PROLIA Solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Prolia 60 mg solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Each pre-filled syringe contains 60 mg of denosumab in 1 mL of solution (60 mg/mL). Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant ...
Pharmaceutical form
Solution for injection (injection). Clear, colourless to slightly yellow solution.
Therapeutic indications
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures. ...
Posology and method of administration
Posology The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm. Patients must be adequately supplemented with ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypocalcaemia (see section 4.4).
Special warnings and precautions for use
Calcium and Vitamin D supplementation Adequate intake of calcium and vitamin D is important in all patients. Precautions for use Hypocalcaemia It is important to identify patients at risk for hypocalcaemia. ...
Interaction with other medicinal products and other forms of interaction
In an interaction study, Prolia did not affect the pharmacokinetics of midazolam, which is metabolised by cytochrome P450 3A4 (CYP3A4). This indicates that Prolia should not alter the pharmacokinetics ...
Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of denosumab in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Prolia is not recommended for use in ...
Effects on ability to drive and use machines
Prolia has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common side effects with Prolia (seen in more than one patient in ten) are musculoskeletal pain and pain in the extremity. Uncommon cases of cellulitis, rare cases ...
Overdose
There is no experience with overdose in clinical studies. Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for the treatment of bone diseases – Other drugs affecting bone structure and mineralisation ATC code: M05BX04 Mechanism of action Denosumab is a human monoclonal antibody ...
Pharmacokinetic properties
Absorption Following subcutaneous administration of a 1.0 mg/kg dose, which approximates the approved 60 mg dose, exposure based on AUC was 78% as compared to intravenous administration at the same dose ...
Preclinical safety data
In single and repeated dose toxicity studies in cynomolgus monkeys, denosumab doses resulting in 100 to 150 times greater systemic exposure than the recommended human dose had no impact on cardiovascular ...
List of excipients
Acetic acid, glacial* Sodium hydroxide (for pH adjustment)* Sorbitol (E420) Polysorbate 20 Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years. Once removed from the refrigerator, Prolia may be stored at room temperature (up to 25°C) for up to 30 days in the original container. It must be used within this 30 days period. ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the container in the outer carton in order to protect from light.
Nature and contents of container
One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle, with or without needle guard. The needle cover of the pre-filled syringe contains dry natural ...
Special precautions for disposal and other handling
Before administration, the solution should be inspected. Do not inject the solution if it contains particles, or is cloudy or discoloured. Do not shake. To avoid discomfort at the site of injection, allow ...
Marketing authorization holder
Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands
Marketing authorization number(s)
EU/1/10/618/001 EU/1/10/618/002 EU/1/10/618/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 May 2010 Date of latest renewal: 15 January 2015
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