Sandostatin Lar 20mg.

WHAT Sandostatin LAR AND WHAT IT IS USED
Sandostatin LAR is a synthetic derivative of somatostatin. Somatostatin is normally produced by the human body, where it inhibits the secretion of certain hormones, such as growth hormone.
The advantage of Sandostatin LAR to somatostatin is that it has a more powerful effect and a more prolonged action.

Sandostatin LAR apply:
treatment of acromegaly;
for improving symptoms caused by the overproduction of certain specific hormones and other substances from the stomach, intestine and pancreas (pancreas);
treatment of neuroendocrine tumors, localized in the intestine (eg. appendix, small intestine or colon).
Acromegaly is a condition in which it is produced too much growth hormone. Under normal conditions, it controls the growth of tissues, organs and bones. Growth hormone excess results in excessive growth of bone and tissue, and particularly those of the hands and feet. Sandostatin LAR significantly affected the symptoms of acromegaly, which includes headache, sweating, numbness of hands and feet, fatigue and joint pain. In most cases, the overproduction of GH is caused by the increase in pituitary gland - pituitary adenoma. Sandostatin LAR treatment can reduce the size of the adenoma.

Sandostatin LAR is used in the treatment of patients with acromegaly:
when the treatment carried out with a formulation for subcutaneous injection of Sandostatin led to satisfactory results; transitioning with Sandostatin LAR means that the injections will be made much less frequently;
in case the application of other forms of treatment of acromegaly (surgery or radiotherapy) is not suitable or was unsuccessful;
after radiotherapy, in the interim period, to achieve the full effect of it.
In some rare diseases of the stomach, intestines and pancreas can reach specific overproduction of hormones and other substances. This leads to disruption of normal hormonal balance of the body and is associated with the emergence of a number of symptoms such as episodes of redness (Flushing), diarrhea, low blood pressure, rash, weight loss. Sandostatin LAR treatment resulted in improvement in these symptoms. Sandostatin LAR is usually recommended for use in patients who have achieved good effects from the treatment with Sandostatin subcutaneous administration.
Neuroendocrine tumors are rare tumors that can be found in different parts of the body. Sandostatin LAR is used to control the growth of these tumors when localized in the intestine (eg. Appendix, small intestine or colon).

2. BEFORE YOU TAKE Sandostatin LAR
Carefully follow all instructions given by your doctor. They may differ from the information contained in this leaflet;
Read the following explanations before you start using Sandostatin LAR.
Do not take Sandostatin LAR
If you are allergic to the active ingredient octreotide or to any of the ingredients of the drug listed in this leaflet.
Take special care with Sandostatin LAR
Tell your doctor if you are taking medications to control blood pressure (beta-blockers or calcium channel blockers), or medicines to control fluid and electrolyte balance. You may need a dose adjustment;
If you now or have previously suffered from gallstones. Tell your doctor as prolonged use of Sandostatin LAR may lead to the formation of gallstones. Your doctor may want to periodically check your gall bladder;
Tell your doctor if you have diabetes because Sandostatin LAR may affect blood sugar levels. If you have diabetes, your blood sugar should be checked regularly;
If you have had in the past a lack of vitamin B12, your doctor may want to periodically check the levels of vitamin B12;
If you are treated / a long time with Sandostatin LAR, your doctor may want to examine the function of your thyroid gland;
During your treatment with Sandostatin LAR, your doctor will monitor the function of your liver.
Sandostatin LAR and children
Experience with the application of Sandostatin LAR in children is limited.

Sandostatin LAR and the elderly
Experience shows that there are no contraindications for the use of Sandostatin LAR in patients ≥ 65 years of age.

pregnancy
Sandostatin LAR should be used during pregnancy only when there are very serious need.

Women of childbearing potential
During treatment, women of childbearing potential should use effective methods of contraception.

breastfeeding
It is not known whether Sandostatin LAR passes into breast milk. There is no experience with the use of Sandostatin LAR in lactating women.
You should not take Sandostatin LAR if you are breast feeding.

Driving and using machines
No information on the effects of Sandostatin LAR on the ability to drive and use machines.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to medicines obtained without a prescription.
Usually during treatment with Sandostatin LAR can continue to take other medicines. It should however be aware that certain medications, such as cimetidine, cyclosporine and bromocriptine responded by taking Sandostatin LAR.
If you have diabetes, you may become necessary to adjust your antidiabetic therapy.

3. HOW TO TAKE Sandostatin LAR
Sandostatin LAR should always be administered as an intramuscular injection into the buttock. With every application Sandostatin LAR should be placed, as places are changed - once left, once right, and so on..
The starting dose of Sandostatin LAR is typically 20 mg, with an interval of 4 weeks. After the first 3 months of treatment, your doctor probably will want to evaluate the therapy. He / she will probably measure the levels of growth hormone and other hormones in the blood. Depending on the results of these studies and the personal history, you may need dose adjustment of Sandostatin LAR. A single dose may be reduced to 10 mg, and for incomplete effect of treatment - be increased to 30 mg. If you are taking Sandostatin LAR treatment of acromegaly, the dose may be increased to 40 mg, if necessary. Once found the right dose for you, your doctor will likely monitor you and assess your treatment every 6 months.
If subcutaneous treatment with Sandostatin has led to satisfactory results in you, you can immediately start treatment with Sandostatin LAR in the above doses. If you have not been treated with Sandostatin subcutaneous before starting treatment with Sandostatin LAR recommended short period of treatment with Sandostatin subcutaneous administration to assess its effect.
Depending on the particular disease, thus taking Sandostatin LAR, it may be necessary to continue the application of subcutaneous Sandostatin for two weeks after placing the first injection of Sandostatin LAR.
If you are taking Sandostatin LAR treatment of neuroendocrine tumors localized in the gut, the usual dose is 30 mg, administered over a 4-week interval. Your doctor will decide how long you should be treated with Sandostatin LAR.

Information for medical staff
Instructions on how to use of Sandostatin LAR given at the end of this leaflet.

If you take more dose of Sandostatin LAR
No reports of life-threatening effects of overdose with Sandostatin LAR. Symptoms include: hot flashes, frequent urination, fatigue, depression, anxiety and lack of concentration.
If you think that an overdose has occurred with Sandostatin LAR and note similar complaints should consult your doctor.

If you forget to take Sandostatin LAR
If you forget to apply another injection is recommended to make it as soon as you remember, then you can continue treatment at the prescribed schedule. Is not dangerous if you are late in taking the medicine a few days, but it is possible temporarily to reappear symptoms of the disease until you return to normal dosing schedule.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sandostatin LAR can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of these side effects.

Some side effects could be serious and need immediate medical attention.
Some are very common (occurring in more than 1 in every 100 patients):
gallstones, leading to sudden back pain;
too high blood sugar.
Some are common (occurring in between 1 and 10 in every 100 patients):
underactive thyroid gland (hypothyroidism) causing changes in heart rate, appetite or weight gain, fatigue, feeling cold, or swelling in the anterior region of the neck;
changes in thyroid function tests;
inflammation of the gallbladder (cholecystitis);
excessively low blood sugar;
impaired glucose tolerance;
slow heart rate.
Some may be uncommon (affects less than 1 in every 100 patients, but more than 1 in 1000 patients):
thirst, low urine output, dark urine, dry, red skin;
accelerated heartbeat.
Other serious side effects
If you have any of these, call your doctor immediately:
hypersensitivity (allergic) reactions including skin rash;
type of allergic reaction (anaphylaxis) which causes difficulty in breathing or dizziness;
inflammation of the pancreas (pancreatitis);
inflammation of the liver (hepatitis), symptoms may include yellowing of the skin and whites of the eyes (jaundice), nausea, vomiting, loss of appetite, feeling generally unwell, itching, light-colored urine;
irregular heartbeat.
Other side effects
The following side effects are usually mild and resolved during treatment.
Some effects are very common (affects more than 1 in 10 patients):
diarrhea;
stomach pain;
nausea;
constipation (constipation);
gas in the abdomen;
headache;
pain at the injection site.
Some effects are common (affecting between 1 and 10 in every 100 patients):
stomach discomfort after meals (dyspepsia);
vomiting;
a feeling of fullness in the stomach;
greasy stools;
loose stools;
discoloration of feces;
dizziness;
loss of appetite;
abnormal liver function tests;
hair loss;
shortness of breath.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE Sandostatin LAR
Do not use Sandostatin LAR after the expiry date.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze. Keep it in secondary packaging (carton) to protect it from light.
On the day of injection Sandostatin LAR can remain at temperatures below 25 ° C, but should be stored in the outer carton to protect from light. The suspension should be prepared immediately before use.
Keep out of the reach and sight of children.

6. FURTHER INFORMATION
What Sandostatin LAR
The active ingredient of Sandostatin LAR is octreotide (as octreotide acetate) as a powder (microspheres) for reconstitution before injection.
The other ingredients are poly (DL-lactide-co-glycolide) and mannitol.

This product contains less than 1 mmol (23 mg) of sodium per serving, i.e. practically "no-sodium".
Before use, the powder should be suspended in a special liquid - solvent / carrier to be provided by the manufacturer.

Sandostatin LAR is available as a kit that includes:
one vial containing 20 mg or 30 mg octreotide;
a pre-filled syringe containing 2,5 ml of solvent for suspension of the powder (liquid containing sodium carboxymethylcellulose, mannitol, and sterile water);
two needles [40 mm (1,5 инча), № (gauge) 19].
If you have any questions about this medicine, please consult your doctor or pharmacist.

Marketing Authorisation Holder and Manufacturer:
Novartis Pharma GmbH, Germany

Date of latest revision of the leaflet March 2012.

Instructions for intramuscular injection at Sandostatin LAR
Apply only deep in the gluteus (im)!
Ingredients:
Vial containing Sandostatin LAR;
Pre-filled with solvent / vehicle syringe + 2 pins
Follow the instructions below carefully to ensure complete saturation of the powder and its uniform suspension before intramuscular injection.
Sandostatin LAR suspension must be prepared just before application.
Sandostatin LAR should only be administered by a trained medical professional.

Allow to Sandostatin LAR and the solvent in the syringe to reach room temperature. Remove the cap from the vial containing Sandostatin LAR. By swirling ensure the collection of dust on the bottom of the vial.
Remove the cap from the syringe with the solvent / carrier. Place one of the needles in the package on the syringe.
Disinfect the rubber stopper of the vial with a swab with alcohol.
Insert the needle into the center of the rubber stopper Sandostatin LAR.
Inject the media side of the vial without touching the powder in the vial. Do not inject the solvent directly onto the powder. Remove the needle from the vial.
Do not shake the vial, waiting 2-5 minutes, until the winner wet the powder. Without looking at the vial, check carefully the dust on the walls and bottom. If there are dry areas, it remains undisturbed wetting to continue. Prepare the patient for injection.
Once the powder is completely wet, shake the vial with moderate force about 30-60 seconds until a uniform milky suspension. The vial should not be shaken too hard, as this may cause flocculation of the suspension and make it unusable.
Immediately re-enter the needle through the rubber stopper with bevel down, slowly withdraw the entire contents of the vial, holding it at an angle of 45 °. Do not invert the vial until full needle because this can affect the amount withdrawn. It is normal for a small amount of suspension to remain on the walls and bottom of the vial. This is pre-estimated loss.
Immediately change the needle of the syringe (with the second needle from the pack).
Implementation should begin immediately after reconstitution. Gently shake the syringe to maintain a homogeneous suspension. Evacuate air from the syringe.
Disinfect the injection site with an alcohol swab. Insert the needle into the left or right gluteal muscle and aspirate, to make sure that you've stumbled into a blood vessel. Enter slowly deep intramuscular Sandostatin LAR suspension by applying even pressure. If the needle is plugged, replace it with a new needle of the same diameter (1,1 mm, size 19).
Sandostatin LAR must be applied only deep gluteus (im) and never intravenously. Penetration into a blood vessel change the needle and select a new injection site.

Sandostatin LAR is available as a kit that includes: