Norditropin SimpleXx 5 mg/1.5 ml, solution for injection in cartridge

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Somatropin

제공처:

Novo Nordisk A/S

ATC 코드:

H01AC; H01AC01

INN (국제 이름):

Somatropin

복용량:

5mg/1.5ml

약제 형태:

Solution for injection in cartridge

처방전 유형:

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

치료 영역:

Somatropin and somatropin agonists; somatropin

승인 상태:

Not marketed

승인 날짜:

1999-10-15

환자 정보 전단

8
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORDITROPIN SIMPLEXX 5 MG/1.5 ML SOLUTION FOR INJECTION IN CARTRIDGE
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 signs of illness 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 NORDITROPIN SIMPLEXX IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NORDITROPIN SIMPLEXX
3.
HOW TO USE NORDITROPIN SIMPLEXX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NORDITROPIN SIMPLEXX
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT NORDITROPIN SIMPLEXX IS AND WHAT IT IS USED FOR
Norditropin SimpleXx contains a biosynthetic human growth hormone
called somatropin which is
identical to the growth hormone produced naturally in the body.
Children need growth hormone to
help them grow, but adults also need it for their general health.
Norditropin SimpleXx comes as a solution in a cartridge ready for you
to inject after you have put it in
the matching NordiPen injection pen.
NORDITROPIN SIMPLEXX IS USED TO TREAT GROWTH FAILURE IN CHILDREN:
•
If they have no or very low production of growth hormone (growth
hormone deficiency)
•
If they have Turner syndrome (a genetic problem which may affect
growth)
•
If they have reduced kidney function
•
If they are short and were born small for gestational age (SGA)
•
If they have Noonan syndrome (a genetic problem which may affect
growth).
NORDITROPIN SIMPLEXX IS USED AS A GROWTH HORMONE REPLACEMENT IN
ADULTS:
In adults Norditropin SimpleXx is used to replace growth hormone if
their growth hormone production
has been decreased since childhood or has been lo

제품 특성 요약

Health Products Regulatory Authority
14 December 2022
CRN00CXMJ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Norditropin SimpleXx 5 mg/1.5 ml, solution for injection in cartridge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Norditropin SimpleXx 5 mg/1.5 ml
One ml of solution contains 3.3 mg somatropin
Somatropin (recombinant DNA origin produced in E-coli)
1 mg of somatropin corresponds to 3 IU (International Unit) of
somatropin
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in cartridge
Clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Children:
Growth failure due to growth hormone deficiency (GHD)
Growth failure in girls due to gonadal dysgenesis (Turner syndrome)
Growth retardation in prepubertal children due to chronic renal
disease
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.
Growth failure due to Noonan syndrome.
Adults:
Childhood onset growth hormone deficiency:
Patients with childhood onset GHD should be re-evaluated for growth
hormone secretory capacity after growth completion.
Testing is not required for those with more than three pituitary
hormone deficits, with severe GHD due to a defined genetic
cause, due to structural hypothalamic pituitary abnormalities, due to
central nervous system tumours or due to high-dose
cranial irradiation, or with GHD secondary to a pituitary/hypothalamic
disease or insult, if measurements of serum insulin-like
growth factor 1 (IGF-1) is < -2 SDS after at least four weeks off
growth hormone treatment.
In all other patients an IGF-1 measurement and one growth hormone
stimulation test is required.
Adult onset growth hormone deficiency:
Pronounced GHD in known hypothalamic-pituitary disease, cranial
irradiation and traumatic brain in