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Somatropin (Genotropin)

Trade Name : GENOTROPIN

Pharmacia and Upjohn Company LLC

KIT

Strength

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Somatropin (Genotropin) which is also known as GENOTROPIN and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of per ml. Read more

Somatropin (Genotropin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • GENOTROPIN is a recombinant human growth hormone indicated for:
  • Pediatric:
  • Adult:
  • The weekly dose should be divided into 6 or 7 injections. n
  • Therapy with GENOTROPIN should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Prader-Willi syndrome (PWS), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.
  • GENOTROPIN should be administered subcutaneously ()
  • Pediatric GHD:
  • Prader-Willi Syndrome:
  • Small for Gestational Age:
  • Turner Syndrome:
  • Idiopathic Short Stature:
  • Adult GHD:
  • Non-weight based dosing:
  • Weight based dosing:
  • GENOTROPIN cartridges are color-coded to correspond to a specific GENOTROPIN PEN delivery device ()
  • Injection sites should always be rotated to avoid lipoatrophy ()
  • GENOTROPIN lyophilized powder in a two-chamber color-coded cartridge ():
  • GENOTROPIN MINIQUICK Growth Hormone Delivery Device containing a two-chamber cartridge (without preservative):
  • No data
  • Acute Critical Illness ()
  • Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment u2013 reports of sudden death ()
  • Active Malignancy ()
  • Hypersensitivity to somatropin or excipients ()
  • Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ()
  • Children with closed epiphyses ()
  • No data
  • Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk ()
  • Prader-Willi syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment Discontinue treatment if these signs occur ()
  • Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin in particular meningiomas in patients treated with radiation to the head for their first neoplasm ()
  • Impaired Glucose Tolerance and Diabetes Mellitus: May be unmaskedPeriodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment ()
  • Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction ()
  • Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention ()
  • Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome u2013 especially in adults): May occur frequently. Reduce dose as necessary ()
  • Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism ()
  • Hypothyroidism: May first become evident or worsen. Monitor thyroid function periodically ()
  • Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain ()
  • Progression of Preexisting Scoliosis: Monitor any child with scoliosis for progression of the curve ()
  • Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain ()
  • The following important adverse reactions are also described elsewhere in the labeling:
  • Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy () and headaches (6.3).
  • Inhibition of 11u00df-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses (, ).
  • Glucocorticoid Replacement: Should be carefully adjusted ()
  • Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin ()
  • Oral Estrogen: Larger doses of somatropin may be required in women ()
  • Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment ()
  • No data
  • No data
  • GENOTROPIN lyophilized powder contains somatropin, which is a polypeptide hormone of recombinant DNA origin. It has 191 amino acid residues and a molecular weight of 22,124 daltons. The amino acid sequence of the product is identical to that of human growth hormone of pituitary origin (somatropin). GENOTROPIN is synthesized in a strain of that has been modified by the addition of the gene for human growth hormone. GENOTROPIN is a sterile white lyophilized powder intended for subcutaneous injection.
  • GENOTROPIN 5 mg is dispensed in a two-chamber cartridge. The front chamber contains recombinant somatropin 5.8 mg, glycine 2.2 mg, mannitol 1.8 mg, sodium dihydrogen phosphate anhydrous 0.32 mg, and disodium phosphate anhydrous 0.31 mg; the rear chamber contains 0.3% m-Cresol (as a preservative) and mannitol 45 mg in 1.14 mL water for injection. The GENOTROPIN 5 mg two-chambered cartridge contains 5.8 mg of somatropin. The reconstituted concentration is 5 mg/mL. The cartridge contains overfill to allow for delivery of 1ml containing the stated amount of GENOTROPIN u2013 5 mg.
  • GENOTROPIN 12 mg is dispensed in a two-chamber cartridge. The front chamber contains recombinant somatropin 13.8 mg, glycine 2.3 mg, mannitol 14.0 mg, sodium dihydrogen phosphate anhydrous 0.47 mg, and disodium phosphate anhydrous 0.46 mg; the rear chamber contains 0.3% m-Cresol (as a preservative) and mannitol 32 mg in 1.13 mL water for injection. The GENOTROPIN 12 mg two-chambered cartridge contains 13.8 mg of somatropin. The reconstituted concentration is 12 mg/ml. The cartridge contains overfill to allow for delivery of 1ml containing the stated amount of GENOTROPIN u2013 12 mg.
  • GENOTROPIN MINIQUICKu00ae is dispensed as a single-use syringe device containing a two-chamber cartridge. GENOTROPIN MINIQUICK is available as individual doses of 0.2 mg to 2.0 mg in 0.2 mg increments. The front chamber contains recombinant somatropin 0.22 to 2.2 mg, glycine 0.23 mg, mannitol 1.14 mg, sodium dihydrogen phosphate 0.05 mg, and disodium phosphate anhydrous 0.027 mg; the rear chamber contains mannitol 12.6 mg in water for injection 0.275 mL. The reconstituted GENOTROPIN MINIQUICK two-chamber cartridge contains overfill to allow for delivery of 0.25 ml containing the stated amount of GENOTROPIN.
  • GENOTROPIN is a highly purified preparation. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7. The concentration of the reconstituted solution varies by strength and presentation.
  • No data
  • Carcinogenicity studies have not been conducted with GENOTROPIN. No potential mutagenicity of GENOTROPIN was revealed in a battery of tests including induction of gene mutations in bacteria (the Ames test), gene mutations in mammalian cells grown in vitro (mouse L5178Y cells), and chromosomal damage in intact animals (bone marrow cells in rats). See section for effect on fertility.
  • No data
  • GENOTROPIN lyophilized powder is available in the following packages:
  • 5 mg two-chamber cartridge (with preservative)
  • Concentration of 5 mg/mL
  • For use with the GENOTROPIN PEN 5 Growth Hormone Delivery Device.
  • 12 mg two-chamber cartridge (with preservative)
  • Concentration of 12 mg/mL
  • For use with the GENOTROPIN PEN 12 Growth Hormone Delivery Device.
  • GENOTROPIN MINIQUICK Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (without preservative)
  • After reconstitution, each GENOTROPIN MINIQUICK delivers 0.25 mL, regardless of strength. Available in the following strengths, each in a package of 7:
  • Storage and Handling
  • Except as noted below, store GENOTROPIN lyophilized powder under refrigeration at 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C).Do not freeze. Protect from light.
  • The 5 mg and 12 mg cartridges of GENOTROPIN contain a diluent with a preservative. Thus, after reconstitution, they may be stored under refrigeration for up to 28 days.
  • The GENOTROPIN MINIQUICK Growth Hormone Delivery Device should be refrigerated prior to dispensing, but may be stored at or below 77u00b0F (25u00b0C) for up to three months after dispensing. The diluent has no preservative. After reconstitution, the GENOTROPIN MINIQUICK may be stored under refrigeration for up to 24 hours before use. The GENOTROPIN MINIQUICK should be used only once and then discarded.
  • Patients being treated with GENOTROPIN (and/or their parents) should be informed about the potential benefits and risks associated with GENOTROPIN treatment. This information is intended to better educate patients (and caregivers); it is not a disclosure of all possible adverse or intended effects.
  • Patients and caregivers who will administer GENOTROPIN should receive appropriate training and instruction on the proper use of GENOTROPIN from the physician or other suitably qualified health care professional. A puncture-resistant container for the disposal of used syringes and needles should be strongly recommended. Patients and/or parents should be thoroughly instructed in the importance of proper disposal, and cautioned against any reuse of needles and syringes. This information is intended to aid in the safe and effective administration of the medication.
  • GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber. A reconstitution device is used to mix the diluent and powder. The two-chamber cartridge contains overfill in order to deliver the stated amount of GENOTROPIN.
  • The GENOTROPIN 5 mg and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN Pen delivery device. The 5 mg cartridge has a green tip to match the green pen window on the Pen 5, while the 12 mg cartridge has a purple tip to match the purple pen window on the Pen 12.
  • Follow the directions for reconstitution provided with each device. ; shaking may cause denaturation of the active ingredient.
  • Please see accompanying directions for use of the reconstitution and/or delivery device.
  • Manufactured by:
  • Vetter Pharma-Fertigung GmbH & Co. KGRavensburg, Germany
  • Or
  • Vetter Pharma-Fertigung GmbH & Co. KGLangenargen, Germany
  • Or
  • Pfizer Manufacturing Belgium N.V.Puurs, Belgium
  • Rx only
  • LAB-0222-24.0
  • GENOTROPIN MINIQUICK is a device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject a single dose of GENOTROPIN.
  • For each injection you will need:
  • Parts of the GENOTROPIN MINIQUICKn- See n
  • Storage instructions for your GENOTROPIN MINIQUICK
  • Using your GENOTROPIN MINIQUICK
  • Step 1.
  • Step 2.
  • Step 12. Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles
  • Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use. throw away (dispose of) the needles and syringes in the household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Important
  • If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.
  • Use this device only for the person for whom it was prescribed.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • LAB-0227-8.0Revised: January 2020
  • INSTRUCTIONS FOR USEGENOTROPIN 12 (JEEN-o-tro-pin 12)GENOTROPIN PEN 12 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. Use this device only for administration of GENOTROPIN.
  • GENOTROPIN PEN 12 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.
  • For your injection you will need:
  • Parts of the GENOTROPIN PEN 12n- See n
  • Storage instructions for your GENOTROPIN PEN 12
  • Using your GENOTROPIN PEN 12
  • Step 1.
  • Step 14. Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 12n- Do not
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Important
  • Dispose of the entire GENOTROPIN PEN 12 as electronic waste per state and local regulations.
  • Caring for your Pen
  • To clean your pen, wipe the outside surface with a damp cloth. Do not put the pen in water as this may damage your pen. Do not use alcohol or any other cleaning agents to clean the pen, as they may damage the plastic body. To clean the needle guard, wipe it with a damp cloth or alcohol pad.
  • Display Information
  • If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.
  • Use this device only for the person for whom it was prescribed.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.Caution:
  • Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, BelgiumProduced by Ypsomed AG, Burgdorf, Switzerland
  • LAB-0224-9.0
  • Revised January 2020
  • INSTRUCTIONS FOR USEGENOTROPIN 5 (JEEN-o-tro-pin 5)GENOTROPIN PEN 5 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. Use this device only for administration of GENOTROPIN.
  • GENOTROPIN PEN 5 is a reusable multiple-use device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.
  • For your injection you will need:
  • Parts of the GENOTROPIN PEN 5n- See n
  • Storage instructions for your GENOTROPIN PEN 5
  • Using your GENOTROPIN PEN 5
  • Step 1.
  • Wash your hands well with soap and water before using the GENOTROPIN PEN 5.
  • Step 14. Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 5n- Do not
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Important
  • Dispose of the entire GENOTROPIN PEN 5 as electronic waste per state and local regulations.
  • Customizing your Pen
  • Caring for your Pen
  • Display Information:
  • If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.
  • Use this device only for the person for whom it was prescribed.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Caution:
  • Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, BelgiumProduced by Ypsomed AG, Burgdorf, Switzerland
  • LAB-0225-9.0
  • Revised January 2020
  • PRINCIPAL DISPLAY PANEL - 5 mg Cartridge Label
  • Genotropinn
  • 5 mg
  • somatropin [rDNA origin] for injectionTwo-chamber cartridgen 5 mg/mLn n Pharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017
  • LOT/EXP
  • MADE INGERMANY
  • 8Q3764
  • Arrayn- Pfizern- u00ae
  • somatropin [rDNA origin] for injection
  • For subcutaneous injectionn n
  • NDC 0013-2626-81
  • Rx only
  • OPEN HERE
  • PRINCIPAL DISPLAY PANEL - 12 mg Cartridge Label
  • Genotropinn
  • 12 mg
  • somatropin [rDNA origin] for injectionTwo-chamber cartridgen 12 mg/mLn n Pharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017
  • LOT/EXP
  • MADE INGERMANY
  • 8Q3763
  • Arrayn- Pfizern- u00ae
  • somatropin [rDNA origin] for injection
  • For subcutaneous injectionn n
  • NDC 0013-2646-81
  • Rx only
  • OPEN HERE
  • PRINCIPAL DISPLAY PANEL - 0.2 mg MiniQuick Label
  • Genotropin 0.2 mg
  • MADE INGERMANY
  • 8Q3769
  • LOTEXP
  • NDC 0013-2649-02
  • Pfizer
  • Genotropinn n- 0.2 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 0.4 mg MiniQuick Label
  • Genotropin 0.4 mg
  • MADE INGERMANY
  • 8Q3768
  • LOTEXP
  • NDC 0013-2650-02
  • Pfizer
  • Genotropinn n- 0.4 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 0.6 mg MiniQuick Label
  • Genotropin 0.6 mg
  • MADE INGERMANY
  • 8Q3765
  • LOTEXP
  • NDC 0013-2651-02
  • Pfizer
  • Genotropinn n- 0.6 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 0.8 mg MiniQuick Label
  • Genotropin 0.8 mg
  • MADE INGERMANY
  • 8Q3766
  • LOTEXP
  • NDC 0013-2652-02
  • Pfizer
  • Genotropinn n- 0.8 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 1 mg MiniQuick Label
  • Genotropin 1 mg
  • MADE INGERMANY
  • 8Q3767
  • LOTEXP
  • NDC 0013-2653-02
  • Pfizer
  • Genotropinn n- 1 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 1.2 mg MiniQuick Label
  • Genotropin 1.2 mg
  • MADE INGERMANY
  • 8Q3770
  • LOTEXP
  • NDC 0013-2654-02
  • Pfizer
  • Genotropinn n- 1.2 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 1.4 mg MiniQuick Label
  • Genotropin 1.4 mg
  • MADE INGERMANY
  • 8Q3773
  • LOTEXP
  • NDC 0013-2655-02
  • Pfizer
  • Genotropinn n- 1.4 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 1.6 mg MiniQuick Label
  • Genotropin 1.6 mg
  • MADE INGERMANY
  • 8Q3774
  • LOTEXP
  • NDC 0013-2656-02
  • Pfizer
  • Genotropinn n- 1.6 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 1.8 mg MiniQuick Label
  • Genotropin 1.8 mg
  • MADE INGERMANY
  • 8Q3772
  • LOTEXP
  • NDC 0013-2657-02
  • Pfizer
  • Genotropinn n- 1.8 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 2 mg MiniQuick Label
  • Genotropin 2 mg
  • MADE INGERMANY
  • 8Q3771
  • LOTEXP
  • NDC 0013-2658-02
  • Pfizer
  • Genotropinn n- 2 mg Genotropin MiniQuickn
  • For single subcutaneous injection onlyGrowth Hormone Delivery Devicen n
  • Rx only

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