The somatropin contained in Zomacton may also be approved to treat other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
<\/p>\n\n\n\n
What you need to know before you use Zomacton<\/h2>\n\n\n\nDo not use Zomacton<\/h2>\n\n\n\n- if you are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6)<\/li>
- for children with closed epiphyses (children who have stopped growing)<\/li>
- do not use Zomacton and tell your doctor if you have an active\u00a0tumor\u00a0(cancer);\u00a0tumors\u00a0must be inactive and you must have finished your tumor treatment before starting treatment with Zomacton<\/li>
- to premature or newborn babies because the diluent contains benzyl alcohol<\/li>
- in case of acute critical medical conditions such as complications for example after open heart or abdominal surgery, multiple trauma from an accident, or breathing problems<\/li>
- to children with\u00a0chronic\u00a0kidney disease during kidney transplantation<\/li><\/ul>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Talk to your doctor before using Zomacton.<\/p>\n\n\n\n
Treatment with Zomacton should only take place under the supervision of a qualified physician experienced in the treatment of patients with growth hormone deficiency.<\/p>\n\n\n\n
- As benzyl alcohol is included as an excipient, Zomacton can cause poisoning and allergic reactions in children under 3 years of age and should not be given to premature babies or newborns.<\/li>
- Patients with Prader-Willi syndrome should not be treated with Zomacton unless they also suffer from\u00a0growth hormone deficiency.<\/li>
- If you have a family history of\u00a0diabetes, your blood sugar levels may need to be checked from time to time by your doctor.<\/li>
- If you have\u00a0diabetes, your blood glucose levels need to be checked regularly and your\u00a0dose\u00a0may need to be adjusted to maintain diabetic control.\u00a0Your doctor will let you know if this is necessary.<\/li>
- If your growth hormone deficiency is due to an\u00a0intracranial\u00a0injury, you should be closely monitored for worsening or recurrence of the injury.\u00a0If this happens, your doctor will tell you if you need to stop taking Zomacton.<\/li>
- Tell your doctor if you notice signs or symptoms of recurrence of previous malignancies.<\/li>
- If you are on\u00a0glucocorticoid\u00a0replacement therapy, you should regularly contact your doctor, as you may need to adjust your glucocorticoid dose.<\/li>
- If you develop signs or symptoms of the following while you are being treated with Zomacton, contact your doctor or emergency department immediately:
- repeated or severe headaches<\/li>
- vision problems<\/li>
- nausea and\/or vomiting<\/li><\/ul><\/li>
- Disturbances in thyroid function may occur during treatment with Zomacton.\u00a0This may require a change\u00a0in therapy.\u00a0Your doctor will usually ask you to have regular tests to make sure your thyroid is working properly.<\/li>
- Some children with\u00a0growth hormone deficiency\u00a0have developed\u00a0leukemia\u00a0(increased amount of\u00a0white blood cells\u00a0) regardless of whether they have received\u00a0growth hormone\u00a0treatment or not.\u00a0However, there is no evidence that the frequency of\u00a0leukemia\u00a0would be greater than in the general population.\u00a0No link between\u00a0growth hormones\u00a0and\u00a0leukemia\u00a0has been proven.<\/li>
- Consult your doctor if you develop lameness or pain in your hip or knee.<\/li>
- If you suffer from complications after surgery, trauma, or acute breathing problems.<\/li>
- If you need surgery, are seriously injured in an accident, or become seriously ill, your doctor may need to review your treatment.<\/li><\/ul>\n\n\n\n
Other medicines and Zomacton<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.<\/p>\n\n\n\n
- Patients treated with\u00a0glucocorticoid\u00a0er may need to have their\u00a0dose\u00a0carefully adjusted because\u00a0glucocorticoid\u00a0er may\u00a0inhibit\u00a0the growth-promoting effect of somatropin.\u00a0Therefore, tell your doctor if you are being treated with\u00a0steroids\u00a0for insufficient production of ACTH (adrenocorticotropic\u00a0hormone\u00a0).<\/li>
- Androgens,\u00a0estrogens,\u00a0and anabolic\u00a0steroids\u00a0can accelerate bone maturation and thus reduce the overall growth rate.<\/li>
- As somatropin can cause insulin resistance, the insulin dose may need to be adjusted in patients with\u00a0diabetes.<\/li>
- Tell your doctor if you are regularly treated with prescription drugs such as\u00a0steroids, anti-epileptic drugs,\u00a0or drugs that weaken the body’s immune system.<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
There is no experience of use in pregnant women. Zomacton should therefore not be used during pregnancy.<\/p>\n\n\n\n
It is unknown whether Zomacton passes into breast milk. Zomacton should therefore not be used during breastfeeding.<\/a><\/p>\n\n\n\nDriving ability and use of machinery<\/h2>\n\n\n\n
Zomacton has no or negligible effect on the ability to drive or use machines.<\/p>\n\n\n\n
You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
Zomacton contains benzyl alcohol 9 mg\/ml<\/h2>\n\n\n\n
As benzyl alcohol is included as an excipient, Zomacton can cause poisoning and allergic reactions in children under 3 years of age and should not be given to premature babies or newborns.
<\/a><\/p>\n\n\n\nHow to use Zomacton<\/h2>\n\n\n\n
Always use Zomacton as directed by your doctor. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
Your doctor or nurse will usually decide with you which is the most appropriate method of administration and provide you with dosing instructions for the method used.\u00a0Dose\u00a0one is administered\u00a0subcutaneously\u00a0(under the skin) with a\u00a0syringe\u00a0or with a needle-free injection aid, Zomajet 4, or with Ferring-Pen, an injection aid with a needle.<\/p>\n\n\n\n
Dosage:<\/strong><\/p>\n\n\n\nGrowth hormone deficiency in children:<\/strong><\/p>\n\n\n\nYour doctor will calculate the exact\u00a0dose\u00a0for you based on your body weight.\u00a0Generally, a\u00a0dose\u00a0of 0.17-0.23 mg per kg of body weight per week is recommended.\u00a0The weekly dose can be divided into six or seven\u00a0doses, corresponding to a daily dose of 0.02-0.03 mg per kg of body weight.\u00a0The maximum recommended\u00a0dose\u00a0per week is 0.27 mg per kg of body weight, corresponding to a daily dose of 0.04 mg per kg of body weight.<\/p>\n\n\n\n
Turner syndrome (females only):<\/strong><\/p>\n\n\n\nYour doctor will calculate the exact\u00a0dose\u00a0for you based on your body weight.\u00a0Generally, a\u00a0dose\u00a0of 0.33 mg per kg of body weight per week is recommended.\u00a0The weekly dose can be divided into six or seven\u00a0doses, corresponding to a daily dose of 0.05 mg per kg of body weight.<\/p>\n\n\n\n
Instructions for use for\u00a0the preparation\u00a0of solution<\/strong><\/p>\n\n\n\nThe powder should only be dissolved in the supplied diluent<\/p>\n\n\n\n
Two strengths can be prepared depending on the volume of solvent used. The doctor will tell you what strength to use.<\/p>\n\n\n\n
- for use of the Zomajet 4, Ferring-Pen, or a regular\u00a0syringe, use 1.3 ml of the solvent and prepare a solution that is 3.3 mg\/ml<\/li>
- for use of a regular\u00a0syringe, use 3.2 ml of the solvent and prepare a solution that is 1.3 mg\/ml<\/li><\/ul>\n\n\n\n
Preparation\u00a0must take place by good aseptic\u00a0practice.<\/p>\n\n\n\n![\"Attach](\"https:\/\/www.fass.se\/res\/RootMedia\/Ferring\/Media\/Zomacton\/PIL4mg\/Bild1.jpg\" "\\"Attach")
<\/a><\/figure>\n\n\n\n1a. Attach the needle to the graduated syringe.<\/p>\n\n\n\n
1b. Open the plastic cap on the vial.<\/p>\n\n\n\n![\"Open](\"https:\/\/www.fass.se\/res\/RootMedia\/Ferring\/Media\/Zomacton\/PIL4mg\/Bild201a2db.jpg\" "\\"Open")
<\/a><\/figure>\n\n\n\n2. Break off the top of\u00a0the ampoule\u00a0one.\u00a0Remove the plastic cover from the needle.\u00a0Make sure the plunger is fully depressed before inserting the needle into\u00a0ampoule\u00a0one.\u00a0Slowly draw up the required volume into the syringe.<\/p>\n\n\n\n![\"Inject](\"https:\/\/www.fass.se\/res\/RootMedia\/Ferring\/Media\/Zomacton\/PIL4mg\/Bild202.jpg\" "\\"Inject")
<\/a><\/figure>\n\n\n\n3. To avoid foaming, inject the solvent along the wall of the vial.<\/p>\n\n\n\n![\"Swing](\"https:\/\/www.fass.se\/res\/RootMedia\/Ferring\/Media\/Zomacton\/PIL4mg\/Bild203.jpg\" "\\"Swing")
<\/a><\/figure>\n\n\n\n4. Swirl the vial gently to mix the solution into a clear, colorless solution. As the powder mainly contains protein , the solution should not be<\/em> shaken.<\/p>\n\n\n\nIf the solution is cloudy or contains particles, the vial and its contents should be discarded.<\/p>\n\n\n\n
If the solution is cloudy after refrigerated storage, allow it to reach room temperature (25\u00b0C). If the turbidity still persists or if the solution is colored, discard the vial and its contents.<\/p>\n\n\n\n
If the solution is stored in a refrigerator, it can be used for up to 14 days after preparation . Unused solution must be discarded after 14 days of storage.<\/p>\n\n\n\n
Administration<\/em><\/p>\n\n\n\nThe clear, colorless solution should be injected subcutaneously as shown either by syringe or Zomajet 4 or Ferring Pen.<\/p>\n\n\n\n
ZomaJet 4 (an injection device without a needle) and Ferring-Pen (an injection device with a needle) are not provided in the package)<\/p>\n\n\n\n
Below is a general description of the use of the adapter prior to the administration procedure with Zomajet 4. Administration should be performed using good aseptic practice .<\/p>\n\n\n\n
- Wash hands thoroughly.<\/li>
- Wipe the top of the vial with antiseptic solution to avoid contamination of the contents.<\/li>
- Center the tip of the adapter on the vial membrane and push the adapter down until it attaches to the vial. Twist the adapter gently when connecting to the vial to allow the adapter tip to easily puncture the vial membrane .<\/li>
- To remove the adapter cap, hold the vial and adapter with one hand and pull the cap straight up. Save the lid for later storage.<\/li><\/ol>\n\n\n\n
The steps for positioning the adapter for use with the ZomaJet 4 are shown below.\u00a0Instructions for using the ZomaJet 4 can be found in a leaflet enclosed with the device.<\/p>\n\n\n\n
- if you are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6)<\/li>
- for children with closed epiphyses (children who have stopped growing)<\/li>
- do not use Zomacton and tell your doctor if you have an active\u00a0tumor\u00a0(cancer);\u00a0tumors\u00a0must be inactive and you must have finished your tumor treatment before starting treatment with Zomacton<\/li>
- to premature or newborn babies because the diluent contains benzyl alcohol<\/li>
- in case of acute critical medical conditions such as complications for example after open heart or abdominal surgery, multiple trauma from an accident, or breathing problems<\/li>
- to children with\u00a0chronic\u00a0kidney disease during kidney transplantation<\/li><\/ul>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Talk to your doctor before using Zomacton.<\/p>\n\n\n\n
Treatment with Zomacton should only take place under the supervision of a qualified physician experienced in the treatment of patients with growth hormone deficiency.<\/p>\n\n\n\n
- As benzyl alcohol is included as an excipient, Zomacton can cause poisoning and allergic reactions in children under 3 years of age and should not be given to premature babies or newborns.<\/li>
- Patients with Prader-Willi syndrome should not be treated with Zomacton unless they also suffer from\u00a0growth hormone deficiency.<\/li>
- If you have a family history of\u00a0diabetes, your blood sugar levels may need to be checked from time to time by your doctor.<\/li>
- If you have\u00a0diabetes, your blood glucose levels need to be checked regularly and your\u00a0dose\u00a0may need to be adjusted to maintain diabetic control.\u00a0Your doctor will let you know if this is necessary.<\/li>
- If your growth hormone deficiency is due to an\u00a0intracranial\u00a0injury, you should be closely monitored for worsening or recurrence of the injury.\u00a0If this happens, your doctor will tell you if you need to stop taking Zomacton.<\/li>
- Tell your doctor if you notice signs or symptoms of recurrence of previous malignancies.<\/li>
- If you are on\u00a0glucocorticoid\u00a0replacement therapy, you should regularly contact your doctor, as you may need to adjust your glucocorticoid dose.<\/li>
- If you develop signs or symptoms of the following while you are being treated with Zomacton, contact your doctor or emergency department immediately:
- repeated or severe headaches<\/li>
- vision problems<\/li>
- nausea and\/or vomiting<\/li><\/ul><\/li>
- Disturbances in thyroid function may occur during treatment with Zomacton.\u00a0This may require a change\u00a0in therapy.\u00a0Your doctor will usually ask you to have regular tests to make sure your thyroid is working properly.<\/li>
- Some children with\u00a0growth hormone deficiency\u00a0have developed\u00a0leukemia\u00a0(increased amount of\u00a0white blood cells\u00a0) regardless of whether they have received\u00a0growth hormone\u00a0treatment or not.\u00a0However, there is no evidence that the frequency of\u00a0leukemia\u00a0would be greater than in the general population.\u00a0No link between\u00a0growth hormones\u00a0and\u00a0leukemia\u00a0has been proven.<\/li>
- Consult your doctor if you develop lameness or pain in your hip or knee.<\/li>
- If you suffer from complications after surgery, trauma, or acute breathing problems.<\/li>
- If you need surgery, are seriously injured in an accident, or become seriously ill, your doctor may need to review your treatment.<\/li><\/ul>\n\n\n\n
Other medicines and Zomacton<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.<\/p>\n\n\n\n
- Patients treated with\u00a0glucocorticoid\u00a0er may need to have their\u00a0dose\u00a0carefully adjusted because\u00a0glucocorticoid\u00a0er may\u00a0inhibit\u00a0the growth-promoting effect of somatropin.\u00a0Therefore, tell your doctor if you are being treated with\u00a0steroids\u00a0for insufficient production of ACTH (adrenocorticotropic\u00a0hormone\u00a0).<\/li>
- Androgens,\u00a0estrogens,\u00a0and anabolic\u00a0steroids\u00a0can accelerate bone maturation and thus reduce the overall growth rate.<\/li>
- As somatropin can cause insulin resistance, the insulin dose may need to be adjusted in patients with\u00a0diabetes.<\/li>
- Tell your doctor if you are regularly treated with prescription drugs such as\u00a0steroids, anti-epileptic drugs,\u00a0or drugs that weaken the body’s immune system.<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
There is no experience of use in pregnant women. Zomacton should therefore not be used during pregnancy.<\/p>\n\n\n\n
It is unknown whether Zomacton passes into breast milk. Zomacton should therefore not be used during breastfeeding.<\/a><\/p>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Zomacton has no or negligible effect on the ability to drive or use machines.<\/p>\n\n\n\n
You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
Zomacton contains benzyl alcohol 9 mg\/ml<\/h2>\n\n\n\n
As benzyl alcohol is included as an excipient, Zomacton can cause poisoning and allergic reactions in children under 3 years of age and should not be given to premature babies or newborns.
<\/a><\/p>\n\n\n\nHow to use Zomacton<\/h2>\n\n\n\n
Always use Zomacton as directed by your doctor. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
Your doctor or nurse will usually decide with you which is the most appropriate method of administration and provide you with dosing instructions for the method used.\u00a0Dose\u00a0one is administered\u00a0subcutaneously\u00a0(under the skin) with a\u00a0syringe\u00a0or with a needle-free injection aid, Zomajet 4, or with Ferring-Pen, an injection aid with a needle.<\/p>\n\n\n\n
Dosage:<\/strong><\/p>\n\n\n\n
Growth hormone deficiency in children:<\/strong><\/p>\n\n\n\n
Your doctor will calculate the exact\u00a0dose\u00a0for you based on your body weight.\u00a0Generally, a\u00a0dose\u00a0of 0.17-0.23 mg per kg of body weight per week is recommended.\u00a0The weekly dose can be divided into six or seven\u00a0doses, corresponding to a daily dose of 0.02-0.03 mg per kg of body weight.\u00a0The maximum recommended\u00a0dose\u00a0per week is 0.27 mg per kg of body weight, corresponding to a daily dose of 0.04 mg per kg of body weight.<\/p>\n\n\n\n
Turner syndrome (females only):<\/strong><\/p>\n\n\n\n
Your doctor will calculate the exact\u00a0dose\u00a0for you based on your body weight.\u00a0Generally, a\u00a0dose\u00a0of 0.33 mg per kg of body weight per week is recommended.\u00a0The weekly dose can be divided into six or seven\u00a0doses, corresponding to a daily dose of 0.05 mg per kg of body weight.<\/p>\n\n\n\n
Instructions for use for\u00a0the preparation\u00a0of solution<\/strong><\/p>\n\n\n\n
The powder should only be dissolved in the supplied diluent<\/p>\n\n\n\n
Two strengths can be prepared depending on the volume of solvent used. The doctor will tell you what strength to use.<\/p>\n\n\n\n
- for use of the Zomajet 4, Ferring-Pen, or a regular\u00a0syringe, use 1.3 ml of the solvent and prepare a solution that is 3.3 mg\/ml<\/li>
- for use of a regular\u00a0syringe, use 3.2 ml of the solvent and prepare a solution that is 1.3 mg\/ml<\/li><\/ul>\n\n\n\n
Preparation\u00a0must take place by good aseptic\u00a0practice.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n1a. Attach the needle to the graduated syringe.<\/p>\n\n\n\n
1b. Open the plastic cap on the vial.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n2. Break off the top of\u00a0the ampoule\u00a0one.\u00a0Remove the plastic cover from the needle.\u00a0Make sure the plunger is fully depressed before inserting the needle into\u00a0ampoule\u00a0one.\u00a0Slowly draw up the required volume into the syringe.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n3. To avoid foaming, inject the solvent along the wall of the vial.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n4. Swirl the vial gently to mix the solution into a clear, colorless solution. As the powder mainly contains protein , the solution should not be<\/em> shaken.<\/p>\n\n\n\n
If the solution is cloudy or contains particles, the vial and its contents should be discarded.<\/p>\n\n\n\n
If the solution is cloudy after refrigerated storage, allow it to reach room temperature (25\u00b0C). If the turbidity still persists or if the solution is colored, discard the vial and its contents.<\/p>\n\n\n\n
If the solution is stored in a refrigerator, it can be used for up to 14 days after preparation . Unused solution must be discarded after 14 days of storage.<\/p>\n\n\n\n
Administration<\/em><\/p>\n\n\n\n
The clear, colorless solution should be injected subcutaneously as shown either by syringe or Zomajet 4 or Ferring Pen.<\/p>\n\n\n\n
ZomaJet 4 (an injection device without a needle) and Ferring-Pen (an injection device with a needle) are not provided in the package)<\/p>\n\n\n\n
Below is a general description of the use of the adapter prior to the administration procedure with Zomajet 4. Administration should be performed using good aseptic practice .<\/p>\n\n\n\n
- Wash hands thoroughly.<\/li>
- Wipe the top of the vial with antiseptic solution to avoid contamination of the contents.<\/li>
- Center the tip of the adapter on the vial membrane and push the adapter down until it attaches to the vial. Twist the adapter gently when connecting to the vial to allow the adapter tip to easily puncture the vial membrane .<\/li>
- To remove the adapter cap, hold the vial and adapter with one hand and pull the cap straight up. Save the lid for later storage.<\/li><\/ol>\n\n\n\n
The steps for positioning the adapter for use with the ZomaJet 4 are shown below.\u00a0Instructions for using the ZomaJet 4 can be found in a leaflet enclosed with the device.<\/p>\n\n\n\n