (VKDB) IN NEONATES AND INFANTS _ _ _PROPHYLAXIS OF VITAMIN K DEFICIENCY BLEEDING _ _Healthyneonates of 36 weeks gestation and older: _Either: - 1 mg administered by intramuscular injection at birth or soon after birth or - 2 mg orally at birth or soon after birth. The oral dose should be followed by a further dose of 2 mg at 4 - 7 days of age. A further 2 mg oral dose should be given at 1 month after birth. In exclusively formula fed infants the third oral dose can be omitted. _Preterm neonates of less than 36 weeks gestation weighing 2.5 kg or greater, and term neonates at special risk (e.g. prematurity, _ _birth asphyxia, obstructive jaundice, inability to swallow, maternal use of anticoagulants or antiepileptics)_: 1 mg by intramuscular or intravenous injection at birth or soon after birth. The amount and frequency of further doses should be based on coagulation status. _Preterm neonates of less than 36 wee Lestu allt skjalið