ACLASTA 5 mg solution pour perfusion (NOVARTIS PHARMA) - Chirurgie
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1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE
Aclasta 5 mg solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid anhydrous corresponding to 5 330 mg zoledronic acid monohydrate One ml solution contains 0 05 mg zoledronic acid anhydrous corresponding to 0 0533 mg zoledronic acid monohydrate |
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT Aclasta 5 mg solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate ) Each ml of the solution contains 0 05 mg zoledronic acid (as monohydrate ) For the full list of excipients see section 6 1 3 |
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ANNEXE I RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT
Aclasta 5 mg solution pour perfusion 2 COMPOSITION QUALITATIVE ET QUANTITATIVE Chaque flacon de 100 ml de solution contient 5 mg d'acide zolédronique (monohydraté) Chaque ml de la solution contient 005 mg d’acide zolédronique (monohydraté) Pour la liste complète des excipients voir rubrique 6 1 3 FORME PHARMACEUTIQUE |
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MONOGRAPHIE DE PRODUIT
ACLASTAMD (acide zolédronique à 5 mg/100 mL) est indiqué dans : le traitement de l’ostéoporose postménopausique administré 1 fois l’an en perfusion intraveineuse afin de réduire la fréquence des fractures de la hanche et des fractures |
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[Product Monograph Template
PRODUCT MONOGRAPH PrACLASTA® (zoledronic acid injection) 5 mg/100 mL solution for intravenous infusion Bone Metabolism Regulator Novartis Pharmaceuticals Canada Inc Dorval Quebec H9S 1A9 Control Number: 174652 Date of Preparation: June 30 2005 Date of Revision: September 11 2014 ACLASTA is a registered trademark Page 2 of 65 |
Can Aclasta be mixed with other medicinal products?
Aclasta must not be mixed or given intravenously with any other medicinal products. Aclasta is compatible with the typical infusion line materials polyvinylchloride (PVC), polyurethane (PUR) and polyethylene (PE). From a microbiological point of view, the product should be used immediately.
How is Aclasta administered?
Aclasta (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate. The infusion time must not be less than 15 minutes. For information on the infusion of Aclasta, see section 6.6. Patients must be appropriately hydrated prior to administration of Aclasta.
How long did the Aclasta trial last?
The duration of the trial was one year, with 416 patients exposed to ACLASTA® administered once as a single infusion 5 mg dose in 100 mL solution infused over 15 minutes and 417 patients exposed to oral risedronate 5 mg daily for one year. All participants received 1000 mg elemental calcium plus 400 to 1000 IU vitamin D supplementation per day.
How long does Aclasta® work for Paget's disease?
For Paget’s disease: single treatment of 5 mg. ACLASTA® may work for longer than one year, and your doctor will let you know if you need to be treated again. The infusion nurse or doctor may ask you to stay for a short period of time after the infusion.
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ACLASTA 5 mg, solution pour perfusion, 2015/05/28 - VIDAL
Chaque flacon de 100 ml de solution contient 5 mg d'acide zolédronique ( monohydraté) Chaque ml de la une perfusion intraveineuse de 5 mg d'Aclasta , administrpe une fois par an 2 place en étroite collaboration entre le médecin traitant et un dentiste ou chirurgien stomatologiste ayant Novartis Pharma GmbH |
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Aclasta, INN-zoledronic acid - europaeu
Chaque flacon de 100 ml de solution contient 5 mg d'acide zolédronique ( monohydraté) Chaque ml de la une perfusion intraveineuse de 5 mg d'Aclasta , administrée une fois par an place en étroite collaboration entre le médecin traitant et un dentiste ou chirurgien stomatologiste ayant Novartis Pharma GmbH |
