BONEFOS Film-coated tablets (2017)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Bayer plc |
|---|---|
| Διεύθυνση | Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA |
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Περιεχόμενα
Name of the medicinal product
Bonefos 800 mg tablets.
Qualitative and quantitative composition
Each tablet contains 1000 mg of disodium clodronate tetrahydrate, equivalent to 800 mg of anhydrous disodium clodronate. For the full list of excipients, see section 6.1.
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
Posology Adults A daily dose of 1600 mg should be taken as a single dose. When higher daily doses are used, the part of the dose exceeding 1600 mg should be taken separately (as a second dose) as recommended ...
Contraindications
Bonefos tablets are contraindicated in patients with severe renal failure where creatinine clearance is below 10ml/min, hypersensitivity to the active substance or to any of the excipients listed in section ...
Special warnings and precautions for use
Adequate fluid intake should be maintained during treatment. Patients with renal impairment Bonefos tablets should be administered with care to patients with renal impairment (see dose adjustment under ...
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. ...
Fertility, pregnancy and lactation
Pregnancy There is a 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. ...
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: Common ≥1/100 to <1/10, Rare ...
Overdose
Symptoms Increases in serum creatinine and renal dysfunction have been reported with high intravenous doses of clodronate. One case of acute renal failure and liver injury has been reported after accidental ...
Pharmacodynamic properties
Pharmacotherapeutic group: Bisphosphonates ATC Code: M05BA Clodronate is a bisphosphonate, (formerly diphosphonates), a group of analogues of pyrophosphate, which have been shown, in vitro, to inhibit ...
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
3 years.
Special precautions for storage
Do not store above 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, 400 South Oak Way, Reading, RG2 6AD
Marketing authorization number(s)
PL 00010/0522
Date of first authorization / renewal of the authorization
01 May 2008
Date of revision of the text
31 August 2017
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Σχετικά φαρμακευτικά σκευάσματα
| Κωδικός | Όνομα | Κ | Ν.Τ. | Χ.Τ. | Λ.Τ. | Κάτοχος άδειας |
|---|---|---|---|---|---|---|
| 90034.01.01 | BONEFOS CAPS 400mg BT x 100 | Ι.Φ.Ε.Τ. A.E. |