Octreotide 50 Micrograms/Ml Solution For Injection In Prefilled Syringe
PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTREOTIDE 50 micrograms /ml,
Solution for injection in prefilled syringe
OCTREOTIDE 100 micrograms /ml,
Solution for injection in prefilled syringe
OCTREOTIDE 500 micrograms /ml,
Solution for injection in prefilled syringe
OCTREOTIDE
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is it in this leaflet
1. What Octreotide is and what it is used for.
2. What you need to known before you use Octreotide.
3. How you use Octreotide.
4. Possible side effects.
5. How to store Octreotide.
6. Contents of the pack and other information.
1. What Octreotide is and what it is used for
Octreotide is a compound derived from somatostatin a substance normally found in the human body which inhibits the effects of certain hormones such as growth hormone. The advantages of Octreotide over somatostatin are that it is stronger and its effects last longer.
Octreotide is used
• in acromegaly, a condition where the body produces too much growth hormone. Normally, growth hormone controls growth of tissues, organs, and bones. Too much growth hormone leads to an increase in the size of bones and tissues, especially in the hands and feet. Octreotide markedly reduces the symptoms of acromegaly, which include headache, excessive perspiration, numbness of the hands and feet, tiredness, and joint pain.
• to relave symptoms associated with some tumours of gastrointestinal trat (e.g. carcinoid tumours, VIPomas, glucagonomas, gastrinomas, insulinomas). In these conditions, there is a overproduction of some specific hormones and other related substances by the stomach, bowels, or pancreas. This overproduction upset the natural hormone balance of the body and results in a variety of symptoms, such as flushing, diarrhoea, low blood pressure, rash, and weight loss. Treatment with Octreotide helps to control these symptoms.
• to prevent complications following surgery of the pancreas gland. Treatment with Octreotide helps lower risk of complications (e.g. abscess in the abdomen, inflammation of the pancreas gland) after the surgery.
• to stop bleeding and to protect from re-bleeding from ruptured gastro-oesophageal varices in the patient suffering from cirrhosis (chronic liver disease). Treatment with Octreotide helps to control bleeding and reduce transfusion requirements.
• to treat pituitary tumours 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 tumours that produce too much thyroid-stimulating hormone (TSH):
- when other types of treatment (surgery or radiotherapy) are not suitable or have not worked;
- after radiotherapy, to cover the interim period until the radiotherapy becomes fully effective.
2. What you need to known before you use Octreotide Do not use Octreotide
- If you are allergic to octreotide or any of the ingredients in this medicine (listed in section 6).
Warning and precautions
Talk to your doctor before taking Octreotide:
- if you known that you have gallstones now, or have had them in the past; tell your doctor, as prolonged use of Octreotide may result in gallstone formation. Your doctor may wish to check your gallbladder periodically.
- if you have some problems with your blood sugar levels, either too high (diabetes) or too low (hypoglycaemia). When Octreotide is used to treat bleeding from gastro-oesophageal varices; monitoring of blood sugar levels.
- if you have a history of vitamin B12 deprivation your doctor may wish to check your vitamin B12 level periodically.
Test and checks
If you receive treatment with Octreotide over a long period of time, your doctor may wish to check your thyroid function periodically.
Your doctor will check your liver function.
Children
There is little experience with the use of Octreotide in children.
Other medicines and Octreotide
Tell your doctor or yor pharmacist if you are taking have recently taken or might take any other medicines.
You can generally continue taking other medicines while on Octreotide. However, certain medicines, such as cimetidine, ciclosporin, bromocriptine, quinidine and terfenadinehave been reported to be affected by Octreotide. If you are taking a medicine to control your blood pressure (e.g. a beta blocker or a calcium channel blocker) or an agent to control your fluid and electrolyte balance, your doctor may need to adjust the dosage.
If you are diabetic, your doctor may need to adjust your insulin dosage.
Pregnancy and breast-feeding
If you are pregnant or brest-feeding, think you may be pregnant or a planning to have a baby, ask your doctor for advice before taking this medicine.
Octreotide should only be used during pregnancy if clearly needed.
Women of child-bearing age should use an effective contraceptive method during treatment.
Do not breast-feed while using Octreotide. It is not known whether Octreotide passes into breast milk.
Driving and using machines
Octreotide has no or negligible effects on the ability to drive and use machines. However, some of the side effects you may experience while using Octreotide, such as headache and tiredness, may reduce your ability to drive and use machines safely.
3. How to use Octreotide
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Depending on the condiction being treated, Octreotide is given by:
- subcutaneous (underneath the skin) injection or
- intravenous (into 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 Octreotide under the skin, but infusion into a vein must always be performed by a health care professional.
• Subcutaneous injection
The upper arms, thighs, and abdomen are good areas for subcutaneous injection.
Choose a new site for each subcutaneous injection so that you do not irritate a particular area. Patients who will be injecting themselves must receive precise instructions from the 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. This will reduce the risk of pain at the site of injection. You can warm it up in your hand but do not heat it. A few people experience pain at the site of the subcutaneous injection. This pain usually only lasts a short time. If this happens to you, you can relieve this by gently rubbing the site of injection for a few seconds afterwards. Before using a Octreotide ampoule, check the solution for particles or a change of colour. Do not use it if you see anything unusual.
If you use more Octreotide than you should
No life-threatening reactions have bee reported after overdose of Octreotide.
The symptoms of overdose are: irregular heart beat, low blood pressure, cardiac arrest, reduced supply of oxygen to the brain, severe upper stomach pain, yellow skin and eyes, nausea, loss of appetite, diarrhoea, weakness, tiredness, lack of energy, weight loss, abdominal swelling, discomfort and high level of lactic acid in the blood.
If you think that an overdose has happened and you experience such symptoms, tell your doctor straight away.
If you forget to use Octreotide
Administer one dose as soon as you remember, and then continue as usual. It will not do any harm if you miss a dose, but you could get some temporary re-appearance of symptoms until you get back on schedule.
Do not inject a double dose of Octreotide to make up for forgotten individual doses.
If you stop using Octreotide
If you interrupt your treatment with Octreotide your symptoms may come back. Therefore, do not stop using Octreotide unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be serious. Tell your doctor straight away if you get any of the following:
Very common (may affect more than 1 in 10 people)
• Gallstones, leading to sudden back pain.
• Too much sugar in the blood.
Common (may affect up to 1 in 10 people):
• Underactive thyroid gland (hypothyroidism) causing changes in heart rate, appetite or weight; tiredness, feeling cold, or swelling at the front of the neck.
• Changes in thyroid function tests.
• Inflammation of the gallbladder (cholecystitis); symptoms may include pain in the upper right abdomen, fever,
nausea, yellowing of the skin and eyes (jaundice).
• Too little sugar in the blood.
• Impaired glucose tolerance.
• Slow heart beat.
Uncommon (may affect up to 1 in 100 people):
• Thirst, low urine output, dark urine, dry flushed skin.
• Fast heart beat.
Other serious side effects
• Hypersensitivity (allergic) reactions including skin rash.
• A type of an allergic reaction (anaphylaxis) which causes difficulty in breathing or dizziness.
• An inflammation of the pancreas gland (pancreatitis); symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhoea.
• Liver inflammation (hepatitis); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, generally feeling unwell, itching, light-coloured urine.
• Irregular heart beat.
Tell your doctor straight away if you notice any of the side effects above.
Other side effects:
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed below. They are usually mild and tend to disappear as treatment progresses.
Very common (may affect more than 1 in 10 people):
• Diarrhoea.
• Abdominal pain.
• Nausea.
• Constipation.
• Flatulence (wind).
• Headache.
• Local pain at the injection site.
Common (may affect up to 1 in 10 people):
• Stomach discomfort after meal (dyspepsia).
• Vomiting.
• Feeling ao fullness in the stomach.
• Fatty stools.
• Loose stools.
• Discolouration of faeces.
• Dizziness.
• Loose of appetite.
• Change in liver function tests.
• Hair loss.
• Shortness of breath.
• Weakness.
If you get any side effects, please tell your doctor, nurse or pharmacist.
A few people experience pain at the site of the subcutaneous injection. This pain usually only lasts a short time. If this happens to you, you can relieve this by gently rubbing the site of injection for a few seconds afterwards.
If you are administering Octreotide by subcutaneous injection, it may help to reduce the risk of gastrointestinal side effects if you avoid eating meals around the time of injection. It is therefore recommended that you inject Octreotide between meals or when you go to bed.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Octreotide
• Store in a refrigerator (2°C to 8°C).
• For day by day use the product may be stored below 30°C for up to 30 days.
• Do not freeze. Store the pre-filled syringes in the blister in order to protect the product from light.
• After dilution in sodium chloride 0.9% solution when stored in glass bottles: chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately.
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 carton and label after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice particles or anything unusual in the appearance of the solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Octreotide contains
- The active substance is octreotide as octreotide acetate
- The other ingredients are: (S)- Lactic acid, Sodium Chloride, Sodium Hydroxide and Water for Injections.
Each prefilled syringe with 1 ml of solution for injection contains 50 micrograms of octreotide as octreotide acetate. Each prefilled syringe with 1 ml of solution for injection contains 100 micrograms of octreotide as octreotide acetate. Each prefilled syringe with 1 ml of solution for injection contains 500 micrograms of octreotide as octreotide acetate.
What Octreotide looks like and content of the pack.
The medicinal product is available as prefilled syringes containing 1 ml of a clear, colourless solution for injection. Packs of 5, 6 or 30 prefilled syringes in thermoformed white, opaque PVC blister, sealed with an aluminium foil. Not all pack sizes may be marketed.
Marketing Authorisation Holder
CHEMI S.p.A.
Via Dei Lavoratori, 54 Cinisello B. (MI) 20092 Italy
Manufacturer
ITALFARMACO S.p.A.
Viale F. Testi, 330 - 20126 Milano.
Tel. + 39 02 64431 Fax. + 39 02644346 e-mail: info@italfarmaco.com
This leaflet was last revised in April 2016
This medicinal product is authorized in the Member States of the EEA under the following names:
Italia: Octreotide Chemi 50 - 100 - 500 microgrammi/ml soluzione iniettabile in siringa preriempita
Germany: Octreotid-hameln 50 - 100 - 500 Mikrogramm/ml Injektionslosung
UK: OCTREOTIDE 50 - 100 - 500 micrograms /ml, Solution for injection in prefilled syringe
The following information is intended for medical or healthcare professionals only.
This is an extract from the SmPC to help you with the administration Octreotide.
For parenteral use only: Subcutaneosu (SC) or (Intravenous (IV)
Storage
Store in a refrigerator (2°C - 8°C).
Do not freeze. Store the prefilled syringes in the blister in the original packaging in order to protect the product from the light.
Storage conditions after dilution in sodium choride 0.9 % solution when stored in glass bottle
Chemical and physical in-use stability has been demostrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately.
Use
To reduce local discomfort, let the solution reach the room temperature before injection. Avoid multiple injections at shot intervals at the same site.
Prio to administration, the solution should be inspected visually for changes of colour or presence of particles.
Do not use unless the solution is clear and free from visible solid particles.
• Intravenous infusion (for healthcare professionals)
When Octreotide is to be administered as intravenous infusion, the content of one 500 micrograms of prefilled syringe should normally be dissolved in 60 mL physiological saline, and the resulting solution should be infused by means of an infusion pump. This should be repeated as often as necessary until the prescribed duration of the treatment is reached.
Disposal
Any solution or item used (or that has been in contact) with Octreotide solution for injection must be discarded according to local recommendations for injections.
How much Octreotide to use
The dose of Octreotide depends on the condition being treated.
• Acromegaly
Treatment is usually started at 0.05 to 0.1 mg every 8 or 12 hours by subcutaneous injection. It is then changed according to its effect and relief of symptoms (such as tiredness, sweating and headache). In most patients the optimal daily dose will be 0.1 mg 3 times/day. A maximum dose of 1.5 mg/day should not be exceeded.
• Tumours of the gastrointestinal tract
Treatment is usually started at 0.05 mg once or twice a day by subcutaneous injection. Depending on response and tolerability, the dosage can be gradually increased to 0.1 mg to 0.2 mg 3 times/day. In carcinoid tumours, therapy should be discontinued if there is no improvement after 1 week of treatment at the maximum tolerated dose.
• Complications following pancreatic surgery
The usual dosage is 0.1 mg 3 times/day by subcutaneous injection for 1 week, starting at least 1 hour before surgery.
• Bleeding gastro-oesophageal varices
The recommended dosage is 25 micrograms/hour for 5 days by continuous intravenous infusion. Monitoring of blood sugar level is necessary during treatment.
• TSH-secreting pituitary adenomas
The dosage most generally effective is 100 micrograms three times a day by subcutaneous injection. The dose can be adjusted according to the responses of TSH and thyroid hormones. At least 5 days of treatment will be needed to judge the efficacy.