SANDOSTATIN amp. 0.1 mg. / Ml. 1 ml. 

SANDOSTATIN WHAT IS AND WHAT IT IS USED
SANDOSTATIN drug is a synthetic derivative of somatostatin, normally present in the body substance , which inhibits the action of a number of hormones such as growth hormone. The advantages of SANDOSTATIN to somatostatin are more powerful and prolonged effect.

SANDOSTATIN apply:
treatment of acromegaly - a condition in which the body produces more growth hormone than is necessary ( in normal conditions , growth hormone controlling the growth of tissues, organs and bones) . As a result of increased production of growth hormone , bones enlarge (especially hands and feet ) . SANDOSTATIN noticeably reduce the symptoms of acromegaly , which include headache , profuse sweating , numbness in hands and feet , fatigue and joint pain ;
relief of symptoms caused by endocrine tumors of the gastrointestinal tract (e.g., carcinoid tumors, producing intestinal vascular peptide glucagonomas , insulinomas , tumors producing factor stimulates the release of growth hormone ) . In these cases, there is an overproduction of specific hormones and other substances in the stomach , intestine or pancreas. Overproduction disrupts normal hormonal balance of the body , leading to various symptoms such as flushing, diarrhea , low blood pressure , hives , and weight loss . Treatment with SANDOSTATIN helps to control these symptoms ;
controlling the treatment- resistant diarrhea in patients with AIDS . Treatment with SANDOSTATIN helps control the release of stool in patients unresponsive to conventional therapy ;
prevention of complications after surgery on the pancreas. Treatment with SANDOSTATIN helps reduce the chance of postoperative complications (eg, abdominal abscess , inflammation of the pancreas)
suspension and prevent re- bleeding from varicose veins in the esophagus and stomach in patients with cirrhosis ( chronic liver disease ) . SANDOSTATIN treatment helps control bleeding and to reduce the need for transfusions.

2 . BEFORE YOU TAKE SANDOSTATIN
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 .
Do not take SANDOSTATIN
if you are allergic to octreotide or any of the other ingredients of the medicines listed in this leaflet.
Take special care with SANDOSTATIN
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 you know you have gallstones or have had in the past. Tell your doctor as prolonged use of SANDOSTATIN can lead to the formation of gallstones . Your doctor may wish to periodically check your gall bladder;
If you have a problem with blood sugar levels , either very high ( diabetes) or too low ( hypoglycemia) ;
SANDOSTATIN When used to treat bleeding from varicose veins in the esophagus and stomach , it is imperative that the tracking of blood glucose level ;
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 Your doctor may want to periodically check the function of your thyroid gland ;
During your treatment with SANDOSTATIN , your doctor will monitor the function of your liver .
Use of SANDOSTATIN food
Avoid eating around the time of application of SANDOSTATIN ;
Best SANDOSTATIN be injected between meals or during bed rest . This will reduce its undesirable gastrointestinal side effects .
SANDOSTATIN and children
SANDOSTATIN can be used in children , but the experience of its application is limited.

SANDOSTATIN and elderly
Experience has shown that SANDOSTATIN may be administered to humans and over 65 years without any special requirements.

pregnancy
During pregnancy SANDOSTATIN can be used only when absolutely necessary .
Tell your doctor if you are pregnant or planning pregnancy .
Women of childbearing potential
During treatment, women of childbearing potential should use effective methods of contraception.

breastfeeding
It is not known whether SANDOSTATIN passes into breast milk . However, you should not breastfeed while using SANDOSTATIN .

Driving and using machines
No information about the impact of SANDOSTATIN 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 , including those for which no prescription is required .
Can generally continue to take other medicines while being treated with SANDOSTATIN . Data on the effect of SANDOSTATIN on blood levels of certain medications , such as cimetidine , bromocriptine and cyclosporine .
If you suffer from diabetes , you may need your doctor to adjust your insulin dose .

3 . HOW TO TAKE SANDOSTATIN
Depending on the disease being treated , SANDOSTATIN is administered by subcutaneous injection or intravenous infusion. Your doctor or nurse will explain how to inject subcutaneously SANDOSTATIN but intravenous administration should always be performed by a medical professional .

subcutaneous
Upper arms , thighs and abdomen are suitable sites for subcutaneous injection .
For each subcutaneous injection choose a new place to not irritate constant specific area. If you apply inject yourself , you can get precise instructions from your doctor or nurse ;
To reduce pain at the injection site is recommended to leave some time at room temperature stored in the refrigerator ampoule. You can warm it up by hand , but do not heat .
Intravenous infusions / injections ( for medical professionals)
SANDOSTATIN ( octreotide acetate ) is physically and chemically stable for 24 hours in sterile saline solutions or sterile solutions of dextrose (glucose) 5% in water. Since SANDOSTATIN may influence glucose homeostasis , it is recommended to use a saline solution instead dekstrozov . The diluted solutions are physically and chemically stable for at least 24 hours at a temperature below 25 ° C. From a microbiological point of view, it is recommended that the diluted solution should be used immediately . If not used immediately , storage to use is responsible patient and storage should be at a temperature of 2 ° C to 8 ° C.
Before implementation, the solution should be at room temperature. The total time for reconstitution, dilution with infusion media , refrigeration and final application should not exceed 24 hours.

SANDOSTATIN When to be administered by intravenous infusion , the contents of 0,5 mg ampoule is normally diluted with 60 ml of physiological solution and the resulting solution to be administered by infusion pump . This can be repeated as many times as necessary, until the prescribed duration of the treatment.
Before using ampoules through the solution without particles and not discolored ;
Do not use if you observe unusual changes in the ampoule.
The dosage of SANDOSTATIN is determined according to the disease being treated .
acromegaly
Therapy begins with 0,05 to 0,1 mg every 8 or 12 hours subcutaneously . If necessary, the dose may be adjusted depending on the effect and control of symptoms such as . fatigue , sweating and headaches. In most patients, the optimum daily dose is twice or three times 0,1 mg. The maximum daily dose is 1,5 mg and it should not be exceeded.

Tumours of the gastrointestinal tract
Therapy begins with 0,05 mg once or twice daily by subcutaneous route. Depending on the effect and tolerability , the dose can be gradually increased to 0,1 - 0,2 mg, three times a day . In carcinoid tumors , treatment should be discontinued if there is no improvement after one week of treatment with the maximum tolerated dose.

Treatment- resistant diarrhea , in patients suffering from AIDS
The recommended starting dose is 0,1 mg, three times daily subcutaneously . In the absence of the effect after one week , the dose could be increased to 0,25 mg, three times a day , if necessary . In the absence of improvement after one week of treatment at this dosage , therapy should be discontinued.

Prevention of complications after surgery of the pancreas
The usual dose is 0,1 mg, three times daily for one week. Therapy should be initiated at least one hour prior to surgery.

Bleeding from varicose veins in the esophagus and stomach
The recommended dose is 25 μg / hr for 5 days. During therapy, it is necessary to monitor blood sugar levels .
If you suffer from cirrhosis ( chronic liver disease ), your doctor should determine your maintenance dose ;
If you sense that the effect of SANDOSTATIN is too strong or too weak, talk to your doctor or pharmacist.
If you take more dose SANDOSTATIN
No evidence of life-threatening reactions after overdose SANDOSTATIN . Symptoms of overdose may include: irregular heartbeat , low blood pressure , cardiac arrest ( cardiac arrest ) , lack of oxygen in the brain ( cerebral hypoxia ) , severe pain in the upper half of the abdomen, yellowing of the skin and whites of the eyes , nausea, loss of appetite , diarrhea , weakness , fatigue , lack of energy , weight loss , bloating , gastric discomfort, and the condition known as lactic acidosis ..
If you think you have taken an overdose and experience these symptoms , consult your doctor.

If you forget to take SANDOSTATIN
If you miss an injection, put it as soon as you remember and then continue on the prescribed schedule . Omission of a single dose is harmless but can be some of the symptoms of the disease until they recover as usual.
Do not take a double dose to make up for missed .

4 . POSSIBLE SIDE EFFECTS
Like all medicines, SANDOSTATIN can cause side effects, although not everybody gets them . Tell your doctor immediately if you experience any of these side effects .
In some patients, it is possible to , pain at the site of subcutaneous injection , but in most cases it is quickly resolved . If you experience this , rub gently for a few seconds the injection site , to soothe the pain.
The above effects can be reduced by administration of SANDOSTATIN intervals between meals or at bedtime .

Some side effects can 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 ( affects less than 1 in every 100 patients but less than 1 in 1000 patients):
thirst , low urine output , dark urine , dry, flushed skin ;
accelerated heartbeat .
Other serious side effects
If you have any of these effects , tell 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 during treatment
Some effects are very common (affects more than 1 in 10 patients):
diarrhea ;
stomach pain ;
nausea ;
constipation ( constipation ) ;
gases in the abdomen ;
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;
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
SANDOSTATIN not use after the expiry date stated on the packaging.
With prolonged storage , SANDOSTATIN vials should be stored at 2 to 8 ° C (in a refrigerator). Keep it in the outer carton ( carton ) to protect it from light.
Do not freeze .
In daily use, vials may be stored at room temperature under 30 ° C for a period not longer than 2 weeks.
SANDOSTATIN ampoules do not contain preservatives , so after opening the ampoules should be used immediately and any remaining amount after application should be discarded .
Keep out of reach of children.

6 . ADDITIONAL INFORMATION
What does SANDOSTATIN
The active substance of SANDOSTATIN is octreotide acetate.
Other ingredients are: lactic acid , mannitol , sodium bicarbonate, and water for injection.
This product contains less than 1 mmol ( 23 mg) of sodium in each dose , i.e. in practice , a "no -sodium " .
SANDOSTATIN comes in ampoules 0,1 mg / ml - 1 ml x 5 .