Somatropin Biopartners
somatropin
Somatropin
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Medicinal product no longer authorised
What Somatropin Biopartners is and what it is used for
What you need to know before you use Somatropin Biopartners
How to use Somatropin Biopartners
Possible side effects
How to store Somatropin Biopartners
Contents of the pack and other information
Somatropin Biopartners contains human growth hormone, also called somatropin. Growth hormone regulates the growth and development of cells.
This medicine is used to treat adults with a lack (deficiency) of growth hormone who
already had growth hormone deficiency when they were children or
do not have enough growth hormone during adulthood.
if you are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6);
if you have cancer;
Tell your doctor if you have an active tumour (cancer). Tumours must be inactive and cancer therapy complete before you can start your treatment with growth hormone. Your doctor will stop your treatment with this medicine if there is evidence of cancerous growth;
if you are ill due to a serious heart or stomach operation;
if you are being treated for more than one injury following a serious accident;
if you experience sudden serious breathing problems.
Talk to your doctor before using Somatropin Biopartners if you:
are an adult who has been treated with growth hormone during childhood:
Your doctor will re-examine you for lack of growth hormone before restarting/continuing treatment;
have a hereditary disease called Prader-Willi syndrome:
You should not be treated with this medicine unless you also have a lack of growth hormone;
have had a tumour:
Your doctor will examine you frequently to ensure that the tumour has not come back;
have symptoms like severe and recurrent headache, visual changes, nausea and/or vomiting which may be due to increased pressure in the skull during growth hormone treatment;
suffer from an organic growth hormone deficiency (lack of growth hormone due to damage to the pituitary gland or the part of the brain called the hypothalamus) or decreased secretion of pituitary gland hormones:
Your doctor will check your levels of adrenal hormones (glucocorticoids) which may require adjustment once growth hormone therapy begins.
Monitoring during treatment
Your doctor may check the level of sugar in your urine or blood since it may be affected by this medicine.
You must have regular thyroid function tests as this medicine can affect the amount of thyroid hormone in the blood.
Medicinal product no longer authorised
If the thyroid is not working properly, this medicine may not work as well as it should.
For the treatment of children and adolescents aged 2 to 18 years vials with 10 mg and 20 mg somatropin should be used.
Tell your doctor or pharmacist if you are using, have recently used or are planning to use any other medicines.
In particular, inform your doctor if you are taking or have recently taken any of the following medicines. Your doctor may need to adjust the dose of Somatropin Biopartners or of the other medicines:
corticosteroids, such as cortisone or prednisolone: medicines to reduce inflammation or immune system activity, to prevent organ transplant rejection or to treat asthma
thyroxine: a medicine to treat reduced thyroid gland function
insulin: a medicine to lower blood sugar levels
The doctor will carefully monitor you during treatment as the effect of insulin may be reduced.
oestrogen taken orally or other sex hormones
medicines to treat epilepsy
cyclosporine: a medicine to suppress the immune system
You should not use Somatropin Biopartners if you are pregnant or are trying to become pregnant. If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known if this medicine passes into breast milk. If you are breast-feeding only use this medicine if your doctor indicates it is clearly necessary.
Somatropin Biopartners has no or negligible effects on the ability to drive and use machines.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
This medicince is injected once a week.
The dose will be calculated by your doctor as described below. Individual doses may vary and your doctor will always prescribe the minimum effective dose based on your specific need.
Your dose should be checked every 6 months by your doctor.
The recommended starting dose is 2 mg of somatropin injected once a week. For women taking oral oestrogens the starting dose is usually 3 mg injected once a week.
Medicinal product no longer authorised
Your doctor may decide upon a lower starting dose. If necessary, your doctor will gradually increase this dose according to your individual response to the treatment and your blood levels of a growth factor called IGF-I. The blood levels of IGF-I require regular monitoring so that they can be kept within the normal range for your age and gender.
Dosage reductions may be necessary:
in patients above 60 years of age
in patients who develop long lasting tissue swelling caused by fluid retention or who develop abnormal sensations such as prickling, tingling and itchiness
to avoid the development of carpal tunnel syndrome, where the nerve running through the wrist (the median nerve) becomes squeezed, resulting in hand numbness and pain
following use of the medicine over an extended period of time, particularly in men.
Please also see the required adjustments described in section 2, ‘Other medicines and Somatropin Biopartners’.
After the powder is evenly mixed with the solvent provided, this medicine is injected under the skin. This means that after preparation, the suspension is injected with a short needle into the fatty skin tissue. After the injection, growth hormone is slowly released into your body over a period of about a week.
Injections should always be given on the same day of the week and at the same time of day because it is easier to remember.
If you are injecting this medicine yourself you will be shown how to prepare and give the injection. Do not inject this medicine yourself unless you have received training and you understand the procedure.
Inject the medicine as instructed by your doctor who will also tell you what dose to use and how to inject this dose with the vials you have been prescribed. Fatty tissue under the skin can shrink at the site of injection on repeated administration at the same site. To avoid this, always change the injection site between injections. This gives your skin and the area under your skin time to recover from one injection before it gets another one in the same place.
Accidental injection of this medicine into the muscle instead of under the skin may result in blood sugar levels becoming too low. Contact your doctor if this happens.
Follow the instructions carefully step by step. Collect the following items before you begin:
supplied in the pack
Somatropin Biopartners vial containing active substance
Somatropin Biopartners vial containing 1.5 mL solvent for suspension for injection
not supplied in the pack
one sterile injection syringe with 19 (19G) or wider Gauge needle to withdraw the solvent
one sterile injection syringe with 26 Gauge (26G) needle for the injection
alcohol swabs
dry gauze or cotton pad
an adhesive plaster
disposal box for used syringes and needles
Medicinal product no longer authorised
Remove the carton from the refrigerator. Wash your hands thoroughly with soap and water and dry them with a clean towel before preparing your injection. This helps to prevent infection.
Warm the solvent vial to room temperature by gently rolling it between your hands. Tap and shake the vial of powder to make sure the powder is moving freely.
Remove the protective caps from the top of both vials as seen in figure 3a. Clean the rubber stopper of both vials with an alcohol swab (figure 3b).
figure 3a
figure 3b
Use a 1 mL graduated syringe with a 19G or wider needle for withdrawing the solvent from its vial.
Remove the needle guard and fill the syringe with a volume of air equal to the required volume of the solvent for injection, making it easier to withdraw the solvent:
0.4 mL in a 1 mL graduated syringe for Somatropin Biopartners 2 mg
0.6 mL in a 1 mL graduated syringe for Somatropin Biopartners 4 mg
0.9 mL in a 1 mL graduated syringe for Somatropin Biopartners 7 mg
Insert the needle through the centre of the rubber stopper of the solvent vial and inject all of the air into the vial.
figure 4
Turn the vial upside down, with the syringe inside and place the tip of the needle in the solvent as seen in figure 5. Slowly withdraw the required volume of solvent.
Medicinal product no longer authorised
To remove any bubbles, gently tap the syringe. Apply gentle pressure by pushing the plunger up, until all bubbles are removed from the syringe and needle. Continue to fill the syringe with the correct volume of the solvent for injection, as described in the text of figure 4 above. Withdraw the syringe needle from the vial. Do not use any remaining solvent for a second preparation!
figure 5
Inject the entire contents of the syringe into the vial of powder, holding the syringe against the vial wall. Withdraw the syringe and discard it.
figure 6
Vigorously swirl the vial without touching the rubber top with your fingers until the content is completely mixed. This usually takes approximately 60 seconds but can take up to 90 seconds. Only stop swirling the vial once the suspension appears uniform, white and all the powder on the bottom is dispersed. Use immediately, as the suspension may settle if left standing.
Do not use this medicine if you notice that it cannot be properly mixed.
figure 7
Clean the rubber stopper again with an unused alcohol swab.
Take a new syringe with a 26G needle. Remove the needle guard. Insert the needle straight through the centre of the vial’s rubber stopper into the suspension.
figure 8
Medicinal product no longer authorised
Turn the vial upside down, with the syringe in and place the tip of the needle in the suspension as shown in figure 9. Slowly withdraw the suspension. Because it is a thick mixture, the syringe might fill slowly. If the flow stops or bubbles appear, gently tap the syringe with your fingers. Apply gentle pressure to the plunger to get rid of the bubbles. Then continue to fill the syringe with the correct volume of suspension as advised by your doctor. Withdraw the syringe from the vial.
figure 9
Gently tap the syringe to remove small air bubbles. Hold the syringe upright. Apply gentle pressure to the plunger until a small drop of suspension appears at the end of the needle.
figure 10
Clean the injection site with an unused alcohol swab. Do not touch the needle or allow it to come into contact with any surface prior to the injection.
Gently pinch the skin that has been cleaned, to make a fold. Hold the fold between the thumb and the forefinger during the entire injection. Hold the syringe firmly by the finger grip. Insert the full length of the needle into the skin fold at a right angle (90 degrees) as shown in figure 12.
Medicinal product no longer authorised
figure 12
Inject the suspension over a period of 5 seconds by gently pushing the plunger until the syringe is empty. Slowly release the skin during the injection. After the injection, wait a few seconds, then quickly withdraw the needle with the plunger still pushed down. Apply gentle pressure to the injection site with a dry gauze or cotton pad. If a drop of blood appears, maintain the pressure for a few moments.
Put an adhesive plaster on the injection site.
The suspension is for immediate single use only. Any suspension remaining after the injection should be discarded.
Safely dispose of all used injection needles and syringes after a single use.
If you use more Somatropin Biopartners than you should, you should consult your doctor.
If you have used too much of this medicine, initially your blood sugar may decrease and become too low. Subsequently, it may increase and become too high. Prolonged overdose may result in a greater than normal growth of ears, nose, lips, tongue and cheekbone.
This medicine is used once a week. It is important to use each dose at the scheduled time. If you miss a dose, contact your doctor who will help establish a new dosing schedule. Do not take a double dose to make up for a forgotten dose.
Ask your doctor for advice before stopping treatment. Interruption or early stopping of treatment with this medicine may impair the success of the therapy.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects very commonly reported in adults (may affect more than 1 in 10 people) were tissue swelling due to fluid retention, mild increase in blood sugar and headache. Side effects were generally transient and mild to moderate.
Development of new tumours or reappearance of previously existing tumours has been reported during treatment with growth hormones. It is not known how often this may occur, but if you suspect that this is the case, contact your doctor since the treatment may have to be stopped.
Side effects can occur with the following frequencies: Common, may affect up to 1 in 10 people
virus infection known as Herpes simplex
skin tag (a form of harmless skin growth)
tiredness
weakness, feeling unwell
face swelling
Medicinal product no longer authorised
thirst
pain, chest pain, pain at the injection site
pain in the back, arms, legs, shoulders, bones, joints
sleeplessness
decreased sensation, numbness and tingling in fingers and palm of the hand due to squeezed nerve at wrist (carpal tunnel syndrome)
dizziness, sleepiness
muscular or bone stiffness, weakness of the muscles, muscle pain, feeling of heaviness
inflammation of the tendons, joint swelling, joint inflammation
reddening of the eyes, reduced vision, vertigo (a feeling of dizziness or spinning)
increased or irregular heart rate
high blood pressure
nosebleed
nausea
increased level of bilirubin, a substance produced by the liver
inflammation of the gall bladder
acne, increased sweating, skin rash
allergic skin reactions such as redness, irritation, itching
blood in the urine
nipple pain
reduced function of the adrenal gland (which could show as tiredness)
reduced function of the thyroid gland
increased fat levels in the blood
weight gain
development of substances (antibodies) in the blood that bind to growth hormone
changes in blood test results such as a change in the number of white blood cells or increased
levels of insulin, sugar, sodium or certain fatty substances in the blood
changes in liver test results
a type of benign brain tumour called craniopharyngioma
Uncommon, may affect up to 1 in 100 people
enlargement of the male breast
Rare, may affect up to 1 in 1,000 people
symptoms of increased pressure in the skull such as severe and recurrent headache, visual changes, nausea and/or vomiting
Not known, frequency cannot be estimated from the available data
a reduced response to insulin (insulin resistance)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.
Medicinal product no longer authorised
After preparation, the product must be used immediately.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is somatropin.
The other ingredients are sodium hyaluronate, egg phospholipids, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous.
Somatropin Biopartners is a powder and solvent for prolonged-release suspension for injection. The powder is white to almost white, the solvent is a clear liquid.
Pack size of 4 vials of powder and 4 vials of solvent.
Pack size of 4 vials of powder and 4 vials of solvent.
Pack size of 4 vials of powder and 4 vials of solvent.
BioPartners GmbH Kaiserpassage 11
D-72764 Reutlingen Germany
Tel: +49 (0)7121 948 7756
Fax: +49 (0)7121 346 255
BIOTON S.A.
Medicinal product no longer authorised
Macierzysz, 12, Poznanska, Str., 05-850 Ozarow Mazowiecki, Poland