Zomacton 10mg powder and solvent for solution for injection vials

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Somatropin (rbe)

متاح من:

Ferring Pharmaceuticals Ltd

ATC رمز:

H01AC01

INN (الاسم الدولي):

Somatropin (rbe)

جرعة:

10mg

الشكل الصيدلاني:

Powder and solvent for solution for injection

طريقة التعاطي:

Subcutaneous

الفئة:

Schedule 4 (CD Anab)

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 06050100; GTIN: 05015919998817

نشرة المعلومات


ZOMACTON
10 MG/ML, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Somatropin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TREATMENT WITH
THIS MEDICINE.
- 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. IN THIS LEAFLET:
1. What ZOMACTON is and what it is used for
2. Before you use ZOMACTON
3. How to use ZOMACTON
4. Possible side effects
5. How to store ZOMACTON
6. Further information
In this leaflet, ‘you’ refers to you or a child or adolescent in
your care.
1. WHAT ZOMACTON IS AND WHAT IT IS USED FOR
ZOMACTON contains the active substance somatropin, also known as
growth hormone.
Growth hormone is produced naturally in the body. It has an important
role in growth.
ZOMACTON contains somatropin made in a pharmaceutical manufacturing
facility.
ZOMACTON is used for the long-term treatment of:
• Growth problems due to a lack of growth hormone in children;
• Growth problems due to Turner’s syndrome (a genetic disorder
affecting females).
2. BEFORE YOU USE ZOMACTON
DO NOT USE ZOMACTON
• In children where the bone growth is completed (closed epiphyses).
• Do not use ZOMACTON and tell your doctor if you have an active
tumour (cancer). Tumours
must be inactive and you must have finished your anti-tumour treatment
before you start your
treatment with ZOMACTON.
• Pancreatitis should be considered in somatropin-treated children
who develop abdominal pain
• If you are allergic to any of the ingredients of ZOMACTON.
• If you are seriously ill due to complications following open heart
or abdominal surgery, multiple
injuries from an accident, or respiratory failure.
• In children with chronic renal disease at time for renal
transplantation.
TAKE SPECIAL

خصائص المنتج

OBJECT 1
ZOMACTON 10MG INJECTION
Summary of Product Characteristics Updated 11-May-2016 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
ZOMACTON 10 mg/ml, powder and solvent for solution for injection.
2. Qualitative and quantitative composition
Somatropin* …..……………………..10 mg
(10 mg/ml after reconstitution for one vial)
* Produced in E_scherichia coli _cells using recombinant DNA
technology
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection.
Zomacton is a white to off-white lyophilised powder. The solvent in
syringe is clear and colourless.
4. Clinical particulars
4.1 Therapeutic indications
Zomacton is indicated for:
- the long-term treatment of children who have growth failure due to
inadequate secretion of growth
hormone
- the long-term treatment of growth retardation due to Turner's
Syndrome confirmed by chromosome
analysis.
4.2 Posology and method of administration
Zomacton therapy should be used only under the supervision of a
qualified physician experienced in the
management of patients with growth hormone deficiency.
The dosage of administration of Zomacton should be individualised for
each patient.
The duration of treatment, usually a period of several years will
depend on maximum achievable
therapeutic benefit.
The subcutaneous administration of growth hormone may lead to loss or
increase of adipose tissue at the
injection site. Therefore, injection sites should be alternated.
GROWTH HORMONE DEFICIENCY
Generally a dose of 0.17 … 0.23 mg/kg bodyweight (approximating to
4.9 mg/m
2
… 6.9 mg/m
2
body
surface area) per week divided into 6 - 7 s.c. injections is
recommended (corresponding to a daily
injection of 0.02 … 0.03 mg/kg bodyweight or 0.7 … 1.0 mg/m
2
body surface area).
The total weekly dose of 0.27 mg/kg or 8 mg/m
2
body surface area should not be exceeded
(corresponding to daily injections of up to about 0.04 mg/kg).
TURNER'S SYNDROME
Generally a dose of 0.33 mg/kg/bodyweight (approximating to 9.86 mg/m
2
/