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DIN (Drug Identification Number)
02334852 Norditropin NordiFlex 5 mg/1.5 mL Solution for injection pre-filled pen
02334860 Norditropin NordiFlex 10 mg/1.5 mL Solution for injection pre-filled pen
02334879 Norditropin NordiFlex 15 mg/1.5 mL Solution for injection pre-filled pen
How does this medication work? What will it do for me?
Somatropin belongs to a class of medications known as growth stimulants. Somatropin is a synthetic growth hormone. Growth hormone is made naturally in our bodies by the pituitary gland and is necessary for stimulation of growth in children.
This medication is used to treat growth hormone deficiency in children (to replace growth hormone that they are unable to produce enough of naturally) and to correct growth failure in children born small for gestational age (SGA) who do not catch up in growth by 2 years or later.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
5 mg/1.5 mL
Each 1.5 mL of sterile solution for injection contains 5 mg of somatropin. Nonmedicinal ingredients: histidine, poloxamer 188, phenol, mannitol, hydrochloric acid or sodium hydroxide, and water for injection.
10 mg/1.5 mL
Each 1.5 mL of sterile solution for injection in the pre-filled pen, contains 10 mg of somatropin. Nonmedicinal ingredients: histidine, poloxamer 188, phenol, mannitol, hydrochloric acid or sodium hydroxide, and water for injection.
15 mg/1.5 mL
Each 1.5 mL of sterile solution for injection in the pre-filled pen, contains 15 mg of somatropin. Nonmedicinal ingredients: histidine, poloxamer 188, phenol, mannitol, hydrochloric acid or sodium hydroxide, and water for injection.
How should I use this medication?
The recommended dose depends on the reason this medication is being used and body weight of the child being treated. Your doctor will determine the appropriate dose of somatropin to be injected.
Somatropin is injected subcutaneously (under the skin), once a day, at approximately the same time every day. It is important to use a different injection site each day in order to minimize the risk of fat wasting at the site of injection.
If you are using this medication at home, your doctor will ensure that you understand exactly how to use it. Make sure you ask any and all questions necessary to ensure that you use it exactly as prescribed. Please refer to the package insert for details on proper injection procedures. It is important to visit your doctor regularly during therapy to ensure that the medication is working safely and effectively.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, , skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication in the refrigerator until the first injection. Do not allow this medication to freeze. After the first injection, the pre-filled pen may be stored in the refrigerator for up to 4 weeks or at room temperature for up the 3 weeks. After this time, any remaining medication in the pen should be discarded safely and a new pen started. Protect the pre-filled pens from light and keep them out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
- are allergic to somatropin or any ingredients of the medication
- have active cancer
- have an active brain tumour
- have an acute illness due to complications of surgery
- have closed epiphyses (growth plates)
- have just had a serious accident
- have Prader-Willi syndrome and are severely obese, have a history of upper airway blockage or sleep apnea, or have severe breathing problems
- have respiratory (breathing) failure
- have vision problems due to long-term effects of diabetes (diabetic retinopathy)
- This medication should be stopped at the time of kidney transplantation.
Do not take this medication if you:
What side effects are possible with this medication?
- redness, pain or itching at the injection site
- breathing problems (if the person has Prader-Willi syndrome)
- carpal tunnel syndrome
- knee or hip pain
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
- symptoms of increased blood pressure in the brain (e.g., nausea, vomiting, headache or vision changes)
- unexplained limp
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Blood pressure: Some people using somatropin may experience increased blood pressure inside the brain. Signs and symptoms of this condition include severe, ongoing headache, vision changes, nausea, and vomiting. If any of these occur, talk to your doctor or your child’s doctor as soon as possible.
Cancer: There may be an increased risk of tumour growth, both cancerous and non-cancerous, when growth hormone is used by survivors of childhood cancer. Discuss any concerns you may have with your doctor.
Diabetes: Somatropin may cause an increase in blood sugar levels, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Hypothyroidism (low level of thyroid hormone): If you have uncontrolled hypothyroidism, treatment with somatropin may not work as well as it could. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Treatment with somatropin may trigger hypothyroidism. If you experience unexplained weight gain, muscle aches or stiffness, constipation, dry skin, or fatigue, this may be a result of too little thyroid hormone and you should contact your doctor as soon as possible.
Pancreatitis: In rare instances, children using somatropin experience inflammation of the pancreas. If your child has a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.
Prader-Willi Syndrome: Children who have been diagnosed with Prader-Willi syndrome may experience breathing difficulties while using somatropin. Rarely, these breathing difficulties may be fatal. This is more likely if the child is obese, already has breathing problems or has an infection. The breathing difficulties may include sleep apnea (not breathing while sleeping) or new or increased snoring.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if somatropin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Seniors: The safety and effectiveness of using this medication have not been established for adults over 65 years of age.
What other drugs could interact with this medication?
- corticosteroids (e.g., cortisone, prednisone)
- diabetes medications (e.g., canagliflozin, chlorpropamide, glipizide, glyburide, insulin, metformin, rosiglitazone, sitagliptin)
- estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
There may be an interaction between somatropin and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Norditropin-NordiFlex
All material © 1996-2019 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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