Natpar

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

parathyroid hormone

Saatavilla:

Takeda Pharmaceuticals International AG Ireland Branch

ATC-koodi:

H05AA03

INN (Kansainvälinen yleisnimi):

parathyroid hormone

Terapeuttinen ryhmä:

Calcium homeostasis

Terapeuttinen alue:

Hypoparathyroidism

Käyttöaiheet:

Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-04-24

Pakkausseloste

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 FOR
INJECTION
NATPAR 100 MICROGRAMS/DOSE POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
Parathyroid hormone
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Natpar is and what it is used for
2.
What you need to know before you use Natpar
3.
How to use Natpar
4.
Possible side effects
5.
How to store Natpar
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT NATPAR IS AND WHAT IT IS USED FOR
WHAT IS NATPAR?
Natpar is a hormone replacement for adults with under-active
parathyroid glands, a condition known
as ‘hypoparathyroidism’.
Hypoparathyroidism is a disease caused by low levels of parathyroid
hormone, which is produced by
the parathyroid glands in the neck. This hormone controls the amount
of calcium and phosphate in the
blood and urine.
If your levels of parathyroid hormone are too low, you can have low
blood calcium. Low calcium can
cause symptoms in many parts of your body, including the bones, heart,
skin, muscles, kidneys, brain
and nerves. For a list of symptoms of low ca

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
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 for
injection
Natpar 100 micrograms/dose powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Natpar 25 micrograms
Each dose contains 25 micrograms parathyroid hormone (rDNA)* in 71.4
microlitre solution
following reconstitution.
Each cartridge contains 350 micrograms parathyroid hormone (rDNA).
Natpar 50 micrograms
Each dose contains 50 micrograms parathyroid hormone (rDNA) in 71.4
microlitre solution following
reconstitution.
Each cartridge contains 700 micrograms parathyroid hormone (rDNA).
Natpar 75 micrograms
Each dose contains 75 micrograms parathyroid hormone (rDNA) in 71.4
microlitre solution following
reconstitution.
Each cartridge contains 1050 micrograms parathyroid hormone (rDNA).
Natpar 100 micrograms
Each dose contains 100 micrograms parathyroid hormone (rDNA) in 71.4
microlitre solution
following reconstitution.
Each cartridge contains 1400 micrograms parathyroid hormone (rDNA).
*Parathyroid hormone (rDNA), produced in _E. coli_ using recombinant
DNA technology, is identical to
the 84 amino acid sequence of endogenous human parathyroid hormone.
Excipient(s) with known effect
Each dose contains 0.32 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white and the solvent is a clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Natpar is indicated as adjunctive treatment of adult patients with
chronic hypoparathyro