Teriparatide Teva 20 micrograms/80 microlitres Solution for Injection in pre-filled pen

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Teriparatide

Available from:

Teva B.V.

ATC code:

H05AA; H05AA02

INN (International Name):

Teriparatide

Dosage:

20/80

Pharmaceutical form:

Solution for injection in pre-filled pen

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Parathyroid hormones and analogues; teriparatide

Authorization status:

Not marketed

Authorization date:

2018-06-22

Patient Information leaflet

1
V3.0 – March 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
TERIPARATIDE TEVA 20 MICROGRAMS/80 MICROLITRES SOLUTION FOR INJECTION
IN PRE-FILLED PEN
TERIPARATIDE
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 Teriparatide Teva is and what it is used for
2.
What you need to know before you use Teriparatide Teva
3.
How to use Teriparatide Teva
4.
Possible side effects
5.
How to store Teriparatide Teva
6.
Contents of the pack and other information
1.
WHAT TERIPARATIDE TEVA IS AND WHAT IT IS USED FOR
Teriparatide Teva contains the active substance teriparatide that is
used to make the bones stronger, and to
reduce the risk of fractures by stimulating bone formation.
Teriparatide Teva is used to treat osteoporosis in adults.
Osteoporosis is a disease that causes your bones to
become thin and fragile. This disease is especially common in women
after the menopause, but it can also
occur in men. Osteoporosis is also common in patients receiving
corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TERIPARATIDE TEVA
DO NOT USE TERIPARATIDE TEVA:
•
if you are allergic to teriparatide or any of the other ingredients of
this medicine (listed in section 6).
•
if you suffer from high calcium levels (pre-existing hypercalcaemia).
•
if you suffer from serious kidney problems.
•
if you have ever been diagnosed with bone cancer or other cancers that
have spread (metastasised) to
your bones.
•
if you have certain bone diseases. If you have a bone disease, tell
your doctor.
•
if you have unexplain

Summary of Product characteristics

Health Products Regulatory Authority
17 April 2019
CRN009091
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teriparatide Teva 20 micrograms/80 microlitres Solution for Injection
in pre-filled pen
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 80 microlitres contains 20 micrograms of teriparatide*.
One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide
(corresponding to 250 micrograms per mL).
*Teriparatide (1-34) is identical to the 34 N-terminal amino acid
sequence of endogenous human parathyroid hormone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection).
Colourless, clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Teriparatide Teva is indicated in adults.
Treatment of osteoporosis in postmenopausal women and in men at
increased risk of fracture (see section 5.1). In
postmenopausal women, a significant reduction in the incidence of
vertebral and non-vertebral fractures but not hip fractures
has been demonstrated.
Treatment of osteoporosis associated with sustained systemic
glucocorticoid therapy in women and men at increased risk for
fracture (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Teriparatide Teva is 20 micrograms
administered once daily.
The maximum total duration of treatment with Teriparatide Teva should
be 24 months (see section 4.4). The 24-month course
of teriparatide should not be repeated over a patient’s lifetime.
Patients should receive supplemental calcium and vitamin D supplements
if dietary intake is inadequate.
Following cessation of teriparatide therapy, patients may be continued
on other osteoporosis therapies.
Special populations
_Patients with renal impairment _
Teriparatide must not be used in patients with severe renal impairment
(see section 4.3). In patients with moderate renal
impairment, teriparatide should be used with caution. No special
caution is required for patients with mild renal impairment.
_Pat