ZEMPLAR Solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
Zemplar 5 micrograms/ml solution for injection.
Qualitative and quantitative composition
Each ml of solution for injection contains 5 micrograms of paricalcitol. Each 1 ml ampoule contains 5 micrograms of paricalcitol. Each 2 ml ampoule contains 10 micrograms of paricalcitol. Each 1 ml vial ...
Pharmaceutical form
Solution for Injection. A clear and colourless aqueous solution free from visible particles.
Therapeutic indications
Paricalcitol is indicated in adults for the prevention and treatment of secondary hyperparathyroidism in patients with chronic kidney disease Stage 5 who are undergoing haemodialysis.
Posology and method of administration
Posology Adults 1) Initial dose should be calculated based on baseline parathyroid hormone (PTH) levels: The initial dose of paricalcitol is based on the following formula: Initial dose (micrograms) = ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Vitamin D toxicity Hypercalcaemia
Special warnings and precautions for use
Over suppression of parathyroid hormone may result in elevations of serum calcium levels and may lead to metabolic bone disease. Patient monitoring and individualised dose titration is required to reach ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with paricalcitol injection. However, an interaction study between ketoconazole and paricalcitol has been performed with the capsule formulation. Ketoconazole: ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of paricalcitol in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Zemplar is not recommended during ...
Effects on ability to drive and use machines
Dizziness may occur following administration of paricalcitol, which may have a minor influence on the ability to drive and use machines (see section 4.8).
Undesirable effects
Summary of the safety profile Approximately 600 patients were treated with paricalcitol in Phase II/III/IV clinical trials. Overall, 6% of the paricalcitol treated patients reported adverse reactions. ...
Overdose
No case of overdose has been reported. Overdosage of paricalcitol may lead to hypercalcaemia, hypercalciuria, hyperphosphatemia, and over suppression of PTH (see section 4.4). In the event of an overdose, ...
Pharmacodynamic properties
Pharmaco-therapeutic group: Anti-parathyroid agents ATC code: H05BX02 Mechanism of action Paricalcitol is a synthetic, biologically active vitamin D analogue of calcitriol with modifications to the side ...
Pharmacokinetic properties
Distribution The pharmacokinetics of paricalcitol have been studied in patients with chronic renal failure (CRF) requiring haemodialysis. Paricalcitol is administered as an intravenous bolus injection. ...
Preclinical safety data
Salient findings in the repeat dose toxicology studies in rodents and dogs were generally attributed to paricalcitols calcaemic activity. Effects not clearly related to hypercalcaemia included decreased ...
List of excipients
Ethanol (20% v/v) Propylene glycol Water for Injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Propylene glycol interacts with heparin and neutralises its effect. Zemplar solution for ...
Shelf life
Vial: 3 years. Ampoule: 2 years. After opening, use immediately.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Each Type 1 glass ampoule contains 1ml or 2ml of solution for injection. Each Type 1 glass vial contains 1ml or 2ml of solution for injection. The presentations of Zemplar are: Pack containing 5 ampoules ...
Special precautions for disposal and other handling
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. The solution is clear and colourless. For single use only. Any unused medicinal ...
Marketing authorization holder
AbbVie Ltd., Maidenhead, SL6 4UB, UK
Marketing authorization number(s)
PL 41042/0010
Date of first authorization / renewal of the authorization
Date of first authorisation: 9 August 2002 Date of Last renewal: 9 August 2007
Date of revision of the text
11 April 2018
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