10 mg / ml injection solution
phytomenadione

What Konakion Novum is and what it is used for

Konakion Novum contains vitamin K 1 (phytomenadione), which is necessary for the blood to coagulate (coagulate).

Konakion Novum is used for bleeding and the risk of bleeding due to vitamin K deficiency.

Konakion Novum is also given as a preventive treatment to newborns.

What you need to know before taking Konakion Novum

Do not take Konakion Novum

  • If you are allergic to phytomenadione or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Konakion Novum.

  • If you suffer from an increased risk of blood clots, e.g. due to heart valve prosthesis.
  • If you have impaired liver function.

Other medicines and Konakion Novum

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Konakion Novum counteracts the effects of warfarin and other anti- vitamin K drugs (drugs that inhibit the blood’s ability to clot).

Antiepileptic drugs can affect the effect of vitamin K.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

No known risks when used during pregnancy.

Breast-feeding:

Konakion Novum passes into breast milk but is unlikely to affect breastfed infants.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Konakion Novum contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free.

How to take Konakion Novum

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

In case of bleeding or risk of bleeding due to vitamin K deficiency:

Your doctor will decide which dose is right for you and how the medicine should be given to you. Konakion Novum is given either intravenously ( injection into a vein) or orally (orally). For injection, Konakion Novum must not be mixed with any other injection. Konakion Novum can be diluted with glucose solution 50 mg/ml (1: 5 or 1:10) but not sodium chloride solution.

How to take Konakion Novum orally (by mouth):

  • Withdraw the desired amount of liquid from an ampoule using a syringe .
  • Remove the needle from the syringe and inject the contents directly into your mouth.
  • Rinse with liquid.

Preventive treatment for newborns:

Konakion Novum can be given to your child as an injection into a vein, injection into a muscle, or through the mouth. How it is given depends on what the medicine is used for and if your baby was born prematurely.

Preventive treatment for bleeding due to vitamin K deficiency

Healthy children who were born full or almost full

These children may either:

  • One injection (1 mg) at birth or shortly after, or
  • By mouth (orally) a first dose (2 mg) at birth or shortly after birth. This is followed by a second dose of 2 mg after 4-7 days and a third dose of 2 mg at 1 month of age. In children who only receive infant formula, the third dose may be excluded.

Premature babies or full-term babies with a special risk of bleeding

  • These babies will receive Konakion Novum as an injection at birth or shortly after birth.
  • More injections may be given later if there is still a risk of bleeding in your baby.

Additional dosage:

  • Children who receive vitamin K through the mouth and who are breastfed (who do not receive infant formula) may need several doses of vitamin K through the mouth.
  • Children who are fed a bottle of infant formula and who have received two doses of vitamin K by mouth may not need additional doses of vitamin K. This is because it is included in the infant formula.

If you take more Konakion Novum than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.

If you forget to take Konakion Novum

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very rare (affects less than 1 user in 10,000):

  • Hypersensitivity reaction with fever, rash, swelling and sometimes drop in blood pressure associated with intravenous injection .
  • Local reactions at the injection site.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

How to store Konakion Novum

Do not store above 25 ° C. Do not freeze. Store ampoule one in the outer carton. Sensitive to light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP: The expiration date is the last day of the specified month.

Do not use this medicine if the liquid in the ampoule is cloudy or has stratified.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is phytomenadione 10 mg per ml.
  • The other ingredients are glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid , water for injections.

What the medicine looks like and contents of the pack

Clear or yellowish solution.

Pack sizes: 5 x 1 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Information is provided by

ProPharma Group Sweden AB

Fleminggatan 18

112 26 Stockholm

Sweden

email: pharmacovigilanceSE@propharmagroup.com

Muhammad Nadeem

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