Consumer medicine information

Konakion MM Paediatric 2 mg/0.2 mL Solution

Phytomenadione

BRAND INFORMATION

Brand name

Konakion MM Paediatric

Active ingredient

Phytomenadione

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Konakion MM Paediatric 2 mg/0.2 mL Solution.

1. Why am I using KONAKION® MM Paediatric?


KONAKION® MM Paediatric contains the active ingredient phytomenadione. KONAKION® MM Paediatric is used to prevent and treat Vitamin K Deficiency Bleeding (blood clotting problems).
For more information, see Section 1. Why am I using KONAKION® MM Paediatric? in the full CMI.

2. What should I know before I use KONAKION® MM Paediatric?


Do not use if your baby has ever had an allergic reaction to KONAKION® MM Paediatric or any of the ingredients listed at the end of the CMI.
Talk to your doctor if your baby has any other medical conditions or take any other medicines or if you have taken any medicines during pregnancy.
For more information, see Section 2. What should I know before I use KONAKION® MM Paediatric? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with KONAKION® MM Paediatric 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 do I use KONAKION® MM Paediatric?

  • Your doctor will usually prescribe one injection in the muscle or a number of doses given by mouth.
  • The length of therapy will vary according to whether your baby is breast-fed, on milk formula or if they are at particular risk of haemorrhagic disease.
  • If your baby is given KONAKION® MM Paediatric orally, they must receive every dose as prescribed for effective disease prevention.

More instructions can be found in Section 4. How do I use KONAKION® MM Paediatric? in the full CMI.

5. What should I know while using KONAKION® MM Paediatric?

Things you should do
  • Remind any doctor, dentist or pharmacist visit that your baby is using KONAKION® MM Paediatric.
  • Tell your doctor or nurse if your baby vomits or has diarrhoea within 24 hours of receiving a dose of KONAKION® MM Paediatric by mouth. A repeat dose may be required.
Things you should not do
  • Do not miss your baby's doctor follow-up appointments to ensure all oral doses are received.
  • Do not give any other medicines to your baby whether they require a prescription or not without first telling your doctor or consulting a pharmacist.
Driving or using machines
  • There is no information on use of KONAKION® MM Paediatric with driving or operating machines.
Drinking alcohol
  • Not expected to be applicable.
Looking after your medicine
  • KONAKION® MM Paediatric will be stored in the pharmacy, at the doctors surgery, on the ward or at the baby health centre.
  • It is kept in a cool dry place where the temperature stays below 25°C.
  • KONAKION® MM Paediatric should be protected from light.

For more information, see Section 5. What should I know while using KONAKION® MM Paediatric? in the full CMI.

6. Are there any side effects?


Side effects usually occur within hours of the dose being administered and may include serious allergic reactions.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Konakion MM Paediatric

Active ingredient

Phytomenadione

Schedule

Unscheduled

 

1 Name of Medicine

Phytomenadione (vitamin K1).

2 Qualitative and Quantitative Composition

Konakion MM Paediatric contains as the active ingredient phytomenadione (vitamin K1) 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.
The ampoule contains the active ingredient phytomenadione 2 mg/0.2 mL in a mixed micelles (MM) solution (the micelles are composed of glycocholic acid and lecithin in an aqueous solution). The formulation is available in two volumes, phytomenadione 10 mg/1 mL (adult) and 2 mg/0.2 mL (paediatric).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection, solution.

4 Clinical Particulars

4.9 Overdose

There is no known clinical syndrome attributable to hypervitaminosis of vitamin K1.
The following adverse events have been reported concerning overdose with use of Konakion in neonates and infants: jaundice, hyperbilirubinaemia, increased glutamine-oxaloacetic transferase and gamma-glutamyl transferase, abdominal pain, constipation, soft stools, malaise, agitation and cutaneous eruption. The causality of those cannot be established. The majority of these adverse events were considered nonserious and resolved without any treatment.
Treatment of suspected overdose should be aimed at alleviating symptoms and consist of general supportive measures.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No studies on the potential carcinogenic activity of phytomenadione have been conducted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPHYTOM.gif CAS number. CAS-84-80-0.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/KONAMPST.gif