Norditropin nordiflex 5 mg/1,5 ml solucion inyectable en pluma precargada
Introduction
Product Information for the User
Norditropin NordiFlex 5mg/1.5ml injectable solution in pre-filled pen
somatropin
Read this entire product information carefully before starting to use this medication, as it contains important information for you.
- Keep this product information, as you may need to read it again
- If you have any questions, consult your doctor or pharmacist
–This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them
–If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this product information. See section 4.
1.What isNorditropin NordiFlexand for what it is used
2.What you need to know before starting touseNorditropin NordiFlex
3.How touseNorditropin NordiFlex
4.Possible adverse effects
5.Storage ofNorditropin NordiFlex
6.Contents of the package and additional information
Back:Instructions for use of the Norditropin NordiFlex pen
1. What is Norditropin NordiFlex and what is it used for
Norditropin NordiFlex contains a synthetic human growth hormone, called somatropin, identical to the growth hormone produced naturally by the body.Children need growth hormone to help them grow, but adults also need it for their overall health.
Norditropin NordiFlex is used for the treatment of growth retardation in children:
•If there is a lack or very low production of growth hormone (growth hormone deficiency)
•If they suffer from Turner syndrome (a genetic condition that can affect growth)
•If they suffer from renal dysfunction
•If they have short stature and were born small for gestational age (SGA)
•If they suffer from Noonan syndrome (a genetic condition that can affect growth).
Norditropin NordiFlex is used as a growth hormone substitute in adults:
In adults, Norditropin NordiFlex is used as a growth hormone substitute when their growth hormone production has decreased since youth or has disappeared in adulthood as a result of a tumor, tumor treatment, or a disease affecting the growth hormone-producing gland. If they were treated for growth hormone deficiency as a child, they will be reevaluated once their growth is complete. If growth hormone deficiency is confirmed, they should continue treatment.
2. What you need to know before starting to use Norditropin NordiFlex
No use Norditropin NordiFlex
•If you areallergicto somatropin, phenol, or any of the other components of this medication (listed in section 6).
•If you have had akidney transplant.
•If you have anactive tumor (cancer). Tumors must be inactive andyou must have completed antitumor therapy before starting treatment with Norditropin NordiFlex.
•If you have asevere acute illness, for example, you have undergone open-heart or abdominal surgery, suffered multiple accidental injuries, or have acute respiratory insufficiency.
•If you have stopped growing (epiphyseal closure) and do not have a growth hormone deficiency.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Norditropin NordiFlex
•If you havediabetes.
•If you have hadcanceror any other type oftumor.
•If you experience frequentheadaches, vision problems, nauseaorvomiting.
•If yourthyroidhas an abnormal functioning.
•You may develop an increase in lateral curvature of the spine (scoliosis) in any child during rapid growth. During treatment with Norditropin NordiFlex, your doctor will examine you (or your child) for signs of scoliosis.
•If you limp or start limping during your treatment with growth hormone, inform your doctor.
•If you areover 60 years oldor if as an adult you have been treated with somatropin for more than 5years, as experience in these cases is limited.
•If you have anyrenal disease,as your doctor will need to monitor your renal function.
•If you are receivingglucocorticoid replacement therapy, you must consult your doctor regularly as it may be necessary to adjust your glucocorticoid dose.
•Norditropin NordiFlex may cause pancreatitis, which causes intense pain in the abdomen and back. If you, or your child, develop stomach pain after administering Norditropin NordiFlex, consult your doctor.
Other medications and Norditropin NordiFlex
Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication.
In particular, inform your doctor if you are taking or have recently taken any of the following medications. Your doctor may need to adjust the dose of Norditropin NordiFlex or other medications:
•Glucocorticoids– your adult height may be affected if you use Norditropin NordiFlex and glucocorticoids simultaneously.
•Ciclosporin(immunosuppressant) -you may need to adjust your dose.
•Insulin– you may need to adjust your dose.
•Hormonesthyroid- you may need to adjust your dose.
•Gonadotropin(gonadal-stimulating hormone)- you may need to adjust your dose.
•Anticonvulsants-you may need to adjust your dose.
•Estrogensadministered orally or other sex hormones.
Pregnancy and lactation
Growth hormone products are not recommended for fertile women who do not use contraceptive methods.
•Pregnancy.Discontinue treatment and inform your doctor if you become pregnant while on treatment with Norditropin NordiFlex.
•Lactation.Do not use Norditropin NordiFlex during lactation, as somatropin may pass into breast milk.
Driving and operating machinery
Norditropin NordiFlex does not affect your ability to drive or operate machinery.
Important information about some of the components of Norditropin NordiFlex
This medication containssomatropin, which may produce a positive result in doping control tests.
Norditropin contains sodium
Norditropin contains less than 1 mmol of sodium (23 mg) per 1.5 ml; this is essentially “sodium-free”.
3. How to use Norditropin NordiFlex
Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Recommended dose
The dose for children depends on weight and body surface area.The dose in later stages of life,depends on height, weight, sex, and sensitivity to growth hormone and will be adjusted until the correct dose for you is found.
•Children with growth hormone deficiency or insufficiency:
The usual dose is 0.025 to 0.035mg per kg of body weight per day or 0.7 to 1.0mg per m2of body surface area per day.
•Girls with Turner syndrome:
The usual dose is 0.045 to 0.067mg per kg of body weight per day or 1.3 to 2.0mg per m2of body surface area per day.
•Children with renal disease:
The usual dose is 0.050mg per kg of body weight per day or 1.4mg per m2of body surface area per day.
•Small for gestational age (SGA) children:
The usual dose is 0.035mg per kg of body weight per day or 1.0mg per m2of body surface area per day until final height is reached.(In clinical studies conducted in short children born SGA, doses of 0.033 and 0.067mg per kg of body weight per day are often used).
•Children with Noonan syndrome:
The usual dose is0.066mg per kg of body weight per day,however, your doctor may decide that 0.033mg/kg/d is sufficient.
•Adults with growth hormone deficiency or insufficiency:
If growth hormone deficiency persists after growth is completed, you will need to continue treatment. The usual starting dose is 0.2 to 0.5mg per day. Your dose will be adjusted until you reach the correct dose. If growth hormone deficiency begins in adulthood, theusual starting dose is 0.1 to 0.3mg per day.Your doctor will increase this dose each month until you reach the appropriate dose for you.The usual maximum dose is 1.0mg per day.
When to use Norditropin NordiFlex
Inject the daily dose under the skin every night before bedtime.
How to use Norditropin NordiFlex
Norditropin NordiFlex growth hormone solution is available in a pre-filled, multi-dose disposable pen of 1.5 ml.
You can find the complete instructions on how to use the Norditropin NordiFlex pen on the back. The key points of the instructions are as follows:
•Check the solution before use by rotating the pen upside down one or two times. Do not use the pen if the solution is cloudy or discolored.
- Norditropin NordiFlex is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length.
- Always use a new needle for each injection.
- Vary the injection site to avoid skin damage.
- Verify the flow of growth hormone (called “preparation” of the pen) before the first injection with a new Norditropin NordiFlex pen to ensure you receive the correct dose and do not inject air. Do not use the pen if no growth hormone appears at the tip of the needle.
- Do not share the Norditropin NordiFlex pen with anyone else.
For how long you will need to continue treatment
•Children with growth hormone deficiency due to Turner syndrome, renal disease, if born small for gestational age (SGA), or Noonan syndrome: your doctor will recommend that you continue treatment until you finish growing.
•Children or adolescents who lack growth hormone: Your doctor will recommend that you continue treatment in adulthood.
Do not stop treatment with Norditropin NordiFlex unless your doctor tells you to.
If you use more Norditropin NordiFlex than you should
Inform your doctorif you inject too much somatropin.A prolonged overdose can cause abnormal growth and facial deformity.
If you forget to use Norditropin NordiFlex
Usethe next dose as usual, at the usual time.Do not take a double doseto make up for the missed doses.
If you stop treatment withNorditropin NordiFlex
Do not stop treatment withNorditropin NordiFlexunless your doctor tells you to.
If you have any other questions about the use of thismedication, ask your doctororpharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Effects observed in children and adults(frequency unknown):
•Skin rash, difficulty breathing, swollen eyelids, face, or lips,complete collapse.Any of these symptoms may indicate an allergic reaction.
•Headache, vision problems, discomfort(nausea)and vomiting.These may be symptoms of increased pressure in the brain.
•The levels ofthyroxine in the blood may decrease.
•Hyperglycemia(elevated blood glucose levels).
If you experience any of these effects, consult a doctor as soon as possible.Stop using Norditropin NordiFlex until your doctor tells you to continue treatment.
Rarely, antibodies against somatropin have been observed during treatment with Norditropin.
Increased levels of liver enzymes have also been observed.
Cases of leukemia and recurrences of brain tumors have been observed in patients treated with somatropin (the active ingredient in Norditropin NordiFlex), although there is no evidence that somatropin is responsible.
If you think you may be experiencing any of these conditions, talk to your doctor.
Other side effects in children:
Rare(may affect up to 1 in 100children):
•Headache.
•Redness, itching, and pain at the injection site.
•Enlargement of the breasts (gynecomastia).
Very rare(may affect up to 1 in 1,000children):
•Skin rash.
•Muscle and joint pain.
•Swollen hands and feet due to fluid retention.
In rare cases, children treated with Norditropin NordiFlex have experienced hip and knee pain, or have started to limp.These symptoms may be due to a disease affecting the upper part of the femur (Legg-Calvé disease) or because the bone tip has slipped out of the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin NordiFlex.
In clinical studies, some cases ofincreased growth of hands and feetin relation to height have been observed in children withsyrndrome of Turner.
In a clinical study in children with Turner syndrome, high doses of Norditropin may possibly increase the risk of ear infections.
If you consider any of the side effects you are experiencing to be severeor if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist, as it may be necessary to reduce the dose.
Other side effects in adults:
Very common(may affect more than 1 in 10adults):
•Swollen hands and feet due to fluid retention.
Common(may affect up to 1 in 10adults):
•Headache.
•Itchy or prickly skin, numbness or pain, mainly in the fingers.
•Muscle and joint pain; joint stiffness.
Rare(may affect up to 1 in 100adults):
•Type 2 diabetes.
•Carpal tunnel syndrome; numbness and pain in the fingers and hands.
•Itching (may be intense) and pain at the injection site.
•Muscle stiffness.
•Enlargement of the breasts (gynecomastia).
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Storage of Norditropin NordiFlex
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging after CAD/.The expiration date is the last day of the month indicated.
Storeunused Norditropin NordiFlex pens in the refrigerator (between 2°C and 8°C) in the outer packaging to protect them from light. Do not freeze or expose to heat.Do not store near the wall or the refrigerator's cooling component.
While usingNorditropin NordiFlex 5mg/1.5 mlyou can:
•Store it for a maximum of 4weeks in the refrigerator (between 2°C and 8°C),or
•Store it for a maximum of 3weeks at room temperature (below 25°C).
Do not use Norditropin NordiFlex pens if they have been frozen or exposed to excessive temperatures.
Do not use Norditropin NordiFlex pens if the growth hormone solution is cloudy or discolored.
Always store Norditropin NordiFlex without the needle attached.
Always keep the pen cap completely closed on the Norditropin NordiFlex pen when not in use.
Always use a new needle for each injection.
Medicines should not be disposed of through the drains or trash. Ask your pharmacist how to dispose of the packaging and unused medications.This will help protect theenvironment.
6. Contents of the packaging and additional information
Composition of Norditropin NordiFlex
•The active ingredient is somatropin
•The other components are mannitol, histidine, poloxamer 188, phenol, water for injection, hydrochloric acid, and sodium hydroxide.
Appearance of the product and contents of the package
Norditropin NordiFlex is a transparent and colorless injectable solution in a pre-filled, multidose disposable pen of 1.5 ml.
1 ml of solution contains 3.3 mg of somatropin.
1 mg of somatropin corresponds to 3 IU of somatropin.
Norditropin NordiFlex is available in three concentrations:
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 authorization holder and manufacturer
Novo Nordisk A/S
Novo Allé
2880 Bagsværd, Denmark
This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Cyprus, Croatia, Denmark, Slovakia, Spain, Finland, Greece, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Norway, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, Sweden: Norditropin NordiFlex 5 mg/1.5 ml
France: Norditropine NordiFlex 5 mg/1.5 ml
Last review date of this leaflet: 11/2022
Other sources of information
The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
Norditropin NordiFlex 5 mg/1.5 ml Instructions for use of the Norditropin NordiFlex pen Read these instructions carefully before using Norditropin NordiFlex.
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1. Pen check •Check the name, concentration, and color of the label on your Norditropin NordiFlex pen to make sure it contains the concentration of growth hormone you need. •Remove the pen cap[A]. •Check that the solution inside the cartridge is clear and colorless by holding the pen upside down one or two times. •Do not use the pen if the solution inside the cartridge is not clear or is cloudy. | ||
2.Insert the needle •Always use a new needle for each injection.This reduces the risk of contamination, infection, solution loss, needle blockage, and inaccurate dosing. Never use a bent or damaged needle. •Remove the paper tab from the needle. •Twist the needle straight into the pen[B]. Make sure the needle is securely attached. The needle has two caps. You need to remove both: •Remove the outer needle cap and keep it to correctly remove the needle after injection. •Remove the inner needle cap by pulling the central tip and discard it. | ||
3.Flow check •Before the first injection with each new pen, you need to check the flowto make sure you get the correct dose and do not inject air: Set the dose selector to 0.025 mg[C]. Make a "click" after 0.0 on the dose selector at the end of the pen. | ||
•Hold the pen with the needle pointing upwards and tap the top of the pen several times to make the air bubbles rise[D]. | ||
•Hold the pen with the needle pointing upwards, press the pen plunger to the bottom[E]. A drop of solution should appear at the needle tip. •If no drop appears, repeat steps C to E up to a maximum of 6 times until a drop appears. If no drop still appears, change the needle and repeat steps C to E once more. •Do not use the pen if no drop appears.Use a new pen. •Always check the flow before the first injection with each new pen. Check the flow again if your pen has fallen or been hit against a hard surface or if you suspect something is wrong. | ||
4.Dose selection •Check that the dose selector is in the 0.0 position. Select the number of mg that your doctor has prescribed[F]. •You can increase or decrease the dose by turning the dose selector in both directions. When turning it back, be careful not to press the plunger as solution will come out. You cannot select a dose greater than the number of mg remaining in the pen. | ||
5.Injection of the dose •Use the injection technique taught by your doctor or nurse. •Change the injection site to avoid damaging the skin. •Insert the needle into the skin. Press the plunger to the end to inject the dose. Be careful only to press the plunger when injecting[G]. •Keep the plunger fully pressed and leave the needle under the skin for at least 6 seconds.This ensures the complete administration of the dose. | ||
•Put the outer needle cap back on carefully without touching the needle. Twist the needle off and discard it according to the instructions given by your doctor or nurse[H]. Never put the inner needle cap back ononce it has been removed from the same. You could accidentally prick yourself with the needle. •Put the pen cap back on after each use. •Always remove and discard the needle after each injection and keep the pen without the needle.This reduces the risk of contamination, infection, solution loss, needle blockage, and inaccurate dosing. •When the pen is empty, discard it without the needle according to the instructions given by your doctor or nurse and in accordance with local regulations. •People who care for patients must be very careful when handling used needles to reduce the risk of needlestick injuries and cross-infections. | ||
7.Maintenance •You must handle the Norditropin NordiFlex pen with care. •Do not drop the pen or hit it against a hard surface. If it falls or you suspect it is not right, always attach a new needle and check the flow before injection. •Do not attempt to refill the pen, it is pre-filled. •Do not attempt to repair the pen or disassemble it. •Protect your pen from dust, dirt, frost, and direct sunlight. •Do not attempt to wash, soak, or lubricate the pen. If necessary, wipe it with a soft detergent and a damp cloth. •Do not freeze the pen or store it near the wall or the refrigerator's cooling element. •See section 5 "Storage of Norditropin NordiFlex" on the reverse page for information on how to store the pen. |
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