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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Miacalcic 50 IU/ml and 100 IU/ml Ampoules (2012)

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Miacalcic® 50 IU/ml solution for injection and infusion. Miacalcic® 100 IU/ml solution for injection ...

Qualitative and quantitative composition

Each 1ml injection delivers 50 IU or 100 IU of calcitonin as calcitonin (salmon, synthetic) where one ...

Pharmaceutical form

Solution for injection and infusion. Miacalcic 50 IU/ml is a clear, colourless aqueous solution. Miacalcic ...

Therapeutic indications

Calcitonin is indicated for: Prevention of acute bone loss due to sudden immobilisation such as in patients ...

Posology and method of administration

Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Calcitonin ...

Special warnings and precautions for use

Because calcitonin is a peptide, the possibility of systemic allergic reactions exists and allergic-type ...

Interaction with other medicinal products and other forms of interaction

Serum calcium levels may be transiently decreased to below normal levels following administration of ...

Pregnancy and lactation

Pregnancy Calcitonin has not been studied in pregnant women. Calcitonin should be used during pregnancy ...

Effects on ability to drive and use machines

No studies exist on the effects of Miacalcic on the ability to drive and use machines. Miacalcic may ...

Undesirable effects

The most frequently observed undesirable effects are nausea, vomiting and flushing. They are dose dependent ...

Overdose

Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered ...

Pharmacological properties

The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be ...

Pharmacodynamic properties

Pharmacotherapeutic group: antiparathyroid hormone ATC code: H05BA01 (calcitonin, salmon) Calcitonin ...

Pharmacokinetic properties

General characteristics of the active substance Salmon calcitonin is rapidly absorbed and eliminated. ...

Preclinical safety data

Conventional long-term toxicity, reproduction, mutagenicity and carcinogenicity studies have been performed ...

List of excipients

Glacial acetic acid Sodium acetate trihydrate Sodium chloride Water for injection

Incompatibilities

Glass or hard plastic i.v. containers should not be used.

Shelf life

5 years.

Special precautions for storage

Store at 2°C-8°C (in refrigerator). Do not freeze. From a microbiological point of view, this medicine ...

Nature and contents of container

Type I, clear glass ampoule containing 1ml of solution. Miacalcic ampoules 50 IU/ml or 100 IU/ml are ...

Special precautions for disposal and other handling

Miacalcic ampoule 50 IU/ml or 100 IU/ml should be inspected visually. If the liquid is not clear and ...

Marketing authorization holder

Novartis Pharmaceuticals UK Limited Trading as Sandoz Pharmaceuticals Frimley Business Park Frimley ...

Marketing authorization number(s)

50IU/ml solution for injection and infusion PL 0101/0202 100IU/ml solution for injection and infusion ...

Date of first authorization / renewal of the authorization

7 May 2007

Date of revision of the text

14 April 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.