Preotact

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

parathyroid hormone (rDNA)

Beschikbaar vanaf:

NPS Pharma Holdings Limited

ATC-code:

H05AA03

INN (Algemene Internationale Benaming):

parathyroid hormone (rDNA)

Therapeutische categorie:

Calcium homeostasis

Therapeutisch gebied:

Osteoporosis, Postmenopausal

therapeutische indicaties:

Treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.

Product samenvatting:

Revision: 4

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-04-24

Bijsluiter

19
B. PACKAGE LEAFLET
Medicinal product no longer authorised
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREOTACT 100 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
IN A PRE-FILLED PEN
Parathyroid hormone
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 your 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 WHAT IS IN THIS LEAFLET
1.
What Preotact is and what it is used for
:
2.
What you need to know before you use Preotact
3.
How to use Preotact
4.
Possible side effects
5
How to store Preotact
6.
Contents of the pack and other information
1.
WHAT PREOTACT IS AND WHAT IT IS USED FOR
Preotact is used to treat osteoporosis in women past menopause with
high risk of fractures.
Osteoporosis is a disease that causes bones to become thin and
fragile. It is especially common in
women after the menopause. The disease progresses gradually so you may
not feel any symptoms at
first. But if you have osteoporosis, it makes you more likely to break
bones, especially in your spine,
hips and wrists. It may also cause back pain, loss of height, and a
curved back.
Preotact reduces the risk of breaking spinal bones because it
increases your bone quality and strength.
It has not been shown that Preotact reduces the risk of breaking your
hip.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PREOTACT
DO NOT USE PREOTACT
•
if you are allergic to parathyroid hormone or any of the other
ingredients of this medicine (listed
in section 6);
•
if you shall have or previously have had radiation therapy to the
skeleton;
•
if you have cancer of the bones;
•
if you suffer from high calcium levels in your blood or oth

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Preotact 100 micrograms powder and solvent for solution for injection
in a pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding
to 14 doses.
After reconstitution, each dose of 71.4 microlitre contains 100
micrograms parathyroid hormone
produced in
_Escherichia coli _
by recombinant DNA technology
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White to off-white powder and clear, colourless solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Preotact is indicated for the treatment of osteoporosis in
postmenopausal women at high risk of
fractures (see section 5.1).
A significant reduction in the incidence of vertebral, but not hip
fractures has been demonstrated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is 100 micrograms of parathyroid hormone
administered once-daily
Posology
Patients should receive supplemental calcium and vitamin D if dietary
intake is inadequate.
Data support continuous treatment with Preotact for up to 24 months
(see section 4.4).
Following treatment with Preotact patients can be treated with a
bisphosphonate to further increase
bone mineral density (see section 5.1).
_Renal impairment _
_Special populations _
No dose adjustment is necessary in patients with mild to moderate
renal impairment (creatinine
clearance 30 to 80 ml/min). There is no data available in patients
with severe renal impairment.
Preotact should therefore not be used in patients with severe renal
impairment (see section 4.3).
_Hepatic impairment _
No dose adjustment is needed for patients with mild or moderate
hepatic impairment (total score of
7 to 9 on the Child-Pugh scale). There is no data available in
patients with severe hepatic impairment.
Preotact should therefore not be used in patients with severe hepatic
impairment (see s