KONAKION MM Solution (ampoules) (2019)
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Περιεχόμενα
Name of the medicinal product
Konakion MM Ampoules 10 mg/ml solution for injection.
Qualitative and quantitative composition
Each Konakion MM Ampoule contains 10.0mg vitamin K1 (phytomenadione) Ph.Eur in 1ml.
Pharmaceutical form
Amber glass ampoules containing 10mg phytomenadione in 1ml. The ampoule solution is clear to slightly opalescent, pale yellow in colour and contains the active constituent in a mixed micelles vehicle of ...
Therapeutic indications
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 ...
Posology and method of administration
Konakion MM ampoules are for i.v. injection. Adults Severe or life-threatening haemorrhage, e.g. during anticoagulant therapy The coumarin anticoagulant should be withdrawn and an intravenous injection ...
Contraindications
Use in patients with a known hypersensitivity to any of the constituents. Konakion MM ampoules should not be administered intramuscularly because the i.m. route exhibits depot characteristics and continued ...
Special warnings and precautions for use
When treating patients with severely impaired liver function, it should be borne in mind that one Konakion MM Ampoule 10 mg/1ml contains 54.6mg glycocholic acid and this may have a bilirubin displacing ...
Interaction with other medicinal products and other forms of interaction
No significant interactions are known other than antagonism of coumarin anticoagulants.
Pregnancy and lactation
There is no specific evidence regarding the safety of Konakion MM in pregnancy but, as with most drugs, the administration during pregnancy should only occur if the benefits outweigh the risks. Konakion ...
Effects on ability to drive and use machines
None.
Undesirable effects
There have been reports of anaphylactoid reactions after intravenous injections of Konakion MM. Very rarely, venous irritation or phlebitis has been reported in association with intravenous administration ...
Overdose
Hypervitaminosis of vitamin K<sub>1</sub> is unknown. Reintroduction of anti-coagulation may be affected.
Pharmacodynamic properties
Pharmacotherapeutic group: Antihaemorrhagics (vitamins) ATC code: B02BA01 Konakion MM is a synthetic preparation of vitamin K. The presence of vitamin K (i.e. vitamin K or substances with vitamin K activity) ...
Pharmacokinetic properties
In blood plasma, 90% of vitamin K<sub>1</sub> is bound to lipoproteins. Following an intramuscular dose of 10mg vitamin K, plasma concentrations of 10–20mcg/l are produced (normal range 0.4–1.2mcg/l). ...
Preclinical safety data
None applicable.
List of excipients
Glycocholic acid HSE Sodium hydroxide Ph. Eur Lecithin (phospholipon 100) HSE Hydrochloric acid Ph. Eur. Water for injection Ph. Eur.
Incompatibilities
None.
Shelf life
Shelf life: The recommended shelf-life of Konakion MM Ampoules is 36 months.
Special precautions for storage
The recommended maximum storage temperature is 25°C. Do not use if the solution is turbid.
Nature and contents of container
Konakion MM is supplied in amber glass ampoules containing 10mg phytomenadione in 1ml. The ampoule solution is clear to slightly opalescent, pale yellow in colour and contains the active constituent in ...
Special precautions for disposal and other handling
See Section 4.2.
Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Marketing authorization number(s)
PL 27041/0011
Date of first authorization / renewal of the authorization
08/04/2008
Date of revision of the text
21/02/2019
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