Humatrope 36Iu 12mg Injection 1'S

INTRODUCTION ABOUT HUMATROPE 36IU 12MG INJECTION

HUMATROPE 36IU 12MG INJECTION contains Somatropin which belongs to the group of
medicines called Growth hormone agonists. It is used in children with growth
failure due to growth hormone deficiency (GHD), idiopathic short stature (ISS),
Turner syndrome (TS), Prader-Willi Syndrome, are too small or light at birth and
in chronic kidney disease (CKD).

In adults it is used to manage either childhood-onset or adult-onset GHD. Growth
hormone deficiency (GHD) is also called dwarfism or pituitary dwarfism. It is a
disease characterized by low growth hormone levels in the body.

Your doctor might want you to take certain tests and follow a particular diet
during management with HUMATROPE 36IU 12MG INJECTION. HUMATROPE 36IU 12MG
INJECTION is not recommended for use if you have an active cancer, are seriously
ill (like you need to get a surgery done) or if your growth has already stopped.

Before receiving HUMATROPE 36IU 12MG INJECTION, inform your doctor if you have
myalgia, diabetes, kidney or thyroid problem. HUMATROPE 36IU 12MG INJECTION is
not recommended for use in pregnant women and caution should be exercised while
using it in breastfeeding women.

It should be used with caution in elderly patients above 80 years of age. The
most common side effects of receiving HUMATROPE 36IU 12MG INJECTION are joint
pain, water retention (which shows as puffy fingers or swollen ankles),
injection site reaction. Contact your physician for advice if any of the
symptoms worsen.

USES OF HUMATROPE 36IU 12MG INJECTION

Manage:

• Children with growth failure due to growth hormone deficiency (GHD), idiopathic short stature (ISS), Turner syndrome (TS), Prader-Willi Syndrome and chronic kidney disease (CKD)
• Children who are too small or light at birth
• Childhood-onset or adult-onset GHD in adults

HOW HUMATROPE 36IU 12MG INJECTION WORKS

HUMATROPE 36IU 12MG INJECTION is a man-made form of growth hormone which
resembles natural human growth hormone that stimulates the production of another
growth hormone called insulin-like growth factor 1 or IGF-1. It helps the bones,
muscles to grow and develop in the right amount.

DIRECTIONS FOR USE

HUMATROPE 36IU 12MG INJECTION will be given to you only by a doctor or a nurse
via subcutaneous injection that is injected into the fatty tissue just under the
skin. The correct dose and duration will be decided by your physician for you
depending on your age, body weight and disease condition.

SIDE EFFECTS OF HUMATROPE 36IU 12MG INJECTION

COMMON

• joint pain
• water retention (which shows as puffy fingers or swollen ankles)
• injection site reaction (signs include temporary reddening, itchiness or pain)
• numbness / tingling
• stiffness in the legs and arms, muscle pain
• pain or burning feelings in the hands or underarms

UNCOMMON

• rash/itching
• breast enlargement (gynecomastia)
• leukemia
• increased intracr
• muscle pain
• raised itchy bumps on skin

RARE

Stop receiving HUMATROPE 36IU 12MG INJECTION and contact your doctor immediately
if you experience any of the following side effects:

• walk with a limp or start to limp during the management due to pain in the hip
• developing raised intracr
• experience worsening abdominal pain
• have headaches, changes in behavior, changes in vision, changes in moles, birthmarks or the color of the skin
• serious allergic reactions (symptoms include swelling of the face, lips, mouth or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness or swelling, dizziness or fainting, fast heartbeat or pounding in the chest and sweating)
• body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in the joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet
• darkening of the skin, dizziness, weakness, severe fatigue or weight loss
• worsening of bend of the spine (scoliosis)
• severe and constant abdominal pain (may be a sign of pancreatitis)

WARNING & PRECAUTIONS

!### PREGNANCY

HUMATROPE 36IU 12MG INJECTION is not recommended for use in pregnant women and
women planning to have a baby as safety data has not been established yet.
Consult your doctor before receiving HUMATROPE 36IU 12MG INJECTION.

!### BREASTFEEDING

HUMATROPE 36IU 12MG INJECTION should be used with caution in breastfeeding women
as it is not known whether it passes through the breastmilk. Consult your doctor
before receiving HUMATROPE 36IU 12MG INJECTION.

!### DRIVING AND USING MACHINES

HUMATROPE 36IU 12MG INJECTION does not affect the ability to drive and use
machines.

!### KIDNEY

HUMATROPE 36IU 12MG INJECTION should be used with caution in patients with
kidney problems. It should not be used during kidney transplant. Consult your
doctor before receiving HUMATROPE 36IU 12MG INJECTION.

!### ALLERGY

Do not receive HUMATROPE 36IU 12MG INJECTION if you are allergic to Somatropin
or any other ingredients of this medicine.

!### HEART DISEASE

HUMATROPE 36IU 12MG INJECTION is not recommended for use in patients with
open-heart surgery. Consult your doctor before receiving HUMATROPE 36IU 12MG
INJECTION.

OTHERS

HUMATROPE 36IU 12MG INJECTION is not recommended for use if you:

• are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute respiratory failure, accidental trauma or similar conditions)
• children with Prader-Willi syndrome who are severely obese
• have a history of severe upper airway obstruction
• have active cancer
• have severe non-proliferative or active proliferative diabetic retinopathy
• pediatric patients with closed epiphyses
• if your growth has stopped

Before receiving HUMATROPE 36IU 12MG INJECTION, inform your doctor if you have:

• myalgia
• diabetes
• thyroid problem

Use in Geriatrics:

HUMATROPE 36IU 12MG INJECTION should be used with caution in elderly patients
above 80 years of age. Consult your doctor before receiving HUMATROPE 36IU 12MG
INJECTION.

INTERACTIONS

A. Drug-Drug interactions:

Before receiving HUMATROPE 36IU 12MG INJECTION, inform your doctor if you are
taking any of the following medicine:

• replacement therapy with glucocorticoids (Ex. prednisone)
• medicine used to manage diabetes (Ex. glimepiride, metformin)
• medicine used as thyroid hormones (Ex. thyroxine)
• synthetic adrenal hormones (corticosteroids)
• medicines used for contrace
• medicine used to weaken the immune system after transplantation (Ex. ciclosporin)
• medicines used to control epilepsy (anticonvulsants) (Ex. carbamazepine, frisium)
• cytochrome P450- metabolized drugs (Ex. benzodiazepines, cyclosporine)

Overdosage:

HUMATROPE 36IU 12MG INJECTION will be administered only by a doctor or a nurse
in a hospital and so it is unlikely to receive an overdose. However, consult
your doctor or nurse if there are any unusual symptoms of hypoglycemia,
hyperglycemia, gigantism and/or acromegaly (excess growth hormone).

SYNOPSIS

Drug	:	Somatropin
Pharmacological Category	:	Growth Hormone Agonists
Therapeutic Indication	:	To increase growth
Dosage Forms	:	Injection

MORE INFORMATION

• Keep HUMATROPE 36IU 12MG INJECTION out of reach of children
• Store in a refrigerator at a temperature of 2°C to 8°C

FAQs ABOUT HUMATROPE 36IU 12MG INJECTION

Q: Is HUMATROPE 36IU 12MG INJECTION safe to use in pregnancy?

A: HUMATROPE 36IU 12MG INJECTION is not recommended for use in pregnancy as
safety data has not been established yet. Consult your doctor before receiving
HUMATROPE 36IU 12MG INJECTION.

Q: Can HUMATROPE 36IU 12MG INJECTION be used in diabetic patients?

A: Caution should be taken while using HUMATROPE 36IU 12MG INJECTION if you are
diabetic. If you have diabetes, constant monitoring of blood sugar levels is
required while receiving HUMATROPE 36IU 12MG INJECTION. Discuss with your doctor
before receiving HUMATROPE 36IU 12MG INJECTION.

Q: Can I receive HUMATROPE 36IU 12MG INJECTION along with thyroid hormones?

A: Caution to be taken if HUMATROPE 36IU 12MG INJECTION is used along with
thyroid hormones because thyroid hormone dose may need to be adjusted. Your
physician may adjust the dose of your thyroid hormone accordingly.

Q: How does HUMATROPE 36IU 12MG INJECTION work?

A: HUMATROPE 36IU 12MG INJECTION is a man-made form of growth hormone which
resembles natural human growth hormone and is required for the growth of bones
and muscles. It also helps the fat and muscle tissues to develop in the correct
proportion.

Q: Who should not receive HUMATROPE 36IU 12MG INJECTION?

A: HUMATROPE 36IU 12MG INJECTION is not recommended for use in patients having
an acute critical illness, pediatric with Prader-Willi syndrome who are severely
obese, have a history of severe upper airway obstruction, active malignancy,
severe non-proliferative or active proliferative diabetic retinopathy and in
pediatric patients with closed epiphyses. Consult your doctor before receiving
HUMATROPE 36IU 12MG INJECTION.

REFERENCES

1. Mark E. Molitch and Bernard P. Schimmer. Introduction to Endocrinology: The
   Hypothalamic-Pituitary Axis. Goodman & Gilman’s: The Pharmacological basics of
   Therapeutic, 13th Edition. New York McGraw Hill Medical 2018. Page – 777-778.

2. KD. Tripathi. Anterior Pituitary Hormones. Essentials of medical
   pharmacology. Seventh edition. 2013. Page – 237.

3. Jens Sandahl Christ
   Beverly M K Biller, Margaret C S Boguszewski, Felipe F Casanueva, Philippe
   Chanson, Pierre Chatelain, Catherine S Choong, David R Clemmons and et.al.
   Growth Hormone Research Society perspective in the development of long-acting
   growth hormone preparations. NIH National Library of Medicine. National Centre
   for Biotechnology Information. Pubmed Central. June 2016. [Accessed on 24th June
   2022]

4. Christina Southern Reh and Mitchell E Geffner. Somatotropin in the treatment
   of growth hormone deficiency and Turner syndrome in pediatric patients: a
   review. NIH National Library of Medicine. National Centre for Biotechnology
   Information. Pubmed Central. June 2010 [Accessed on 24th June
   2022]

5. Pfizer Manufacturing Belgium NV. Electronic Medicines Compendium (EMC).
   [Revised in October 2021] [Accessed on 24th June
   2022]

6. Novo Nordisk A/S. Somatotropin. [Revised in March 2020] [Accessed on 24th
   June 2022]

USEFUL DIAGNOSTIC TESTS

• Kidney function tests
• Blood sugar test
• Thyroid function test