Saizen 6mg/1.03ml solution for injection cartridges
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
18-06-2018
Summary of Product characteristics
(SPC)
18-06-2018
Active ingredient:
Somatropin (rmc)
Available from:
Merck Serono Ltd
ATC code:
H01AC01
INN (International Name):
Somatropin (rmc)
Dosage:
5.825mg/1ml
Pharmaceutical form:
Solution for injection
Administration route:
Subcutaneous
Class:
Schedule 4 (CD Anab)
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 06050100; GTIN: 5013837321915
Patient Information leaflet
PAGE 1
PACKAGE LEAFLET: INFORMATION FOR THE USER 5.83 MG/ML
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 only.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
•
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET:
1.
What Saizen is and what it is used for
2.
What you need to know before you use Saizen
3.
How to use Saizen
4.
Possible side effects
5.
How to store Saizen
6.
Contents of the pack and other information
1.
WHAT SAIZEN IS AND WHAT IT IS USED FOR
Saizen is a growth hormone. Saizen's main action is
to increase growth in children and adolescents and
to treat adults with growth hormone deficiency.
The growth hormone (somatropin) contained in
Saizen is almost the same as human’s natural growth
hormone except that it is made outside the body by
a process called “recombinant DNA technology”
(genetic engineering).
SAIZEN IS USED:
In children and adolescents:
•
in the treatment of children with short stature
who have failed to grow because their body
produces no growth hormone or insufficient
levels of growth hormone
•
in the treatment of girls who have failed to grow
due to gonadal dysgenesis (also referred to as
Turner syndrome), confirmed by a test on the
chromosomes
•
in the treatment of pre-pubertal children who
have failed to grow due to chronic renal failure,
a condition in which kidneys are damaged
•
in the treatment of growth problems in children
who were born small and who have not reached
normal height by the age of 4 years or later.
In adults:
•
in the treatment of adults with a marked lack of
growth hormone (growth hormone deficiency).
This the
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Summary of Product characteristics
OBJECT 1
SAIZEN 5.83 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 14-Sep-2017 | Merck
1. Name of the medicinal product
Saizen 5.83 MG/ML solution for injection
Saizen 8MG/ML solution for injection
2. Qualitative and quantitative composition
Saizen 5.83mg/ml solution for injection: Each cartridge contains 1.03
ml solution (6 mg somatropin*)
Saizen 8mg/ml solution for injection: Each cartridge contains 1.50 ml
solution (12 mg somatropin*) or
2.50 ml solution (20 mg somatropin*).
*recombinant human growth hormone, produced by recombinant DNA
technology in mammalian cells
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear to slightly opalescent solution with pH of 5.6-6.6 and
osmolality 250-450 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Saizen is indicated in the treatment of:
Children and adolescents:
– Growth failure in children caused by decreased or absent secretion
of endogenous growth hormone.
– Growth failure in girls with gonadal dysgenesis (Turner syndrome),
confirmed by chromosomal
analysis.
– Growth failure in prepubertal children due to chronic renal
failure (CRF).
– Growth disturbance (current height 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 (HV SDS <0 during the last year) by 4 years of age or
later.
Adults:
– Replacement therapy in adults with pronounced growth hormone
deficiency as diagnosed by a single
dynamic test for growth hormone deficiency. Patients must also fulfil
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 Saizen 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 diagn
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