50 micrograms / ml; 100 micrograms / ml; 200 micrograms / ml; 500 micrograms / ml solution for injection
octreotide
What the Octreotide Campus is and what it is used for
Octreotide Campus 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 Campus compared to somatostatin are that it is stronger and that the effect lasts longer.
Octreotide Campus 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 Campus 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 Campus helps control these symptoms.
- to prevent complications after surgery of the pancreas. Treatment with Oktreotide Campus helps 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 Campus 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 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 the Octreotide Campus may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Oktreotide Campus
Do not use Octreotide Campus
- 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 Campus:
- If you know you have or have had gallstones before, or if you experience other complications such as fever, chills, abdominal pain or yellow skin or yellow eyes, tell your doctor as long-term use of octreotide 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 ). Blood glucose monitoring is mandatory when using the Octreotide Campus to treat bleeding gastroesophageal varices.
- If you have 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 in very high doses can cause abnormal heart rhythms. Your doctor may monitor your heart rate during treatment.
Sampling and inspections
If you are being treated with Octreotide Campus for an extended period, 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 octreotide in children is limited.
Other Drugs and Octreotide Campus
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 Campus. However, certain drugs such as cimetidine, ciclosporin, bromocriptine, quinidine, and terfenadine have been reported to be affected by octreotide.
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 discontinue and/or adjust your treatment with Octreotide Campus.
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 Campus 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 Campus. It is not known whether octreotide passes into breast milk.
Driving and using machines
Octreotide Campus has no or negligible effects on the ability to drive and use machines. However, some of the side effects that you may experience from treatment with Oktreotide Campuses, 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.
Octreotide Campus contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ml solution, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use the Octreotide Campus
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, the Octreotide Campus 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 Campus 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 Campus 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 have used too much of the Octreotide Campus
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 pain in the upper abdomen, yellowing of the skin and eyes, nausea, loss of appetite, diarrhea, weakness, fatigue, lack of energy, weight loss, abdominal swelling, discomfort, high levels of lactic acid in the blood and abnormal heart rhythm.
If you think you have an overdose and are experiencing such symptoms, talk to your doctor immediately.
If you have forgotten to use Oktreotide Campus
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 Campus to compensate for a missed dose.
If you stop using Oktreotide Campus
If you stop taking Octreotide Campus, 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, 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 leading 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 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 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, 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.
- Low platelet count , which may lead to an increased tendency for bleeding or bruising.
Talk to your doctor immediately if you experience any of the above side effects.
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 Octreotide Campus 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 Oktreotide Campus between meals or at bedtime.
How to Store the Octreotide Campus
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2ºC-8ºC).
Store in the original package. Sensitive to light.
Octreotide Campus 50, 100 and 500 micrograms / ml:
Shelf life in broken packaging: Opened ampoules must be used immediately and any remaining contents destroyed.
Octreotide Campus 200 micrograms / ml:
Opened vials can be stored for 15 days in a refrigerator (2 ° C-8 ° C). To avoid contamination, it is recommended that the membrane on the vial be punctured no more than 10 times.
Do not use this medicine after the expiry date which is stated on the label and the carton after EXP. The expiration date is the last day of the specified month.
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 package and other information
Content declaration
- The active substance is octreotide. 1 ml solution for injection contains octreotide acetate corresponding to 50, 100, 200 and 500 micrograms octreotide respectively.
- Other excipients are: Octreotide Campus 50, 100 and 500 micrograms / ml: water for injections, glycine , hydrochloric acid (for pH adjustment) , mannitol.
Octreotide Campus 200 micrograms / ml: water for injections, phenol ( preservative ), glycine , hydrochloric acid (for pH adjustment), mannitol.
What the medicine looks like and contents of the pack
Clear, colorless solution for injection.
Octreotide Campus 50 micrograms / ml: 5 ampoules with 1 ml solution (5×1 ml)
Octreotide Campus 100 micrograms / ml: 5 ampoules with 1 ml solution (5×1 ml)
Octreotide Campus 500 micrograms / ml: 5 ampoules with 1 ml solution (5×1 ml)
Octreotide Campus 200 micrograms / ml: 1 multidose vial with 5 ml solution (1×5 ml)
Not all pack sizes may be marketed.
Marketing Authorisation Holder
CampusPharma AB,
Karl Gustavsgatan 1A,
411 25 Gothenburg
Manufacturer
GP Pharm, SA
Polígono Industrial Els Vinyets-Els Fogars, 2. Ctra. C-244, km. 22
08777 Sant Quintí de Mediona (Barcelona)
Spain