Consumer medicine information

Konakion MM Paediatric

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.

SUMMARY CMI

KONAKION® MM Paediatric

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 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.



FULL CMI

KONAKION® MM Paediatric (phonetic pronunciation – koe-nak-ee-on)

Active ingredient(s): phytomenadione


Consumer Medicine Information (CMI)

This leaflet provides important information about using KONAKION® MM Paediatric. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using KONAKION® MM Paediatric.

Where to find information in this leaflet:

1. Why am I using KONAKION® MM Paediatric?
2. What should I know before I use KONAKION® MM Paediatric?
3. What if I am taking other medicines?
4. How do I use KONAKION® MM Paediatric?
5. What should I know while using KONAKION® MM Paediatric?
6. Are there any side effects?
7. Product details

1. Why am I using KONAKION® MM Paediatric?

KONAKION® MM Paediatric contains the active ingredient phytomenadione. KONAKION® MM Paediatric belongs to a group of medicines called Vitamin K.

KONAKION® MM Paediatric is used to treat blood clotting problems.

Vitamin K is used to prevent and treat Vitamin K Deficiency Bleeding (VKDB). This is when the newborn or older babies bleed excessively as the blood clotting system is not fully developed. Vitamin K works by reversing some of the causes of excessive bleeding.

There are many different types of medicines used to treat bleeding disorders. KONAKION® MM Paediatric belongs to one of these groups.

Your doctor, however, may have prescribed KONAKION® MM Paediatric for another purpose.

Ask your doctor if you have any questions about why KONAKION® MM Paediatric has been prescribed for your baby.

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

Warnings

Do not use KONAKION® MM Paediatric if:

  • Your baby is allergic to phytomenadione, or any other type of Vitamin K or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure your baby can use this medicine.
  • The ampoule is damaged or shows signs of tampering.
  • The expiry date (EXP) printed on the pack has passed.
  • The solution is cloudy or separated.

Check with your doctor if your baby:

  • Has any other medical conditions including:
    - Liver disease or blockage of the bile ducts.
    - Poor absorption of nutrients (called malabsorption).
    - Is allergic to any other medicines, foods, dyes or preservatives.
    - Takes any medicines for any other condition.

Check with your doctor if you:

  • Have taken any of the following medicines during pregnancy:
    - Warfarin (Coumadin®, Marevan®).
    - Phenindione (Dindevan®).
    - Antiepilepsy medicines.
    - Tuberculosis medicines.
    - Long-term antibiotics.

If you have not told your doctor about any of the above, tell them before your baby starts KONAKION® MM Paediatric.

During treatment, your baby may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if your baby is taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with KONAKION® MM Paediatric and affect how it works.

These medicines include:

  • Long-term antibiotics.

Your baby may need to use different amounts of medicine, or may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while your baby is receiving KONAKION® MM Paediatric.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements your baby is taking and if these affect KONAKION® MM Paediatric.

4. How do I use KONAKION® MM Paediatric?

How it is used

  • KONAKION® MM Paediatric must be given to your baby exactly as prescribed by the doctor.
  • KONAKION® MM Paediatric can be used as an injection or as a liquid for the baby to swallow.
  • Usually, a doctor or nurse will give an injection into a muscle.
  • If it is given as a liquid into the baby's mouth, then the oral dispenser or another accurate measuring device should be used. After the liquid is placed in the baby's mouth, it is best to follow the dose with a feed, to ensure it is swallowed.
  • In the rare case that your baby already has a bleeding condition, then it may be given as an injection into a vein.
  • If your baby is given KONAKION® MM Paediatric orally, make sure they receive every dose as prescribed.
  • It is important that your baby receives every dose. If every dose is not given to your baby, KONAKION® MM Paediatric may not work as well to prevent this disease.

How long is KONAKION® MM Paediatric given for

  • 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 you suspect that your baby misses a dose of 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.

If your baby spits out or vomits an oral dose or if diarrhoea occurs within 24 hours, a repeat dose of Konakion® MM Paediatric may be needed.

If you give your baby too much KONAKION® MM Paediatric

If you think that you have given your baby too much KONAKION® MM Paediatric, your baby may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

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

Things you should do

  • For KONAKION® MM Paediatric to work properly all doses must be given to your baby.

Call your doctor straight away if you:

  • Notice your baby vomiting or having diarrhoea within 24 hours from receiving a dose of KONAKION® MM Paediatric by mouth.

Remind any doctor, dentist or pharmacist you visit that your baby is using KONAKION® MM Paediatric.

Things you should not do

  • Do not miss any of your baby's follow-up oral doses of KONAKION® MM Paediatric.
  • Do not give KONAKION® MM Paediatric to anyone else, other than your baby even if they have the same condition.
  • Do not use KONAKION® MM Paediatric to treat other complaints that your baby has unless your doctor says to.
  • 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

Although not expected to be applicable, tell your doctor if you drink alcohol and your baby is breast-fed.

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.

6. Are there any side effects?

All medicines can have side effects. If your baby does experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Side effects usually occur within hours of the dose being administered.

Less serious side effects

Less serious side effectsWhat to do
  • Unusual flushing or sweating
  • Irritation, soreness or redness near the injection site, in rare cases this can be severe
Speak to your doctor if your baby has any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Allergic reactions may include:
  • Rash
  • Swelling
  • Breathing difficulties
Other rare side effects that could be severe:
  • Inflammation and tissue injury of the injection site
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making your baby feel unwell.

Other side effects not listed here may occur in some babies.

Reporting side effects

After you have received medical advice for any side effects your baby experiences, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop giving your baby any of their medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What KONAKION® MM Paediatric contains

Active ingredient
(main ingredient)
Phytomenadione (also called Vitamin K1)
Each 0.2 mL ampoule contains 2 mg of phytomenadione
Other ingredients
(inactive ingredients)
  • Glycocholic acid
  • Lecithin (322)
  • Sodium hydroxide
  • Hydrochloric acid (507)
  • Water for injection
Potential allergensKONAKION® MM Paediatric is lactose and gluten free

Do not take this medicine if your baby is allergic to any of these ingredients.

What KONAKION® MM Paediatric looks like

KONAKION® MM Paediatric is an amber glass ampoule containing a clear, yellow solution. (AUST R 71758).

KONAKION® MM Paediatric comes in one paediatric strength:

2 mg/0.2 mL.

KONAKION® MM Paediatric comes in packs of 5 ampoules with 5 dispensers. The dispensers are for use if it is given by mouth.

KONAKION® MM Paediatric is also available as an adult injection.

Who distributes KONAKION® MM Paediatric?

Pharmaco (Australia) Ltd
Level 13, 465 Victoria Avenue
Chatswood NSW 2067
Australia
Phone: 1800 201 564

Under license of CHEPLAPHARM Arzneimittel GmbH, Germany

This leaflet was prepared in June 2023.

Published by MIMS September 2023

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

4.1 Therapeutic Indications

Prophylaxis and treatment of vitamin K deficiency bleeding (VKDB).

4.2 Dose and Method of Administration

Konakion MM Paediatric may be given by intramuscular, oral or intravenous routes. Care should be taken to ensure the correct dose is given for the chosen route of administration.

Prophylaxis.

All healthy neonates.

1 mg (0.1 mL) IM at birth is recommended. Alternatively, 2 mg (0.2 mL) orally at birth, at the time of newborn screening (3-5 days of age) and at 4 weeks.
For predominately formula fed neonates the last oral dose may be omitted.

Neonates with special risk factors.

1 mg IM at birth is recommended in neonates with special risk factors. If the neonate has special risk factors and weighs less than 1.5 kg, then 0.5 mg (0.05 mL) is recommended (see Section 4.4 Special Warnings and Precautions for Use).
The size and frequency of further doses should be based on clinical grounds and coagulation status.
Clotting and PIVKA-II (proteins induced in vitamin K absence) tests are not to be relied upon as indications of deficiency as the relationship between biochemical evidence of deficiency and late VKDB is not clear.

Special risk factors.

Early and/or classical VKDB.

Risk factors include: prematurity, birth asphyxia, delay in establishment of oral feeding, maternal use of anticoagulants, antiepileptics or tuberculostatics and antibiotic treatment.

Late VKDB.

Risk factors include: liver dysfunction including obstructive jaundice, malabsorption and prolonged use of antibiotics.

Therapy.

Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical grounds and coagulation status. In certain circumstances, treatment with Konakion MM Paediatric may need to be accompanied by more direct forms of effective haemorrhage control, such as transfusion of whole blood or coagulation factors, to compensate for severe blood loss and the delayed response to vitamin K1.
VKDB should be suspected with any minor bleed in infants less than 6 months of age, even if coagulation tests are within normal limits. Clotting and PIVKA-II tests are not to be relied upon as indications of deficiency as the relationship between biochemical evidence of deficiency and late VKDB is not clear.

Administration.

Parenteral use.

Konakion MM Paediatric should not be diluted or mixed with other parenteral medications.

Oral use (with the dispenser included in the package).

After breaking the ampoule, place the dispenser vertically into the ampoule.
Withdraw the solution from the ampoule into the dispenser until the solution reaches the marking on the dispenser (= 2 mg vitamin K1).
Administer the contents of the dispenser directly into the infant's mouth.
Repeated doses are advised if the infant spits out or vomits an oral dose or alternatively diarrhoea occurs within 24 hours of administration.

4.3 Contraindications

Konakion MM Paediatric is contraindicated in patients with known hypersensitivity to any of the ingredients.

4.4 Special Warnings and Precautions for Use

Anticoagulant therapy.

Konakion MM Paediatric should be considered as adjunctive therapy to blood transfusions for severe haemorrhage due to anticoagulant therapy; it is not effective when heparin-like compounds have been used for anticoagulant therapy; minimal doses should be used to offset refractoriness to coumarin-like anticoagulants if long-term anticoagulant therapy is intended.

Mutagenesis.

Neither phytomenadione nor phytomenadione in the mixed micellar formulation showed evidence of mutagenic activity in Salmonella typhimurium. No evidence of chromosomal aberration in human lymphocytes was demonstrated in vitro for phytomenadione, but no tests of potential for DNA damage have been conducted.

Use in the elderly.

Please see Konakion MM 10 mg/1 mL Product Information for recommendations for this group.

Paediatric use.

Parenteral administration is associated with a possible risk of kernicterus in premature infants weighing less than 2.5 kg.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Vitamin K1 antagonises the effects of coumarin and indanedione type anticoagulants (e.g. warfarin, phenindione).
Coadministration of anticonvulsants can impair the action of vitamin K1.
Konakion MM Paediatric should not be mixed with infusion solutions (see Section 4.2 Dose and Method of Administration).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There have been no studies investigating the effect of phytomenadione on reproductive fertility.
Not applicable, please see Konakion MM 10 mg/1 mL Product Information.
Vitamin K1 is poorly excreted into breast milk. Konakion is not recommended for nursing mothers as prophylaxis of haemorrhagic disease in the newborn.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

In rare cases anaphylactoid reactions have been reported after parenteral use of Konakion MM Paediatric. Should an anaphylactoid reaction occur, the usual measures must be taken (e.g. administration of adrenaline and supportive measures as required).
Very rarely, injection site reaction, venous irritation or phlebitis has been reported in association with parenteral administration of Konakion MM solution to adults. This reaction is unlikely in neonates due to the small injection volume (0.2 mL). Rarely, injection site reactions may occur which may be severe, including inflammation, atrophy and necrosis.
Facial flushing and sweating, and unusual taste have been reported.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

As a component of an enzyme system, vitamin K1 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 K1 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 K1 administration, which promotes synthesis of the abovementioned coagulation factors by the liver, can reverse an abnormal coagulation status or bleeding due to vitamin K1 deficiency. Vitamin K1 is ineffective in hereditary hypoprothrombinaemia or hypoprothrombinaemia induced by severe hepatic failure.
Lack of vitamin K1 leads to an increased tendency of vitamin K deficiency bleeding (VKDB). Administration of vitamin K1 promotes synthesis of above mentioned coagulation factors, can reverse an abnormal coagulation status or bleeding due to vitamin K1 deficiency and thereby reduces the risk of early, classic or late VKDB.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Orally ingested phytomenadione is absorbed primarily in the middle portions of the small intestine. Optimum absorption is possible only in the presence of bile and pancreatic juice. The absolute bioavailability following intramuscular (IM) administration is approximately 80%. The onset of action occurs approximately 1-3 hours after intravenous (IV) administration and 4-6 hours after oral doses.
Impaired gastrointestinal absorption may occur in conditions such as malabsorption syndromes, short bowel syndrome, biliary atresia and pancreatic insufficiency.

Distribution.

The primary distribution compartment corresponds to the plasma volume. In blood plasma, 90% of vitamin K1 is bound to lipoproteins (VLDL portion). Vitamin K1 plasma concentration is normally between 0.4 and 1.2 nanogram/L. After IV administration of 10 mg Konakion MM to adults the plasma level after 1 hour is approximately 500 nanogram/mL and approximately 50 nanogram/mL at 12 hours. Vitamin K1 is stored in the body for only short periods of time, does not readily cross the placenta and is poorly distributed into breast milk.

Metabolism.

Vitamin K1 is rapidly converted into more polar metabolites, including an active metabolite vitamin K1-2,3-epoxide. Some of this metabolite is reconverted into vitamin K1. Metabolism of vitamin K1 after birth through epoxidation may occur more rapidly in premature infants.

Excretion.

The elimination half-life in plasma is 1.5-3 hours. After metabolic degradation, vitamin K1 is excreted in the bile and urine as the glucuronide and sulphate conjugates. Less than 10% of the medicine is excreted unchanged in the urine.

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

6.1 List of Excipients

Glycocholic acid, lecithin, sodium hydroxide, hydrochloric acid, water for injection.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
During the shelf life of Konakion it is known that impurities will develop. Although there has been no definite evidence of a safety problem due to these impurities, there are also no adequate safety and toxicity data in relation to the impurities. In order to minimise the amount of impurities, prescribers are encouraged to use the product early in the shelf life wherever possible.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.
At the time of use, the MM ampoule solution should be clear. Following incorrect storage, the solution may become turbid or phase-separation may occur. In this case the ampoule must not be used.

6.5 Nature and Contents of Container

Konakion MM Paediatric ampoules 2 mg/0.2 mL (filling volume 0.3 mL): pack of five amber glass ampoules and 5 dispensers (graduated oral plastic syringes).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

CAS-84-80-0.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes