Norditropin FlexPro Somatropin 15 mg/1.5 ml - 1 Pre-Filled Pen

Product Overview:

• Norditropin (somatropin) injection 15 mg/1.5 ml is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.

Key Features:

• Somatropin is a synthetic human growth hormone (HGH, hGH) used to treat growth failure in children, growth hormone deficiency (GHD) in adults, and other related disorders. Some brands of somatropin injection are also used for short bowel syndrome (Zorbtive brand) and HIV-associated wasting (Serostim brand).


• Somatropin works by replacing human growth hormone in the body to stimulate growth and improve body weight and metabolism.


• Somatropin is given as subcutaneous (under-the-skin) injections using a pen device, cartridge, or vials. It is usually administered once daily or 6–7 times a week.

How it Works:

• Somatropin acts like a natural hormone in your body called growth hormone. It works by acting on certain receptors on cells in the body, triggering signals that produce the same effects as human growth hormone. In children, this helps promote normal growth and development. In adults, this helps regulate metabolism and maintain healthy functioning of bones, muscles, and tissues.

Benefits:

• Children who are not growing because of low or no growth hormone


• Children who are short (in stature) and who have Noonan syndrome, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years


• Children who have Idiopathic Short Stature (ISS)


• Children who are not growing who have Prader-Willi syndrome (PWS)


• Adults who do not make enough growth hormone

Directions for Use:

• Use Norditropin exactly as your health care provider tells you to.

Active Ingredients:

• (somatropin) injection 5 mg, 10 mg, 15 mg pens

Side Effects:

Norditropin may cause serious side effects, including:

• high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems


• high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems including sleep apnea


• increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Contact the healthcare provider if you or your child start to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin


• new or worsening high blood sugar (hyperglycemia) or diabetes


• increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider


• serious allergic reactions. Get medical help right away if you or your child has the following symptoms: swelling of your face, lips, mouth, or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, or sweating


• your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning, or tingling in the hands, arms, legs and feet. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention


• decrease in a hormone called cortisol. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss


• decrease in thyroid hormone levels


• hip and knee pain or a limp in children (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help right away if your child develops a limp or has hip or knee pain


• worsening of curvature of the spine (scoliosis)


• severe and constant abdominal pain can be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain


• loss of fat and tissue weakness in the area of skin you inject


• increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood

The most common side effects of Norditropin include:

• injection site reactions and rashes, and headaches

Cautions & Warnings:

Do not use Norditropin if:

• you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems


• you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stop breathing during sleep)


• you have cancer or other tumors


• you are allergic to somatropin or any of the ingredients in Norditropin


• your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy)


• you are a child with closed bone growth plates (epiphyses)

Before taking Norditropin, tell your healthcare provider about all of your medical conditions, including if you:

• have had heart or stomach surgery, trauma or serious breathing (respiratory problems)


• have had a history of problems breathing while you sleep (sleep apnea)


• have or have had cancer or any tumor


• have diabetes


• are pregnant or breastfeeding, or plan to become pregnant or breastfeed


• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Norditropin may affect how other medicines work, and other medicines may affect how Norditropin works.


• ng while taking linezolid.

Storage:

• Follow the instructions for the somatropin product you have to make sure you store it properly. Most somatropin products should be stored in the refrigerator, between 36 F and 46 F (2 C and 8 C). Do not freeze. Some somatropin products may be stored at room temperature, between 68 F and 77 F (20 C and 25 C), for a shorter period of time. Protect the medicine from light. Ask your pharmacist if you are unsure how to store your somatropin product.

FAQ:

• Q:Does somatropin interact with foods or drinks?


• A:There are no known interactions between somatropin and foods or drinks.It is unknown if drinking alcohol will affect somatropin.

• Q:Does somatropin interact with other medicines (drug interactions)?


• A:Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

• Q:What should I do if I miss a dose of somatropin?


• A:If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use the next dose. Do not use double or extra doses.

• Q:How should I care for and clean my Pen withPenMate?


• A:• Do not try to refill your Pen. It is prefilled.
  
  
  
  • • Do not try to repair your PenMate or your Pen.
  
  
  • • Only clean your PenMate or Pen with a mild detergent on a moistened cloth.
  
  
  • • Do not wash, soak, or lubricate your PenMate or Pen.
  
  
  • Do not use products containing bleaching agents, such as chlorine, iodine, or alcohol to clean your PenMate or Pen,These products may damage them.
  
  
  • • If there is liquid growth hormone on the outside of your PenMate or Pen, clean it with a mild detergent on a moistened cloth before it dries up.