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FDA Drug Import News

Import Rules Regarding Personal Medicine Orders:

Current FDA policy is not a law or a regulation, but serves as guidance for FDA personnel.

The importation of certain unapproved prescription medications for personal use may be allowed in some circumstances where these factors apply:


    1). The Drug is for personal use and is a 3-month supply or less and not for resale or commercialization.

    2). If no drug commercialization or drug promotion to U.S. residents by pharmacy companies involved in the distribution of the necessary drug exists.

    3). If an individual seeking to import the drug affirms in writing, that it is for the patient's private use and provides the name and address of the licensed American physician responsible for treatment.

    4). Provides evidence that the drug is for continuation of a treatment begun in a foreign country.

    5). The intended use is for a serious condition for which effective treatment may not be available domestically.

    6). If the product is not considered to represent an unreasonable health issue.

    7). Overnite FedEx shipments require copy of your identification and the prescription.

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Cryotropin 4iu x1.33mg (somatropin) hGH

Cryotropin 4iu x1.33mg (somatropin) hGH
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Price: $69.00
Product ID : cryotropin_4IU
Manufacturer: CRYOPHARMA LABS
Shipping Price: $15.00
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Min/Max Order: 3 / 99

Description

SPECIAL NOTE: Due to strict requirements surrounding this product, we require the following documents for customs clearance and quick delivery:
                               A) Copy of your American Prescription
(or script from your countries registered health facility)
                               B) Copy of Passport or Government Approved I.D. (Photo Identification)
                               C) Payments by Credit-Card May have an issue being accepted by our C/Card Processor(s)

Therefore if you experience an issue when attempting to complete payment by CreditCard for this product; rest assured you are still able to make payment either by CHECK, MONEYGRAM, WESTERN-UNION or BANK TRANSFER. (Re:Rules by specific processors regarding Intl. Online pharmacies is the reason given to us by our many credit card processing companies)


CRYOTROPIN: hGH, Growth hormone (somatropin)

BRAND NAME: CRYOTROPIN

GENERIC NAME: somatropin, hGH aka Human Growth Hormone

Patient Education - English

  • Generic Name: somatropin
  • Pronounced: soe ma TROE pin
  • Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive

What is the most important information I should know about somatropin?

 

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.

If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Call your doctor at once if you have sudden and severe pain or tenderness in your upper stomach, with nausea, vomiting, sweating, fever, fast heartbeat, and yellowing of the skin or eyes. You should also call your doctor promptly if you have vision changes and sudden, severe pain behind your eyes.

What is somatropin?

Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.

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 syndrome.

Somatropin may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using somatropin?

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).

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 B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive.

FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin,Nutropihn, and Tev-tropin.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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.

How should I use somatropin?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.

Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.

Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested on a regular basis. Your eyes may also need to be checked. Visit your doctor regularly.

If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.

If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.

How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.

Throw away any somatropin left over after the expiration date on the label has passed.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

What should I avoid while using somatropin?

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

What are the possible side effects of somatropin?

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden and severe pain or tenderness in your upper stomach;
  • nausea, vomiting, sweating, fever, fast heartbeat, yellowing of the skin or eyes;
  • increased thirst and urination;
  • sudden and severe pain behind your eyes, vision changes;
  • swelling in your head, face, hands, or feet; or
  • numbness or tingling in your wrist, hand, or fingers.

Less serious side effects may include:

  • headache;
  • redness, soreness, swelling, skin rash, itching, pain, or bruising where the medicine was injected;
  • breast swelling;
  • joint pain, swelling, or stiffness; or
  • mild nausea, stomach pain, gas.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. .

What other drugs will affect somatropin?

Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor's advice.

Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor's instructions.

Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.

This list is not complete and other drugs may interact with somatropin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about somatropin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Cryotropin is used clinically to treat children's growth disorders and adult growth hormone deficiency. In recent years, replacement therapies with human growth hormones (HGH) have become popular in the battle against aging and weight management. Reported effects include decreased body fat, increased muscle mass, increased bone density, increased energy levels, improved skin tone and texture, increased sexual function and improved immune system function. At this time HGH is still considered a very complex hormone and many of its functions are still unknown.

Somatropin (human growth hormone) is an anabolic hormone secreted by the pituitary, which stimulates tissue growth and anabolism, affects the metabolism of fats, carbohydrates and minerals.

Somatropin has the normal structure of the major component of human growth hormone produced by the pituitary and consists of only one polypeptide composed of 191 amino acids with disulphide bonds.

THERAPEUTIC INDICATIONS

CRYOTROPIN is indicated for the treatment of disorders due to deficiency of secretion of growth hormone, pituitary dwarfism and in children of short stature in Turner syndrome.

CLINICAL PHARMACOLOGY

CRYOTROPIN is well absorbed after subcutaneous or intramuscular administration. After intravenous injection, the half-life is 20 to 30 minutes but after subcutaneous or intramuscular administration, the serum concentration declines with a half life of 3 to 5 hours. It is metabolized in the liver and excreted in the bile.

The pharmacological properties are identical to human growth hormone produced by the pituitary, the amino acid sequence, chain length (191 amino acids) and pharmacokinetic profile, as can be expected to produce the same biosynthetic somatropin drug effects than those of endogenous hormone.

DOSE AND ROUTE OF ADMINISTRATION

The dosage should be individualized for each patient.  In growth hormone deficiency, recommended 0.25 to 0.30 mg / kg body weight per week or 0.07 to 0.10 IU / kg body weight per day. In Turner syndrome, 0.14 IU / kg body weight per day.

Growth hormone deficiency in adults from 0018 to 0036 IU / kg body weight per day.

Recommendations for the Preparation: With sterile syringe and needle, add the diluent to the vial containing the lyophilized solution, dissolve with gentle circular motions, do not stir, as it may denature the active ingredient.

 

RECOMMENDATIONS ON STORAGE
Keep under refrigeration 2 to 8 ° C. Do not freeze.
Once mixed/made together, the product mixture should be kept under refrigeration.

 

LABORATORIOS CRYOPHARMA, S. A. de C. V.

Reg. Núm. 457M93, SSA IV

DEAR-06330022090009/RM2006

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