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SPC, UK: Bonefos Tablets (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Bayer plc
Διεύθυνση :
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
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Δωρεάν εγγραφή

Name of the medicinal product

Bonefos Tablets.

Qualitative and quantitative composition

Each tablet contains 1000 mg of disodium clodronate tetrahydrate, equivalent to 800 mg of anhydrous disodium clodronate.

Pharmaceutical form

Pale white, oval-shaped, film-coated tablets for oral use.

Therapeutic indications

Bonefos tablets are indicated in the management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with carcinoma of the breast or multiple myeloma. Bonefos ...

Posology and method of administration

Adequate fluid intake should be maintained during treatment. A Bonefos 800mg tablet may be divided into two to ease swallowing, but the halves have to be taken at the same time of administration. Bonefos ...

Contraindications

Bonefos tablets are contraindicated in patients with severe renal failure (creatinine clearance below 10ml/min), hypersensitivity to the active substance or to any of the excipients and in patients receiving ...

Special warnings and precautions for use

Adequate fluid intake should be maintained during treatment. Patients with renal insufficiency Bonefos tablets should be administered with care to patients with renal insufficiency. It is recommended that ...

Interaction with other medicinal products and other forms of interaction

Concomitant use with other bisphosphonates is contraindicated. Patients receiving NSAIDs in addition to sodium clodronate have developed renal dysfunction. However, a synergistic action has not been established. ...

Pregnancy and lactation

There are limited amount of data from the use of clodronate in pregnant women. Bonefos is not recommended during pregnancy and in women of childbearing potential not using effective contraception. Although ...

Effects on ability to drive and use machines

None known.

Undesirable effects

The most common reported drug reaction is diarrhoea which is usually mild and occurs more commonly with higher doses. These adverse reactions may occur when using Bonefos: Metabolism and nutrition disorders ...

Overdose

Symptoms Increases in serum creatinine and renal dysfunction have been reported with high intravenous doses of clodronate. It is theoretically possible that hypocalcaemia may develop up to 2 or 3 days ...

Pharmacodynamic properties

Clodronate is a bisphosphonate, (formerly diphosphonates), a group of analogues of pyrophosphate, which have been shown, in vitro, to inhibit the formation and dissolution of calcium phosphate (hydroxyapatite). ...

Pharmacokinetic properties

Absorption As with other bisphosphonates, the gastrointestinal absorption of clodronate is low, about 2%. The absorption of clodronate is rapid, the peak serum concentration after a single oral dose is ...

Preclinical safety data

Systemic tolerance Repeated dose oral and intravenous toxicity studies in rats and mini-pigs up to 6 to 12 months duration respectively have been performed. . At oral daily doses up to 480 mg/kg in rats ...

List of excipients

Croscarmellose sodium Magnesium stearate Silicified microcrystalline cellulose Stearic acid Coating: Opadry II white, containing: Macrogol (PEG) 3350 Polyvinyl alcohol (partially hydrolysed) Purified water ...

Incompatibilities

None stated.

Shelf life

The shelf life of Bonefos 800 mg tablets is three years.

Special precautions for storage

Bonefos tablets are stored below 25°C.

Nature and contents of container

Bonefos tablets are supplied in clear, colourless PVC/aluminium blister packs of 10 and 60 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Bayer plc Bayer House Strawberry Hill Newbury Berks RG14 1JA Trading as Bayer plc, Bayer Schering Pharma

Marketing authorization number(s)

PL 00010/0522

Date of first authorization / renewal of the authorization

01 May 2008

Date of revision of the text

16 August 2011

Σχετικά φαρμακευτικά σκευάσματα

Κωδικός Όνομα Κ Ν.Τ. Χ.Τ. Λ.Τ. Υπεύθυνος κυκλοφορίας
90034.01.01 BONEFOS CAPS 400mg BT x 100 Ι.Φ.Ε.Τ. A.E.