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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

MIACALCIN 50 IU/ml and 100 IU/ml Ampoules (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Novartis Pharmaceuticals UK Ltd
Διεύθυνση :
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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Δωρεάν εγγραφή

Name of the medicinal product

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

Qualitative and quantitative composition

Each 1ml injection delivers 50 IU or 100 IU of calcitonin as calcitonin (salmon, synthetic) where one IU corresponds to 0.167 micrograms of the drug substance. Miacalcic is essentially sodium-free, see ...

Pharmaceutical form

Solution for injection and infusion. Miacalcic 50 IU/ml is a clear, colourless aqueous solution. Miacalcic 100 IU/ml is a clear, colourless aqueous solution.

Therapeutic indications

Calcitonin is indicated for: Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures. Pagets disease Hypercalcaemia of malignancy.

Posology and method of administration

Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy. Prevention of acute bone loss The recommended dosage ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Calcitonin is also contraindicated in patients with hypocalcaemia.

Special warnings and precautions for use

Because calcitonin is a peptide, the possibility of systemic allergic reactions exists and allergic-type reactions including isolated cases of anaphylactic shock have been reported in patients receiving ...

Interaction with other medicinal products and other forms of interaction

Serum calcium levels may be transiently decreased to below normal levels following administration of calcitonin, notably upon initiation of therapy in patients with abnormally high rates of bone turnover. ...

Pregnancy and lactation

Pregnancy Calcitonin has not been studied in pregnant women. Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician. Breast-feeding It is not known ...

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 cause fatigue, dizziness and visual disturbances (see section 4.8) which may impair the patients reactions. ...

Undesirable effects

The most frequently observed undesirable effects are nausea, vomiting and flushing. They are dose dependent and more frequent after i.v. than after i.m. or s.c. administration. Adverse reactions have been ...

Overdose

Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally. Single doses (up to 10,000 IU) of injectable salmon calcitonin have been administered ...

Pharmacodynamic properties

Pharmacotherapeutic group: antiparathyroid hormone ATC code: H05BA01 (calcitonin, salmon) The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively ...

Pharmacokinetic properties

General characteristics of the active substance Salmon calcitonin is rapidly absorbed and eliminated. Peak plasma concentrations are attained within the first hour of administration. After subcutaneous ...

Preclinical safety data

Conventional long-term toxicity, reproduction, mutagenicity and carcinogenicity studies have been performed in laboratory animals. Salmon calcitonin is devoid of embryotoxic, teratogenic and mutagenic ...

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 should be used immediately after it has reached room temperature if it is to be injected or immediately ...

Nature and contents of container

Type I, clear glass ampoule containing 1ml of solution. Miacalcic ampoules 50 IU/ml or 100 IU/ml are supplied as packs containing 5, 10, 50 and 100 ampoules. Not all pack sizes may be marketed.

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 colourless, or contains any particles, or the ampoule is damaged, do not use the medicine. Solutions ...

Marketing authorization holder

Novartis Pharmaceuticals UK Limited, Trading as Sandoz Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Marketing authorization number(s)

50IU/ml solution for injection and infusion PL 0101/0202 100IU/ml solution for injection and infusion PL 0101/0095R

Date of first authorization / renewal of the authorization

7 May 2007

Date of revision of the text

14 April 2012