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SPC: BONDRONAT Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Atnahs Pharma Netherlands B.V.
Διεύθυνση :
Strawinskylaan 3127, 1077 ZX Amsterdam, Ολλανδία
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Περιεχόμενα

Name of the medicinal product

Bondronat 50 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate). Excipients with known effect: Contains 88.1 mg lactose (as lactose monohydrate). For the full list of excipients, see ...

Pharmaceutical form

Film-coated tablets. White to off-white film-coated tablets, of oblong shape engraved L2 on one side and IT on the other side.

Therapeutic indications

Bondronat is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. ...

Posology and method of administration

Bondronat therapy should only be initiated by physicians experienced in the treatment of cancer. Posology The recommended dose is one 50 mg film-coated tablet daily. Special populations Patients with hepatic ...

Contraindications

Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1. Hypocalcaemia. Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia. Inability ...

Special warnings and precautions for use

Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bondronat therapy. Adequate intake ...

Interaction with other medicinal products and other forms of interaction

Medicinal product Food Interactions Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of ibandronic acid in pregnant women. Studies in rats have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Therefore, ...

Effects on ability to drive and use machines

On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Bondronat has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular ...

Overdose

No specific information is available on the treatment of overdosage with Bondronat. However, oral overdosage may result in upper gastrointestinal events, such as upset stomach, heartburn, oesophagitis, ...

Pharmacodynamic properties

Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate ATC Code: M05BA06 Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on ...

Pharmacokinetic properties

Absorption The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration. Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 ...

Preclinical safety data

Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. As with other bisphosphonates, the kidney ...

List of excipients

Tablet core: Lactose monohydrate Povidone Cellulose, microcrystalline Crospovidone Stearic acid Silica, anhydrous colloidal Tablet coat: Hypromellose Titanium dioxide (E171) Talc Macrogol 6000

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years.

Special precautions for storage

Store in the original package in order to protect from moisture.

Nature and contents of container

Bondronat 50 mg film coated tablets are supplied in blisters (aluminium) containing 7 tablets, which are presented as packs containing 28 or 84 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The release of pharmaceuticals in the environment should be minimized.

Marketing authorization holder

Atnahs Pharma Netherlands B.V., Strawinskylaan 3127, 1077 ZX Amsterdam, Netherlands

Marketing authorization number(s)

EU/1/96/012/009 EU/1/96/012/010

Date of first authorization / renewal of the authorization

Date of first authorisation: 25 June 1996 Date of latest renewal: 25 June 2006

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