It is no longer possible to identify counterfeit medical products, by simply checking packaging and labeling. Improvements in technology have made it cheaper and easier to produce fake packaging and labels, making it nearly impossible for consumers and authorities to detect counterfeits without conducting tests on the products themselves, as illustrated by the sale of over one million counterfeit blood glucose test strips sold to unsuspecting U.S. consumers at drugstores in more than 35 states and in other countries around the world in the fall of 2006. The FDA reported no injuries related to the event, but the situation could have seriously harmed patients who used the faulty strips. Falsely high readings may have caused patients to inject unnecessary quantities of insulin, which could have caused severe hypoglycemia and possibly death.
The pricier the drugs, the more counterfeiters seek to mimic them to maximize returns, victimizing those patients at highest risk who rely on life-saving medications.
Although the majority of reports are tied to drugs, a case arose in 2006 in which counterfeit glucose test strips made their way into U.S. circulation. The FDA reported no injuries related to the event, but the situation could have seriously harmed patients who used the faulty strips. Falsely high readings may have caused patients to inject unnecessary quantities of insulin, which could have caused severe hypoglycemia and possibly death.
What is Norditropin SimpleXx?
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).
Uses
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.
What you need to know before you use Norditropin SimpleXx
Do not use Norditropin SimpleXx
- If you are allergic to somatropin, to phenol, or to any of the other ingredients of this medicine
- If you have had a kidney transplant
- If you have an active tumour (cancer). Tumours must be inactive and you must have finished your antitumour treatment before you start your treatment with Norditropin SimpleXx
- If you have an acute critical illness e.g. open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure
- If you have stopped growing (closed epiphyses) and you do not have growth hormone deficiency.
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.
- Children with low production or lack of growth hormone: The usual dose is 0.025 to 0.035 mg per kg body weight per day or 0.7 to 1.0 mg per m2 body surface area per day
- Children with Turner syndrome: The usual dose is 0.045 to 0.067 mg per kg body weight per day or 1.3 to 2.0 mg per m2 body surface area per day
- Children with kidney disease: The usual dose is 0.050 mg per kg body weight per day or 1.4 mg per m² body surface area per day
- Children born small for gestational age (SGA): The usual dose is 0.035 mg per kg body weight per day or 1.0 mg per m2 body surface area per day until final height is reached. (In clinical trials of short children born SGA doses of 0.033 and 0.067 mg per kg body weight per day have typically been used)
- Children with Noonan syndrome: The usual dose is 0.066 mg per kg body weight per day, however your doctor may decide that 0.033 mg per kg body weight per day is sufficient
- Adults with low production or lack of growth hormone: If your growth hormone deficiency continues after completion of growth, treatment should be continued. The usual starting dose is 0.2 to 0.5 mg per day. The dose will be adjusted until you are on the right dose. If your growth hormone deficiency starts during adult life, the usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose each month until you are on the right dose. The usual maximum dose is 1.0 mg per day.
When to use Norditropin SimpleXx
Inject your daily dose into the skin every evening just before bedtime.
How to use Norditropin SimpleXx
- Norditropin SimpleXx solution comes in cartridges with a colour-coded cap and is ready to be used in the matching colour-coded NordiPen. If the corresponding NordiPen is not used, it will result in incorrect dosing. The NordiPen instruction manual tells you how to use the cartridges in the injection pen
- Check each new Norditropin SimpleXx cartridge before you use it. Do not use any cartridge that is damaged or cracked
- Do not use the Norditropin SimpleXx cartridges if the solution inside is cloudy or discoloured
- Vary the area you inject so you do not harm your skin
- Do not share your Norditropin SimpleXx cartridge with anyone else.
How long you will need treatment for
- Children with growth failure because of Turner syndrome, kidney disease, SGA or Noonan syndrome: Your doctor will recommend you continue treatment until you stop growing
- Children or adolescents who lack growth hormone: Your doctor will recommend you continue treatment into adulthood
Do not stop using Norditropin SimpleXx without discussing it with your doctor first.
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.
How to Spot Norditropin Simplexx Fake
Fake medicines are rarer, especially when bought from reputable retailers such as registered pharmacies. A pharmacist found to deal in counterfeits could have their registration as a pharmacist cancelled. Fake Norditropin Simplexx is easy to differentiate from the real product, the following should help you spot a Norditropin Simplexx Fake vs real:
Real Norditropin Simplexx should be available in 15ml cartridges
How to recognize a counterfeit medicine
- Spot the difference. Is the lettering on the packaging hazy and printed flat (rather than raised), or is the expiry date missing?
- Read carefully. Are the labelling and patient information in a language you understand? If there are misspelled words, contact the manufacturers – it can be a telltale sign.
- Use your senses. Is the medicine the same size, shape, texture, colour and taste as your previous prescription?
- Feel for consistency. When you handle the drug does it fall apart easily? If so, it could signal a fake.
- Do a price check. Does the cost of the drug seem very cheap in comparison with your official provider? If it’s much lower, it could be a scam.
Buying medicines online
Prescriptions. Make sure the website you buy from requires a prescription and has a pharmacist you can contact for questions.
Licensing. Only buy from certified online pharmacies. Search the website for a declaration of authenticity or certification and double- check this with your country’s official drug regulatory agency. For example, pharmacies in the UK that are registered with the Royal Pharmaceutical Society of Great Britain can display a logo on their website.
Bank details. Don’t supply any credit card numbers unless you are sure the website has policies in place to protect your information and has a secure online payment system.
Promises. Statements such as ‘no risk’ and ‘money-back guarantees’ can be key giveaways of a counterfeit website.
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):
- Rash; wheezing; swollen eyelids, face or lips; complete collapse. Any of these may be signs of an allergic reaction
- Headache, eyesight problems, feeling sick (nausea) and being sick (vomiting). These may be signs of raised pressure in the brain
- Serum thyroxin levels may decrease
- Hyperglycaemia (elevated levels of blood glucose).
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. SEE: How To Inject Testosterone In Buttocks And Thighs
