Teriparatide-Teva

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Teriparatide acetate 0.25 mg/mL

Available from:

Teva Pharma (New Zealand) Limited

Dosage:

250 mcg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Teriparatide acetate 0.25 mg/mL Excipient: Glacial acetic acid Hydrochloric acid Mannitol Metacresol Nitrogen Sodium acetate trihydrate Sodium hydroxide Water for injection

Prescription type:

Prescription

Therapeutic indications:

In combination with calcium and Vitamin D, for the treatment osteoporosis in postmenopausal women and in men at high risk of fracture.

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, in pen device - 2.4 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2022-03-03

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
TERIPARATIDE-TEVA
Teriparatide solution for injection
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Teriparatide-Teva. It
does not contain all the available information and does not take the
place of
talking to your doctor or health care professional.
All medicines have risks and benefits. Your doctor has weighed the
risks of
you using Teriparatide-Teva against the benefits they expect it will
have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
HEALTH CARE PROFESSIONAL.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
TERIPARATIDE-TEVA
IN RATS THAT WERE TREATED WITH TERIPARATIDE FOR MORE THAN A QUARTER OF
THEIR
LIFETIME, TERIPARATIDE CAUSED SOME RATS TO DEVELOP OSTEOSARCOMA, A
BONE
CANCER. THE POTENTIAL TO CAUSE OSTEOSARCOMA IN RATS WAS INCREASED WITH
HIGHER DOSES AND LONGER PERIODS OF TREATMENT.
Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma
occurs in about 4 out of every million people each year. THERE IS ONE
REPORT
OF OSTEOSARCOMA IN A PATIENT ADMINISTERED TERIPARATIDE FOR 14 MONTHS.
DUE
TO
THE
COMPLEX
MEDICAL
HISTORY,
CAUSE
AND
EFFECT
BETWEEN
TERIPARATIDE AND OSTEOSARCOMA COULD NOT BE ESTABLISHED. AT PRESENT, IT
IS NOT KNOWN WHETHER HUMANS TREATED WITH TERIPARATIDE WOULD HAVE AN
INCREASED CHANCE OF GETTING OSTEOSARCOMA. You should discuss any
safety
concerns you have about the use of teriparatide with your doctor.
WHAT TERIPARATIDE-TEVA IS USED FOR
Teriparatide is used to treat osteoporosis in women after menopause
and in
men.
It is also used to treat women and men who have developed osteoporosis
as
a result of taking corticosteroids.
Osteoporosis is a disease which
causes bones to become less
dense,
gradually making them weaker, more brittle and likely to break. This
disease
is especially common in women after menopause.
Osteoporosis can also occur in patients receiving corticosteroids such
as
prednisone, co

Summary of Product characteristics

Version 2.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Teriparatide-Teva, 250 mcg/mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Teriparatide* 250 mcg/mL (or 20 micrograms/80 microlitres) as
teriparatide acetate.
* teriparatide (1-34) is identical to the 34 N-terminal amino acid
sequence of endogenous human
parathyroid hormone.
Excipient with known effect:
metacresol (3 mg/mL as preservative)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless solution, free from visible particles, packaged in a
glass cartridge (2.4 mL cartridge)
closed with a plunger at one end and with a rubber disc and aluminum
cap (combiseal) at the other
end. The filled cartridge is assembled into a pen injector.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Teriparatide-Teva, in combination with calcium and vitamin D, is
indicated for the treatment of
osteoporosis in postmenopausal women and in men at high risk of
fracture (see 5.1 Pharmacodynamic
properties - Clinical Efficacy and Safety).
Teriparatide-Teva is indicated for the treatment of osteoporosis
associated with sustained systemic
glucocorticoid therapy in women and men at high risk for fracture (see
5.1
Pharmacodynamic
properties - Clinical Efficacy and Safety).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The recommended dose of teriparatide is 20 microgram administered once
daily by
subcutaneous
injection in the thigh or abdomen.
The maximal lifetime duration of treatment should be limited to 24
months (for post
treatment
efficacy, see section 5.1 Pharmacodynamic properties - Clinical
Efficacy and Safety).
Following
cessation
of
teriparatide
therapy,
patients
may
be
continued
on
other
osteoporosis
therapies.
Teriparatide-Teva should be administered in conjunction with calcium
and vitamin D.
Patients must be educated to use the proper injection techniques.
Please refer to the Instructions for
Use included in the pack.
AGE
Dosage adjustment based on age is not required (see section 5.2
Pharmacokinetic properties).
GEN