Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Konakion MM 10 mg/ml solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Phytomenadione may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 bleeding after the use of certain medicines to thin the blood (called anti-coagulants).
- To treat children (aged 1 year and older) who have liver disease or low levels of vitamin K in their body because of illness. Konakion MM is normally used to treat these children 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 take it
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 Check with 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 Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Konakion MM can affect the way some medicines work. Also some other medicines may affect the way Konakion MM works. In particular, tell your doctor or nurse if you are taking medicines to stop your blood clotting (anticoagulants). Pregnancy and breast-feeding Talk to your doctor before having Konakion if you are pregnant, think you are pregnant, or breastfeeding. Your doctor will then decide if you should receive Konakion. 1
Driving and using machines Konakion MM is not likely to affect you being able to drive or use any tools or machines. Talk to your doctor if you notice any problems that might affect driving, using tools or machines while having Konakion. Important information about some of the ingredients of Konakion MM Konakion MM is essentially 'sodium (a type of salt) free' as it contains less than 1 mmol sodium (2.64 mg per 1 ml).
3.
How to take it
Konakion MM will be given to you by a doctor or nurse. It will be given to you by injection into a vein or through a small tube into one of your veins (intravenous infusion). Adults
- For people who are bleeding after taking blood-thinning (anticoagulant) medicines, the usual dose is 5 to 10 mg.
- For people who have severe bleeding the Konakion dose (5 to 10 mg) is usually given with a blood transfusion.
- For people with mild bleeding or at risk of bleeding, the usual dose is 0.5 to 1 mg.
- If you need to have emergency surgery you may be given 5 mg Konakion before surgery to reverse the effects of blood-thinning (anticoagulant) medicines.
- The maximum dose is usually no more than 40 mg Konakion in 24 hours. Your doctor will usually check your blood for the levels of clotting factors, 3 hours after having Konakion MM and, if you need them give you more doses of Konakion MM. Elderly Because elderly adults are sometimes more sensitive to Konakion MM your doctor may decide to start you on a lower dose. This dose may be increased or repeated if necessary. Children (aged 1 to 18 years) Konakion MM is normally used to treat children following advice from a specialist haematologist (blood doctor).
- The dose is usually no more than 5 mg.
- Some children may also need a blood transfusion. The doctor will usually check the child's blood for the levels of clotting factors, 2 to 6 hours after they have Konakion MM and, if necessary, give more doses of Konakion MM. If you are given more Konakion MM than you should Because Konakion MM is given by a doctor or nurse, it is unlikely that you or your child will be given too much or that you or your child will miss a dose. However, if you are worried talk to your doctor or nurse. If you have any further questions on the use of this medicine, ask your doctor or nurse.
2
4.
Possible side effects
Like all medicines Konakion MM may cause side effects, although not everyone will get them. The following side effects may happen with this medicine: Allergic reactions The signs may include:
- Swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow.
- Sudden swelling of the hands, feet and ankles. If you have an allergic reaction, tell a doctor straight away. A reaction where the injection was given The signs may include swelling and redness along the vein where the medicine was given, which is very tender or painful when touched. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. • • • •
6.
How to store it
Konakion MM Your doctor or pharmacist is responsible for storing Konakion MM. They are also responsible for disposing of any unused Konakion MM correctly. Keep out of the sight and reach of children. Do not use Konakion MM after the expiry date printed on the pack. Konakion MM ampoules should be stored at a temperature below 25°C.
Contents of the pack and other information
What Konakion MM contains The active substance in Konakion MM Ampoules 10 mg/ml is vitamin K 1 (phytomenadione). Each 1 ml of liquid medicine contains 10 mg vitamin K 1 . Other ingredients are glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid and water for injections. What Konakion MM looks like and contents of the pack Konakion MM is a slightly opalescent, pale yellow liquid ('solution for infusion'). This liquid will be further diluted to make it weaker before it is given to you. Konakion MM is supplied in amber coloured glass ampoules in packs of 10. Marketing Authorisation Holder and Manufacturer
3
Marketing Authorisation Holder Neon Healthcare Limited 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom Manufacturer CHEPLAPHARM Arzneimittel GmbH Ziegelhof 23-24 17489 Greifswald Germany This leaflet was last revised in May 2023 ————————————————————————————————————————The following information is intended for medical or healthcare professionals only: The tear-off portion above is intended for the patient INFORMATION FOR HEALTHCARE PROFESSIONALS
Konakion MM Ampoules 10 mg/ml solution for injection Phytomenadione (vitamin K 1 )
Please refer to the Summary of Product Characteristics for full prescribing information. Presentation Amber glass ampoules containing 1 ml solution. The solution is clear to slightly opalescent and pale yellow in colour. Excipients are glycocholic acid, lecithin, sodium hydroxide, hydrochloric acid and water for injections. Konakion MM Ampoules 10 mg/ml are essentially 'sodium free' as they contain less than 1 mmol sodium (2.64 mg per 1 ml). Cartons of 10 ampoules. Therapeutic indication Konakion MM is indicated as an antidote to anticoagulant drugs of the coumarin type in the treatment of haemorrhage or threatened haemorrhage, associated with a low blood level of prothrombin or factor VII. Posology and method of administration Konakion MM Ampoules 10 mg/ml is for intravenous injection. Adults 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 (over at least 30 seconds) at a dose of 5 – 10 mg together with prothrombin complex concentrate (PCC). Fresh frozen plasma (FFP) may be used if PCC is not available. The patient's INR should be estimated three hours later and, if the response has been inadequate, the dose should be repeated. Not more than 40 mg of Konakion MM should be given intravenously in 24 hours. Coagulation profiles must be monitored on a daily basis until these have returned to acceptable levels; in severe cases more frequent monitoring is necessary. For full details of dose recommendations for vitamin K 1 therapy in patients with major and life-threatening bleeding, please refer to the Summary of Product Characteristics. Less severe haemorrhage: An intravenous injection of Konakion MM given slowly at a dose of 0.5 – 1 mg. For full details of dose recommendations for vitamin K 1 therapy in patients with asymptomatic high 4
International Normalised Ratio (INR) with or without mild haemorrhage, please refer to the Summary of Product Characteristics. Reversal of anticoagulation prior to surgery: For emergency surgery that can be delayed for 6-12 hours, 5 mg intravenous vitamin K 1 can be given. If surgery cannot be delayed, PCC can be given in addition to intravenous vitamin K 1 and the INR checked before surgery. Use with anticoagulants other than warfarin: The dosing recommendations above apply to patients taking warfarin. There are limited data regarding reversal of the effects of other anticoagulants, such as acenocoumarol or phenprocoumon. The half lives of these anticoagulants are different to warfarin and different doses of vitamin K 1 may be required. Elderly Elderly patients tend to be more sensitive to reversal of anticoagulation with Konakion MM; dosage in this group should be at the lower end of the ranges recommended. Children aged 1 to 18 years It is advisable that a haematologist is consulted about appropriate investigation and treatment in any child in whom Konakion MM is being considered. For patients on warfarin therapy, therapeutic intervention must take into consideration the reason for the child being on warfarin and whether or not anticoagulant therapy has to be continued (e.g. in a child with mechanical heart valve or repeated thromboembolic complications) as vitamin K administration is likely to interfere with anticoagulation with warfarin for 2 – 3 weeks. It should be noted that the earliest effect seen with vitamin K treatment is at 4 – 6 hours and therefore in patients with severe haemorrhage replacement with coagulation factors may be indicated (discuss with haematologist). Dose of vitamin K There are few data available regarding use of Konakion MM in children over 1 year. There have been no dose ranging studies in children with haemorrhage. The optimal dose should therefore be decided by the treating physician according to the indication, clinical situation and weight of the patient. Suggested dosages based on clinical experience are as follows: Children with major and life-threatening bleeding: a dose of 5 mg vitamin K 1 i.v. is suggested (together with PCC if appropriate, or FFP if PCC is not available). Children with asymptomatic high International Normalised Ratio (INR) with or without mild haemorrhage: i.v. vitamin K 1 at doses of 30 micrograms/kg have been reported to be effective in reversing asymptomatic high (>8) INR in clinically well children. INR should be measured 2 to 6 hours later and if the response has not been adequate, the dose may be repeated. Frequent monitoring of vitamin K dependent clotting factors is essential in these patients. Neonates and babies Konakion MM Paediatric 2 mg/0.2 ml should be used in these patients. Method of administration – Instructions for infusion in adults At the time of use, the ampoule contents should be clear. Following incorrect storage, the contents may become turbid or present a phase-separation. In this case the ampoule must not be used. Konakion MM Ampoules are for intravenous injection and should be diluted with 55 ml of 5% glucose before slowly infusing the product. The solution should be freshly prepared and protected from light. Konakion MM Ampoule solution should not be diluted or mixed with other injectables, but may be injected into the lower part of an infusion apparatus. 5
Shelf life Unopened: 2 years. Special precautions for storage Store below 25°C and protect from light. Do not freeze. Do not use if the solution is turbid. This leaflet was last revised in October 2023
6
Frequently asked questions about Konakion MM 10 mg/ml solution for injection
How do I take Konakion MM 10 mg/ml solution for injection?
Konakion MM 10 mg/ml solution for injection comes as injection containing 10mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Konakion MM 10 mg/ml solution for injection?
The active substance in Konakion MM 10 mg/ml solution for injection is phytomenadione.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Konakion MM 10 mg/ml solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Konakion MM 10 mg/ml solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: phytomenadione
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Konakion MM/Phytomenadione 10 mg/1 ml is indicated as an antidote to anticoagulant drugs of the coumarin type in 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
Konakion MM/Phytomenadione 10 mg/1 ml is for intravenous injection.
Adults
Severe or life-threatening haemorrhage, e.g. during anticoagulant therapy: The coumarin anticoagulant should be withdrawn and an intravenous injection of Konakion MM/Phytomenadione 10 mg/1 ml given slowly (over at least 30 seconds) at a dose of 5-10 mg together with prothrombin complex concentrate (PCC). Fresh frozen plasma (FFP) may be used if PCC is not available. The patient's INR should be estimated three hours later and, if the response has been inadequate, the dose should be repeated. Not more than 40 mg of Konakion MM/Phytomenadione 10 mg/1 ml should be given intravenously in 24 hours. Coagulation profiles must be monitored on a daily basis until these have returned to acceptable levels; in severe cases more frequent monitoring is necessary.
Dose recommendations for vitamin K1 therapy in patients with major and life-threatening bleeding:
Anticoagulant
Condition
Intravenous vitamin K1
Concomitant therapy
Warfarin
Major bleeding
5.0 mg
PCC1
Life-threatening bleeding
5.0 to 10.0 mg
PCC1
PCC, prothrombin complex concentrate
1 Fresh frozen plasma (FFP) may be used if PCC is not available
Less severe haemorrhage:
Treatment of asymptomatic patients with elevated INR values depends on factors such as the underlying indication for anticoagulation, INR value, length of time spent outside the therapeutic INR range, patient characteristics (e.g. age, comorbidity, concomitant medication), and the associated risk of major bleeding. The following dose recommendations are provided for therapeutic guidance only:
Dose recommendations for vitamin K1 therapy in patients with asymptomatic high International Normalised ratio (INR) with or without mild haemorrhage:
Anticoagulant
INR
Intravenous vitamin K1
Warfarin
5-9
0.5 to 1.0 mg
>9
1.0 mg
For small doses one or more ampoules of Konakion MM Paediatric/ Phytomenadione 2 mg/0.2 ml solution for injection (same solution) can be used.
Reversal of anticoagulation prior to surgery
Patients who require emergency surgery that can be delayed for 6-12 hours can be given 5 mg intravenous vitamin K1 to reverse the anticoagulant effect. If surgery cannot be delayed, PCC can be given in addition to intravenous vitamin K1 and the INR checked before surgery.
Use with anticoagulants other than warfarin
The dosing recommendations above apply to patients taking warfarin. There are limited data regarding reversal of the effects of other anticoagulants, such as acenocoumarol or phenprocoumon. The half-lives of these anticoagulants are different to warfarin and different doses of vitamin K1 may be required.
Special dosage instructions
Elderly
Elderly patients tend to be more sensitive to reversal of anticoagulation with Konakion MM/Phytomenadione 10 mg/1 ml. The dosage for this patient group should therefore be at the lower end of the ranges recommended.
Instructions for infusion in adults
This medicine is for intravenous injection and should be diluted with 55 ml of 5% glucose before slowly infusing the product. The solution should be freshly prepared and protected from light. Konakion MM/Phytomenadione 10 mg/1 ml solution should not be diluted or mixed with other injectables, but may be injected into the lower part of an infusion apparatus.
Children aged 1 to 18 years
It is advisable that a haematologist is consulted about appropriate investigation and treatment in any child in whom Konakion MM/Phytomenadione 10 mg/1 ml is being considered.
Likely indications for using vitamin K in children are limited and may include:
1. Children with disorders that interfere with absorption of vitamin K (chronic diarrhoea, cystic fibrosis, biliary atresia, hepatitis, coeliac disease).
2. Children with poor nutrition who are receiving broad spectrum antibiotics.
3. Liver disease.
4. Patients receiving anticoagulant therapy with warfarin in whom the INR is increased outside the therapeutic range and therefore are at risk of, or are bleeding, and those with an INR in the therapeutic range who are bleeding.
For patients on warfarin therapy, therapeutic intervention must take into consideration the reason for the child being on warfarin and whether or not anticoagulant therapy has to be continued (e.g. in a child with mechanical heart valve or repeated thromboembolic complications) as vitamin K administration is likely to interfere with anticoagulation with warfarin for 2-3 weeks.
It should be noted that the earliest effect seen with vitamin K treatment is at 4-6 hours and therefore in patients with severe haemorrhage replacement with coagulation factors may be indicated (discuss with haematologist).
Dose of vitamin K
There are few data available regarding use of this medicine in children over 1 year. There have been no dose ranging studies in children with haemorrhage. The optimal dose should therefore be decided by the treating physician according to the indication, clinical situation and weight of the patient. Suggested dosages based on clinical experience are as follows:
Children with major and life-threatening bleeding
A dose of 5 mg vitamin K1 IV is suggested (together with PCC if appropriate, or FFP if PCC is not available).
Children with asymptomatic high International Normalised Ratio (INR) with or without mild haemorrhage
Intravenous vitamin K1 at doses of 30 micrograms/kg have been reported to be effective in reversing asymptomatic high (>8) INR in clinically well children.
The patient's INR should be measured 2 to 6 hours later and if the response has not been adequate, the dose may be repeated. Frequent monitoring of vitamin K dependent clotting factors is essential in these patients.
Neonates and babies
Konakion MM Paediatric/Phytomenadione 2 mg/0.2 ml solution for injection should be used in these patients (see separate prescribing information).
4.3. Contraindications
Use in patients with a known hypersensitivity to any of the constituents.
This medicine should not be administered intramuscularly because the IM route exhibits depot characteristics and continued release of vitamin K1 would lead to difficulties with the re-institution of anticoagulation therapy. Furthermore, IM injections given to anticoagulated subjects cause a risk of haematoma formation.
4.4. Special warnings and precautions for use
When treating patients with severely impaired liver function, it should be borne in mind that one 1 ml ampoule of Konakion MM/Phytomenadione 10 mg/1 ml contains 54.6 mg glycocholic acid and this may have a bilirubin displacing effect. Careful monitoring of the INR is necessary after administration of this medicine in patients with severely impaired liver function.
At the time of use, the ampoule contents should be clear. Following incorrect storage, the contents may become turbid or present a phase separation. In this case the ampoule must no longer be used.
In potentially fatal and severe haemorrhage due to overdosage of coumarin anticoagulants, intravenous injections of Konakion MM/Phytomenadione 10 mg/1 ml must be administered slowly and not more than 40 mg should be given during a period of 24 hours. Konakion MM/Phytomenadione 10 mg/1 ml therapy should be accompanied by a more immediate effective treatment such as transfusion of whole blood or blood clotting factors. When patients with prosthetic heart valves are given transfusions for the treatment of severe or potentially fatal haemorrhage, fresh frozen plasma should be used. The use of vitamin K1 in patients with mechanical heart valves is generally to be avoided, unless there is major bleeding.
Large doses of Konakion MM/Phytomenadione 10 mg/1 ml (not more than 40 mg per day) should be avoided if it is intended to continue with anticoagulant therapy because there is no experience with doses above this maximum of 40 mg per day and higher doses may give rise to unexpected adverse events. Clinical studies have shown a sufficient decrease in the INR with the recommended dosage. If haemorrhage is severe, a transfusion of fresh whole blood may be necessary whilst awaiting the effect of the vitamin K1.
Vitamin K1 is not an antidote to heparin.
4.5. Interaction with other medicinal products and other forms of interaction
No significant interactions are known other than antagonism of coumarin anticoagulants.
4.6. Fertility, pregnancy and lactation
There is no specific evidence regarding the safety of Konakion MM/Phytomenadione 10 mg/1 ml in pregnancy but, as with most drugs, the administration during pregnancy should only occur if the benefits outweigh the risks.
This medicine is not recommended for pregnant women as prophylaxis of vitamin K deficiency bleeding in the newborn.
4.8. Undesirable effects
There have been reports of anaphylactoid reactions after intravenous injections of this medicine. Very rarely, venous irritation or phlebitis has been reported in association with intravenous administration of Konakion MM/Phytomenadione 10 mg/1 ml mixed micelles solution.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Hypervitaminosis of vitamin K1 is unknown.
Reintroduction of anti-coagulation may be affected.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- FITOMENADION TERAPIA 10 mg/ml prescriptionPHYTOMENADIONUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- VitaconPhytomenadionum · injection / infusion
- Phytomenadione BB Pharmaint-rac-Phytomenadionum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Konakion MM 10 mg/ml solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.