NATPAR Powder and solvent for solution for injection (2022)
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Περιεχόμενα
Name of the medicinal product
Natpar 25 micrograms/dose powder and solvent for solution for injection. Natpar 50 micrograms/dose powder and solvent for solution for injection. Natpar 75 micrograms/dose powder and solvent for solution ...
Qualitative and quantitative composition
<u>Natpar 25 micrograms:</u> Each dose contains 25 micrograms parathyroid hormone (rDNA)* in 71.4 microlitre solution following reconstitution. Each cartridge contains 350 micrograms parathyroid hormone ...
Pharmaceutical form
Powder and solvent for solution for injection. The powder is white and the solvent is a clear, colourless solution.
Therapeutic indications
Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
Posology and method of administration
General Treatment should be supervised by a physician or other qualified healthcare professional experienced in the management of patients with hypoparathyroidism. The goal of treatment with Natpar is ...
Contraindications
Natpar is contraindicated in patients: with hypersensitivity to the active substance or to any of the excipients listed in section 6.1 who are receiving or who have previously received radiation therapy ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. The aim of treatment with Natpar is ...
Interaction with other medicinal products and other forms of interaction
The inotropic effects of cardiac glycosides are affected by serum calcium levels. Combined use of Natpar and cardiac glycosides (e.g. digoxin or digitoxin) may predispose patients to digitalis toxicity ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Natpar in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). A risk to ...
Effects on ability to drive and use machines
Natpar has no or negligible influence on the ability to drive and use machines. Since neurologic symptoms may be a sign of uncontrolled hypoparathyroidism, patients with disturbances in cognition or attention ...
Undesirable effects
Summary of the safety profile The most frequent adverse reactions among patients treated with Natpar were hypercalcaemia, hypocalcaemia, and their associated clinical manifestations including headache, ...
Overdose
Overdose can cause hypercalcaemia, the symptoms of which may include heart palpitations, ECG changes, hypotension, nausea, vomiting, dizziness and headache. Severe hypercalcaemia may be a life-threatening ...
Pharmacodynamic properties
Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues ATC code: H05AA03 Mechanism of action Endogenous parathyroid hormone (PTH) is secreted by the parathyroid glands as a ...
Pharmacokinetic properties
The pharmacokinetics of Natpar following subcutaneous administration in the thigh of hypoparathyroidism subjects was consistent with that observed in healthy post-menopausal women who received parathyroid ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity, toxicity to fertility and general reproduction, and local tolerance. Rats treated ...
List of excipients
Powder: Sodium chloride Mannitol Citric acid monohydrate Sodium hydroxide (for pH adjustment) Solvent: Metacresol Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. <u>Reconstituted solution:</u> After reconstitution, chemical and physical in-use stability of the solution has been demonstrated for up to 14 days when stored in a refrigerator (2°C–8°C) and ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section ...
Nature and contents of container
The glass dual-chamber cartridge inside the cartridge holder is made from type I glass with 2 bromobutyl rubber stoppers and a crimp cap (aluminium) with a bromobutyl rubber seal. <u>Natpar 25 micrograms: ...
Special precautions for disposal and other handling
Parathyroid hormone (rDNA) is injected using the cartridge with a reusable pen. Each pen must be used by only one patient. A new sterile needle must be used for every injection. Use 31 G x 8 mm pen needles. ...
Marketing authorization holder
Takeda Pharmaceuticals International AG Ireland Branch, Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland
Marketing authorization number(s)
EU/1/15/1078/001 EU/1/15/1078/002 EU/1/15/1078/003 EU/1/15/1078/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 April 2017 Date of latest renewal: 15 April 2021
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