TERROSA teriparatide (rbe) 250 microgram/mL

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Teriparatide, Quantity: 250 microgram/mL

Tilgængelig fra:

Gedeon Richter Australia Pty Ltd

Lægemiddelform:

Injection, solution

Sammensætning:

Excipient Ingredients: metacresol; water for injections; sodium hydroxide; hydrochloric acid; glacial acetic acid; mannitol; sodium acetate trihydrate

Indgivelsesvej:

Subcutaneous

Enheder i pakken:

3 cartridges, 1 cartridge

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

TERROSA is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.,TERROSA is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

Produkt oversigt:

Visual Identification: Clear, colourless solution in 3 mL cartridge; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

2020-12-01

Indlægsseddel

Version:terrosa_v3_A300822
Supercedes: terrosa_v2_A030622
1
TERROSA
®
______________________________________________________________________________________________________
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
________________________________________________________________________________________________________
1. WHY AM I USING TERROSA?
Terrosa contains the active ingredient teriparatide. Terrosa is used
to treat osteoporosis in women after menopause and in men.
Osteoporosis is a disease that causes your bones to become thin and
fragile. For more information, see Section 1. Why am I using
Terrosa? in the full CMI.
2. WHAT SHOULD I KNOW BEFORE I USE TERROSA?
Do not use if you have ever had an allergic reaction to Terrosa or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2
.What should I know before I use Terrosa? in the full CMI.
3. WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Terrosa and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI
4. HOW DO I USE TERROSA?
•
A dose of 80 microlitres containing 20 micrograms of Terrosa is given
once a day by injection under the skin in the thigh or
abdomen
•
The dose is injected using a reusable Terrosa Pen that is supplied
with the medicine for the first prescription.
•
The cartridge must be used for multiple injections by ONE person only.
More instructions can be found in Section 4 .How do I use Terrosa? in
the full CMI
5. WHAT SHOULD I KNOW WHILE USING TERROSA?
THINGS YOU SHOULD DO
•
Before you start to use Terrosa, you will be required to sign your
consent that you
understand the 24 month lifetime limit for treatment. Keep a copy of
the consent

Produktets egenskaber

Version: terrosa-v4-A300822 Superceded: terrosa- v3-A080622
1
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AUSTRALIAN PRODUCT INFORMATION
TERROSA
® (TERIPARATIDE (RBE)) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Teriparatide (rbe)
TERROSA
®
solution for injection
is a biosimilar medicine to FORTEO
®
solution for injection. The evidence
for comparability supports the use of TERROSA
®
for the listed indications.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient for TERROSA solution for injection is
teriparatide.
TERROSA solution for injection contains 250 micrograms /mL of
teriparatide.
Teriparatide (rbe) is produced in
_E. coli_
, using recombinant DNA technology, 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 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Solution for injection.
TERROSA is a sterile, colourless, clear solution for injection with a
pH of 3.8 - 4.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TERROSA is indicated for the treatment of osteoporosis in
postmenopausal women and the treatment of
primary osteoporosis in men when other agents are considered
unsuitable and when there is a high risk of
fractures.
TERROSA is indicated for the treatment of osteoporosis associated with
sustained systemic glucocorticoid
therapy in women and men at high risk for fracture.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Dosage _
The recommended dose of TERROSA is 20 micrograms administered once
daily by subcutaneous injection in
the thigh or abdomen.
Based on clinical experience, treatment with teriparatide is
recommended for a lifetime duration of 24 months
Version: terrosa-v4-A300822 Superceded: terrosa- v3-A080622
2
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treatment (for post-treatment efficacy
,
see
SECTION 5.1
PHARMACODYNAMIC PROPERTIES / CLINICAL
TRIALS
). TERROSA should be prescribed to patients with a full explanation
and their informed consent on the
lifetime duration of 24 months treatment
.
Following cessation of teriparatide therapy, patients may be continued