50 micrograms / ml, 100 micrograms / ml and 500 micrograms / ml solution for injection / infusion
octreotide
What Sandostatin is and what it is used for
Sandostatin is a synthetic version of somatostatin, a substance that occurs naturally in the body and which inhibits the effects of certain hormones such as. growth hormone. The advantages of Sandostatin compared to somatostatin are that it is stronger and that the effect lasts longer.
Sandostatin is used
- in acromegaly, a condition in which the body produces too much growth hormone. Normally, growth hormone controls the growth of tissues, organs, and bones. Too much growth hormone causes the size of your bones and tissues to increase, especially in your hands and feet. Sandostatin significantly reduces the symptoms of acromegaly, which include headaches, excessive sweating, numbness in the hands and feet, fatigue, and joint pain.
- to relieve symptoms associated with certain tumors in the gastrointestinal tract (eg carcinoid tumors, VIP tumors, glucagon, gastrinoma, insulinoma). In these conditions, there is an overproduction of certain hormones and other similar substances in the stomach, intestines, or pancreas. This overproduction upsets the natural hormone balance in the body and results in a variety of symptoms, such as redness, diarrhea, low blood pressure, rash, and weight loss. Sandostatin treatment helps control these symptoms.
- to prevent complications after surgery on the pancreas. Treatment with Sandostatin helps to reduce the risk of complications (eg accumulation in the abdomen and inflammation of the pancreas) after surgery.
- to stop bleeding and protect against re-bleeding from ruptured gastroesophageal varices in patients with cirrhosis ( chronic liver disease). Sandostatin treatment helps control bleeding and reduces the need for transfusions.
- to treat pituitary tumors that produce too much thyroid-stimulating hormone ( TSH ). Too much thyroid-stimulating hormone ( TSH ) leads to hyperthyroidism. Sandostatin is used to treat people with pituitary tumors that produce too much thyroid-stimulating hormone ( TSH ):
- when other types of treatments ( surgery or radiation therapy) are not appropriate or have not worked.
- after radiation treatment to cover the transition period until the radiation treatment becomes fully effective.
Octreotide contained in Sandostatin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Sandostatin
Do not use Sandostatin:
- if you are allergic to octreotide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before using Sandostatin:
- If you know you have gallstones or have had it before or if you experience other complications such as fever, chills, abdominal pain, yellow skin, or yellow eyes, tell your doctor as long-term use of Sandostatin can lead to gallstone formation. Your doctor may want to check your gallbladder at regular intervals.
- if you have problems with your blood sugar levels, either they are too high ( diabetes ) or too low (hypoglycemia). Blood glucose control is mandatory when Sandostatin is used to treat bleeding gastroesophageal varices.
- If you have had a B12 deficiency in the past, your doctor may want to check your B12 levels at regular intervals.
- Octreotide can lower the heart rate and can cause abnormal heart rhythms in very high doses. Your doctor may monitor your heart rate during treatment.
Sampling and inspections
If you are being treated with Sandostatin for a long time, your doctor may want to check your thyroid function at regular intervals.
Your doctor will check your liver function.
Your doctor may want to check your pancreatic enzyme function.
Children and young people
Experience with Sandostatin in children is limited
Other medicines and Sandostatin
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
You can usually continue to take other medicines while you are being treated with Sandostatin. However, certain drugs such as cimetidine, ciclosporin, bromocriptine, quinidine, and terfenadine have been reported to be affected by Sandostatin.
If you are being treated with medicine to control your blood pressure (such as a beta-blocker or a calcium channel blocker) or medicine to regulate your fluid and electrolyte balance, your doctor may need to adjust your dose.
If you are diabetic, your doctor may need to adjust your insulin dose.
If you are being treated with lutetium ( 177 Lu) oxodotreotide, a radioactive medicine, your doctor may stop and/or adjust your treatment with Sandostatin.
Pregnancy, breastfeeding, and fertility
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 taking this medicine.
Sandostatin should only be used during pregnancy if necessary.
Female patients who may become pregnant should use a safe method of contraception during treatment.
Do not breastfeed during treatment with Sandostatin. It is not known if Sandostatin passes into breast milk.
Driving and using machines
Sandostatin has no or negligible effects on the ability to drive and use machines. However, some of the side effects that you may get from Sandostatin treatment, such as headaches and fatigue, may impair your ability to drive and use machines safely.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sandostatin contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free’.
How to use Sandostatin
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Depending on the condition being treated, Sandostatin is given as:
- subcutaneous (under the skin) injection or
- intravenous (in a vein) infusion.
If you have liver cirrhosis ( chronic liver disease), your doctor may need to adjust your maintenance dose.
Your doctor or nurse will explain to you how to inject Sandostatin under the skin, but a vein infusion should always be performed by a healthcare professional.
- Subcutaneous injection
The upper arms, thighs, and abdomen are suitable areas for subcutaneous injection.
Choose a new site for each subcutaneous injection so that you do not irritate a specific area. Patients who will inject themselves must receive careful instructions from a doctor or nurse.
If you store the medicine in the refrigerator, it is recommended that you allow it to reach room temperature before using it. It reduces the risk of pain at the injection site. You can warm it in your hand but do not heat it.
A few people experience pain at the site of the subcutaneous injection. This pain usually lasts only a short time. If this happens to you, you can relieve the pain by gently rubbing the injection site for a few seconds after the injection.
Review the solution for particulate matter or discoloration before using a Sandostatin ampoule. Do not use it if you see anything unusual.
If you use more Sandostatin than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
The symptoms of overdose are: irregular heartbeat, low blood pressure, cardiac arrest, decreased supply of oxygen to the brain, severe upper abdominal pain, yellowing of the skin and eyes, nausea, decreased appetite, diarrhea, weakness, fatigue, lack of energy, weight loss, swollen abdomen, discomfort, high levels of lactic acid in the blood and abnormal heart rhythm.
If you think you have had an overdose and are experiencing such symptoms, talk to your doctor immediately.
If you forget to use Sandostatin
Take a dose as soon as you remember, then continue as usual. It does not harm if you miss a dose, but you can temporarily get symptoms back before you return to the dosing schedule.
Do not inject a double dose of Sandostatin to make up for a forgotten dose.
If you stop using Sandostatin
If you stop taking Sandostatin, your symptoms may return. Therefore, you should not stop treatment unless your doctor advises you to do so.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. Talk to your doctor immediately if you get any of the following:
Very common (may affect more than 1 in 10 people):
- Gallstones lead to sudden back pain.
- High blood sugar.
Common (may affect up to 1 in 10 people):
- Underactive thyroid gland ( hypothyroidism ) which causes changes in heart rate, appetite, or weight; fatigue, coldness, or swelling on the front of the throat.
- Changes in thyroid function tests.
- Inflammation of the gallbladder (cholecystitis); Symptoms may include pain in the upper right part of the abdomen, fever, nausea, yellowing of the skin, and eyes (jaundice).
- Low blood sugar.
- Impaired glucose tolerance.
- Slow heartbeat.
Uncommon (may affect up to 1 in 100 people):
- Thirst, low urine production, dark urine, dry reddened skin.
- Fast heartbeat.
Other serious side effects are
- Hypersensitivity reaction (allergic) including skin rash.
- A type of allergic reaction ( anaphylaxis ) that can cause difficulty swallowing or breathing, swelling and tingling, and even drops in blood pressure that can lead to dizziness or unconsciousness.
- Inflammation of the pancreas ( pancreatitis ); symptoms may include sudden pain in the upper abdomen, nausea, vomiting, and diarrhea.
- Inflammation of the liver ( hepatitis ); Symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general malaise, itching, and light-colored urine.
- Irregular heartbeats.
- Low platelet count, may lead to an increased tendency for bleeding or bruising.
Talk to your doctor immediately if you experience any of the side effects listed above.
Other side effects:
Tell your doctor, pharmacist, or nurse if you notice any of the side effects below. They are usually mild and tend to disappear during treatment.
Very common (may affect more than 1 in 10 people):
- Diarrhea.
- Stomach pain.
- Nausea.
- Constipation.
- Gas formation.
- Headache
- Pain at the injection site.
Common (may affect up to 1 in 10 people):
- Stomach upset after a meal ( dyspepsia ).
- Vomiting.
- Feeling full.
- Fatty stools.
- Loose stools.
- Discolored stools.
- Dizziness.
- Loss of appetite.
- Changes in liver function tests.
- Hair loss.
- Respiratory distress.
- Faintness
If you get any side effects, talk to your doctor, pharmacist, or nurse.
A few people experience pain at the site of the subcutaneous injection. This pain usually lasts only a short time. If this happens to you, you can relieve the pain by gently rubbing the injection site for a few seconds after the injection.
If you take Sandostatin as a subcutaneous injection, you can reduce the risk of side effects from the gastrointestinal tract if you avoid meals around the time of injection. It is therefore recommended that you inject Sandostatin between meals or at bedtime.
How to store Sandostatin
Keep this medicine out of the sight and reach of children.
Store in the original package. Sensitive to light.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
The ampoules can be stored at a maximum of 30 ° C for up to two weeks.
The ampoules should be used immediately after opening.
Diluted solutions should be used immediately after reconstitution.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice particles or discoloration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is octreotide.Sandostatin 50 micrograms / ml: 1 ml solution contains 50 micrograms octreotide.Sandostatin 100 micrograms / ml: 1 ml solution contains 100 micrograms octreotide.Sandostatin 500 micrograms / ml: 1 ml solution contains 500 micrograms octreotide.
- Other ingredients are: lactic acid, mannitol (E421), sodium bicarbonate, water for injections
What the medicine looks like and the contents of the pack
Stained glass ampoule with two color-coded rings containing clear, colorless solution
Sandostatin 50 micrograms/ml: one blue and one yellow
Sandostatin 100 micrograms/ml: one blue and one green
Sandostatin 500 micrograms/ml: one blue and one pink
Packs of three, five, six, ten, twenty, and fifty ampoules.
Multipack of ten packs containing three ampoules each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Sverige AB
Box 1218
SE-164 28 Kista
This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
| Bulgaria, Cyprus, Denmark, Estonia, Finland, United Kingdom (Northern Ireland), Greece, Iceland, Ireland, Croatia, Latvia, Lithuania, Malta, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, Germany, Hungary, Austria, | Sandostatin |
| Belgium, France, Luxembourg, the Netherlands | Sandostatin |
| Italy, Portugal | Sandostatin |