HUMATROPE somatropin 36IU (12mg) powder for injection cartridge with diluent syringe

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Somatropin, Quantity: 12 mg (Equivalent: Somatropin, Qty 36 IU)

Tilgjengelig fra:

Eli Lilly Australia Pty Ltd

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: hydrochloric acid; metacresol; sodium hydroxide; glycerol; water for injections

Administreringsrute:

Intramuscular, Subcutaneous

Enheter i pakken:

1 cartridge of powder - 36IU (12.0mg), 1 syringe with diluent 3.15mL

Resept typen:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Indikasjoner:

HUMATROPE is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.,HUMATROPE is also indicated for the treatment of growth disturbances associated with gonadal dysgenesis (Turner syndrome).,HUMATROPE is also indicated for the treatment of adults with severe growth hormone deficiency defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth deficiency. In patients with childhood onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranal irradiation), two dynamic tests should be recommended, except for those having low IGF-I concentrations less than or equal to 2 SDS who may be considered for one test. The cut-off point of the dynamic test should be strict.,HUMATROPE is also indicated for the treatment of growth retardation in prepubertal children with chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. Chronic renal insufficiency is defined as glomerular filtration rate of less than 30 mL/min/1.73 m2.,HUMATROPE is also indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to demonstrate catch-up growth by age two to four years (see CLINICAL TRIALS). Humatrope is also indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to demonstrate catch-up growth by age two to four years. (See Clinical Trials)

Produkt oppsummering:

Visual Identification: Clear liquid.; Container Type: Cartridge; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

1995-10-24

Informasjon til brukeren

HUMATROPE
®
_Somatropin (rbe)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It does
not contain all the available
information and does not take the
place of talking with your doctor.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine. You can also
download the most up to date leaflet
from www.lilly.com.au. The updated
leaflet may contain important
information about HUMATROPE
and its use that you should be aware
of.
All medicines have risks and
benefits. Your doctor has more
information about this medicine than
is contained in this leaflet. Also, your
doctor has had the benefit of taking a
full and detailed history from you
and is in the best position to make an
expert judgement to meet your
individual needs.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, TALK TO YOUR
DOCTOR OR HEALTH CARE PROFESSIONAL.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT HUMATROPE IS
USED FOR
HUMATROPE is a biosynthetic
human growth hormone. It is used in
children who do not produce enough
natural growth hormone, in girls who
have Turner syndrome, in children
with chronic renal insufficiency, and
children born small for gestational
age. HUMATROPE helps these
children to grow at a natural rate.
HUMATROPE is also used in adults
who do not produce enough natural
growth hormone. In adults,
HUMATROPE helps to decrease
body fat, in growth hormone
deficient adults only.
Your doctor may have prescribed
HUMATROPE for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
HUMATROPE HAS BEEN
PRESCRIBED FOR YOU.
BEFORE USING
HUMATROPE
A doctor who is experienced in the
diagnosis and management of
patients who do not produce enough
natural growth hormone should direct
your treatment with HUMA

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
vA11-0_2Jan19
SUPERSEDES: vA10-0_09Oct15
Page 1 of 16
HUMATROPE
® (SOMATROPIN, RBE) POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
HUMATROPE
®
(somatropin).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
HUMATROPE is a highly purified preparation and is available in
cartridges containing 6 mg
(18 IU

), 12 mg (36 IU*), or 24 mg (72 IU*) somatropin and when reconstituted
with the
diluent provided the cartridge contains 2.07 mg/mL, 4.17 mg/mL or 8.46
mg/mL somatropin
respectively. Each cartridge also contains the inactive ingredients:
mannitol, glycine and
dibasic sodium phosphate heptahydrate and is supplied with an
accompanying diluent. The
diluent contains water for injections, metacresol and glycerol (see
section 6.5 NATURE AND
CONTENTS OF CONTAINER and section 6.4 SPECIAL PRECAUTIONS FOR
STORAGE). The glycerol in the
diluent ensures the tonicity of the reconstituted product is within
acceptable ranges.
Reconstituted solutions have a pH of approximately 7.5.
3.
PHARMACEUTICAL FORM
HUMATROPE is a sterile, white, lyophilised powder intended for
subcutaneous or
intramuscular administration after reconstitution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HUMATROPE is indicated for the long-term treatment of children who
have growth failure
due to inadequate secretion of normal endogenous growth hormone.
HUMATROPE is also indicated for the treatment of growth disturbances
associated with
gonadal dysgenesis (Turner syndrome).
HUMATROPE is also indicated for the treatment of adults with severe
growth hormone
deficiency defined as patients with known hypothalamic-pituitary
pathology and at least one
known deficiency of a pituitary hormone not being prolactin. These
patients should undergo
a single dynamic test in order to diagnose or exclude a growth
deficiency.

The specific activity of the International Standard for somatropin is
defined as 3 International Units per mg of protein.
HUMATROPE is now labelled based on a specific activity of 3 IU/mg and
was formerly labelled bas