Somatropin (Humatrope)

Trade Name : HUMATROPE

Eli Lilly and Company

KIT

Strength

Delivery Process

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Disclaimer

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 (Humatrope) which is also known as HUMATROPE and Manufactured by Eli Lilly and Company. It is available in strength of per ml. Read more

Somatropin (Humatrope) 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

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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

No data

No data

HUMATROPE is a recombinant human growth hormone indicated for:n

Pediatric Patients:
Adult Patients:

No data

Administer by subcutaneous injection to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites. ()n
Pediatric Dosage
Adult Dosage
See Full Prescribing Information for reconstitution instructions. (, )n

HUMATROPE for injection is a white lyophilized powder available in the following vial and cartridge sizes:n
HUMATROPE for injection available as:n

5 mg vial and 5-mL vial of Diluent for HUMATROPE. ()n
6 mg, 12 mg, and 24 mg cartridge with prefilled syringe of Diluent for HUMATROPE. ()n

No data

Acute critical illness. ()n
Pediatric patients with Prader-Willi syndrome who are severely obese, have history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to risk of sudden death. ()n
Active malignancy. ()n
Hypersensitivity to somatropin or excipients. ()n
Active proliferative or severe non-proliferative diabetic retinopathy. ()n
Pediatric patients with closed epiphyses. ()n

No data

Increased Risk of Neoplasm:
Glucose Intolerance and Diabetes Mellitus:
Intracranial Hypertension (IH):
Hypersensitivity:
Fluid Retention:
Hypoadrenalism:
Hypothyroidism:
Slipped Capital Femoral Epiphysis in Pediatric Patients:
Progression of Preexisting Scoliosis in Pediatric Patients:
Pancreatitis:

The following important adverse reactions are also described elsewhere in the labeling:n
Common adverse reactions reported in adult and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, carpal tunnel syndrome, peripheral edema, flu syndrome, hypothyroidism, hyperglycemia, and impaired glucose tolerance. ()n

Table 7

Replacement Glucocorticoid Treatment:
Non-Replacement Glucocorticoid Treament in Pediatric Patients:
Cytochrome P450-Metabolized Drugs:
Oral Estrogen:
Insulin and/or Other Hypoglycemic Agents:

No data

No data

Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess endogenous growth hormone.n

HUMATROPE (somatropin) for injection is a recombinant human growth hormone. It is a polypeptide of recombinant DNA origin and is synthesized in a strain of Escherichiau00a0coli that has been modified by the addition of the gene for human growth hormone. The peptide is comprised of 191u00a0amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence of the peptide is identical to that of human GH of pituitary origin.n
HUMATROPE is a sterile, white, lyophilized powder intended for subcutaneous injection after reconstitution to its liquid form. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive.n
Vial
Cartridge
Each cartridge is supplied in a combination package with an accompanying syringe containing approximately 3u00a0mL of diluting solution (diluent). The diluent contains Water for Injection; 0.3% metacresol as a preservative; and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24u00a0mg cartridges, respectively.n

No data

Carcinogenicity, mutagenicity and impairment of fertility studies have not been conducted with HUMATROPE.n

No data

No data

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).n
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USAn
HTR-0004-USPI-20191028n

Instructions for Use
HUMATROPEn- Arrayn- (HU-ma-trope)
(somatropin) for injection
Vial Kit
Read this Instructions for Use before you start using HUMATROPE and each time you get a new HUMATROPE vial. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.n
Your healthcare provider should show you how to prepare, mix, measure, and inject HUMATROPE the right way before you use it for the first time. Ask your healthcare provider if you have any questions.n
Do not share your syringes or needles with anyone else, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
HUMATROPE is not recommended for use by blind or visually impaired individuals without the help of a sighted individual trained on how to use it.n
How should I store HUMATROPE?
You will need the following supplies to mix your HUMATROPE and give your injection ( and ):
Before mixing your HUMATROPE, check the expiration date on the vial labels (See ). Do not use any vial that has expired. Contact your healthcare provider or call Lilly at 1-800-545-5979 if either vial has expired.
Mixing the Vial of HUMATROPE:
Wash your hands with soap and water.
Step 1.
Step 2.
Step 3.
Step 4.
Step 5.
Step 6.
Step 7.
Step 8.
Step 9.
Step 10.
Step 11.
Step 12.
Preparing to give your Injection:
Step 13.
Step 14.
Step 15.
Step 16.
Step 17.
Step 18.
Step 19.
Step 20.
Injecting HUMATROPE:
Step 21.
Step 22.
Step 23.
Step 24.
Step 25.
Step 26.
Step 27.
Step 28.
Disposing of used needles and syringes:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.n
HUMATROPE is a registered trademark of Eli Lilly and Company.n
Copyright u00a9 2019, Eli Lilly and Company. All rights reserved.n
Revised October 2019n
Marketed by: LILLY USA, LLC, INDIANAPOLIS, IN 46285, USAn
HTRVL-0001-IFU-20191028n

Instructions for Use
HUMATROPEn- Arrayn- (HU-ma-trope)
(somatropin) for injection
Cartridge Kit
HUMATROPE cartridges are only to be used with HumatroPenn- Arrayn- injection devices.
Read this Instructions for Use before you start using HUMATROPE Cartridge Kit and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.n
Your healthcare provider should show you how to prepare, mix, measure, and inject HUMATROPE the right way before you use it for the first time. Ask your healthcare provider if you have any questions.n
How should I store HUMATROPE?
Important:
HUMATROPE Cartridge Kit (See )
Note:
Mixing the HUMATROPE in the Cartridge
Only use the prefilled Diluent Syringe that comes with your HUMATROPE Cartridge Kit to mix the HUMATROPE in the Cartridge. use the diluent that comes in the HUMATROPE vial box, or any other liquid.n
HUMATROPE Cartridge Kit mixing Instructions
Only use a HUMATROPE Cartridge Kit to prepare the HUMATROPE Cartridge.
*: The liquid (Diluent) should be clear, colorless, and free of particles and is shown as blue in the figure (See ).n
Talk to your healthcare provider about the right way to use your HUMATROPE Cartridge Kit and HumatroPen injection device, the right sites to inject HUMATROPE, and how to rotate your injection sites.n
Disposing of used Diluent Syringes:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.n
HUMATROPE and HumatroPen are registered trademarks of Eli Lilly and Company.n
Copyright u00a9 2019, Eli Lilly and Company. All rights reserved.n
Revised October 2019n
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USAn
www.HUMATROPE.comn
HTRCART-0001-IFU-20191028n

Instructions for Use
HumatroPenn- Arrayn- 6 mg
(HU-ma-tro-Pen 6 mg)n
HUMATROPE Delivery System Devicen
for use withn
HUMATROPE (somatropin) 6 mg Cartridgesn
Section 1: Read Section 1 completely before you move on to Section 2.
What you need to know about HumatroPenn- Arrayn- 6 mg
Read this Instructions for Use including the u201cCommonly asked questionsu201d section, at the end of this Instructions for Use, before you start using HumatroPen 6 mg and each time you get a new Pen. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.n
Your healthcare provider should show you how to use HumatroPen (Pen) the right way before you use it for the first time. Ask your healthcare provider if you have any questions. n
Introduction
Important information about HumatroPen 6 mg:
Information about needles used with HumatroPen 6 mg:
How do I care for HumatroPen 6 mg?
How do I store HumatroPen 6 mg with an attached cartridge?
When do I need to replace my HumatroPen?
Do not
Record the date the Pen was first used here: __ / __ / __.n
Record the expiration date from your carton here: __ / __ / __.n
Contact your healthcare provider if you need a new HumatroPen 6 mg, or when the Pen has been used for 3 years.n
For more information, call Lilly at 1-800-545-5979 or go to www.humatrope.com.
Hidden Needle Cover
Storage Case
Section 2: Read Section 2 only after you have read Section 1.
Getting Started
New Cartridge Set-up
Important Notes:
Step 2E u2013 Continue on to Daily Use
Section 3: Now that you have done the 1 time only New Cartridge Set-up, follow Section 3 for each of your daily injections.
Important Note:
Step 3C u2013 Dial and inject the dose
Step 3D u2013 Remove and dispose of the needle
Important Note: Do not remove
Step 3E u2013 Store Pen and Cartridge for next use
Commonly asked questions:
Disposing of used needles:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.n
Manufacturer: Eli Lilly and Company Pharmaceutical Delivery Systems Lilly Corporate Center Indianapolis, IN 46285, USAn
HUMATROPE and HumatroPen 6 mg are registered trademarks of Eli Lilly and Company.n
Copyright u00a9 2009, 2019, Eli Lilly and Company. All rights reserved.Revised October 2019n
HTRPEN6-0002-IFU-20191028n

Instructions for Use
HumatroPenn- Arrayn- 12 mg
(HU-ma-tro-Pen 12 mg)n
HUMATROPE Delivery System Devicen
for use withn
HUMATROPE (somatropin) 12 mg Cartridgesn
Section 1: Read Section 1 completely before you move on to Section 2.
What you need to know about HumatroPenn- Arrayn- 12 mg
Read this Instructions for Use including the u201cCommonly asked questionsu201d section, at the end of this Instructions for Use, before you start using HumatroPen 12 mg and each time you get a new Pen. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.n
Your healthcare provider should show you how to use HumatroPen (Pen) the right way before you use it for the first time. Ask your healthcare provider if you have any questions. n
Introduction
Important information about HumatroPen 12 mg:
Information about needles used with HumatroPen 12 mg:
How do I care for HumatroPen 12 mg?
How do I store HumatroPen 12 mg with an attached cartridge?
When do I need to replace my HumatroPen?
Do not use your pen for more than 3 years after the first use or past the expiration date on the carton, whichever comes first.n
Record the date the Pen was first used here: __ / __ / __.n
Record the expiration date from your carton here: __ / __ / __.n
Contact your healthcare provider if you need a new HumatroPen 12 mg, or when the Pen has been used for 3 years.n
For more information, call Lilly at 1-800-545-5979 or go to www.humatrope.com.
Hidden Needle Cover
Storage Case
Section 2: Read Section 2 only after you have read Section 1.
Getting Started
New Cartridge Set-up
Important Notes:
Step 2E u2013 Continue on to Daily Use
Section 3: Now that you have done the 1 time only New Cartridge Set-up, follow Section 3 for each of your daily injections.
Important Note:
Step 3C u2013 Dial and inject the dose
Step 3D u2013 Remove and dispose of the needle
Important Note: Do not remove
Step 3E u2013 Store Pen and Cartridge for next use
Commonly asked questions:
Disposing of used needles:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.n
Manufacturer: Eli Lilly and Company Pharmaceutical Delivery Systems Lilly Corporate Center Indianapolis, IN 46285, USAn
HUMATROPE and HumatroPen 12 mg are registered trademarks of Eli Lilly and Company.n
Copyright u00a9 2009, 2019, Eli Lilly and Company. All rights reserved.Revised October 2019n
HTRPEN12-0002-IFU-20191028n

Instructions for Use
HumatroPenn- Arrayn- 24 mg
(HU-ma-tro-Pen 24 mg)n
HUMATROPE Delivery System Devicen
for use withn
HUMATROPE (somatropin) 24 mg Cartridgesn
Section 1: Read Section 1 completely before you move on to Section 2.
What you need to know about HumatroPenn- Arrayn- 24 mg
Read this Instructions for Use including the u201cCommonly asked questionsu201d section, at the end of this Instructions for Use, before you start using HumatroPen 24 mg and each time you get a new Pen. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.n
Your healthcare provider should show you how to use HumatroPen (Pen) the right way before you use it for the first time. Ask your healthcare provider if you have any questions. n
Introduction
Important information about HumatroPen 24 mg:
Information about needles used with HumatroPen 24 mg:
How do I care for HumatroPen 24 mg?
How do I store HumatroPen 24 mg with an attached cartridge?
When do I need to replace my HumatroPen?
Do not use your pen for more than 3 years after the first use or past the expiration date on the carton, whichever comes first.n
Record the date the Pen was first used here: __ / __ / __. Record the expiration date from your carton here: __ / __ / __.n
Contact your healthcare provider if you need a new HumatroPen 24 mg, or when the Pen has been used for 3 years.n
For more information, call Lilly at 1-800-545-5979 or go to www.humatrope.com.
Hidden Needle Cover
Storage Case
Section 2: Read Section 2 only after you have read Section 1.
Getting Started
New Cartridge Set-up
Important Notes:
Step 2E u2013 Continue on to Daily Use
Section 3: Now that you have done the 1 time only New Cartridge Set-up, follow Section 3 for each of your daily injections.
Important Note:
Step 3C u2013 Dial and inject the dose
Step 3D u2013 Remove and dispose of the needle
Important Note: Do not remove
Step 3E u2013 Store Pen and Cartridge for next use
Commonly asked questions:
Disposing of used needles:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.n
Manufacturer: Eli Lilly and Company Pharmaceutical Delivery Systems Lilly Corporate Center Indianapolis, IN 46285, USAn
HUMATROPE and HumatroPen 24 mg are registered trademarks of Eli Lilly and Company.n
Copyright u00a9 2009, 2019, Eli Lilly and Company. All rights reserved.Revised October 2019n
HTRPEN24-0002-IFU-20191028n

Instructions for Use
Hidden Needle Cover
For use with HumatroPenn- Arrayn- (6 mg, 12 mg, or 24 mg)
What you need to know about the Hidden Needle Cover
Read this Instructions for Use for the Hidden Needle Cover before you use it. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.n
Your healthcare provider should show you how to use the Hidden Needle Cover with the HumatroPen the right way before you use it for the first time. Ask your healthcare provider if you have any questions. n
The Hidden Needle Cover allows you to give your injection with the needle hidden from view. Be sure the HumatroPen is set up by following the steps in the HumatroPen Instructions for Use.n
What kinds of needles can be used with the Hidden Needle Cover?
This Instructions for Use has been approved by the U.S. Food and Drug Administration.n
Manufacturer: Eli Lilly and Company Pharmaceutical Delivery Systems Lilly Corporate Center Indianapolis, IN 46285, USAn
HUMATROPE and HumatroPen are registered trademarks of Eli Lilly and Company.Copyright u00a9 2009, 2019, Eli Lilly and Company. All rights reserved.Revised October 2019n
HTRHNC-0001-IFU-20191028n

COMBINATION PACKAGEn
NDC 0002-7335-11n
VIAL No. 7335n
VIAL No. 7336n
Rx onlyn
Humatropen
somatropin for injectionn
5 mgn
Vial Kit Includes:n
One Vial of Humatrope (somatropin) for injectionn
One Vial of Sterile Diluent 5 mLn
For Parenteral Use Onlyn
Refrigeraten
Do Not Freezen
Do Not Shaken
Lillyn

NDC 0002-8147-01n
MS 8147n
6 mg Combination Packagen
Humatropen
(somatropin) for injectionn
6 mgn
Cartridge Kitn
for use only with the Humatrope (somatropin) for injection pen injection devicen
Rx onlyn
Refrigeraten
Do Not Freezen
Do Not Shaken
Kit contains:n
One Humatrope Cartridge 6 mgn
One Prefilled Diluent Syringen
www.humatrope.comn
Lillyn

NDC 0002-8148-01n
MS 8148n
12 mg Combination Packagen
Humatropen
(somatropin) for injectionn
12 mgn
Cartridge Kitn
for use only with the Humatrope (somatropin) for injection pen injection devicen
Rx onlyn
Refrigeraten
Do Not Freezen
Do Not Shaken
Kit contains:n
One Humatrope Cartridge 12 mgn
One Prefilled Diluent Syringen
www.humatrope.comn
Lillyn

NDC 0002-8149-01n
MS 8149n
24 mg Combination Packagen
Humatropen
(somatropin) for injectionn
24 mgn
Cartridge Kitn
for use only with the Humatrope (somatropin) for injection pen injection devicen
Rx onlyn
Refrigeraten
Do Not Freezen
Do Not Shaken
Kit contains:n
One Humatrope Cartridge 24 mgn
One Prefilled Diluent Syringen
www.humatrope.comn
Lillyn

Humatropen
(somatropin) for injectionn
Professional Package Not to be Soldn
HumatroPen 6 mgn
Growth Hormone Delivery Systemn
Injection Device for Use with Humatrope (somatropin) for injection 6 mg Cartridgesn
HumatroPen 6 mg is suitable for use with Becton, Dickinson and Company pen needlesn
Not included: Humatrope cartridge and Becton, Dickinson and Company pen needles.n
Contentsn
HumatroPen 6 mgn
Pen Casen
HumatroPen 6 mg User Manualn
Hidden Needle Covern
Hidden Needle Cover User Manualn
MS9560n
Lillyn

Humatropen
(somatropin) for injectionn
Professional Package Not to be Soldn
HumatroPen 12 mgn
Growth Hormone Delivery Systemn
Injection Device for Use with Humatrope (somatropin) for injection 12 mg Cartridgesn
HumatroPen 12 mg is suitable for use with Becton, Dickinson and Company pen needlesn
Not included: Humatrope cartridge and Becton, Dickinson and Company pen needles.n
Contentsn
HumatroPen 12 mgn
Pen Casen
HumatroPen 12 mg User Manualn
Hidden Needle Covern
Hidden Needle Cover User Manualn
MS9561n
Lillyn

Humatropen
(somatropin) for injectionn
Professional Package Not to be Soldn
HumatroPen 24 mgn
Growth Hormone Delivery Systemn
Injection Device for Use with Humatrope (somatropin) for injection 24 mg Cartridgesn
HumatroPen 24 mg is suitable for use with Becton, Dickinson and Company pen needlesn
Not included: Humatrope cartridge and Becton, Dickinson and Company pen needles.n
Contentsn
HumatroPen 24 mgn
Pen Casen
HumatroPen 24 mg User Manualn
Hidden Needle Covern
Hidden Needle Cover User Manualn
MS9562n
Lillyn

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Somatropin (Humatrope)

Trade Name : HUMATROPE

KIT

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

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Somatropin (Humatrope)

Trade Name : HUMATROPE

KIT

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

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QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?