Somatulin 1 x 30 mg powder for suspension in a vial with 2 ml of solvent
- $1 079.60
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The instruction for use
of medicine for experts
Somatulin®
the Trade name
Somatulin®
the International unlicensed
name Lanreotid Lekarstvennaya a form
Lyophilisate for preparation of suspension for intramuscular introduction of the prolonged action, 30 mg
Structure
Active agent - lanreotid, 30 mg
excipients: copolymers (lactide-glycolide and laktik-glikolik), Mannitolum, sodium carboxymethylcellulose, polysorbate 80,
2 ml of solvent contain in an ampoule: Mannitolum, water for injections.
* taking into account features of a dosage form, each bottle contains 40 mg of a lanreotid of the acetate corresponding to 30 mg of a lanreotid
the Description
the Lyophilisate of color, white or white with a cream shade, which is dispersed in the enclosed solvent with formation of suspension of color, white or white with a creamy shade,
Pharmacotherapeutic group
hypothalamus Hormones, growth-retarding.
The code of automatic telephone exchange H01CB03
the Pharmacological
Pharmacokinetics Absorption properties of a lanreotid is characterized by the first phase of fast release of the peptide which is on a surface of microspheres which is replaced by the second slow phase of release.
Peak of the first phase (Cmax 1: 6.8 ± 3.8 mkg/l) it is celebrated through 1.4 ± 0.8 hours and peak of the second phase (Cmax 2: 2.5 ± 0.9 mkg/l) through 1.9 ± 1.8 days after reception. The absolute bioavailability is 46.1 ± 16.7%. The average time of keeping of drug 8 ± and elimination half-life is 1 days 5.2 ± 2.5 days. These indicators confirm the prolonged drug release.
At the same time concentration of growth hormone and an insulinopodobny growth factor (IFR-1) decrease during, at least, 14 days after single administration of drug.
At constant administration of drug within several months the cumulation is noted. Studying binding of a lanreotid components of blood showed that similar interaction is improbable at such level.
The pharmacodynamics
Somatulin represents synthetic peptide, a somatostatin analog (natural hormone).
To similarly natural somatostatin, lanreotid inhibits a number of endocrine, exocrine and paracrine mechanisms, possesses more expressed tropnost to peripheral somatostatinovy receptors (hypophysial and pancreatic), than to central. It caused selectivity of action concerning secretion of growth hormone, glands of intestines and a pancreas. Drug suppresses patholologically growth hormone hypersecretion and also secretion of glands of intestines and pancreas.
Indications
- an acromegalia
- carcinoid tumors (symptomatic therapy).
The route of administration and doses
the Drug is administered only intramusculary (in oil) in specialized institutions and in strict accordance with this instruction.
Treatment is begun with trial introduction (in case of its inefficiency the further therapy is inexpedient) and estimate response (dynamics of secretion of growth of growth hormone, the symptoms connected with a carcinoid tumor).
The mode of dosing and duration of therapy establish individually for each patient.
Appoint 30 mg of drug in oil of 1 times in 14 days. At insufficient efficiency it is possible to increase the frequency of administration of drug to 1 injection each 10 days. The course of treatment depends on the level of secretion of growth hormone and expressiveness of clinical manifestations of a disease
of IInstruktsiya on preparation and administration
of the drug Lyophilisate Mixing with the enclosed solvent has to be carried out just before an injection by agitation of contents of a bottle by smooth movements, rotating a bottle of 20 or 30 times between fingers before receiving uniform suspension of color, white or white with a creamy shade. Suspension should not mix up with other drugs.
1. Remove a cap from a needle with a pink nozzle and attach it to the syringe.
2. Gather in the syringe all solvent from an ampoule
3. Uncover a bottle with lyophilisate, having removed a blue plastic cover
4. Enter a needle through a stopper and chlorbutyl and transfer solvent
to a bottle.
5. Accurately shake up contents, rotating a bottle of 20 or 30 times between fingers before receiving uniform suspension. Do not extort it there and back.
6. Without turning a bottle, gather all suspension in the syringe.
7. Remove a needle from the syringe. Press on the syringe piston so that all air came out.
8. Attach other needle with a pink nozzle.
The injection has to be carried out always intramusculary.
9. It is necessary to inject immediately.
Side effects
- an itching, burning, the moderate passing pain in the place of an injection which sometimes is followed by hyperaemia
- diarrhea or a soft chair, a steatorrhea, abdominal pain, a meteorism, nausea, vomiting. At prolonged use of drug the formation of stones in a gall bladder (asymptomatic cholelithiasis) is possible
- it is rare: increase in concentration of glucose, change of tolerance to glucose
- is very rare: leukosis.
Contraindications
- pregnancy
- the breastfeeding period
- hypersensitivity to drug components.
Medicinal interactions
At co-administration with insulin its hypoglycemic action in this connection, the dose of insulin has to be modified amplifies.
At co-administration with cyclosporine (orally), it is necessary to carry out cyclosporine dose adjustment.
Special instructions
At Somatulin's appointment the patients with diabetes (both type 1, and type 2) should carry out regular control of level of glucose of blood and, if necessary, to carry out dose adjustment of hypoglycemic drugs.
In carcinoid tumors of digestive tract the treatment by Somatulin is appointed after elimination of intestinal obstruction a tumor.
At treatment of an acromegalia the careful observation of a condition of a hypophysis is necessary.
At long-term treatment each 6 months it is necessary to make ultrasound examination of a gall bladder.
In an abnormal liver function or kidneys it is necessary to adjust a drug dose.
It is necessary to warn patients to whom treatment by Somatulin about possible disturbance of reproductive function, and also about expediency of use of contraceptives is carried out during treatment by Somatulin and within 3 months after the end of treatment.
Drug does not affect ability to driving of motor transport and control of moving mechanisms.
Overdose
Symptoms: diarrhea or soft chair, steatorrhea, abdominal pain, meteorism, nausea, vomiting, electrolytic disturbances.
Treatment: symptomatic.
A form of release and packing
On 30 mg of a lanreotid in a bottle from colourless hydrolytic glass of I type (Evr.F.), corked by a stopper from chlorbutyl under an aluminum running in with an opening for a needle in the center and closed by a protective plastic cover of control of the first opening. On 2 ml of solvent in an ampoule from colourless hydrolytic II glass (Evr.F.). One empty sterile disposable polypropylene syringe with a capacity of 3 ml and two sterile disposable needles with tips (size of a needle of 1.20X 40 mm) in the blister packing from PVC and the laminated paper.
One bottle with lanreotidy, one ampoule with solvent, one blister packing with the syringe and two needles is placed together with the instruction for use in a cardboard box.
To Store storage conditions at a temperature from +2 ° to +8 °C (in the fridge).
To store out of children's reach!
2 years
not to use an expiration date after the expiration date specified on packing.
The drug expiration date after mixing with solvent and ready to the use makes 6 hours at storage in usual conditions (room temperature).
Prescription status
According to the prescription
of medicine for experts
Somatulin®
the Trade name
Somatulin®
the International unlicensed
name Lanreotid Lekarstvennaya a form
Lyophilisate for preparation of suspension for intramuscular introduction of the prolonged action, 30 mg
Structure
Active agent - lanreotid, 30 mg
excipients: copolymers (lactide-glycolide and laktik-glikolik), Mannitolum, sodium carboxymethylcellulose, polysorbate 80,
2 ml of solvent contain in an ampoule: Mannitolum, water for injections.
* taking into account features of a dosage form, each bottle contains 40 mg of a lanreotid of the acetate corresponding to 30 mg of a lanreotid
the Description
the Lyophilisate of color, white or white with a cream shade, which is dispersed in the enclosed solvent with formation of suspension of color, white or white with a creamy shade,
Pharmacotherapeutic group
hypothalamus Hormones, growth-retarding.
The code of automatic telephone exchange H01CB03
the Pharmacological
Pharmacokinetics Absorption properties of a lanreotid is characterized by the first phase of fast release of the peptide which is on a surface of microspheres which is replaced by the second slow phase of release.
Peak of the first phase (Cmax 1: 6.8 ± 3.8 mkg/l) it is celebrated through 1.4 ± 0.8 hours and peak of the second phase (Cmax 2: 2.5 ± 0.9 mkg/l) through 1.9 ± 1.8 days after reception. The absolute bioavailability is 46.1 ± 16.7%. The average time of keeping of drug 8 ± and elimination half-life is 1 days 5.2 ± 2.5 days. These indicators confirm the prolonged drug release.
At the same time concentration of growth hormone and an insulinopodobny growth factor (IFR-1) decrease during, at least, 14 days after single administration of drug.
At constant administration of drug within several months the cumulation is noted. Studying binding of a lanreotid components of blood showed that similar interaction is improbable at such level.
The pharmacodynamics
Somatulin represents synthetic peptide, a somatostatin analog (natural hormone).
To similarly natural somatostatin, lanreotid inhibits a number of endocrine, exocrine and paracrine mechanisms, possesses more expressed tropnost to peripheral somatostatinovy receptors (hypophysial and pancreatic), than to central. It caused selectivity of action concerning secretion of growth hormone, glands of intestines and a pancreas. Drug suppresses patholologically growth hormone hypersecretion and also secretion of glands of intestines and pancreas.
Indications
- an acromegalia
- carcinoid tumors (symptomatic therapy).
The route of administration and doses
the Drug is administered only intramusculary (in oil) in specialized institutions and in strict accordance with this instruction.
Treatment is begun with trial introduction (in case of its inefficiency the further therapy is inexpedient) and estimate response (dynamics of secretion of growth of growth hormone, the symptoms connected with a carcinoid tumor).
The mode of dosing and duration of therapy establish individually for each patient.
Appoint 30 mg of drug in oil of 1 times in 14 days. At insufficient efficiency it is possible to increase the frequency of administration of drug to 1 injection each 10 days. The course of treatment depends on the level of secretion of growth hormone and expressiveness of clinical manifestations of a disease
of IInstruktsiya on preparation and administration
of the drug Lyophilisate Mixing with the enclosed solvent has to be carried out just before an injection by agitation of contents of a bottle by smooth movements, rotating a bottle of 20 or 30 times between fingers before receiving uniform suspension of color, white or white with a creamy shade. Suspension should not mix up with other drugs.
1. Remove a cap from a needle with a pink nozzle and attach it to the syringe.
2. Gather in the syringe all solvent from an ampoule
3. Uncover a bottle with lyophilisate, having removed a blue plastic cover
4. Enter a needle through a stopper and chlorbutyl and transfer solvent
to a bottle.
5. Accurately shake up contents, rotating a bottle of 20 or 30 times between fingers before receiving uniform suspension. Do not extort it there and back.
6. Without turning a bottle, gather all suspension in the syringe.
7. Remove a needle from the syringe. Press on the syringe piston so that all air came out.
8. Attach other needle with a pink nozzle.
The injection has to be carried out always intramusculary.
9. It is necessary to inject immediately.
Side effects
- an itching, burning, the moderate passing pain in the place of an injection which sometimes is followed by hyperaemia
- diarrhea or a soft chair, a steatorrhea, abdominal pain, a meteorism, nausea, vomiting. At prolonged use of drug the formation of stones in a gall bladder (asymptomatic cholelithiasis) is possible
- it is rare: increase in concentration of glucose, change of tolerance to glucose
- is very rare: leukosis.
Contraindications
- pregnancy
- the breastfeeding period
- hypersensitivity to drug components.
Medicinal interactions
At co-administration with insulin its hypoglycemic action in this connection, the dose of insulin has to be modified amplifies.
At co-administration with cyclosporine (orally), it is necessary to carry out cyclosporine dose adjustment.
Special instructions
At Somatulin's appointment the patients with diabetes (both type 1, and type 2) should carry out regular control of level of glucose of blood and, if necessary, to carry out dose adjustment of hypoglycemic drugs.
In carcinoid tumors of digestive tract the treatment by Somatulin is appointed after elimination of intestinal obstruction a tumor.
At treatment of an acromegalia the careful observation of a condition of a hypophysis is necessary.
At long-term treatment each 6 months it is necessary to make ultrasound examination of a gall bladder.
In an abnormal liver function or kidneys it is necessary to adjust a drug dose.
It is necessary to warn patients to whom treatment by Somatulin about possible disturbance of reproductive function, and also about expediency of use of contraceptives is carried out during treatment by Somatulin and within 3 months after the end of treatment.
Drug does not affect ability to driving of motor transport and control of moving mechanisms.
Overdose
Symptoms: diarrhea or soft chair, steatorrhea, abdominal pain, meteorism, nausea, vomiting, electrolytic disturbances.
Treatment: symptomatic.
A form of release and packing
On 30 mg of a lanreotid in a bottle from colourless hydrolytic glass of I type (Evr.F.), corked by a stopper from chlorbutyl under an aluminum running in with an opening for a needle in the center and closed by a protective plastic cover of control of the first opening. On 2 ml of solvent in an ampoule from colourless hydrolytic II glass (Evr.F.). One empty sterile disposable polypropylene syringe with a capacity of 3 ml and two sterile disposable needles with tips (size of a needle of 1.20X 40 mm) in the blister packing from PVC and the laminated paper.
One bottle with lanreotidy, one ampoule with solvent, one blister packing with the syringe and two needles is placed together with the instruction for use in a cardboard box.
To Store storage conditions at a temperature from +2 ° to +8 °C (in the fridge).
To store out of children's reach!
2 years
not to use an expiration date after the expiration date specified on packing.
The drug expiration date after mixing with solvent and ready to the use makes 6 hours at storage in usual conditions (room temperature).
Prescription status
According to the prescription
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