Overview
ZENOSIM 8IU HGH
* Active substance: somatropin* Amino chain: 191 amino-acid
* Vial packing: vacuum and nitrogen sealed
Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndromeand may also be used for other purposes not listed in this medication guide.
Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.
Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.
Prescribing info
ZENOSIM 8IU treats the following conditions:
- Growth Hormone Deficiency
- Hypopituitarism in Adults
- Turner Syndrome
- Idiopathic Short Stature
- Short stature childhood cases
Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature at birth with no catch-up growth, and other causes.
Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin.
You should not use this medication if you are allergic to somatropin, or if you have:
* diabetic retinopathy (a serious eye condition caused by diabetes), cancer or Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.
You should also not use somatropin if you have a serious medical condition after having: open heart surgery or stomach surgery; trauma or other medical emergency; or breathing problems (such as lung failure).
Where to inject ZENOSIM 8IU:
Below are presented the spots where you can inject ZENOSIM 8IU by subcutaneous injection.
How to injection: either subcutaneous or intramuscular. Not Intradermal.
Adverse reactions:
Growth Hormone Deficient Pediatric Patients
Growth Hormone Deficient Adult Patients
Growth hormone deficiency:
Short called GHDaGHD (adult GHD)
What causes growth hormone deficiency?
Head injuries, brain tumors, and brain damage due to disease or iradiation can also cause poor functioning of the pituitary gland. There are various ways to determine GHD including stim-tests.
Treatment of growth hormone deficiency
ZENOSIM 8IU is used for the treatment of children who have growth failure due to low production of natural growth hormone but also in adults that suffer of aGHD (adult Growth Hormone Deficiency).
Reconstitution of ZENOSIM 8IU:
contains particulate matter, the contents MUST NOT be injected. Before and after injection, the septum of the vial should be wiped with rubbing alcohol or an
alcoholic antiseptic solution to prevent contamination of the contents by repeated needle
Contraindications:
Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.Somatropin should not be used to treat patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency.
Drug interactions:
For treatment of weight loss caused by acquired immunodeficiency disease (AIDS):
Adults weighing more than 121 pounds (55 kg)—6 mg injected under the skin once a day at bedtime.
Adults weighing 99 to 121 pounds (45 to 55 kg)—5 mg injected under the skin once a day at bedtime.
Adults weighing 77 to 98 pounds (35 to 44 kg)—4 mg injected under the skin once a day at bedtime.
Adults weighing less than 77 pounds (35 kg)—Dose is based on body weight and must be determined by your doctor. It is usually 0.1 mg per kg (0.045 mg per pound) of body weight injected under the skin once a day at bedtime.
Children: Use and dose must be determined by your doctor.
Reconstitution:
Vial — Each 8IU vial of ZENOSIM 8IU should be reconstituted with 1 to 2 ml of Bacteriostatic Water for Injection. The diluent should be injected into the vial of ZENOSIM 8IU by aiming the stream of liquid against the glass wall. Following reconstitution, the vial should be swirled with a GENTLE rotary motion until the contents are completely dissolved. DO NOT SHAKE. The resulting solution should be inspected for clarity. It should be clear. If the solution is cloudy or
contains particulate matter, the contents MUST NOT be injected. Before and after injection, the septum of the vial should be wiped with rubbing alcohol or an
alcoholic antiseptic solution to prevent contamination of the contents by repeated needle
insertions.
Sterile disposable syringes and needles should be used for administration of ZENOSIM 8IU. The volume of the syringe should be small enough so that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Before Reconstitution — Vials of ZENOSIM 8IU is stabile when refrigerated [2° to 8°C (36° to 46°F)]. However, because of the advanced technology process in the manufacturing of somatropin, ZENOSIM 8IU is stabile at room temperature (~30°C) for about 50 days. We recommend keeping ZENOSIM 8IU refrigerated for best preservation.
After Reconstitution — Vials of ZENOSIM 8IU are stable for up to 14 days when reconstituted and stored in a refrigerator at 2° to 8°C (36° to 46°F). Avoid freezing the reconstituted vial of ZENOSIM 8IU.
ZENOSIM 8IU can be used either subcutaneously or intramuscular. In the image is presented the subcutaneously injection spots.
Excessive glucocorticoid therapy may attenuate the growth promoting effects of somatropin in children. Therefore, glucocorticoid replacement therapy should be carefully adjusted in children with concomitant GH and glucocorticoid deficiency to avoid both hypoadrenalism and an inhibitory effect on growth. Limited published data indicate that somatropin treatment increases cytochrome P450 (CP450) mediated antipyrine clearance in man. These data suggest that somatropin administration may alter the clearance of compounds known to be metabolized by CP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporin). Careful monitoring is advisable when somatropin is administered in combination with other drugs known to be metabolized by CP450 liver enzymes. However, formal drug interaction studies have not been conducted.
In adult women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal (see DOSAGE AND ADMINISTRATION).
In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral agent may require adjustment when somatropin therapy is initiated
Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your health care professional will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be certain that you understand exactly how the medicine is to be prepared and injected.
It is important to read the patient information and instructions for use, if provided with your medicine, each time your prescription is filled.
It is important to follow any instructions from your doctor about the careful selection and rotation of injection sites on your body . This will help to prevent skin problems.
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using somatropin, tell your doctor if you have: liver disease; kidney disease (or if you are on dialysis); diabetes; scoliosis; high blood pressure (hypertension); a pancreas disorder; a history of cancer; carpal tunnel syndrome; underactive thyroid; or a brain tumor or lesion. FDA pregnancy category C. It is not known whether somatropin is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby.
Dosing ZENOSIM 8IU
For treatment of growth failure caused by growth hormone deficiency:
* Adults: Dose is based on body weight and must be determined by your doctor. At first, it is usually 0.005 milligram (mg) per kilogram (kg) (0.0023 mg per pound) of body weight injected under the skin once a day. Your doctor may then increase the dose if needed.
* Children: Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.16 to 0.3 mg per kg (0.073 to 0.136 mg per pound) of body weight. This is divided into smaller doses and usually is injected under the skin, but may be injected into a muscle as determined by your doctor.
For treatment of growth failure caused by kidney disease:
For treatment of growth failure caused by Turner's syndrome:
* Children: Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.375 mg per kg (0.17 mg per pound) of body weight. This is divided into smaller doses and is injected under the skin.
For treatment of growth failure caused by Prader-Willi syndrome:
* Children: Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.24 mg per kg (0.11 mg per pound) of body weight. This is divided into 6 or 7 smaller doses over the course of the week and is injected under the skin.
For treatment of weight loss caused by acquired immunodeficiency disease (AIDS):
Adults weighing more than 121 pounds (55 kg)—6 mg injected under the skin once a day at bedtime.
Adults weighing 99 to 121 pounds (45 to 55 kg)—5 mg injected under the skin once a day at bedtime.
Adults weighing 77 to 98 pounds (35 to 44 kg)—4 mg injected under the skin once a day at bedtime.
Adults weighing less than 77 pounds (35 kg)—Dose is based on body weight and must be determined by your doctor. It is usually 0.1 mg per kg (0.045 mg per pound) of body weight injected under the skin once a day at bedtime.
Children: Use and dose must be determined by your doctor.
Warnings and precautions:
In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral agent may require adjustment when somatropin therapy is initiated
In adult women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal (see DOSAGE AND ADMINISTRATION).
In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral agent may require adjustment when somatropin therapy is initiated
See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients having acute critical illnesses should be weighed against the potential risk.
ZENOSIM 8IU Users Manual
INDICATIONS AND USAGE
Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature at birth with no catch-up growth, and other causes.
Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndromeand may also be used for other purposes not listed in this medication guide. Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor. Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.
You should not use this medication if you are allergic to somatropin, or if you have:
* diabetic retinopathy (a serious eye condition caused by diabetes), cancer or Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.
You should also not use somatropin if you have a serious medical condition after having: open heart surgery or stomach surgery; trauma or other medical emergency; or breathing problems (such as lung failure).
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using somatropin, tell your doctor if you have: liver disease; kidney disease (or if you are on dialysis); diabetes; scoliosis; high blood pressure (hypertension); a pancreas disorder; a history of cancer; carpal tunnel syndrome; underactive thyroid; or a brain tumor or lesion. FDA pregnancy category C. It is not known whether somatropin is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby.
It is important to read the patient information and instructions for use, if provided with your medicine, each time your prescription is filled.
It is important to follow any instructions from your doctor about the careful selection and rotation of injection sites on your body . This will help to prevent skin problems.
DOSAGE AND ADMINISTRATION
Dosing: The dose of these medicines will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.
For treatment of growth failure caused by growth hormone deficiency:
* Adults: Dose is based on body weight and must be determined by your doctor. At first, it is usually 0.005 milligram (mg) per kilogram (kg) (0.0023 mg per pound) of body weight injected under the skin once a day. Your doctor may then increase the dose if needed.
* Children: Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.16 to 0.3 mg per kg (0.073 to 0.136 mg per pound) of body weight. This is divided into smaller doses and usually is injected under the skin, but may be injected into a muscle as determined by your doctor.
For treatment of growth failure caused by kidney disease:
* Children: Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.35 mg per kg (0.16 mg per pound) of body weight. This is divided into smaller daily doses and is injected under the skin or into a muscle.
For treatment of growth failure caused by Turner's syndrome:
* Children: Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.375 mg per kg (0.17 mg per pound) of body weight. This is divided into smaller doses and is injected under the skin.
For treatment of growth failure caused by Prader-Willi syndrome:
* Children: Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.24 mg per kg (0.11 mg per pound) of body weight. This is divided into 6 or 7 smaller doses over the course of the week and is injected under the skin.
Security
Each ZENOSIM 8IU box has a Security Seal that prevents the counterfeiting of the product. Each Security Seal includes a Security Code that can be revealed when the Security Seal is scratched with a coin. Insert this coin in the Anti-Counterfeiting verifier to check the genuinity of your ZENOSIM 8IU box.
Quality certificate
Below you can find the laboratory testing analysis on two batches of ZENOSIM 8IU human growth hormone. The results are proving that the substance inside the ZENOSIM 8IU vial is somatropinum (22.122 Da) at a purity of over 96% (the European standard is 95%).
