The name of your medicine is Somatuline Autogel. It is a long-acting form of lanreotide.<\/p>\n\n\n\n
Lanreotide, the active substance, belongs to a group of medicines called “growth hormone inhibitors”.\u00a0They are similar to another substance (\u00a0hormone\u00a0) called “somatostatin”.\u00a0Lanreotide lowers the levels of\u00a0hormones\u00a0in the body, such as\u00a0growth hormone\u00a0(\u00a0GH\u00a0) and insulin-like growth factors 1 (\u00a0IGF\u00a0-1 ), and inhibits\u00a0the release\u00a0of certain\u00a0hormones\u00a0in the gastrointestinal tract and intestinal secretions.<\/p>\n\n\n\n
In addition, it has an effect on certain advanced types of\u00a0tumors\u00a0(so-called neuroendocrine\u00a0tumors\u00a0) in the intestine and the pancreas by stopping or delaying their growth.<\/p>\n\n\n\n
What Somatuline Autogel is used for<\/strong><\/p>\n\n\n\n <\/a><\/p>\n\n\n\n Talk to your doctor or pharmacist before using this medicine.<\/p>\n\n\n\n Somatuline Autogel can cause changes in the blood glucose level.\u00a0If you have\u00a0diabetes, the need for insulin may change.<\/p>\n\n\n\n Tell your doctor if you:<\/strong><\/p>\n\n\n\n If any of the above applies to you, talk to your doctor or pharmacist before using Somatuline Autogel.<\/a><\/p>\n\n\n\n Somatuline Autogel is not recommended for children and adolescents.<\/a><\/p>\n\n\n\n Some medicines can affect the effectiveness of other medicines.\u00a0Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Special care should be taken during simultaneous treatment with:<\/p>\n\n\n\n Dose adjustment of these drugs co-administered with lanreotide may be considered by your doctor.<\/a><\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.<\/p>\n\n\n\n Lanreotide should only be given to you if necessary.<\/p>\n\n\n\n Dizziness, fatigue, and weakness have been reported during treatment with Somatuline Autogel.\u00a0Your ability to drive and use machines may be affected.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance.\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.\u00a0Description 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. Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n Recommended dose:<\/strong><\/p>\n\n\n\n Treatment of acromegaly<\/em><\/p>\n\n\n\n The recommended\u00a0dose\u00a0is one\u00a0injection\u00a0every 28 days.\u00a0Your doctor can adjust the\u00a0dose\u00a0using one of the three available strengths of Somatuline Autogel (60, 90, or 120 mg).<\/p>\n\n\n\n If your treatment is under good control, your doctor may recommend a change in the frequency of your injections with Somatuline Autogel 120 mg to an injection every 42 or 56 days.<\/p>\n\n\n\n Your doctor will also decide how long the treatment period should be.<\/p>\n\n\n\n Symptom relief (such as flushing and diarrhea) associated with neuroendocrine tumors<\/em><\/p>\n\n\n\n The recommended\u00a0dose\u00a0is one\u00a0injection\u00a0every 28 days.\u00a0Your doctor can adjust the\u00a0dose\u00a0using one of the three available strengths of Somatuline Autogel (60, 90, or 120 mg).<\/p>\n\n\n\n If your treatment is under good control, your doctor may recommend a change in the frequency of your injections with Somatuline Autogel 120 mg, to an injection every 42 or 56 days.<\/p>\n\n\n\n Your doctor will also decide how long the treatment period should be.<\/p>\n\n\n\n Treatment of advanced tumors in the intestine and pancreas, so-called gastroenteropancreatic neuroendocrine tumors or GEP-NET. Used when this type of tumor cannot be removed by surgery.<\/em><\/p>\n\n\n\n The recommended dose is 120 mg every 28 days.<\/p>\n\n\n\n Your doctor will decide how long you should be treated with Somatuline Autogel for tumor control.<\/p>\n\n\n\n Mode of administration<\/strong><\/p>\n\n\n\n Somatuline Autogel should be given as a deep\u00a0subcutaneous\u00a0injection.<\/p>\n\n\n\n The injection\u00a0can be given by either a healthcare professional or caregiver (family member or friend) or by yourself, after appropriate training from a healthcare professional.<\/p>\n\n\n\n If the same\u00a0dose\u00a0of Somatuline Autogel is given, you or a trained person, after appropriate training, can inject the medicine yourself.\u00a0It is the healthcare staff who decide whether you or a trained person should\u00a0administer\u00a0the product.\u00a0For instructions on how to inject the medicine yourself or a trained person, read the instructions for use below.\u00a0If you have any doubts about how to\u00a0administer\u00a0this\u00a0injection, contact your doctor or healthcare professional for advice or further training.<\/p>\n\n\n\n Instructions for use<\/strong><\/p>\n\n\n\n NOTE! READ THE ENTIRE INSTRUCTIONS CAREFULLY BEFORE STARTING INJECTION ONE.<\/strong><\/p>\n\n\n\n Injection\u00a0one is a deep\u00a0subcutaneous\u00a0injection\u00a0that requires a specific technique that differs from normal subcutaneous\u00a0injections.<\/p>\n\n\n\n The following instructions describe how Somatuline Autogel should be injected.<\/p>\n\n\n\n Somatuline Autogel is supplied ready to use in a pre-filled syringe equipped with an automatic needle guard. The needle will retract automatically after completing the full injection, to prevent needlestick injuries.<\/p>\n\n\n\n If you have ingested too much medicine or if, for example,\u00a0a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.<\/p>\n\n\n\n Contact the healthcare system as soon as you discover that you have missed an\u00a0injection.\u00a0They will advise you when to take your next\u00a0injection.\u00a0Do not self-inject an extra\u00a0injection\u00a0to make up for a missed\u00a0injection\u00a0without talking to your healthcare provider.<\/p>\n\n\n\n A break in more than one dose or premature termination of treatment with Somatuline Autogel may affect the success of the treatment. Talk to your doctor before stopping treatment.<\/p>\n\n\n\nWhat you need to know before using Somatuline Autogel<\/h2>\n\n\n\n
Do not use Somatuline Autogel<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Somatuline Autogel<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Somatuline Autogel<\/h2>\n\n\n\n
<\/a><\/figure>\n\n\n\n
Do not use the pre-filled syringe:
The product should be given immediately after opening the laminated protective bag.<\/li>
a) If a healthcare professional or someone else, such as a trained family member or friend, is giving the injection: inject it into the upper outer quadrant of the buttock or the upper outer thigh. b) If you\u00a0inject\u00a0yourself: inject into the upper outer part of the thigh.
<\/a>
Alternate the injection site\u00a0between the right and left sides each time you receive Somatuline Autogel.\u00a0Avoid areas with liver spots, scar tissue,\u00a0reddened\u00a0skin, or skin that feels uneven.<\/li>
Do not aspirate\u00a0(do not retract)<\/a><\/li>
Note: Maintain thumb pressure on the plunger to prevent premature activation of the automatic needle guard.<\/a><\/li>If you have used too much Somatuline Autogel <\/h2>\n\n\n\n
If you forget to use Somatuline Autogel<\/h2>\n\n\n\n
If you stop using Somatuline Autogel<\/h2>\n\n\n\n