50 micrograms / ml, 100 micrograms / ml, 200 micrograms / ml, 500 micrograms / ml solution for injection octreotide
What Oktreotide SUN is and what it is used for
Octreotide SUN 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 Octreotide SUN compared to somatostatin are that it is stronger and that the effect lasts longer.
Octreotide SUN 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. Octreotide SUN 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 , insulinomas, GRF-producing tumors ). 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. Treatment with Octreotide SUN helps control these symptoms.
- to prevent complications after surgery of the pancreas . Treatment with Octreotide SUN 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 rebleeding from ruptured gastroesophageal varices in patients with cirrhosis ( chronic liver disease). Treatment with Octreotide SUN 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 .
- Octreotide SUN 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 Oktreotide SUN may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Oktreotide SUN
Do not use Octreotide SUN
- 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 Oktreotide SUN:
- If you know you have gallstones or have had it before, tell your doctor as long-term use of Octreotide SUN may 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 ( hypoglycaemia ). Monitoring of blood glucose levels is mandatory when Octreotide SUN is used to treat bleeding gastroesophageal varices.
- If you have a history of vitamin B12 deficiency, your doctor may want to check your B12 levels at regular intervals.
Sampling and inspections
If you have been treated with Octreotide SUN for a long time, your doctor may want to check your thyroid function at regular intervals.
Your doctor will check your liver function.
Children and young people
Experience with Octreotide SUN in children is limited.
Other medicines and Oktreotide SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can usually continue to take other medicines while you are being treated with Oktreotide SUN. However, certain drugs such as cimetidine, ciclosporin, bromocriptine, quinidine, and terfenadine have been reported to be affected by Octreotide SUN.
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.
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.
Octreotide SUN 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 Oktreotide SUN. It is not known if Oktreotide SUN passes into breast milk.
Driving and using machines
Octreotide SUN has no or negligible effect on the ability to drive and use machines. However, some of the side effects that you may get from treatment with Oktreotide SUN, 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.
Important information about some of the ingredients of Oktreotide SUN
This medicine contains less than 1 mmol sodium (23 mg) per ml solution, ie essentially ‘sodium-free’.
How to use Oktreotide SUN
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, Oktreotide SUN 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 Oktreotide SUN under the skin, but infusion into a vein 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 an Octreotide SUN ampoule. Do not use it if you see anything unusual.
The lid of the multidose vials should be punctured a maximum of 10 times to prevent contamination.
If you use more Oktreotide SUN 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.
No life-threatening reactions have been reported following overdose of Octreotide SUN.
The symptoms of overdose are:
- irregular heartbeat.
- low blood pressure
- cardiac arrest
- reduced supply of oxygen to the brain
- severe upper abdominal pain
- yellowing of the skin and eyes
- nausea
- reduced appetite
- diarrhea
- weakness
- fatigue
- lack of energy
- weight loss
- swollen abdomen
- discomfort
- high level of lactic acid in the blood.
If you think you have an overdose and are experiencing such symptoms, talk to your doctor immediately.
If you forget to take Oktreotide SUN
Take a dose as soon as you remember, then continue as usual. It does not hurt if you miss a dose , but you can temporarily get symptoms back before you are back on the dosing schedule.
Do not inject a double dose of Octreotide SUN to make up for a forgotten dose.
If you stop using Oktreotide SUN
If you stop taking Oktreotide SUN, your symptoms may return. Therefore, do 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 or pharmacist
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 , which lead to sudden back pain
- high blood sugar.
Common (may affect up to 1 in 10 people):
- hypothyroidism ( hypothyroidism ) which causes changes in heart rate, appetite or weight; fatigue, coldness or swelling on the front of the neck
- 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 heart rate.
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 reactions (allergic), including rash
- a type of allergic reaction ( anaphylaxis ) that causes difficulty breathing or dizziness
- inflammation of the pancreas ( pancreatitis ); Symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhea
- inflammation of the liver ( hepatitis ); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general malaise, itching , light-colored urine
- irregular heartbeats.
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
– abdominal pain
– nausea
– constipation
gas formation
– headache
injection site pain.
Common (may affect up to 1 in 10 people):
– upset stomach after a meal ( dyspepsia )
vomiting
– feeling full
– high-fat stools
– loose stools
– discolored stools
– dizziness
– loss of appetite
changes in liver function tests
– hair loss
– shortness of breath
– dullness.
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 Octreotide SUN 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 Octreotide SUN between meals or at bedtime.
How to store Oktreotide SUN solution for injection
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. The expiration date is the last day of the specified month.
Store ampoules and multidose bottles in a refrigerator (between 2 ° C and 8 ° C). Do not freeze.
Store in the original package. Sensitive to light.
Unopened ampoules and bottles of Oktreotide SUN can be stored for a maximum of 2 weeks at a maximum of 25 ° C and in the original packaging.
An opened multi-dose bottle can be stored for a maximum of 2 weeks in a refrigerator (2‑8 ° C) and in the original packaging. You can use the multidose bottle up to 10 times, and you must return any remaining medicine to the pharmacy if you have not used everything within two weeks.
Chemical and physical in-use stability has been demonstrated for 8 hours at 25 ° C. From a microbiological point of view, the drug should be used immediately after dilution. If not used immediately, in-use storage times and conditions before use is the responsibility of the user.
If your doctor decides to stop your treatment, you should return any remaining medicine to the pharmacy. Only keep it if your doctor tells you to.
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.
Other information
Content declaration
The active substance is octreotide, in the form of octreotide acetate.
One ampoule of 1 ml solution for injection contains octreotide acetate equivalent to 0.05 milligrams, 0.1 milligrams, and 0.5 milligrams of octreotide.
A multidose vial of 5 ml solution for injection contains octreotide acetate equivalent to 1 milligram of octreotide. 1 ml solution contains 0.2 milligrams of octreotide.
The other ingredients are sodium acetate trihydrate, sodium chloride, water for injections, and phenol (applies to multidose vials only).
What the medicine looks like and contents of the pack
This medicine is available as a clear and colorless solution for injection.
50 micrograms / ml, 100 micrograms / ml and 500 micrograms / ml:
Pack sizes of 5, 10 or 30 ampoules with 1 ml solution each.
200 micrograms / ml:
Pack size of 1, 10, or 30 multidose bottles with 5 ml solution.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
This medicinal product is authorized in the EEA Member States with the following designation:
| Denmark: | Octreotide SUN 0.05, 0.1, 0.5 mg / 1 ml, 1 mg / 5 ml solution for injection |
| Germany: | Octreotide SUN 0.05, 0.1, 0.5 mg / 1 ml solution for injection |
| Italy: | Octreotide SUN 0.05, 0.1, 0.5 mg / 1ml, 1mg / 5ml inettable solution |
| Netherlands: | Octreotide SUN 0.05, 0.1, 0.5 mg / 1ml, 1mg / 5ml solution for injection |
| Norway | Octreotide SUN 50, 100, 200, 500 micrograms / 1 ml solution for injection |
| Spain: | Octreotide SUN 50, 100, 200, 500 micrograms / ml injectable solution |
| UK | Octreotide 50, 100, 200, 500 micrograms / ml Solution for Injection |
| Sweden | Octreotide SUN 50, 100, 200, 500 micrograms / ml solution for injection |