ZEMPLAR Capsule, soft (2019)
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Περιεχόμενα
Name of the medicinal product
Zemplar 1 microgram capsules, soft.
Qualitative and quantitative composition
Each capsule of Zemplar 1 microgram contains 1 microgram of paricalcitol. Excipient with known effect: Each capsule of Zemplar 1 microgram contains 0.71 mg of ethanol. For the full list of excipients, ...
Pharmaceutical form
Capsule, soft. <u>1 microgram capsule:</u> oval, grey soft capsule imprinted with ZA.
Therapeutic indications
Zemplar is indicated in adult and paediatric patients 10 to 16 years of age for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stages 3 and 4. Zemplar ...
Posology and method of administration
Posology Chronic Kidney Disease (CKD) Stages 3 and 4 Zemplar should be administered once a day, either daily or three times a week taken every other day. Initial dose The initial dose is based on baseline ...
Contraindications
Paricalcitol should not be given to patients with evidence of vitamin D toxicity, hypercalcaemia, or hypersensitivity to paricalcitol or any of the excipients listed in section 6.1.
Special warnings and precautions for use
Over suppression of parathyroid hormone may result in elevations of serum calcium levels and may lead to low-turnover bone disease. Patient monitoring and individualised dose titration is required to reach ...
Interaction with other medicinal products and other forms of interaction
<u>Ketoconazole:</u> Ketoconazole is known to be a nonspecific inhibitor of several cytochrome P450 enzymes. The available <em>in vivo</em> and <em>in vitro</em> data suggest that ketoconazole may interact ...
Pregnancy and lactation
Pregnancy There are no adequate data on the use of paricalcitol in pregnant women. Animal studies have shown reproductive toxicity (see Section 5.3). Potential risk in human use is not known, therefore ...
Effects on ability to drive and use machines
Zemplar has negligible influence on ability to drive and use machines.
Undesirable effects
Summary of the safety profile The safety of paricalcitol capsules has been evaluated in three 24-week, double-blind, placebo-controlled, multi-centre clinical trials involving 220 CKD Stage 3 and 4 adult ...
Overdose
Excessive administration of Zemplar capsules can cause hypercalcaemia, hypercalciuria, hyperphosphataemia, and over suppression of parathyroid hormone. High intake of calcium and phosphate concomitant ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-parathyroid agents ATC code: H05BX02 Mechanism of Action Paricalcitol is a synthetic, biologically active vitamin D analog of calcitriol with modifications to the side chain ...
Pharmacokinetic properties
Absorption Paricalcitol is well absorbed. In healthy adult subjects, following oral administration of paricalcitol at 0.24 micrograms/kg, the mean absolute bioavailability was approximately 72%; the maximum ...
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
<u>Capsule contents:</u> Medium chain triglycerides Ethanol Butylhydroxytoluene <u>Capsule shell:</u> Gelatin Glycerol Water Titanium dioxide (E171) Iron oxide black (E172) <u>Black Ink:</u> Propylene ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
High-density polyethylene (HDPE) bottles closed with child resistant polypropylene caps. Each bottle contains 30 capsules. PVC/fluoropolymer/aluminium blister strips containing 7 capsules. Each carton ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
AbbVie Ltd., Maidenhead, SL6 4UB, UK
Marketing authorization number(s)
PL 41042/0011
Date of first authorization / renewal of the authorization
Date of first authorisation: 06 December 2007 Date of latest renewal: 20 January 2012
Date of revision of the text
20 November 2019
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