Konakion MM for children 2 mg/0.2 mL solution – vitamin K1 (phytomenadione) to prevent and treat bleeding in newborns and infants

Konakion MM 2 mg/0.2 mL is the paediatric form of a medicine containing phytomenadione – synthetic vitamin K1. Vitamin K helps the body make clotting factors that stop bleeding.

It is a solution for injection in 0.2 mL (2 mg) ampoules, and the pack also contains graduated oral dispensers for giving it by mouth. It is used in newborns and infants to prevent and treat bleeding due to vitamin K deficiency and, on a haematologist's advice, in children who have received too much anticoagulant.

What is Konakion MM for children used for and how is it given?

Key facts about the medicine

What is Konakion MM for children used for?

• prevention and treatment of vitamin K deficiency bleeding (VKDB) in newborns and infants – a serious but rare condition; vitamin K1 is given to all newborn babies with the parents' consent;
• on the advice of a haematologist – as an antidote in infants and children who have received too much coumarin-type anticoagulant (e.g. warfarin). For adolescents and adults, Konakion MM 10 mg/mL ampoules are intended.

How is Konakion MM for children given and dosed?

• Healthy babies born at or near term (36 weeks' gestation or later): one 1 mg injection into a muscle at or soon after birth, or 2 mg by mouth at birth, followed by 2 mg between days 4 and 7 and 2 mg one month after birth. In exclusively formula-fed babies the third dose may be omitted.
• Premature babies (2.5 kg or more) and babies at special risk (e.g. birth asphyxia, obstructive jaundice, inability to swallow, maternal anticoagulants or antiepileptics): 1 mg into a muscle or vein at birth; further doses according to clotting status.
• Premature babies under 2.5 kg: 0.4 mg/kg (0.04 mL/kg) into a muscle or vein at birth – this dose must not be exceeded (e.g. 1 kg: 0.4 mg; 1.5 kg: 0.6 mg; 2 kg: 0.8 mg).
• Treatment of vitamin K deficiency bleeding: initially 1 mg into a vein, further doses according to the clinical picture and clotting; a transfusion is sometimes needed.
• Antidote to coumarin-type anticoagulants: only by injection into a vein, under haematologist supervision; prothrombin time is checked 2–6 hours after administration.
• Giving by mouth at home: parents may be asked to give the second dose (2 mg) 4–7 days after birth and, in exclusively breast-fed babies, monthly 2 mg doses. Open the ampoule, draw the solution into the dispenser up to the 2 mg (0.2 mL) mark and gently release it into the baby's mouth; do not give the excess left in the ampoule.

Special patient groups

• Exclusively breast-fed babies: after oral prophylaxis further doses may be needed; formula-fed babies who have had two oral doses do not need more vitamin K.
• Premature babies under 2.5 kg: injection may increase the risk of kernicterus (bilirubin encephalopathy).
• Cholestatic disease and malabsorption: oral prophylaxis is insufficient – the medicine is given by injection.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to phytomenadione or to any of the excipients.

Warnings and precautions

• tell the doctor if the baby has a problem with bile flow (cholestatic disease);
• when used as an antidote to anticoagulants, the medicine is given into a vein because an injection into a muscle may cause significant bleeding;
• the medicine must not be diluted or mixed with other injectable medicines;
• it contains less than 23 mg sodium per dose, i.e. it is essentially sodium-free.

Interactions with other medicines, food and drink

• No significant interactions are known except antagonism with coumarin-type anticoagulants (e.g. warfarin) – tell the doctor if the baby or child is taking a medicine to prevent blood clotting.
• Tell the doctor about all other medicines, including non-prescription and herbal medicines.

Pregnancy and breast-feeding

• The medicine is intended for newborns, infants and children; according to the SmPC, pregnancy and breast-feeding data are not relevant for this form.

Driving and using machines

• Not relevant (the medicine is intended for babies and children).

Possible side effects

• Allergic reactions: swelling of the throat, face, lips and mouth (may make breathing and swallowing difficult) or sudden swelling of the hands, feet or ankles – contact a doctor without delay; according to the SmPC, anaphylactoid reactions have been reported after intravenous injection.
• Injection-site reactions: redness, swelling, pain, rarely scarring; rarely a more severe local reaction (inflammation, atrophy, necrosis).

Overdose, missed dose and stopping treatment

• Overdose: if the baby has received more medicine than it should, contact a doctor, nurse or midwife. Jaundice, stomach pain, constipation, loose stools, weakness, irritability, rash and changes in liver tests may occur; most of these resolve without treatment.
• Missed oral dose: agree with the health visitor, midwife or doctor when to give the next dose; do not give a double dose.
• If someone else takes the baby's medicine by mistake, they should contact a doctor.

Related information

Konakion MM for children is given in the maternity ward or another healthcare facility, as decided by the doctor. For questions about vitamin K prophylaxis, contact your paediatrician or health visitor; always read the package leaflet supplied with the medicine.

Composition, pack and manufacturer

• Active substance: phytomenadione 2 mg in 0.2 mL solution (one ampoule).
• Excipients: glycocholic acid; sodium hydroxide; lecithin; hydrochloric acid (for pH adjustment); water for injections.
• Appearance: clear to slightly opalescent, yellowish solution.
• Pack: 5 amber glass ampoules (1 mL capacity, containing 0.2 mL solution) in a plastic tray and 5 graduated oral dispensers.
• Marketing authorisation holder: Clinres Farmacija d.o.o., Beogradskog bataljona 4, Belgrade – Čukarica. Manufacturer: Cheplapharm Arzneimittel GmbH, Ziegelhof 23–24, Greifswald, Germany.
• Authorisation number: 515-01-00530-23-001 of 24.10.2023 (renewal).

Storage

• Store below 25 °C in the original package to protect from light; do not freeze. Shelf life: 3 years.
• Use immediately after opening the ampoule; do not use a cloudy solution.
• Keep out of the sight and reach of children.

Frequently asked questions

Why does a newborn receive vitamin K?

Newborns have little vitamin K, so there is a risk of rare but serious bleeding due to its deficiency. Konakion MM is given at birth (with the parents' consent) to prevent this bleeding.

What is the difference between injection and oral dosing?

A healthy term baby can receive one 1 mg injection or three oral doses of 2 mg (at birth, on days 4–7 and after one month). In premature and at-risk babies and in cholestasis, the medicine is given by injection.

Does a breast-fed baby need extra doses?

Exclusively breast-fed babies who received vitamin K by mouth may need further oral doses; formula-fed babies need no more after two oral doses, because formula contains vitamin K.

How is an oral dose given?

Open the ampoule, place the dispenser at the bottom and draw the solution up to the 2 mg (0.2 mL) mark; gently release it into the baby's mouth. The small remainder in the ampoule is not given.

Sources

• ALIMS – Konakion MM 2 mg/0.2 mL patient leaflet (PIL)
• ALIMS – Konakion MM 2 mg/0.2 mL summary of product characteristics (SmPC)

Date sources were checked: 25.10.2026.