Omnitrope

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Somatropin 6.67 mg/mL

Disponible des:

Sandoz New Zealand Limited

Designació comuna internacional (DCI):

Somatropin 6.67 mg/mL

Dosis:

10 mg/1.5mL

formulario farmacéutico:

Solution for injection

Composición:

Active: Somatropin 6.67 mg/mL Excipient: Dibasic sodium phosphate Glycine Monobasic sodium phosphate Phenol Phosphoric acid Poloxamer 188 Sodium hydroxide Water for injection

tipo de receta:

Prescription

Fabricat per:

Sandoz GmbH

indicaciones terapéuticas:

Adults Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in two different dynamic tests for growth hormone deficiency. Patients must also fulfill the following criteria. Childhood onset: Patients, who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy is started. Adult onset: Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. Prader-Willi syndrome, for improvement of body composition.

Resumen del producto:

Package - Contents - Shelf Life: Cartridge, glass, 1 pack - 1.5 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. In-use shelf-life is 28 days refrigerated from first injection - Cartridge, glass, 5 pack - 7.5 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. In-use shelf-life is 28 days refrigerated from first injection - Cartridge, glass, 10 pack - 15 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. In-use shelf-life is 28 days refrigerated from first injection

Data d'autorització:

2013-05-31

Informació per a l'usuari

OMNITROPE
®
1
OMNITROPE
®
_Somatropin (rbe) (recombinant human growth hormone, r-hGH) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Omnitrope.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you or your child.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OMNITROPE IS
USED FOR
This medicine is used to treat:
•
short stature in children due to
growth hormone deficiency
•
girls with growth disturbance
associated with Turner syndrome
•
growth disturbance in children
with chronic renal insufficiency
Omnitrope is also used in adults who
have low levels of growth hormone
due to a disease in the pituitary gland
or hypothalamus in the brain.
Omnitrope is used for children and
adults who have a genetic disorder
called Prader-Willi syndrome
(symptoms include intellectual
impairment, uncontrollable urge to
eat).
It contains the active ingredient
somatropin. Somatropin is a
biosynthetic human growth hormone
which is a protein molecule
occurring naturally in humans.
Omnitrope is identical to the body's
own growth hormone.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU OR
YOUR CHILD.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
OMNITROPE
_WHEN YOU MUST NOT USE IT _
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
somatropin, the active ingredient
•
any of the other ingredients listed
at the end of this leaflet under
Product description.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
s

Fitxa tècnica

230320-omnitrope-ds
Page 1 of 19
NEW ZEALAND DATA SHEET
OMNITROPE
_®_ (SOMATROPIN (R-HGH))
1.
PRODUCT NAME
OMNITROPE
_® _
_ _
Somatropin (r-hGH) 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL solution
for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Omnitrope is a biosimilar medicinal product. The prescribing physician
should be involved in
any decision regarding interchangeability with other products.
Additional information is
available on the following website
(http://www.medsafe.govt.nz/profs/RIss/Biosimilars.asp).
Data comparing Omnitrope to Genotropin can be found in Section 5.3
Preclinical safety data
of this datasheet.
Omnitrope 5 mg/1.5 mL Solution for Injection contains 3.33 mg/mL
somatropin (rbe).
Omnitrope 10 mg/1.5 mL Solution for Injection contains 6.67 mg/mL
somatropin (rbe).
Omnitrope 15 mg/1.5 mL Solution for Injection contains 10 mg/mL
somatropin (rbe).
_ _
For full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Omnitrope Solution for Injection is a clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Children
Growth disturbance due to insufficient secretion of growth hormone and
growth disturbance
associated with Turner syndrome or chronic renal insufficiency.
Prader-Willi syndrome, for
improvement of growth and body composition.
Adults
Replacement therapy in adults with pronounced growth hormone
deficiency as diagnosed in
two different dynamic tests for growth hormone deficiency. Patients
must also fulfill the
following criteria.
_Childhood onset: _
Patients, who were diagnosed as growth hormone deficient during
childhood,
must be retested and their growth hormone deficiency confirmed before
replacement therapy
with OMNITROPE is started.
_Adult onset: _
Patients must have growth hormone deficiency as a result of
hypothalamic or
pituitary disease and at least one other hormone deficiency diagnosed
(except for prolactin)
and
adequate
replacement
therapy
instituted,
before
replacement
therapy
using
growth
hormone may begin.
Prade