Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

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

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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 Adults Severe or life-threatening haemorrhage, e.g. during anticoagulant therapy The coumarin anticoagulant should be withdrawn and an intravenous injection ...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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

File
application/pdf - 115,0 KB