BONDRONAT Concentrate for solution for infusion (2019)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Atnahs Pharma Netherlands B.V. |
|---|---|
| Διεύθυνση | Strawinskylaan 3127, 1077 ZX Amsterdam, Netherlands |
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Περιεχόμενα
Name of the medicinal product
Bondronat 6 mg concentrate for solution for infusion.
Qualitative and quantitative composition
One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Concentrate for solution for infusion.
Therapeutic indications
Bondronat is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment ...
Posology and method of administration
Patients treated with Bondronat should be given the package leaflet and the patient reminder card. Bondronat therapy should only be initiated by physicians experienced in the treatment of cancer. Posology ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypocalcaemia.
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 for metastatic ...
Interaction with other medicinal products and other forms of interaction
Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats ...
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 for the jaw and ocular inflammation (see paragraph ...
Overdose
Up to now there is no experience of acute poisoning with Bondronat concentrate for solution for infusion. Since both the kidney and the liver were found to be target organs for toxicity in preclinical ...
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
After a 2 hour infusion of 2, 4 and 6 mg ibandronic acid pharmacokinetic parameters are dose proportional. Distribution After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted ...
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
Sodium chloride Acetic acid (99%) Sodium acetate Water for injections
Incompatibilities
To avoid potential incompatibilities Bondronat concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution. Bondronat should not be mixed ...
Shelf life
5 years. After reconstitution: 24 hours.
Special precautions for storage
This medicinal product does not require any special storage conditions prior to reconstitution. After reconstitution: Store at 2°C–8°C (in a refrigerator). From a microbiological point of view, the product ...
Nature and contents of container
Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vial with a bromobutyl rubber stopper). 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/1/96/012/011 EU/1/96/012/012 EU/1/96/012/013
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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