Konakion Novum
Vitamin K1 (Phytomenadione) for Bleeding Prevention and Treatment
Quick Facts About Konakion Novum
Key Takeaways About Konakion Novum
- Essential for newborn health: Konakion Novum is the standard vitamin K prophylaxis given to all newborns to prevent potentially fatal vitamin K deficiency bleeding (VKDB)
- Reverses warfarin overdose: It is a first-line treatment for reversing excessive anticoagulation and bleeding caused by warfarin and other vitamin K antagonists
- Versatile administration: The unique mixed-micelle formulation allows intravenous, intramuscular, or oral administration from the same ampoule
- Very well tolerated: Serious side effects are extremely rare, occurring in fewer than 1 in 10,000 patients, primarily anaphylactoid reactions with IV use
- Slow IV injection required: When given intravenously, Konakion Novum must be injected slowly over at least 30 seconds to minimise the risk of adverse reactions
What Is Konakion Novum and What Is It Used For?
Konakion Novum contains phytomenadione (vitamin K1), a fat-soluble vitamin that is essential for the normal clotting of blood. It is used to treat and prevent bleeding caused by vitamin K deficiency, and is routinely given to all newborn infants to prevent a serious bleeding condition known as vitamin K deficiency bleeding (VKDB).
Vitamin K1 (phytomenadione) is a naturally occurring form of vitamin K that plays an indispensable role in the blood coagulation cascade. It serves as a cofactor for the hepatic enzyme gamma-glutamyl carboxylase, which activates several key coagulation factors – specifically factors II (prothrombin), VII, IX, and X – as well as the anticoagulant proteins C and S. Without adequate vitamin K, these clotting factors remain in their inactive form, resulting in impaired blood clotting and an increased risk of haemorrhage.
Konakion Novum is formulated as a mixed-micelle preparation containing glycocholic acid and lecithin. This unique formulation is significant because it allows the product to be administered not only as an injection but also orally, bypassing the need for bile salts for absorption. Traditional fat-soluble vitamin K preparations require bile salts for intestinal absorption, but the mixed-micelle formulation ensures reliable absorption even in patients with cholestasis (impaired bile flow) or fat malabsorption syndromes.
The primary clinical indications for Konakion Novum include:
- Treatment of bleeding due to vitamin K deficiency: This encompasses bleeding associated with excessive anticoagulation with warfarin or other coumarin-type anticoagulants, as well as bleeding caused by malabsorption, liver disease, prolonged antibiotic therapy, or inadequate dietary intake.
- Prevention of bleeding due to vitamin K deficiency: Including situations where there is a known risk of vitamin K deficiency, such as obstructive jaundice, biliary fistula, coeliac disease, or other conditions affecting fat-soluble vitamin absorption.
- Prophylaxis in newborn infants: All newborns are at risk of VKDB because vitamin K does not efficiently cross the placenta, neonatal gut flora that synthesise vitamin K are not yet established, and breast milk contains only small amounts of vitamin K. The World Health Organization (WHO), the American Academy of Pediatrics (AAP), and other major health authorities recommend vitamin K prophylaxis for all newborns.
Vitamin K deficiency bleeding (VKDB) in newborns was formerly called “haemorrhagic disease of the newborn.” Without prophylaxis, approximately 1 in 60 to 1 in 250 newborns may develop some form of VKDB. The most severe form – late-onset VKDB – can cause intracranial haemorrhage with devastating neurological consequences. Since the introduction of universal newborn vitamin K prophylaxis, this condition has become extremely rare in countries with established prophylaxis programmes.
Konakion Novum is also an essential component of the emergency management of major bleeding in patients taking warfarin or similar vitamin K antagonists. In these situations, it is typically administered intravenously alongside prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) to rapidly restore coagulation factor levels. The European Heart Rhythm Association (EHRA) and other major guidelines recommend intravenous vitamin K as a key part of the reversal strategy for vitamin K antagonist-related bleeding.
What Should You Know Before Taking Konakion Novum?
Konakion Novum should not be used if you are allergic to phytomenadione or any of the other ingredients. Use with caution if you have an increased risk of blood clots (such as with a prosthetic heart valve) or if you have impaired liver function. Always tell your doctor about all medications you are taking.
Contraindications
You should not receive Konakion Novum if any of the following apply:
- Known allergy (hypersensitivity) to phytomenadione or any of the other ingredients in the product, including glycocholic acid, lecithin, sodium hydroxide, or hydrochloric acid
There are very few absolute contraindications to vitamin K1 administration, reflecting its essential role in normal physiology and its generally excellent safety profile. However, caution is needed in specific clinical situations as outlined below.
Warnings and Precautions
Talk to your doctor before receiving Konakion Novum if any of the following conditions apply:
- Increased risk of thromboembolism: Patients with prosthetic heart valves or other conditions associated with elevated thrombotic risk require careful vitamin K dosing. Rapid and complete reversal of anticoagulation with large doses of vitamin K can precipitate thromboembolic events in these patients. Your doctor will use the minimum effective dose and monitor your coagulation status closely.
- Impaired liver function: Severe hepatic disease (such as advanced cirrhosis) can impair the synthesis of clotting factors regardless of vitamin K availability. In these patients, vitamin K alone may not be sufficient to correct the coagulation defect, as the liver may lack the capacity to produce functional clotting factors even when vitamin K is present. Your doctor will assess whether additional treatments (such as fresh frozen plasma or prothrombin complex concentrate) are needed.
- Intravenous administration: Anaphylactoid reactions, although very rare, have been reported with intravenous administration of vitamin K preparations. For this reason, intravenous injection must be given slowly, over at least 30 seconds. Facilities for the management of anaphylaxis should be available when Konakion Novum is administered intravenously.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, talk to your doctor before using this medicine.
Pregnancy: There are no known risks associated with the use of phytomenadione during pregnancy. Vitamin K1 is a naturally occurring substance required for normal physiological function, and no teratogenic effects have been reported. Your doctor may prescribe Konakion Novum during pregnancy if there is a clinical indication, such as warfarin reversal.
Breastfeeding: Phytomenadione passes into breast milk, but this is not considered harmful to the nursing infant. In fact, the low vitamin K content of breast milk is the primary reason why breastfed infants require vitamin K prophylaxis at birth and may need additional oral doses during the first weeks of life.
Driving and Operating Machinery
No effects on the ability to drive or operate machinery have been observed with Konakion Novum. This is consistent with its mechanism of action as a vitamin cofactor rather than a drug with central nervous system activity. However, you should always consider your overall health condition and the reason for treatment when assessing your fitness to drive.
Sodium Content
Konakion Novum contains less than 1 mmol (23 mg) sodium per ampoule, meaning it is essentially “sodium-free.” This is relevant for patients on a sodium-restricted diet or those receiving multiple intravenous products where total sodium load needs to be monitored.
How Does Konakion Novum Interact with Other Drugs?
The most important drug interaction of Konakion Novum is with warfarin and other vitamin K antagonist anticoagulants, whose effect it directly reverses. Anti-epileptic drugs may also affect vitamin K metabolism. Always tell your doctor about all medications you are currently taking.
Phytomenadione has a relatively narrow range of clinically significant drug interactions compared to many other medications. However, the interactions that do exist are critically important and can have life-threatening consequences if not managed appropriately. The following sections outline the most important interactions.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Warfarin | Vitamin K antagonist | Konakion Novum directly reverses the anticoagulant effect of warfarin by restoring vitamin K-dependent clotting factor synthesis | Use only when clinically indicated (bleeding, excessive INR); re-establishing stable anticoagulation may take several days |
| Acenocoumarol | Vitamin K antagonist | Same mechanism as warfarin – vitamin K reverses the anticoagulant effect | Administer vitamin K under medical supervision; use the minimum effective dose in patients who need to restart anticoagulation |
| Phenindione | Vitamin K antagonist (indanedione) | Vitamin K reverses anticoagulation by the same mechanism | Monitor INR closely after vitamin K administration; adjust anticoagulant dose accordingly |
The interaction between vitamin K and warfarin-type anticoagulants is one of the most clinically significant drug interactions in all of medicine. Patients who receive vitamin K while on warfarin therapy may become resistant to re-anticoagulation for several days afterwards, as the newly synthesised clotting factors have a lifespan of up to 48–72 hours. This is particularly important in patients with prosthetic heart valves or other conditions requiring uninterrupted anticoagulation, where the temporary loss of anticoagulant protection can be dangerous.
Other Notable Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Phenytoin | Anti-epileptic | Phenytoin may interfere with vitamin K metabolism, potentially increasing vitamin K requirements | Monitor coagulation parameters in patients on long-term phenytoin therapy who receive vitamin K |
| Carbamazepine | Anti-epileptic | May increase vitamin K metabolism through hepatic enzyme induction | Consider potential for increased vitamin K requirements; monitor INR if also on anticoagulants |
| Phenobarbital | Anti-epileptic / Sedative | Enzyme inducer that may affect vitamin K metabolism and clotting factor synthesis | Neonates born to mothers on phenobarbital may have increased vitamin K requirements; monitor coagulation |
| Broad-spectrum antibiotics | Anti-infective | Prolonged antibiotic therapy can deplete intestinal vitamin K-producing bacteria, increasing the need for vitamin K supplementation | Monitor for signs of vitamin K deficiency in patients on prolonged courses of broad-spectrum antibiotics |
| Cholestyramine / Colestipol | Bile acid sequestrant | May reduce oral absorption of vitamin K by binding bile acids needed for fat-soluble vitamin absorption | Separate dosing by at least 2 hours; consider parenteral vitamin K if oral route is unreliable |
If you are taking warfarin or a similar anticoagulant and need to receive vitamin K for any reason, your doctor will carefully balance the need to control bleeding against the risk of temporarily losing anticoagulant protection. In non-emergency situations, low doses of vitamin K (1–2.5 mg orally) may be used to partially lower an elevated INR without completely reversing anticoagulation. This approach allows for easier re-establishment of therapeutic anticoagulation.
What Is the Correct Dosage of Konakion Novum?
Dosage depends on the clinical indication. For newborn prophylaxis, either a single 1 mg intramuscular injection or three oral doses of 2 mg each are recommended. For adults with vitamin K deficiency bleeding or warfarin reversal, the typical intravenous dose is 5–10 mg, given slowly over at least 30 seconds.
Always use Konakion Novum exactly as your doctor has prescribed. The dosage, route of administration, and number of doses vary depending on the clinical situation. Your doctor will determine the most appropriate regimen based on your specific circumstances.
Newborn Prophylaxis
Vitamin K prophylaxis is recommended for all newborn infants, regardless of whether they are breastfed or formula-fed, to prevent vitamin K deficiency bleeding (VKDB). Two regimens are available:
Option 1: Intramuscular Injection (Preferred)
Dose: 1 mg as a single intramuscular injection at birth or shortly after
This is the preferred method because it provides reliable, long-lasting protection with a single dose. The WHO, AAP, and most national paediatric societies recommend intramuscular vitamin K prophylaxis as the gold standard.
Option 2: Oral Administration
Dose: 2 mg at birth, 2 mg at 4–7 days, 2 mg at 1 month of age
This regimen is suitable for healthy, term or near-term infants whose parents prefer oral administration. However, there are important considerations:
- Breastfed infants who receive the oral regimen may need additional doses of vitamin K because breast milk is low in vitamin K and does not provide sufficient amounts for reliable protection.
- Formula-fed infants who have received two oral doses may not require the third dose, as infant formula is supplemented with vitamin K.
- The oral route provides less reliable protection than the intramuscular route, particularly against late-onset VKDB.
Preterm Infants and High-Risk Neonates
Dose: Determined by the treating neonatologist based on gestational age and clinical risk
Preterm infants or full-term infants at particular risk of bleeding (such as those born to mothers taking anti-epileptic drugs, anticoagulants, or antituberculous medications) typically receive vitamin K by injection at birth. Additional injections may be given subsequently if the risk of bleeding persists.
Adults – Treatment of Vitamin K Deficiency Bleeding
Intravenous Administration
Dose: 5–10 mg by slow intravenous injection (over at least 30 seconds)
In life-threatening bleeding associated with excessive anticoagulation, 5–10 mg of vitamin K1 is given intravenously alongside prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP). The coagulation response begins within 1–3 hours, with full effect typically achieved within 12–24 hours. Repeat doses may be necessary.
Oral Administration (Non-Emergency)
Dose: 1–10 mg orally, depending on clinical situation
For elevated INR without active bleeding, 1–2.5 mg orally may be sufficient to gradually lower the INR while maintaining some degree of anticoagulation. For complete reversal, higher oral doses (5–10 mg) may be used. The solution is drawn from the ampoule using a syringe, the needle is removed, and the contents are administered directly into the mouth and swallowed with liquid.
Elderly Patients
No specific dose adjustment is required for elderly patients based on age alone. However, elderly patients are more likely to be taking anticoagulants and may have comorbidities (such as liver disease or malabsorption) that affect vitamin K requirements. Your doctor will determine the appropriate dose based on your individual clinical situation and coagulation test results.
Missed Dose
If you miss a scheduled dose of Konakion Novum, take it as soon as you remember. Do not take a double dose to compensate for the missed one. If you are unsure about what to do, contact your doctor or pharmacist for advice.
Overdose
Vitamin K1 has a very wide therapeutic margin, and acute overdose with phytomenadione is unlikely to cause serious harm. There is no specific antidote for vitamin K overdose. In patients taking anticoagulants, excessive vitamin K can lead to overcorrection of anticoagulation, making the patient temporarily resistant to re-anticoagulation and potentially increasing the risk of thrombotic events. If you suspect you or someone else has taken too much Konakion Novum, contact your doctor, hospital, or local poison control centre for assessment and advice.
How to Take Konakion Novum Orally
Although Konakion Novum is a solution for injection, it can also be given by mouth thanks to its mixed-micelle formulation. To administer orally:
- Draw the required amount of solution from the ampoule using a syringe fitted with a needle.
- Remove the needle from the syringe.
- Administer the contents of the syringe directly into the patient’s mouth.
- Swallow and rinse down with liquid (water or milk).
Intravenous Administration (Healthcare Professionals)
When given intravenously, Konakion Novum must be injected slowly, over at least 30 seconds, or administered as an intravenous infusion in the lower portion of an existing infusion set. It must not be mixed with other parenteral medications in the same syringe or infusion bag. If dilution is required, Konakion Novum may be diluted with glucose 5% (50 mg/ml) solution at a ratio of 1:5 or 1:10, but not with sodium chloride (normal saline) solution.
What Are the Side Effects of Konakion Novum?
Konakion Novum is generally very well tolerated. Serious side effects are very rare (fewer than 1 in 10,000 patients) and include hypersensitivity reactions following intravenous injection, with symptoms such as fever, skin rash, swelling, and occasionally low blood pressure. Local reactions at the injection site may also occur.
Like all medicines, Konakion Novum can cause side effects, although not everybody gets them. The overall safety profile of phytomenadione is excellent, reflecting the fact that vitamin K1 is a naturally occurring substance essential for normal physiology. The following side effects have been reported:
- Difficulty breathing, wheezing, or chest tightness
- Swelling of the face, lips, tongue, or throat
- Sudden drop in blood pressure with dizziness or fainting
- Severe skin rash, hives, or itching
- High fever developing shortly after intravenous injection
These may be signs of a serious allergic (anaphylactoid) reaction, which requires immediate medical treatment.
Very Rare
May affect fewer than 1 in 10,000 people
- Hypersensitivity (anaphylactoid) reaction with fever, skin rash, swelling, and occasionally low blood pressure – primarily associated with intravenous injection
- Local reactions at the injection site (pain, swelling, redness, or irritation)
The risk of anaphylactoid reactions is significantly minimised by ensuring that intravenous injections are administered slowly, over at least 30 seconds. The mixed-micelle formulation of Konakion Novum was specifically developed to reduce the risk of adverse reactions compared to older, Cremophor-based vitamin K preparations, which were associated with higher rates of anaphylactoid reactions.
In newborns, Konakion Novum is very well tolerated by all routes of administration. No specific neonatal side effects have been identified beyond the general possibility of local reactions at the injection site after intramuscular administration.
It is important to report any suspected side effects, even if they are not listed here. Reporting helps ensure continuous monitoring of the medicine’s benefit-risk balance. You can report side effects to your national medicines regulatory authority or through your healthcare provider.
How Should You Store Konakion Novum?
Store Konakion Novum at or below 25°C. Do not freeze. Keep the ampoules in the outer carton to protect from light. Do not use the solution if it appears cloudy or has separated into layers.
Proper storage is important to maintain the efficacy and safety of Konakion Novum:
- Temperature: Store at or below 25°C (77°F). Do not refrigerate below the recommended range, and never freeze the product.
- Light protection: Phytomenadione is light-sensitive and degrades when exposed to direct light. Always keep the ampoules in the original outer carton until ready for use.
- Expiry date: Do not use after the expiry date printed on the carton and label (marked “EXP”). The expiry date refers to the last day of the stated month.
- Visual inspection: Before use, inspect the solution visually. Do not use if the solution is cloudy, discoloured, or has separated into layers. A clear to slightly yellowish solution is normal.
- After opening: Ampoules are for single use only. Any unused solution should be discarded. Do not store partially used ampoules for later use.
Keep this medicine out of the sight and reach of children. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need, as these measures help to protect the environment.
What Does Konakion Novum Contain?
Each 1 ml ampoule of Konakion Novum contains 10 mg of phytomenadione (vitamin K1) as the active substance, in a mixed-micelle solution containing glycocholic acid, lecithin, sodium hydroxide, hydrochloric acid, and water for injections.
Active Ingredient
The active substance is phytomenadione (also known as phylloquinone or vitamin K1), at a concentration of 10 mg per ml. Phytomenadione is the naturally occurring form of vitamin K found in green leafy vegetables and is chemically identical to the vitamin K1 produced by plants.
Inactive Ingredients (Excipients)
The other ingredients are:
- Glycocholic acid: A bile acid that forms part of the mixed-micelle system, enabling the fat-soluble vitamin K to be dispersed in an aqueous solution and absorbed orally without requiring the patient’s own bile salts.
- Lecithin: A phospholipid that, together with glycocholic acid, creates the mixed-micelle structure that is central to the unique properties of Konakion Novum.
- Sodium hydroxide: Used to adjust the pH of the solution.
- Hydrochloric acid: Used to adjust the pH of the solution.
- Water for injections: The solvent for the preparation.
Appearance and Packaging
Konakion Novum is a clear to slightly yellowish solution supplied in glass ampoules. Each ampoule contains 1 ml of solution (10 mg phytomenadione). The product is supplied in packs of 5 ampoules (5 × 1 ml).
Sodium Content
This medicine contains less than 1 mmol (23 mg) sodium per ampoule, meaning it is essentially “sodium-free.”
How Does Konakion Novum Work in the Body?
Phytomenadione acts as an essential cofactor for the liver enzyme gamma-glutamyl carboxylase, which activates coagulation factors II, VII, IX, and X. Without vitamin K, these clotting factors remain in an inactive form and cannot participate in the blood clotting cascade, leading to impaired haemostasis and risk of bleeding.
To understand how Konakion Novum works, it is helpful to understand the role of vitamin K in the blood clotting (coagulation) process. Blood clotting is a highly complex cascade involving numerous proteins (clotting factors) that work together in a precise sequence to form a stable blood clot at the site of vessel injury.
Four of these clotting factors – factor II (prothrombin), factor VII, factor IX, and factor X – depend on vitamin K for their activation. These factors are initially synthesised by the liver as inactive precursor proteins. To become functional, specific glutamic acid residues on these proteins must be converted to gamma-carboxyglutamic acid (Gla) residues through a process called gamma-carboxylation. This carboxylation reaction is catalysed by the enzyme gamma-glutamyl carboxylase, which requires vitamin K as an essential cofactor.
The Gla residues are critical because they enable the clotting factors to bind calcium ions, which is necessary for their attachment to phospholipid surfaces at sites of vascular injury. Without this calcium-binding capability, the clotting factors cannot assemble into the functional complexes needed to generate thrombin and form a fibrin clot.
In addition to the procoagulant factors, vitamin K is also required for the activation of the anticoagulant proteins C and S, which serve as natural regulators of the coagulation cascade. This dual role means that vitamin K is essential for maintaining the delicate balance between clot formation and clot prevention.
The Vitamin K Cycle
During the carboxylation reaction, vitamin K is oxidised to vitamin K epoxide. The body has an efficient recycling system called the vitamin K epoxide reductase (VKOR) cycle, which reduces the epoxide back to its active (hydroquinone) form, allowing it to participate in further carboxylation reactions. Warfarin and other coumarin anticoagulants work by inhibiting the VKOR enzyme, thereby preventing the recycling of vitamin K and depleting the active form. Konakion Novum bypasses this blockade by providing a fresh supply of vitamin K1, allowing clotting factor synthesis to resume.
Pharmacokinetics
After intravenous administration, phytomenadione begins to normalise coagulation parameters within 1–3 hours, with the full effect typically seen within 12–24 hours. This time course reflects the time required for the liver to synthesise new, fully functional clotting factors.
After oral administration, absorption of the mixed-micelle formulation occurs primarily in the small intestine and does not depend on the patient’s own bile salts, unlike conventional fat-soluble vitamin K preparations. Peak plasma concentrations are achieved within 2–4 hours after oral dosing. Phytomenadione is distributed to the liver, where it participates in clotting factor synthesis, and is metabolised primarily to more polar metabolites that are excreted in bile and urine.
Although vitamin K is immediately available to the liver after intravenous injection, the coagulation response takes 1–3 hours to begin because the liver needs time to synthesise new clotting factor proteins. The existing inactive (des-carboxylated) clotting factors in the circulation must be replaced by newly synthesised, fully carboxylated (active) clotting factors. This is why, in life-threatening bleeding, vitamin K is given alongside prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP), which provide immediate replacement of functional clotting factors while vitamin K enables the liver to produce its own.
Frequently Asked Questions About Konakion Novum
Konakion Novum contains phytomenadione (vitamin K1) and is used to treat and prevent bleeding caused by vitamin K deficiency. This includes bleeding from excessive warfarin therapy, malabsorption disorders, liver disease, or prolonged antibiotic use. It is also routinely given to all newborn infants as prophylaxis against vitamin K deficiency bleeding (VKDB), a potentially life-threatening condition that can cause intracranial haemorrhage.
Newborns are born with very low vitamin K stores for several reasons: vitamin K does not cross the placenta efficiently, the neonatal gut lacks the bacteria that produce vitamin K, and breast milk contains only small amounts of vitamin K. Without supplementation, newborns are at risk of vitamin K deficiency bleeding, which can present as early-onset (within 24 hours), classical (days 1–7), or late-onset (2 weeks to 6 months). Late-onset VKDB is particularly dangerous as it frequently involves intracranial bleeding. All major health organisations, including the WHO and AAP, recommend vitamin K prophylaxis for every newborn.
Yes, this is one of the unique features of Konakion Novum. Its mixed-micelle formulation, containing glycocholic acid and lecithin, allows the fat-soluble vitamin K to be absorbed orally without requiring the patient’s own bile salts. The solution is drawn up from the ampoule with a syringe, the needle is removed, and the contents are administered directly into the mouth. This versatility makes it particularly useful in neonatal medicine, where both injectable and oral regimens are used for prophylaxis.
After intravenous administration, coagulation parameters begin to improve within 1–3 hours, with full normalisation typically occurring within 12–24 hours. The delay is because the liver needs time to synthesise new, functional clotting factors using the vitamin K that has been provided. For this reason, in life-threatening bleeding situations, vitamin K is given alongside immediate coagulation factor replacement (such as prothrombin complex concentrate or fresh frozen plasma).
Yes, there are no known risks associated with phytomenadione use during pregnancy. Vitamin K1 is a naturally occurring substance essential for normal blood clotting. While it passes into breast milk, this is not harmful to the nursing infant. In fact, the naturally low vitamin K content of breast milk is the reason why breastfed newborns need vitamin K supplementation. Your doctor may prescribe Konakion Novum during pregnancy if clinically needed, such as for warfarin reversal.
No, Konakion Novum must not be mixed with other injectable medications in the same syringe or infusion bag. If dilution is required, it may only be diluted with glucose 5% (dextrose) solution at a ratio of 1:5 or 1:10. It must not be diluted with sodium chloride (normal saline) solution, as this can cause the mixed-micelle formulation to destabilise. When given as an IV infusion, it should be injected into the lower part of an existing infusion set.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.
- American Academy of Pediatrics Committee on Fetus and Newborn. Controversies Concerning Vitamin K and the Newborn. Pediatrics. 2003;112(1):191–196. Reaffirmed 2022.
- Puckett RM, Offringa M. Prophylactic vitamin K for vitamin K deficiency bleeding in neonates. Cochrane Database of Systematic Reviews. 2000;(4):CD002776. doi:10.1002/14651858.CD002776
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
- European Medicines Agency (EMA). Konakion Novum – Summary of Product Characteristics. EMA product information database. Accessed January 2026.
- Shearer MJ, Fu X, Booth SL. Vitamin K Nutrition, Metabolism, and Requirements: Current Concepts and Future Research. Advances in Nutrition. 2012;3(2):182–195. doi:10.3945/an.111.001800
- National Institute for Health and Care Excellence (NICE). Neonatal parenteral nutrition: Vitamin K. NICE guideline. Updated 2023.
- Keeling D, Baglin T, Tait C, et al. Guidelines on oral anticoagulation with warfarin – fourth edition. British Journal of Haematology. 2011;154(3):311–324. doi:10.1111/j.1365-2141.2011.08753.x
- British National Formulary (BNF). Phytomenadione. NICE BNF monograph. Accessed January 2026.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in haematology, neonatology, and clinical pharmacology.
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