Table of Contents
What is Norditropin NordiFlex?
Norditropin NordiFlex contains somatropin, a biosynthetic human growth hormone that is equivalent to the natural growth hormone produced by the body. Growth hormone is required for children's growth, but it is also required for adults' overall health.
Norditropin NordiFlex is a drug that is used to treat children who are experiencing growth problems:
- If they produce no or very little growth hormone (growth hormone deficiency)
- If they have Turner syndrome, they should seek medical attention (a genetic problem which may affect growth)
- If their kidney function is impaired,
- If they are little for their gestational age and are short (SGA)
- If they have Noonan syndrome, they should see a doctor (a genetic problem which may affect growth).
Norditropin Adults take NordiFlex as a growth hormone replacement:
Norditropin NordiFlex is used to replace growth hormone in people whose growth hormone production has been reduced since childhood or has been lost in adulthood because to a tumor, tumor treatment, or an illness affecting the gland that makes growth hormone. If you were treated for growth hormone deficiency as a child, you will be retested once you have finished growing. If growth hormone insufficiency is verified, medication should be continued.
Before you use norditropin nordiFlex
Norditropin should not be used. NordiFlex
- If you have an allergy to somatropin, phenol, or any of the other substances in this drug, you should not use it (listed in section 6)
- If you've had a kidney transplant, you'll know what it's like.
- If you have a tumor that is actively growing (cancer). Before you begin treatment with Norditropin NordiFlex, your tumors must be dormant and you must have completed your antitumor treatment.
- If you have a life-threatening illness, such as open heart surgery, abdominal surgery, multiple accidental injuries, or acute respiratory failure, call 911 immediately.
- If you have stopped growing (closed epiphyses) and do not have a shortage in growth hormones.
Precautions and warnings
Before taking Norditropin, consult your doctor or pharmacist. NordiFlex
- If you have diabetes, you should consult your doctor.
- If you've ever had cancer or a tumor of any type,
- If you suffer frequent headaches, vision problems, nausea, or vomiting, you should see a doctor.
- If your thyroid function is abnormal,
- Scoliosis, or an increase in the sideways curve of the spine, can develop in any kid with rapid growth. During therapy with Norditropin NordiFlex, your doctor will look for evidence of scoliosis in you (or your child).
- You should tell your doctor if you walk with a limp or if you start limping throughout your growth hormone treatment.
- If you are over 60 years old or have been treated with somatropin as an adult for more than 5 years, your options are limited.
- If you have kidney disease, your doctor should keep an eye on your kidney function.
- If you're on glucocorticoid replacement treatment, you should see your doctor on a frequent basis because your dose may need to be adjusted.
- Norditropin NordiFlex can cause pancreas inflammation, which produces significant abdominal and back pain. If you or your kid gets stomach pain after taking Norditropin NordiFlex, contact your doctor.
Norditropin NordiFlex and other medications
If you are using, have recently used, or may use any additional medicines, tell your doctor or pharmacist.
If you are taking or have recently taken any of the following medications, tell your doctor. The dose of Norditropin NordiFlex or the other drugs may need to be adjusted by your doctor:
- Glucocorticoids – If you use Norditropin NordiFlex and glucocorticoids at the same time, your adult height may be altered.
- Cyclosporine (immunosuppressive) – you may need to alter your dose.
- Insulin – you may need to alter your dose.
- Thyroid hormone – you may need to alter your dose.
- Your dose of gonadotropin (gonad stimulating hormone) may need to be changed.
- Anticonvulsants – you may need to alter your dose.
- Oral oestrogen, as well as other sex hormones
Breast-feeding and pregnancy
In women of reproductive potential who are not utilizing contraception, somatropin-containing medications are not suggested.
- Pregnancy – If you become pregnant while taking Norditropin NordiFlex, stop taking it and tell your doctor.
- If you are breast-feeding, do not use Norditropin NordiFlex because somatropin may enter into your milk.
Using machines and driving
Norditropin NordiFlex has no effect on machine operation or the ability to drive safely.
Sodium is found in norditropin.
Norditropin has a sodium content of less than 1 mmol (23 mg) per 1.5 ml, making it basically sodium-free.
how is it used?
Always follow your doctor's instructions when taking this medication. If you're not sure, ask your doctor or pharmacist.
Children's doses are determined by their body weight and surface area. Later in life, the dose will be changed based on your height, weight, gender, and growth hormone sensitivity until you are on the correct dose.
- 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, is the normal dose for children with poor growth hormone production or a lack of growth hormone.
- 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, is the average dose for children with Turner syndrome.
- Kidney illness in children:
- The average daily dose is 0.050 mg per kilogram of body weight or 1.4 mg per square meter of body surface area.
- 0.035 mg per kg body weight per day or 1.0 mg per m2 body surface area per day until ultimate height is reached in children born small for gestational age (SGA). (SGA doses of 0.033 and 0.067 mg per kg body weight per day have frequently been utilized in clinical trials of short children born.)
- The usual dose for children with Noonan syndrome is 0.066 mg per kilogram of body weight per day, however your doctor may decide that 0.033 mg per kilogram of body weight per day is sufficient.
- Adults with low growth hormone production or deficiency: If your growth hormone shortage persists after you've finished growing, medication should be continued. Starting doses range from 0.2 to 0.5 mg per day. The dose will be gradually increased until you reach the desired level. If you develop a growth hormone shortage as an adult, the recommended starting dose is 0.1 to 0.3 mg per day. Your doctor will gradually increase the dose until you are receiving the correct dosage. The daily maximum dose is usually 1.0 mg.
When should you use Norditropin? NordiFlex
Every evening, right before bedtime, inject your daily dose into the skin.
Norditropin NordiFlex: How to Use It
Norditropin NordiFlex growth hormone solution is pre-filled in a multidose 1.5 ml disposable pen.
Overleaf are detailed instructions for using the Norditropin NordiFlex pen. The following are the main points of instruction:
- Before using the pen, turn it upside down once or twice to check the solution. If the solution is cloudy or discolored, do not use the pen.
- Norditropin NordiFlex is designed to be used with disposable needles up to the length of 8 mm from NovoFine or NovoTwist. Always use a new needle for each injection.
- To avoid harming your skin, vary the areas where you inject.
- Check the growth hormone flow (known as ‘priming' the pen) before the first injection from a fresh Norditropin NordiFlex pen to ensure you obtain the right dose and don't inject air. If a drop of growth hormone solution does not emerge at the needle tip, do not use the pen.
- Do not give anyone else your Norditropin NordiFlex pen.
How long will you require treatment?
- Turner syndrome, renal illness, SGA, or Noonan syndrome are all causes of growth failure in children. Your doctor will advise you to keep on receiving treatment until you stop developing.
- Growth hormone deficiency in children or adolescents: Your doctor will advise you to continue treatment until you reach adulthood.
- Stopping Norditropin NordiFlex without first consulting your doctor is not a good idea.
If you use more Norditropin NordiFlex than is recommended, you may experience side effects.
If you inject too much somatropin, tell your doctor. Long-term overdose might result in aberrant facial development and coarsening.
If you neglect to take Norditropin NordiFlex, it will be too late.
Take the next dose at the regular intervals. To make up for a missed dose, do not take a double dose.
If you quit using Norditropin NordiFlex, you may have some side effects.
Stopping Norditropin NordiFlex without first consulting your doctor is not a good idea.
Ask your doctor or pharmacist if you have any further questions about how to take this medicine.
Norditropin nordiflex side effects
This drug, like all medicines, can produce negative effects, though not everyone experiences them.
Effects observed in children and adults (frequency unknown):
- Rash, wheezing, swelling eyes, face, or lips, and total collapse Any of these symptoms could indicate an allergic reaction.
- Nausea, headaches, vision problems, feeling sick (nausea), and being sick are all symptoms of being sick (vomiting). These could be indicators of increased brain pressure.
- Hyperglycemia may be reduced by serum thyroxin levels (elevated levels of blood glucose).
If you experience any of these side effects, visit a doctor right away. Stop using Norditropin NordiFlex until your doctor indicates it's safe to do so.
Antibodies directed against somatropin have only been seen in a few cases of Norditropin therapy.
Increased liver enzyme levels have been noted.
There have also been reports of leukemia and brain tumor relapse in people treated with somatropin (the active ingredient in Norditropin NordiFlex), while there is no evidence that somatropin is to blame.
Consult your doctor if you believe you are suffering from one of these illnesses.
Children's side effects include:
Uncommon (affecting up to one in every 100 children):
- Redness, itchiness, and pain in the injection site
- Enlargement of the breasts (gynaecomastia).
Rare (affecting up to one child in 1,000):
- Muscle and joint pain Rash
- Fluid retention causes swollen hands and feet.
Children on Norditropin NordiFlex have occasionally complained of hip and knee pain or begun limping. These symptoms could be caused by a disease that affects the top of the thigh bone (Legg-Calvé disease) or by the end of the bone slipping away from the cartilage (slipped capital femoral epiphysis), and not by Norditropin NordiFlex.
Clinical research have found a few examples of enhanced hand and foot growth relative to height in children with Turner syndrome.
High doses of Norditropin have been shown in a clinical investigation in children with Turner syndrome to potentially increase the risk of ear infections.
Please notify your doctor or pharmacist if any of these adverse effects become severe, or if you notice any side effects not specified in this leaflet, as the dose may need to be lowered.
Adults may have the following additional adverse effects:
Very common (affecting more than one out of every ten adults):
- Fluid retention causes swollen hands and feet.
Common (affecting up to one out of every ten adults):
- Numbness or soreness in the fingertips, with a sensation of skin crawling (formication).
- Muscle ache; joint pain and stiffness
Uncommon (affecting up to one in every 100 adults):
- Diabetes type 2
- Tingling and pain in the fingers and hands are symptoms of carpal tunnel syndrome.
- Itching (which might be severe) and pain in the injection site
- Muscle tenseness
- Enlargement of the breasts (gynaecomastia).
- Side effects must be reported.
Consult your doctor or pharmacist if you experience any negative effects. This includes any unlisted potential adverse effects in this leaflet.
You can also report side effects directly through the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard, or by searching for MHRA Yellow Card on Google Play or Apple App Store. You can help offer more information on the safety of this medicine by reporting side effects.
Norditropin NordiFlex Storage
Keep this drug out of children's sight and reach.
Following the expiry date, which is indicated on the package after EXP/, do not use this drug. The expiration date refers to the month's last day.
To keep unused Norditropin NordiFlex pens safe from light, keep them in the outer box in the refrigerator (2°C–8°C). Do not let to freeze or be exposed to excessive heat. Store away from any cooling elements.
You can use Norditropin NordiFlex 5 mg/1.5 ml in the following ways:
- Keep it in the refrigerator for up to 4 weeks (2°C–8°C) or at room temperature for up to 3 weeks (below 25°C).
If the Norditropin NordiFlex pens have been frozen or exposed to extreme temperatures, they should not be used any longer.
If the growth hormone solution is hazy or discolored, do not use Norditropin NordiFlex pens.
Norditropin NordiFlex should never be stored with a needle connected.
When you're not using the Norditropin NordiFlex pen, make sure the cap is completely closed.
For each injection, use a fresh needle.
Do not dispose of medications in the wastewater or household waste. Inquire with your pharmacist about how to dispose of medicines you no longer use. These steps will aid in environmental protection.
Information about the contents of the package and other details
Ingredients Norditropin NordiFlex:
- Somatropin is the active ingredient.
- Mannitol, histidine, poloxamer 188, phenol, water for injection, hydrochloric acid, and sodium hydroxide are the other excipients.
The appearance of Norditropin NordiFlex and the contents of the package
Norditropin NordiFlex is a clear, colorless injection solution that is pre-filled in a multidose 1.5 ml pre-filled pen.
One milliliter of solution contains 3.3 milligrams of somatropin.
3 IU of somatropin is equal to 1 mg of somatropin.
Norditropin NordiFlex comes in three different strengths:
3.3 mg/ml, 6.7 mg/ml, and 10 mg/ml (equal to 3.3 mg/ml, 6.7 mg/ml, and 10 mg/ml, respectively).
Manufacturer and holder of a marketing authorization
holder of a marketing authorization
Manufacturer Novo Nordisk Limited 3 City Place Beehive Ring Road Gatwick West Sussex RH6 0PA
Novo Nordisk A/S Novo Allé DK-2880 Bagsvrd Denmark Novo Nordisk A/S Novo Allé DK-2880 Bagsvrd Denmark Novo Nordisk A/S Novo
In the European Economic Area, this pharmaceutical substance is approved under the following names:
Norditropin NordiFlex 5 mg/1.5 ml
Norditropine NordiFlex 5 mg/1.5 ml, France
This leaflet was last updated on May 20, 2021
Other information sources
On the website of the Medicines and Healthcare Products Regulatory Agency (MHRA), you may find detailed information on this medicine.
How to use the Norditropin NordiFlex pen instructions
Before using Norditropin NordiFlex, thoroughly read the directions.
- Norditropin NordiFlex 5 mg/1.5 ml is a multidose injection pen containing human growth hormone ( Hgh ) solution already pre-filled.
- You can choose any amount from 0.025 to 1.50 mg in increments of 0.025 mg using the dosage selector. The correct dose for you will be determined by your doctor.
- Norditropin NordiFlex is designed to work with disposable needles up to 8 mm in length from NovoFine or NovoTwist.
- To ensure that your Norditropin NordiFlex pen includes the growth hormone strength you require, check the name, strength, and color label.
- If the growth hormone solution inside the cartridge is clear and colorless, use the pen.
- For each injection, use a fresh needle.
- Before injecting the first time with a fresh pen, always check the flow – see step 3. Examine the flow.
- Never let anyone else use your pen or needles. It could result in cross-infection.
- Keep your pen and needles out of sight and out of reach of youngsters at all times.
- Caregivers must handle used needles with extreme caution to avoid needle sticking and cross-infection.
Double-check the pen
- To ensure that your Norditropin NordiFlex pen contains the growth hormone strength you require, look at the name, strength, and color label.
- [A] Remove the pen cap.
- By turning the pen upside down a couple of times, you can see if the solution inside the cartridge is clear and colorless.
- If the solution inside the cartridge is murky or unclear, do not use the pen.
Put the needle in place
- For each injection, use a fresh needle. Contamination, infection, solution leakage, blocked needles, and improper dosing are all reduced as a result. The needle should never be bent or damaged.
- Remove the needle's protective paper tab.
- Attach the needle to the pen in a straight line [B]. Make sure the needle is securely fastened.
- There are two needle caps on the needle. You must get rid of both of them:
To correctly remove the needle from the pen after the injection, remove the outer needle cap and save it.
Pull on the central tip of the inner needle cap to remove it and discard it.
Examine the flow
- Check the flow before your first injection with each fresh pen to ensure you obtain the correct dose and don't inject any air:
- Choose [C] at 0.025 mg. On the dosage selection at the end of the pen, this is one ‘click' after 0.0.
- Hold the pen with the needle pointing up and tap the top of the pen a few times to release any trapped air bubbles [D].
- Press the push button at the bottom of the pen all the way in [E] while holding the pen with the needle up. At the tip of the needle, a drop of solution will appear.
- If no drop occurs, repeat steps C through E as many times as necessary until one does. If there is still no drop, switch needles and go through step C through E again.
- If there isn't a drop, don't use the pen. Invest in a new pen.
- Before injecting the first time with a new pen, always check the flow. If your pen has been dropped or knocked against a hard surface, or if you believe something is amiss with it, double-check the flow.
Determine the dosage
- Make sure your dosage selector is set to 0.0. Choose the mg that your doctor has suggested for you [F].
- By moving the dosage selector in either direction, the dose can be increased or lowered. If you turn the dose selection backwards, be careful not to touch the push button since the solution will spill out. You can't set a dose that's higher than the remaining mg in the pen.
Inject the medication
- Use the injection technique that your doctor or nurse has shown you.
- To avoid harming your skin, vary the areas where you inject.
- Make a puncture in your skin with the needle. Push the push button all the way in to deliver the dose. When injecting [G], be sure to just use the push button.
- Keep the push button pressed all the way down and the needle inside your skin for at least 6 seconds. This ensures that the entire dose is administered.
Take out the needle
- Replace the outer needle cap on the needle with care, being careful not to contact the needle. As directed by your doctor or nurse, unscrew the needle and carefully dispose of it [H].
- After removing the inner needle cap from the needle, never replace it. You can inadvertently pierce yourself with the needle.
- After each usage, replace the pen cap.
- After each injection, always remove and discard the needle, and store the pen without the needle attached. Contamination, infection, solution leakage, blocked needles, and improper dosing are all reduced as a result.
- When the pen is empty, dispose of it without the needle as directed by your doctor or nurse, as well as local authorities.
- To avoid needle sticking and cross-infection, caregivers must handle used needles with extreme caution.
How to deal with norditropin nordiFlex
- Handle your Norditropin NordiFlex pen with caution.
- Do not drop or bang your pen against a hard surface. Always screw on a new needle and check the flow before injecting if you drop it or believe something is wrong with it.
- Do not attempt to refill your pen; it has already been full.
- Do not attempt to repair or disassemble your pen.
- Dust, grime, frost, and direct sunlight should all be avoided when using your pen.
- Washing, soaking, or lubricating your pen is not a good idea. If required, clean it with a dampened towel and a light detergent.
- Do not freeze or store your pen near a cold element, such as a refrigerator.
- On the opposite side, section 5 “How to store Norditropin NordiFlex” has instructions on how to store your pen.