General and professional information of SOMATIN®
General and professional information of SOMATIN®
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SOMATIN injection

Clinical trial

Professional drug information

video

Introduction of product

SOMATIN® is the brand name of the somatropin or recombinant human growth hormone. Each injection pen of SOMATIN® contains 5 mg or 15 IU and 10 mg or 30 IU of recombinant human growth hormone, which the dose indicator valve indicates150 in the drug container. This drug is available in packs of five along with a patient guide sheet.

Indications

  • Children and adults suffer from growth hormone deficiency.
  •  Idiopathic short status and Turner syndrome
  •  Idiopathic short status and Noonan syndrome
  •  Small for gestational age (SGA) at birth who fail to catch up by 2 to 4 years age
  •  Growth failure secondary to chronic kidney disease (CKD)
  •  children who have short stature with an unknown cause
  •  Short status homeobox gene (SHOX) deficiency

Contraindications

  • Hypersensitivity to somatropin or any component of the formulation
  • Growth promotion in pediatric patients with closed epiphyses
  • Acute critical illness due to increased complications/mortality following open heart or abdominal surgery
  • Multiple accidental trauma
  • Active malignancy
  • Active proliferative or severe no proliferative diabetic retinopathy
  • Pediatric patients with Prader-Willi syndrome

Side effects of the drug

  • Common side effects of this drug include injection site reactions, edema, headache, hypothyroidism, nausea and vomiting, flatulence, abdominal pain, joint pain, muscle pain, ear and respiratory infection, etc. In case of other symptoms that you think may be caused by taking the drug, inform your pharmacist or doctor.

How store and/or throw out this drug?

  • Be sure to keep the SOMATIN pen in its box.
  • Protect from light and out of the reach of children and pets.
  • Avoid shaking the pen.
  • Check that the SOMATIN in your pen is transparent and colorless. To reach this goal, turn the pen upside down once or twice. If SOMATIN is cloudy, do not use that pen and contact the Aria Tinagen Patient Support Unit.
  • Store a new, unused SOMATIN pen in a refrigerator at a temperature between 2 and 8 degrees Celsius.
  • Keep the rest of SOMATIN in the refrigerator at a temperature between 2 and 8 degrees Celsius and use it within 4 weeks. You can also keep the rest of Somatin at room temperature up to 25 degrees Celsius and use it within 3 weeks.
  • Do not use SOMATIN that has been frozen or stored at a temperature higher than 25 degrees Celsius.
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Somatin video
Professional drug information
Clinical trial
SOMATIN injection

Introduction of product

SOMATIN® is the brand name of the somatropin or recombinant human growth hormone. Each injection pen of SOMATIN® contains 5 mg or 15 IU and 10 mg or 30 IU of recombinant human growth hormone, which the dose indicator valve indicates150 in the drug container. This drug is available in packs of five along with a patient guide sheet.

Indications

  • Children and adults suffer from growth hormone deficiency.
  •  Idiopathic short status and Turner syndrome
  •  Idiopathic short status and Noonan syndrome
  •  Small for gestational age (SGA) at birth who fail to catch up by 2 to 4 years age
  •  Growth failure secondary to chronic kidney disease (CKD)
  •  children who have short stature with an unknown cause
  •  Short status homeobox gene (SHOX) deficiency

Contraindications

  • Hypersensitivity to somatropin or any component of the formulation
  • Growth promotion in pediatric patients with closed epiphyses
  • Acute critical illness due to increased complications/mortality following open heart or abdominal surgery
  • Multiple accidental trauma
  • Active malignancy
  • Active proliferative or severe no proliferative diabetic retinopathy
  • Pediatric patients with Prader-Willi syndrome

Side effects of the drug

Common side effects of this drug include injection site reactions, edema, headache, hypothyroidism, nausea and vomiting, flatulence, abdominal pain, joint pain, muscle pain, ear and respiratory infection, etc. In case of other symptoms that you think may be caused by taking the drug, inform your pharmacist or doctor.

How store and/or throw out this drug?

  • Be sure to keep the SOMATIN pen in its box.
  • Protect from light and out of the reach of children and pets.
  • Avoid shaking the pen.
  • Check that the SOMATIN in your pen is transparent and colorless. To reach this goal, turn the pen upside down once or twice. If SOMATIN is cloudy, do not use that pen and contact the Aria Tinagen Patient Support Unit.
  • Store a new, unused SOMATIN pen in a refrigerator at a temperature between 2 and 8 degrees Celsius.
  • Keep the rest of SOMATIN in the refrigerator at a temperature between 2 and 8 degrees Celsius and use it within 4 weeks. You can also keep the rest of Somatin at room temperature up to 25 degrees Celsius and use it within 3 weeks.
  • Do not use SOMATIN that has been frozen or stored at a temperature higher than 25 degrees Celsius.
سوماتین
سوماتین

SOMATIN injection

Injection method of SOMATIN® is included prepare the pen, choose the injection dose, Injection sites and how to inject.

 

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Clinical trial

Final report (12 months) of SOMATIN® clinical trial  produced by Arya Tina Gene company

 

 

File PDF

Professional drug information

professional information of SOMATIN®

 

 

File PDF

Video

Instructional video of information of SOMATIN®

Video
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