SANDOSTATIN amp. 20 mg. 

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 is more powerful and has a long duration of action .

SANDOSTATIN LAR apply:
treatment of acromegaly ;
improvement of symptoms caused by the overproduction of certain specific hormones and other substances in the stomach, intestine and pancreas ( pancreas ) ;
treatment of neuroendocrine tumors , localized in the intestine (e.g., 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, increased 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 lead to a reduction of the sizes of the adenoma .

Sandostatin LAR is used in the treatment of patients with acromegaly :
when treatment is conducted with a formulation for subcutaneous injection of Sandostatin has led to satisfactory results , switching to treatment with Sandostatin LAR means that the injections will be made much more frequently;
in the event that the application of other forms of treatment of acromegaly ( surgery or radiotherapy ) is not suitable or was unsuccessful ;
after the radiotherapy in the interim period to achieve the full effect of it.
In some rare diseases of the stomach , intestines and pancreas can be achieved by specific overproduction of hormones and other substances . This leads to disruption of normal hormonal balance of the body and is associated with emergence of a number of symptoms such as bouts of redness ( Flushing ), diarrhea , low blood pressure , rash, weight loss. Sandostatin LAR treatment leads to an improvement in these symptoms. Sandostatin LAR is generally 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 are localized when in the intestine (e.g., appendix , small intestine or colon) .

2 . BEFORE YOU TAKE SANDOSTATIN LAR
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 any of the other ingredients of the medicines listed in this leaflet.
Take special care with SANDOSTATIN LAR
Tell your doctor if you are taking medication to control blood pressure ( beta blockers or calcium channel blockers ) or medicines to control water and electrolyte balance. You may need a dose adjustment ;
If now or in the past have suffered from gallstones . Tell your doctor as prolonged use of Sandostatin LAR may lead to the formation of gallstones . Your doctor may wish 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've had in the past a lack of vitamin B12 , your doctor may want to check the levels of vitamin B12 ;
If you are treated / a long time with Sandostatin LAR, your doctor may want to periodically check 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 elderly
Experience shows that there are no contraindications to the use of Sandostatin LAR in patients over 65 years of age.

pregnancy
Sandostatin LAR must be used during pregnancy only when the presence of a very strong 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 use Sandostatin LAR in case you are breast feeding.

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

Intake of other drugs
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines . This includes medicines that you can buy without a prescription.
Usually during Sandostatin LAR treatment can continue taking other medicines. It should however be aware that some medications, such as cimetidine, cyclosporine and bromocriptine responded by taking Sandostatin LAR.
If you suffer from diabetes , it may be necessary to adjust your antidiabetic therapy.

3 . HOW TO TAKE SANDOSTATIN LAR
Sandostatin LAR should always be administered as an intramuscular injection in the buttocks. With every application Sandostatin LAR should be placed as places change - once left , once right , etc.
Sandostatin LAR starting dose usually was 20 mg, with an interval of 4 weeks. After the first 3 months of treatment , your doctor probably will want to evaluate therapy. He / she will probably measure the levels of growth hormone and other hormones in the blood. Depending on the results of these studies on the personal history, you may need to adjust the dose of Sandostatin LAR. A single dose may be reduced to 10 mg, and in part by the effect of the treatment - be increased to 30 mg. If you are taking Sandostatin LAR for treatment of acromegaly , the dose may be increased to 40 mg, if necessary. Once you find the appropriate dose for you , your doctor will likely monitor your condition and assess your treatment every 6 months.
If sc treatment with Sandostatin has led to satisfactory results 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 disorder , so taking Sandostatin LAR, it may be necessary to continue the subcutaneous Sandostatin for two weeks after being first injection Sandostatin LAR.
If you are taking Sandostatin LAR in the treatment of neuroendocrine tumors localized in the intestines , the usual dose is 30 mg, administered at 4- week intervals . Your doctor will decide how long you should be treated with Sandostatin LAR.

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

If you take more than the amount of Sandostatin LAR
No reports of life-threatening effects of overdose with Sandostatin LAR. Symptoms include : hot flashes , urinary frequency , fatigue , depression , anxiety and lack of concentration.
If you think that an overdose has occurred with Sandostatin LAR and observe these symptoms should consult your doctor.

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

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

Some side effects may be serious and need immediate medical attention.
Some are very common ( affects 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), a change 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 ;
heartbeat .
Some may be uncommon (occurring in less than 1 in 100 patients , but more often from 1 to 1 000 patients ):
thirst , low urine output , dark urine , dry, flushed 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) that 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 with continued treatment .
Some effects are very common (affects more than 1 in 10 patients):
diarrhea ;
stomach pain ;
nausea ;
constipation ( constipation ) ;
gases in the abdomen ;
headache ;
Pain at the injection site .
Some effects are common (affects between 1 and 10 in every 100 patients ):
discomfort in the stomach after a meal (dyspepsia ) ;
vomiting ;
feeling of fullness in the stomach ;
fatty stools;
loose stools ;
discoloration of feces ;
dizziness ;
loss of appetite ;
abnormal liver function tests ;
hair loss ;
breathlessness.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

6 . ADDITIONAL INFORMATION
Sandostatin LAR contents
The active substance of Sandostatin LAR is octreotide ( in the form of octreotide acetate ) as a powder ( microspheres ) for suspension prior to injection .
Other ingredients are: poly (DL- lactide -co- glycolide) and mannitol.

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

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

Marketing Authorisation Holder and Manufacturer
Novartis Pharma GmbH, Germany

Date of latest revision of the leaflet in March 2012 .

INSTRUCTIONS intramuscular injection at SANDOSTATIN LAR
Apply only deep in the gluteus (im)!
content:
Vial containing Sandostatin LAR;
Pre-filled with solvent / carrier syringe + 2 needles
Follow the instructions below carefully to ensure complete saturation of dust and uniformly suspended before intramuscular injection.
Sandostatin LAR suspension should be prepared just before application thereof
Sandostatin LAR should be administered only by a trained medical professional.

Allow to Sandostatin LAR and solvent in the syringe to reach room temperature. Remove the cap from the vial containing Sandostatin LAR. By swirling ensure the collection of dust at the bottom of the vial.
Remove the cap from the syringe with solvent / vehicle . Place one probe on the packaging 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.
Avoid shaking , waiting 2-5 minutes until the winner wet completely. Without turning the vial, check carefully dust the walls and bottom. If there are dry places , it remains soaking continue undisturbed . Prepare the patient for injection.
After the powder is completely wet , shaking with moderate force about 30-60 seconds until a uniform milky suspension . The vial should 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 the bevel down, slowly withdraw the entire contents of the vial , holding it at an angle of 45 °. Do not invert the vial until the full needle because it can affect withdrawn . Normally a small amount of the slurry remains on the walls and bottom of the vial . This is a pre- calculated 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, aspirate to ensure that you are stuck in a blood vessel. Enter slowly by deep intramuscular Sandostatin LAR suspension by applying even pressure . If the needle becomes blocked , 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 . When a blood vessel penetration change the needle and select a new injection site.