SciTropin A Solution for Injection 5 mg1.5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Recombinant Somatropin

Available from:

SCIGEN PTE. LTD.

ATC code:

H01AC01

Dosage:

5mg/1.5mL

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Recombinant Somatropin 5mg/1.5mL

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Sandoz GmbH (Shaftenau Plant)

Authorization status:

ACTIVE

Authorization date:

2009-03-06

Patient Information leaflet

SCITROPIN A
TM
SciTropin A 5mg/1.5mL Solution for Injection
SciTropin A 10mg/1.5mL Solution for Injection
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, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What SciTropin A is and what it is used for
2.
What you need to know before you use SciTropin A
3.
How to use SciTropin A
4.
Possible side effects
5.
How to store SciTropin A
6.
Contents of the pack and other information
1.
WHAT SCITROPIN A IS AND WHAT IT IS USED FOR
SciTropin A 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.
SciTropin A is used to treat children who grow too slowly because of a
deficiency of growth
hormone or Turner syndrome, and as a replacement therapy in adults
with pronounced growth
hormone deficiency.
Your doctor, however, may have prescribed SciTropin A for another
purpose. Ask your
doctor if you have any questions about why SciTropin A has been
prescribed for you
You should only be given this medicine by a doctor who has experience
with growth
hormone treatment and who has confirmed your diagnosis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SCITROPIN A
DO NOT USE SCITROPIN A IF
•
if you are allergic (hypersensitive) to somatropin or to any of the
other ingredients of
SciTropin A.
•
if you have an active tumour (cancer). Tumours must be inact

Summary of Product characteristics

SCITROPIN A
™
1. NAME OF THE MEDICINAL PRODUCT
SciTropin A Solution for Injection 5 mg/1.5 ml
SciTropin A Solution for Injection 10 mg/1.5 ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SciTropin A Solution for Injection 5 mg/1.5 ml
Each ml of solution contains 3.3 mg of somatropin* (corresponding to
10 IU)
One cartridge contains 1.5 ml corresponding to 5 mg somatropin* (15
IU).
Excipient(s) with known effect:
This medicine contains 9mg benzyl alcohol in each ml. Benzyl alcohol
may cause
allergic reactions.
SciTropin A Solution for Injection 10 mg/1.5 ml
Each ml of solution contains 6.7 mg of somatropin* (corresponding to
20 IU)
One cartridge contains 1.5 ml corresponding to 10 mg somatropin* (30
IU).
* produced in _Escherichia coli_ by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
The solution is clear and colourless.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Children
Growth disturbance due to insufficient secretion of growth hormone
(growth
hormone deficiency, GHD)
Growth disturbance associated with Turner syndrome
Adults
Replacement therapy in adults with pronounced growth hormone
deficiency. Patients
with severe growth hormone deficiency in adulthood are defined as
patients with
known hypothalamic pituitary pathology and at least one known
deficiency of pituitary
hormone not being prolactin. These patients should undergo a single
dynamic test in
order to diagnose or exclude a growth hormone deficiency. In patients
with childhood
onset isolated GH deficiency (no evidence of hypothalamic-pituitary
disease or cranial
irradiation), two dynamic tests should be recommended, except for
those having low
IGF-I concentrations (SDS < -2) who may be considered for one test.
The cut-off point
of the dynamic test should be strict.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Diagnosis and therapy with somatropin should be initiated and
monitored by
physicians who are appropriately qualified and experienced in the
diagnosis and
managemen