TERIPARATIDE LUPIN teriparatide 250 microgram per mL solution for injection pre-filled cartridge

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Teriparatide, Quantity: 0.25 mg/mL

Disponibil de la:

Generic Health Pty Ltd

Forma farmaceutică:

Injection, solution

Compoziție:

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

Calea de administrare:

Subcutaneous

Unități în pachet:

1 x pre-filled cartridge, 3 x pre-filled cartridge

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Teriparatide Lupin 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. ,Teriparatide Lupin is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

Rezumat produs:

Visual Identification: Clear, colourless solution.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2023-04-05

Caracteristicilor produsului

▼
This medicinal product is subject to additional monitoring in
Australia. This will allow quick identification
of new safety information. Healthcare professionals are asked to
report any suspected adverse events at
https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – TERIPARATIDE LUPIN
(TERIPARATIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Teriparatide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One
pre-filled
pen
of
Teriparatide
Lupin
of
2.4 mL
contains
600 micrograms
of
teriparatide
(corresponding to 250 micrograms per mL).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Teriparatide Lupin is a sterile, colourless, clear, isotonic solution
in pre-filled pens.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Teriparatide Lupin 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.
Teriparatide Lupin 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
Each dose of 80 microlitres contains 20 micrograms of teriparatide.
The
recommended
dose
of
Teriparatide
Lupin
is
20 micrograms
administered
once
daily
by
subcutaneous injection in the thigh or abdomen.
Based on clinical experience, treatment with Teriparatide Lupin is
recommended for a lifetime duration
of 24 months treatment (for post-treatment efficacy, see SECTION 5.1
PHARMACODYNAMIC PROPERTIES -
Teriparatide Lupin-pi-v1
Page 2 of 24
(teriparatide) solution for injection
CLINICAL TRIALS). Teriparatide Lupin should be prescribed to patients
with a full explanation and their
informed consent on the lifetime duration of 24 months treatment.
Calcium and vitamin D supplements are advised in patients with a low
dietary intake of these nutrients.
USE IN MALES – Primary or secondary h