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SPC, UK: KONAKION MM PAEDIATRIC Solution (ampoules) (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Konakion MM Paediatric.

Qualitative and quantitative composition

Each ampoule contains 2mg phytomenadione in 0.2ml.

Pharmaceutical form

The ampoule solution is clear to slightly opalescent, pale yellow in colour and contains the active constituent in a mixed micelles vehicle of glycocholic acid and lecithin.

Therapeutic indications

Konakion MM Paediatric is indicated for the prophylaxis and treatment of vitamin K deficiency bleeding (VKDB) in neonates and infants. Konakion MM Paediatric can be used, following specialist advice from ...

Posology and method of administration

Prophylaxis of vitamin K deficiency bleeding (VKDB) Healthy neonates of 36 weeks gestation and older: Either: 1 mg administered by intramuscular injection at birth or soon after birth or 2 mg orally at ...

Contraindications

Use in patients with a known hypersensitivity to any of the constituents.

Special warnings and precautions for use

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. Parenteral ...

Interaction with other medicinal products and other forms of interaction

No significant interactions are known other than antagonism of coumarin anticoagulants.

Pregnancy and lactation

Not applicable.

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

There have been reports of anaphylactoid reactions after intravenous injections of Konakion MM. Local irritation may occur at the injection site but is unlikely due to the small injection volume. Rarely, ...

Overdose

There is no known clinical syndrome attributable to hypervitaminosis of vitamin K<sub>1</sub>. The following adverse events have been reported concerning overdose with use of Konakion in neonates and infants: ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antihaemorrhagics (vitamins) ATC code: B02BA01 Konakion MM is a preparation of synthetic phytomenadione (vitamin K<sub>1</sub>). The presence of vitamin K<sub>1</sub> is essential ...

Pharmacokinetic properties

In the mixed micelle solution, vitamin K<sub>1</sub> is solubilised by means of a physiological colloidal system consisting of lecithin and a bile acid. Following oral administration vitamin K<sub>1</sub> ...

Preclinical safety data

None applicable.

List of excipients

Glycocholic acid Lecithin Sodium hydroxide Hydrochloric acid Water

Incompatibilities

Incompatibilities have been observed with diluted Konakion MM solution and certain siliconised syringes, therefore, Konakion MM Paediatric must not be diluted before injection. Do not dilute with sodium ...

Shelf life

Shelf life: 3 years.

Special precautions for storage

Konakion MM Paediatric Ampoule solution should be stored below 25°C and be protected from light. The solution should not be frozen. Do not use if the solution is turbid.

Nature and contents of container

Amber glass ampoules containing 2 mg phytomenadione in 0.2 ml. Plastic oral dispensers. Packs of 5.

Special precautions for disposal and other handling

See section 4.2 Posology and method of administration, section 4.4 Special warnings and precautions for use and section 6.2 Incompatibilities for advice regarding the administration of Konakion MM Paediatric. ...

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Marketing authorization number(s)

PL 27041/0010

Date of first authorization / renewal of the authorization

20/06/1996 / 11/03/2008

Date of revision of the text

22/02/2019

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