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Primatropin® [somatropin (rDNA origin) for injection] is human growth hormone, available by prescription only.

Doctors prescribe Primatropin for children and teenagers with growth failure who:

  • do not make enough growth hormone on their own
  • have chronic renal insufficiency—a slow loss of kidney function—and have not had a transplant
  • have Turner syndrome
  • are not likely to grow to their potential adult height, as determined by a doctor, and whose bones are still able to grow

Doctors prescribe Primatropin for adults who:

  • have growth hormone deficiency that started either in childhood or as an adult due to brain surgery, radiation therapy, trauma, or diseases of the pituitary gland or the hypothalamus.

Your doctor will test to see if growth hormone is right for you.

Primatropin and your safety:
Please read this important safety information carefully. Then, if you have any questions, talk with your doctor.

Primatropin is NOT for:

  • children and teenagers whose bones have finished growing
  • patients who have certain types of eye disease caused by diabetes
  • patients who have active cancer or any brain tumors
  • patients who are critically ill after open heart surgery or abdominal (stomach) surgery, are severely hurt, or have severe breathing problems
  • children and teenagers who have Prader-Willi syndrome and are very overweight or have trouble breathing

If any of these apply, talk to your doctor before you start taking Primatropin.

If you are about to start taking Primatropin, or are already taking it, be sure to tell the doctor who prescribed it:

  • about ALL of the medications you are taking, including supplements
  • if you have or develop a brain tumor
  • if you are given any new medication—especially cortisone, hydrocortisone, prednisone, prednisolone, dexamethasone, triamcinolone, or betamethasone
  • if you are pregnant or if you become pregnant
  • about ANY other condition or illness you have or develop

What are the possible side effects of Primatropin?
You may experience discomfort, soreness, or redness where Primatropin is injected.

Contact your doctor immediately if you experience:

  • ongoing injection site discomfort
  • curvature of the spine (scoliosis)
  • joint pain
  • puffy hands and/or feet (caused by fluid retention)
  • changes in vision, a bad headache, or nausea with or without vomiting
  • hip or knee pain
  • a need to limp when you walk
  • pain in wrist (carpel tunnel)
  • allergic reaction

Be sure to inject Primatropin at a different recommended place on your body each time. Your doctor or nurse should supervise the first injection and provide training and instruction.

Your doctor is your primary source of information about your treatment.


Ingredients:
Each bottle contains 10 IU of biosynthetic human growth hormone (from recombinant DNI), excipients include Glycine, mannitol, dibasic sodium phosphate.

Pharmaceutical Classification:
Sterile freeze-dried powder of systemic hormone preparation.

Directions for use:
Long-term treatment for stunted growth, due to the reduction or lack of somatotrophic endogenous hormone secretion in-patients who have not yet finished puberty. Treatment of short stature in girls suffering from Turner’s syndrome confirmed by chromosomal analysis (the effect on final height has not yet been established).

Hypersensitivity in certain patients to the product or any of its ingredients. Patients with complete knitting of the epiphyses. Diabetes mellitus. Primatropin should not be used if there is any sign of active neoplasms. Endocrane lesions must be inactive and anti-tumoral treatment finished before beginning hormonal treatment. The use of Primatropin must be interrupted in the event of renewed tumoral growth.

Caution:
Primatropin treatment should only be carried out under a doctor’s authorization, by prescription, by university medical centers or hospitals specializing in the treatment of patients with growth hormone deficiency. Diagnoses must be confirmed before beginning Primatropin injections. This requires a clinical examination of the patient with detailed case histories, particularly with regard to auxilogical evaluations and the carrying out of laboratory tests, including stimulus test, to verify hypophysial hypothalamus functioning. Primatropin therapy should be carried out by a specialist in the diagnosis and treatment of patients related to stunted growth. Patients who, following diagnosis, undergo treatment with the
somatotrophic hormone will have to be inscribed in a regional register and monitored by means of clinical auxilogical and laboratory evaluations every six months to check the functioning of the thyroid, glucide metabolism etc. The lack of available information may mean the exposure of the patient to a risk, which may exceed the therapeutic benefit obtained. Human hormone growth treatment should be complemented by an adequate supply of calories and amino acids. Once reconstituted with diluent, Primatropin can be taken in subcutaneous or intramuscular injections.

Carcinogenesis, Mutagenesis and Fertility Alterations:
Long term studies with Primatropin on animals have not been carried out, which would enable the evaluation of any carcinogenic or fertility altering effect which this pharmaceutical product may possibly have. No mutagenic effect due to Primatropin has been seen in tests up to the present.

Use during pregnancy and nursing:
Studies on Primatropin and its effects on animal reproduction have not been carried out. It has not been seen that Primatropin can harm the fetus during pregnancy, nor that it can affect reproduction. Nevertheless, Primatropin should only be taken during pregnancy if absolutely necessary. Studies of the effects of Primatropin on nursing mothers have not been carried out and hence it is not known whether this product is excreted into mother’s milk. However, since many pharmaceutical products are indeed passed into mother’s milk, nursing mothers are advised to take Primatropin with extreme caution.

Interactions:
Since taking Primatropin may cause resistance to insulin, patients should undergo periodic check ups in order to detect any intolerance to glucose. Children suffering from diabetes mellitus should be carefully supervised during Primatropin treatment, as it may be necessary to increase their insulin dosage. Excessive glucocortoid treatments may inhibit the effect of growth stimulation provided by the human somatotrophic hormone. In the case of patients who also suffer from ACTH (adrenocrticotrophic hormone) deficiency, the substitutive dosage of glucocorticoids must be accurately regulated in order to prevent any inhibitory effect on growth.

Please Note:
Attentive and constant supervision by the specialist is advised during growth hormone treatment of patients with neoplasms in remission. Those with a shortage of the growth hormone accompanying an endocrane lesion must be checked particularly frequently so as to prevent spreading or a relapse. Patients with growth hormone deficiency may frequently show alterations having to do with the epiphysis. For this reason, children who limp or show unsteadiness in their walking during growth hormone treatment should have thorough check ups. Hypothyroidism may arise during Primatropin treatment. Because untreated hypothyroidism can prevent an optimal response to Primatropin, patients should have periodic tests for
thyroid functioning and undergo thyroid hormone treatment when necessary. Patients with psoriasis are also advised to have regular check ups so as to avoid a possible aggravation of the condition. The bottles may be reconstituted with sterile water for injections. If Primatropin is reconstituted this way, the solution must be administered within 24 hours and any left over solution thrown away. If, once reconstituted, the solution is not administered immediately, it may be kept up to 24 hours in the refrigerator at a temperature between +2 degrees Celsius and +8 degrees Celsius. Primatropin’s effect on the patient’s capacity to drive or operate machinery has not been determined.

Directions for use:
Dosage and duration of treatment are to be decided by the specialist according to the needs of the patient.

Patients with growth hormone deficiency:
The recommended subcutaneous or intramuscular dosage is 0.18 mg/ kg of body weight (0.48 IU/ Kg) per week, approximately equivalent to 12 IU/m2 per week. The weekly dosage is to be divided into either 3 intramuscular injections or 6 to 7 subcutaneous injections.

Patients with Turner’s syndrome:
The recommended dosage is 0.3- 0.34 mg/ Kg of body weight (0.8- 0.9 IU/ Kg) per week, equivalent to 24- 28 IU m2 per week. The weekly dosage is to be divided into 6-7 subcutaneous injections, to be administered preferably in the evening. With subcutaneous injection, it is advised that the place of injection be varied so as to avoid the onset of lipoatrophy. To prepare the Primatropin solution: Inject 0.5- 2ml of diluent into the bottle containing the freeze-dried powder, directing the flow of the liquid towards the sides of the bottle. Then shake the bottle with a gentle rotating movement until the contents are completely dissolved. DO NOT SHAKE VIGOROUSLY. The use of sterile syringes and needles are recommended for the injections. After reconstitution, the solution must be transparent and without precipitates. If it is opalescent or has
precipitates, then it MUST NOT be used. Clean the surface of the bottle’s rubber stopper with antiseptic before and after using it to prevent contaminating its contents. Syringes must have a volume small enough to enable the prescribed dosage to be extracted with reasonable accuracy.

Directions for reconstitution and administration:
Do not reconstitution or administer this pharmaceutical product without first receiving adequate instructions as to the correct technique by the specialist. Follow the doctor’s sterilizing technique by the specialist. Follow the doctor’s sterilizing technique. Destroy and get rid of syringes or needles following each use. Primatropin must be kept in a cool place (from +2 degrees Celsius to +8 degrees Celsius) before and after reconstitution. DO NOT FREEZE. ONCE RECONSTITUTED, PRIMATROPIN MUST BE USED WITHIN 14 DAYS.

Reconstitution of the Primatropin bottle:
Reconstitute Primatropin only with the proper Bacteriostatic Water diluent. Do not use any other solution for reconstitution unless it is by your doctor’s prescription. The doctor will also decide the correct sizes of the syringe and needle and the amount of diluent to add to the Primatropin
bottle. ALWAYS WASH YOUR HANDS FIRST

  1. Remove and throw away the stoppers of the bottles of diluent and of Primatropin. Clean the rubber covering of the bottles with cotton wad soaked in alcohol. Remove the protective covering of the needle and set it aside. Pull the piston of the syringe until the same volume of air is let in as the volume of diluent prescribed by the doctor. Insert the needle into the rubber stopper of the bottle of diluent and inject air into the bottle.
  2. Holding the bottle upside down and making sure that the needlepoint is in the solution, extract the amount of diluent prescribed by the specialist. Once you are sure there are no air bubbles left in the syringe, turn the bottle right side up and extract the syringe, taking care that the position of the piston does not change.
  3. Insert the same needle into the bottle of Primatropin and gently turn the needle point inwards towards the side of the bottle. Slowly inject the diluent, directing the flow towards the side. DO NOT AIM IT IN THE DIRECTION OF THE WHITE POWDER AT THE BOTTOM OF THE BOTTLE. To balance the pressure and before removing the syringe from the bottle, let in a volume of air equal to that of the diluent just added. If the needle can become separated from the body of the syringe, remove, destroy and throw it away. If the needle and the syringe cannot be separated, eliminate the entire unit.
  4. Shake the bottle with a gentle rotating movement until the contents are completely dissolved.

Preparing the injections:

  1. Do not use Primatropin, if upon reconstitution, it is opalescent or contains precipitates.
  2. If the needle can be separated from the syringe, apply a new needle before giving the injection. If the syringe and needle from an inseparable unit use another syringe for the preparation of the injection.
  3. Before and after administrating the injection, the rubber stopper of the bottle must be cleaned with alcohol or an alcohol based antiseptic solution to avoid that repeated insertions of the needle contaminate the contents.
  4. Remove the cover of the needle and let an amount of air equal to the amount of Primatropin into the syringe.
  5. Insert the cover of the bottle of reconstituted Primatropin and inject air into the bottle. Turn the bottle upside down and making sure that the needlepoint is in the solution, inject the exact dosage. Make sure that there are no air bubbles in the syringe.
  6. Remove the syringe and wrap up the needle. Write down the date of reconstitution on the label of the bottle and eliminate any diluent, which has not been used.
  7. Put the unused part of reconstituted Primatropin in the refrigerator and use it within 14 days.
  8. Destroy the needle or syringe needle unit once finished.

Primatropin Injections:

  1. Tap the spot chosen for the injection gently with one finger.
  2. Carefully clean the area with a cotton wad, which has been soaked in alcohol, making a circular movement, moving from the inside of the circle outward.
  3. Subcutaneous injections. Stabilize the skin between the thumb and the index finger and raise an ample portion of skin. Holding the needle at a 90-degree angle to the spot chosen for the injection, insert the entire needle into the skin. Slowly inject the liquid. Remove the needle quickly, exerting pressure on the place chosen for the injection with a dry gauze pad or a cotton wad. Rub for several seconds. Destroy the needle or the needle, syringe unit.
  4. Intramuscular injections. With the thumb and first two fingers, press firmly against an ample portion of muscle mass, such as the thigh. Holding the syringe at a 90-degree angle to the spot chosen for the injection, insert the entire needle into the skin. Holding the needle inside the place chosen for injection, slowly pull back the piston. Should blood appear in the syringe, remove the needle, throw out the syringe with the pharmaceutical product and prepare another injection. If blood does not enter the syringe, slowly inject the solution. Pull the needle out quickly,
    exerting pressure on the place of injection with a dry gauze pad or cotton wad. Rub for several seconds. Destroy the
    needle or the needle/ syringe unit when finished. If you are in any doubt, consult your doctor.

In case of overdose:
Overdose may cause hypoglycemia followed by hyperglycemia. Long term overdose may result in symptoms of acromegaly, similar to the effects of an excess of human somatotrophic hormone.

Side Effects:
In the course of clinical research studies on patients with growth hormone deficiency, which has never been treated on patients with Turner’s syndrome, a development of antibodies against the growth hormone, has been detected, but which has no effect on the rhythm of growth. Up to the present, long term effects caused by the presence of these antibodies have not been noted. Research into antibodies against the growth hormone should be carried out on all subjects who fail to respond to treatment. High doses of Primatropin deliberately given to healthy adults have on rare occasions produced the following effects- headache, local muscular pain, weakness, mild hypoglycemia and glycosuria. In studies on children with growth hormone deficiency, rare cases have been reported of pain in the area of the injection. 2.5% of those children treated has shown mild transitory oedema in the early stages of treatment. Should the patient notice any unpleasant side effect not described in this leaflet, he should consult his specialist or family doctor. Attention- Do not use this or any medicine once its expiry date has passed.

Special notes on storage:
Store in the refrigerator at +2 degrees Celsius to +8 degrees Celsius. Keep the diluent and the reconstituted product from freezing. If reconstituted with the accompanying diluent, the product may be kept for 14 days in the refrigerator without significant loss of properties. The above information is the translation of the manufacturer’s insert.

 

© Primatropin