SIROCTID 0.05 MG/ML Инъекционный раствор

Содержание инструкции

1. Siroctid 50 micrograms/ml, injectable solution in pre-filled syringe, 100 micrograms/ml, injectable solution in pre-filled syringe, 500 micrograms/ml, injectable solution in pre-filled syringe
   1. What is Siroctid and what is it used for
   2. What you need to know before you take Siroctid
   3. How to take Siroctid
   4. Possible side effects
   5. How to store Siroctid
   6. Package Contents and Other Information

Siroctid 50 micrograms/ml, injectable solution in pre-filled syringe, 100 micrograms/ml, injectable solution in pre-filled syringe, 500 micrograms/ml, injectable solution in pre-filled syringe

Octreotide

Read this leaflet carefully before you start to use this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Siroctid is and what it is used for
• 2. What you need to know before you use Siroctid
• 3. How to use Siroctid
• 4. Possible side effects
• 5. How to store Siroctid
• 6. Contents of the pack and other information

1. What is Siroctid and what is it used for

Siroctid is a synthetic compound analogous to somatostatin. Somatostatin is
normally present in the human body, where it inhibits the release of certain hormones such as
growth hormone. The advantages of Siroctid over somatostatin are that it is more
potent and its action lasts longer.

Siroctid is used:

• in acromegaly, a condition in which the body produces an excessive amount of growth hormone. Normally, growth hormone controls the growth of tissues, organs and bones. When present in excessive amounts, it causes an increase in the size of bones and tissues, especially of the hands and feet. Siroctid significantly reduces the symptoms of acromegaly, which include headache, excessive sweating, numbness of the hands and feet, fatigue and joint pain.
• to relieve symptoms associated with some gastrointestinal tract tumors(e.g. carcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas). In these conditions there is an excessive production of certain specific hormones and related substances in the stomach, intestine or pancreas. This excessive production alters the body's natural hormonal balance and causes a variety of symptoms,

such as hot flashes, diarrhea, hypotension, skin rashes and weight loss. Treatment with Siroctid helps to control these symptoms.

• to prevent complications following surgery on the pancreas. Treatment with Siroctid helps to lower the probability of complications (e.g. abdominal abscess, inflammation of the pancreas) after surgery.
• to stop bleeding and to protect against re-bleeding from ruptures ofesophageal varicesin patients with cirrhosis (chronic liver disease). Treatment with Siroctid helps to control bleeding and reduce the need for transfusions.
• to treat pituitary adenomas that produce an excessive amount of thyroid-stimulating hormone (TSH). An excessive amount of thyroid-stimulating hormone (TSH) leads to hyperthyroidism. Siroctid is used to treat people with pituitary tumors that produce too much thyroid-stimulating hormone (TSH):
• when other treatments (surgery or radiotherapy) are not indicated or have not been effective;
• after radiotherapy, to cover the period necessary for the radiotherapy to reach maximum effectiveness.

2. What you need to know before you take Siroctid

Do not take Siroctid:

• if you are allergic to octreotide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Siroctid:

• if you know you have gallstones, or have had them in the past; tell your doctor, as prolonged use of Siroctid may lead to the formation of gallstones. Your doctor may ask you to have periodic checks of your gallbladder.
• if you know you have problems with blood sugar levels, too high (diabetes) or too low (hypoglycemia). When Siroctid is used to treat bleeding from gastro-esophageal varices, blood sugar levels must be monitored.
• if you have previously had episodes of vitamin B deficiency, your doctor may ask you to periodically check your vitamin B levels.

Tests and checks
If you receive treatment with Siroctid for a long period, your doctor may ask you to
periodically check your thyroid function.
The doctor will check your liver function.

Children
Experience with the use of Siroctid in children is limited.

Other medicines and Siroctid
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. In general, you can continue to take other
medicines while being treated with Siroctid. However, it has been reported that Siroctid
can interact with some drugs, such as cimetidine, cyclosporine, bromocriptine,
quinidine and terfenadine.
If you are taking medicines to control blood pressure (such as beta-blockers
or calcium antagonists) or agents for controlling fluid and electrolyte balance, your doctor
may decide to adjust the dosage.
If you are diabetic, your doctor may decide to adjust your insulin dosage.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or if you
are breastfeeding, ask your doctor for advice before taking this
medicine.
Siroctid can be used during pregnancy only if clearly necessary.
Women of childbearing potential must use adequate contraception during
treatment.
Patients should not breastfeed during treatment with Siroctid. It is not known whether
Siroctid is excreted in breast milk.

Driving and using machines
Siroctid does not alter or alters negligibly the ability to drive vehicles or use
machinery. However, some undesirable effects such as headache and fatigue may occur during treatment with Siroctid which may reduce the ability to
drive and use machinery safely.
Siroctid contains sodium
Siroctid contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically “sodium-free”.

3. How to take Siroctid

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Depending on the condition to be treated, Siroctid can be administered as:

• subcutaneous injection (under the skin) or
• intravenous infusion (into a vein).

If you are a patient with cirrhosis (chronic liver disease), your doctor may
need to adjust the maintenance dose.
Your doctor or nurse will explain how to inject Siroctid under the skin, but
intravenous infusion must always be performed by a healthcare professional.

• Subcutaneous injection

The most suitable sites for subcutaneous injection are arms, thighs and abdomen.
Choose a new site for each subcutaneous injection so as not to irritate a
particular area. Patients who wish to proceed with the injection independently must
receive precise instructions from their doctor or nurse.
If you store the medicine in the refrigerator, it is advisable to bring it back to room temperature
before using it. This reduces the risk of pain at the injection site. It can be
brought to room temperature by holding it in your hand, but it must not be heated.
Few people experience pain at the subcutaneous injection site. This pain
usually lasts only a short period of time. If this occurs, it can be relieved
by gently massaging the injection site for a few seconds afterwards.
Before using Siroctid, check for the presence of particles or changes in color.
Do not use if you notice anything unusual.

If you take more Siroctid than you should
No reactions have been reported that have determined a life-threatening situation after
Siroctid overdose.
The symptoms of overdose are: irregular heartbeat, low blood pressure,
cardiac arrest, reduced oxygen supply to the brain, severe pain in the upper part of the
stomach, yellowing of the skin and eyes, nausea, loss of appetite, diarrhea,
weakness, fatigue, lack of energy, weight loss, abdominal swelling,
malaise and high levels of lactic acid in the blood.
If you think you have symptoms of an overdose, inform your doctor immediately.

If you forget to take Siroctid
Take a dose as soon as you remember and then continue therapy as usual.
If you miss a dose, there will be no particular consequences, but you may experience a temporary
recurrence of symptoms until returning to normal.
Do not inject a double dose of Siroctid to compensate for forgetting the dose.

If you stop taking Siroctid
If you stop treatment with Siroctid, the symptoms may reappear. Therefore, do not
stop therapy with Siroctid unless your doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist
or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects may be serious. Tell your doctor immediately
if you experience any of the following:
Very common(may affect more than 1 in 10 people):

• Gallstones which may cause sudden back pain
• High levels of sugar in the blood.

Common(may affect up to 1 in 10 people):

• Decreased thyroid activity (hypothyroidism) with changes in heart rate, appetite or weight, fatigue, feeling cold or swelling in the front of the neck.
• Changes in thyroid function tests.
• Inflammation of the gallbladder (cholecystitis); symptoms may include pain in the upper right side 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, decreased urination, dark urine, flushed and dry skin.
• Fast heartbeat.

Other serious side effects

• Hypersensitivity reactions (allergy), including skin rash.
• A type of allergic reaction (anaphylaxis) that can cause difficulty swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure with dizziness or loss of consciousness.
• Inflammation of the pancreas (pancreatitis) symptoms may include sudden pain in the upper part of the 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 feeling of unwellness, itching, slightly colored urine.
• Irregular heartbeat.
• Low level of platelets in the blood; this may cause increased bleeding or bruising.

Tell your doctor immediately if you notice any of the side effects described above.

Other side effects:
Tell your doctor, pharmacist or nurse if you notice any of the side
effects listed below. These are normally mild and tend to
disappear as treatment continues.

Very common(may affect more than 1 in 10 people):

• Diarrhea.
• Abdominal pain.
• Nausea.
• Constipation.
• Flatulence.
• Headache.
• Local pain at the injection site.

Common(may affect up to 1 in 10 people):

• Stomach discomfort after meals (dyspepsia).
• Vomiting.
• Feeling of fullness in the stomach.
• Greasy stools.
• Soft stools.
• Pale stools.
• Dizziness.
• Loss of appetite.
• Changes in liver function tests.
• Hair loss.
• Shortness of breath.
• Weakness.

If you experience any of these side effects, tell your doctor, nurse or
pharmacist.
A few people experience pain at the subcutaneous injection site. This pain
usually lasts only a short time. If this occurs, it can be relieved
by gently massaging the injection site for a few seconds.
If you are taking Siroctid for subcutaneous injection, avoid the injection near meals,
this may help reduce the risk of gastrointestinal side effects. It is
therefore recommended to administer the injection between meals or at
bedtime.

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 through the national reporting system at the address
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversaBy reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Siroctid

Store in a refrigerator (2°C - 8°C).
During daily use, the product may be stored at a temperature below
30°C for a period of 30 days.
Do not freeze. Store in the original package to protect the medicine from
light.
After dilution in 0.9% sodium chloride when stored in glass bottles: the
physico-chemical stability of the product after use has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product must 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 pack and
on the 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.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package Contents and Other Information

What Siroctid Contains
Each pre-filled syringe with 1 ml of injectable solution contains 50 micrograms of
octreotide as octreotide acetate.
Each pre-filled syringe with 1 ml of injectable solution contains 100 micrograms of
octreotide as octreotide acetate.
Each pre-filled syringe with 1 ml of injectable solution contains 500 micrograms of
octreotide as octreotide acetate.
The active ingredient is octreotide as octreotide acetate.
The excipients are: (S) lactic acid, sodium chloride, sodium hydroxide and water for
injections.

Description of Siroctid and Package Contents
The medicine is available in pre-filled syringes containing 1 ml of transparent and colorless
injectable solution.
Packs of 5, 6 or 30 pre-filled syringes in white opaque PVC thermoformed blisters
sealed with an aluminum foil.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Chemi S.p.A.
Via dei Lavoratori 54
20092 Cinisello Balsamo (MI)
Tel: +39.02.64431
Fax: +39.02.6128960
e-mail: [email protected]
Manufacturer
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milano
Italy
Tel. + 39 02 64431
Fax. + 39 02644346
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic
Area with the following denominations:
Italy: Siroctid 50 – 100 – 500 micrograms/ml, injectable solution
in pre-filled syringe
Austria: Siroctid 0.05 mg/ml - 0.1 mg/ml - 0.5 mg/ml injection solution in a
pre-filled syringe
Greece: Siroctid 50 – 100 - 500 micrograms/ml, injectable solution in
prefilled syringe
France: SIROCTID® 0.05 mg/ml - 0.1 mg/ml - 0.5 mg/ml solution injectable or
solution for perfusion dilution in pre-filled syringe
Poland: Siroctid, 50 – 100 – 500 micrograms/ml, solution for injection in
ampoule-syringe
The following information is intended exclusively for physicians or healthcare
professionals:

The following is an excerpt from the SmPC and must be used for correct
administration of Siroctid.

• For parenteral use only: subcutaneous (SC) or intravenous (IV).

Storage
Store in a refrigerator (2°C - 8°C). Do not freeze. Store the pre-filled
syringes in the blister and in the outer packaging to protect the product from light.

Use:
In order to reduce discomfort at the injection site, allow the solution to reach
room temperature before injection. Avoid performing repeated injections at
short intervals of time, in the same injection site.
Before administration, the solution must be visually inspected for any change in
color or for the presence of particles.
Do not use unless the solution is clear and free from visible solid particles.

• Intravenous infusion (for healthcare professionals) When Siroctid is to be administered by intravenous infusion, the contents of a 500 microgram pre-filled syringe must be dissolved in 60 mL of sodium chloride solution and the resulting solution must be administered using an infusion pump. This procedure should be repeated as needed for the prescribed duration of treatment.

Disposal:
Any solution or object used (or that has been in contact) with Siroctid injectable
solution must be disposed of in accordance with local regulations for injectables.

Amount of Siroctid to Use
The dose of Siroctid depends on the condition being treated.

• AcromegalyTreatment is usually started with 0.05-0.1 mg every 8 or 12 hours subcutaneously. It may subsequently be modified based on effects and control of symptoms (such as fatigue, sweating and headache). In the majority of patients the optimal daily dose is 0.1 mg 3 times a day. It is recommended not to exceed the maximum dose of 1.5 mg per day.
• Gastrointestinal tract tumorsTreatment is usually started with a dose of 0.05 mg once or twice a day by subcutaneous injection. Based on response and tolerability, the dosage may be gradually increased to 0.1 - 0.2 mg 3 times a day. In carcinoid tumors, therapy should be discontinued if no benefit is obtained after 1 week of treatment at the maximum

tolerated dose.

• Complications following surgery on the pancreasThe dosage normally used is 0.1 mg 3 times a day subcutaneously for 1 week, starting at least 1 hour before surgery.
• Bleeding from gastro-esophageal varicesThe recommended dosage is 25 micrograms/hour in continuous intravenous infusion for 5 days. During treatment, blood sugar levels must be monitored.
• Treatment of TSH-secreting pituitary adenomasThe generally most effective dosage is 100 micrograms three times a day by subcutaneous injection. The dose may be adjusted based on TSH and thyroid hormone responses. At least 5 days of treatment will be needed to assess efficacy.