GENOTROPIN MINIQUICK

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Somatropin; Somatropin

Available from:

Pfizer Healthcare Ireland

ATC code:

H01AC; H01AC01

INN (International Name):

Somatropin; Somatropin

Dosage:

1.6 milligram(s)

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Somatropin and somatropin agonists; somatropin

Authorization status:

Marketed

Authorization date:

1998-12-10

Patient Information leaflet

Page
1
of
10
PfLEET 2023-0087122
PACKAGE LEAFLET: INFORMATION FOR THE USER
GENOTROPIN MINIQUICK 0.2MG, 0.4MG, 0.6MG, 0.8MG, 1.0MG, 1.2MG, 1.4MG,
1.6MG, 1.8MG, 2.0MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
somatropin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
:
1.
What Genotropin MiniQuick is and what it is used for
2.
What you need to know before you use Genotropin MiniQuick
3.
How to use Genotropin MiniQuick
4.
Possible side effects
5.
How to store Genotropin MiniQuick
6.
Contents of the pack and other information
1.
WHAT GENOTROPIN MINIQUICK IS AND WHAT IT IS USED FOR
Genotropin MiniQuick is a recombinant human growth hormone (also
called somatropin). It has the
same structure as natural human growth hormone which is needed for
bones and muscles to grow. It
also helps your fat and muscle tissues to develop in the right
amounts. It is recombinant meaning it is
not made from human or animal tissue.
In children, Genotropin MiniQuick is used to treat growth
disturbances:
•
If you are not growing properly and you do not have enough of your own
growth hormone.
•
If you have Turner syndrome. Turner syndrome is a chromosomal error in
girls that can affect
growth - your doctor will have told you if you have this.
•
If you have chronic renal (kidney) insufficiency. As kidneys lose
their ability to function
normally, this can affect growth.
•
If you have Prader-Willi syndrome (a chromosomal disorder). Growth
hormone will help you
grow taller if you are still growing, and will also improve your body
composition.

Summary of Product characteristics

Health Products Regulatory Authority
10 August 2022
CRN00CNM8
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
GENOTROPIN MINIQUICK
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
GENOTROPIN MINIQUICK 1.6 mg powder and solvent for solution for
injection. One cartridge contains 1.6 mg per 0.25 ml of
somatropin* after reconstitution corresponding to a concentration of
6.4 mg/ml.
* produced in Escherichia coli cells by recombinant DNA technology.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection. A two chamber cartridge
with a white powder in the front compartment and a
clear solution in the rear compartment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Children
Growth disturbance due to insufficient secretion of growth hormone
(growth hormone deficiency, GHD) and growth
disturbance associated with Turner syndrome or chronic renal
insufficiency.
Growth disturbance [current height standard deviation score (SDS) < -
2.5 and parental adjusted height SDS < - 1] in short
children born small for gestational age (SGA), with a birth weight
and/or length below - 2 SD, who failed to show catch-up
growth [height velocity (HV) SDS < 0 during the last year] by 4 years
of age or later.
Prader-Willi syndrome (PWS), for improvement of growth and body
composition. The diagnosis of PWS should be confirmed
by appropriate genetic testing.
Adults
Replacement therapy in adults with pronounced growth hormone
deficiency.
_Adult Onset:_ Patients who have severe growth hormone deficiency
associated with multiple hormone deficiencies as a result of
known hypothalamic or pituitary pathology, and who have at least one
known deficiency of a pituitary hormone not being
prolactin. These patients should undergo an appropriate dynamic test
in order to diagnose or exclude a growth hormone
deficiency.
_Childhood Onset:_ Patients who were growth hormone deficient during
childhood as a result of congenital, genetic, acquired, or
idiopathic causes. Patients