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Norditropin SimpleXx 5mg/1.5ml 15iu
Norditropin SimpleXx 10mg/1.5ml 30iu
Norditropin SimpleXx 15mg/1.5ml 45iu

Norditropin SimpleXx 5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL;
Norditropin NordiFlex 5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL (SPC)

Manufacturer: Novo Nordisk
Pharmaceutical name: Human Growth Hormone 191aa
Pack: 1 cartridge (45 iu (15mg/1,5 ml))


Norditropin SimpleXx 15 mg/1.5 ml:

15 mg in a 1.5 ml of solution in a cartridge (Type I glass) closed at the bottom with a rubber stopper (Type I rubber closures) shaped as a plunger and at the top with a laminated rubber stopper (Type I rubber closures) shaped as a disc and sealed with an aluminium cap. The aluminium cap is sealed with a coloured cap (green). Pack sizes of 1, 3 and 5. The cartridges are blister packed in a carton.


Norditropin is a polypeptide hormone of recombinant DNA origin. The hormone is synthesized by a special strain of E. coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone. Norditropin contains the identical sequence of 191 amino acids constituting the naturally occurring pituitary human growth hormone with a molecular weight of about 22,000 Daltons.

Therapy with Norditropin should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Noonan syndrome, Turner syndrome or SGA, and adult patients with either childhood onset or adult onset GHD.

The Norditropin dosage and administration schedule should be individualized based on the growth response of each patient. Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.
Norditropin injection is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature at birth with no catch-up growth, and other causes. It is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome. It is a form of human growth hormone. Common side effects include headache, nausea, vomiting, fatigue, muscle pain, or weakness.

Norditropin may interact with insulin or oral diabetes medicine, steroids, cyclosporine, seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women. Tell your doctor all medications you use. Norditropin should be used only when prescribed during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.



Norditropin SimpleXx 5mg/1.5ml (15IU) and 10mg (30IU)

Overview

Norditropin SimpleXx 5mg/1.5ml (15IU) and 10mg (30IU) solution for injection cartridges are indicated in children with growth problems, Turner’s syndrome, in people with certain kidney problems and in children who are too small for their age.

Norditropin is supplied by Novo Nordisk Limited and contains:

Norditropin Simplexx is manufactured using recombinant DNA technology in E. coli secretion expression system.

Precautions

Caution must be taken if the patient:

Norditropin SimpleXx is contraindicated in children under the age of four and in those who are having a kidney transplant.

Drug interaction

The following drugs may interact with Norditropin SimpleXx:

The following types of drugs may also interact with Norditropin SimpleXx:

Doctor must be informed if the patients is taking any of the above, or is undergoing treatment with any alternative medicaments, including vitamins, herbal supplements, and non-prescription drugs.

Handling

For the best result from Norditropin SimpleXx it should be taken in the evening.

Do not use Norditropin SimpleXx if the packaging has been tampered with, or if it shows any signs of damage. If you started a cartridge, leave it in the pen. Once opened, store it in a fridge at 2-8°C, and dispose no later than 28 days after opening. You can also store it at the room temperature; however, you must dispose of it 21 days after opening. Store it in the carton box (it is light sensitive), out of the sight and reach of children and pets. Do not freeze, or use after the expiry date shown on the packaging.

Side-effects

In children, side-effects are usually uncommon or rare.

In adults, oedema of the extremities is very common (1 in 10). Less common side effects include headaches, joint pain or stiffness, muscle pain or tenderness and paraesthesia. In addition, carpal tunnel syndrome, diabetes, pain at the injection sites, itching or muscle stiffness is uncommon. On rare occasions skin rash may occur, sometimes in children.

Other symptoms (with unknown frequencies) include:




Norditropin Simplexx 15mg/1.5ml

Package leaflet: Information for the user

Norditropin® SimpleXx® 15 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.


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:


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 lost in adulthood because of a tumour, treatment of a tumour, or a disease that affects the gland which produces growth hormone. If you have been treated for growth hormone deficiency during childhood, you will be retested after completion of growth. If growth hormone deficiency is confirmed, you should continue treatment.



2. What you need to know before you use Norditropin® SimpleXx®

Do not use Norditropin® SimpleXx®


Warnings and precautions

Talk to you doctor or pharmacist before using Norditropin® SimpleXx®


Other medicines and Norditropin® SimpleXx®

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines


Pregnancy and breast-feeding

Somatropin containing products are not recommended in women of childbearing potential not using contraception.


Driving and using machines

Norditropin® SimpleXx® does not affect the use of any machines or the ability to drive safely.



3. How to use Norditropin® SimpleXx®

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose

The dose for children depends on their body weight and body surface area. Later in life, the dose depends on height, weight, gender and growth hormone sensitivity and will be adjusted until you are on the right dose.


When to use Norditropin® SimpleXx®


How to use Norditropin® SimpleXx®


How long you will need treatment for


If you use more Norditropin® SimpleXx® than you should:

Tell your doctor if you inject too much somatropin. Long-term overdosing can cause abnormal growth and coarsening of facial features.


If you forget to use Norditropin® SimpleXx® :

Take the next dose as usual, at the normal time. Do not take a double dose to make up for a forgotten dose.


If you stop using Norditropin® SimpleXx®

Do not stop using Norditropin® SimpleXx® without discussing it with your doctor first.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Effects seen in children and adults (unknown frequency):

If you get any of these effects, see a doctor as soon as possible. Stop using Norditropin® SimpleXx® until your doctor says you can continue treatment.

Formation of antibodies directed against somatropin has been rarely observed during Norditropin® therapy.

Increased levels of liver enzymes have been reported.

Cases of leukaemia and relapse of brain tumours have also been reported in patients treated with somatropin (the active ingredient in Norditropin® SimpleXx® ), although there is no evidence that somatropin was responsible.

If you think you are suffering from any of these diseases, speak to your doctor.

Additional side effects in children:

Uncommon (may affect up to 1 in 100 children):

Rare (may affect up to 1 in 1,000 children):

In rare cases, children using Norditropin® SimpleXx® have experienced hip and knee pain or have started limping. These symptoms may be caused by a disease affecting the top of the thigh bone (Legg-Calve disease) or because the end of the bone has slipped from the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin® SimpleXx® .

In children with Turner syndrome, a few cases of increased growth of hands and feet compared to height have been observed in clinical trials.

A clinical trial in children with Turner syndrome has shown that high doses of Norditropin® can possibly increase the risk of getting ear infections.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, as the dose may need to be reduced.


Additional side effects in adults:

Very common (may affect more than 1 in 10 adults):

Common (may affect up to 1 in 10 adults):

Uncommon (may affect up to 1 in 100 adults):


Reporting of side effects

If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.



5. How to store Norditropin® SimpleXx®

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package after EXP/. The expiry date refers to the last day of that month.

Store unused Norditropin® SimpleXx® cartridges in a refrigerator (2°C — 8°C) in the outer carton, in order to protect from light. Do not freeze or expose to heat.

While using Norditropin® SimpleXx® 15 mg/1.5 ml cartridge in an injection pen you can either:

Do not continue to use Norditropin® SimpleXx® cartridges if they have been frozen or exposed to excessive temperatures.

Check each new Norditropin® SimpleXx® cartridge before you use it. Do not use any cartridge that is damaged or cracked.

Do not use Norditropin® SimpleXx® cartridges if the solution inside is cloudy or discoloured.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information

What Norditropin® SimpleXx® contains


What Norditropin® SimpleXx® looks like and contents of the pack

Norditropin® SimpleXx® is a clear and colourless solution in a 1.5 ml glass cartridge ready for injection in the NordiPen® injection pen.

1 ml of solution contains 10 mg somatropin.

1 mg of somatropin corresponds to 3 IU of somatropin.

Norditropin® SimpleXx® is available in three strengths:

5 mg/1.5 ml, 10 mg/1.5 ml and 15 mg/1.5 ml (equivalent to 3.3 mg/ml, 6.7 mg/ml and 10 mg/ml, respectively).


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Novo Nordisk Limited
3 City Place
Beehive Ring Road
Gatwick
West Sussex
RH6 0PA

Manufacturer

Novo Nordisk A/S
Novo Alle
DK-2880 Bagsv?rd
Denmark

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Slovenia, Sweden, United Kingdom: Norditropin® SimpleXx® 15 mg/1.5 ml

France: Norditropine® SimpleXx® 15 mg/1.5 ml



This leaflet was last revised in 05/2015

Norditropin® , SimpleXx® and NordiPen® are trademarks owned by Novo Nordisk Health Care AG, Switzerland

Novo Nordisk A/S