Instruction for use: Somatuline

ATX Code H01CB03 Lanreotide

Active substance: Lanreotide

Pharmacological group

Somatostatin, a synthetic analogue [Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists]

Nosological classification (ICD-10)

C26 Malignant neoplasm of other and inaccurately indicated digestive organs

Bowel cancer, Gastrointestinal cancer, Carcinoid GI tract, Adenocarcinoma of the intestine, Cancer of other parts of the large intestine, Argentaffinoma, Carcinoid, Enterochromaffinoma, Cancer of the colon, Colon cancer

D01.9 Carcinoma in situ of digestive organs, unspecified

E22.0 Acromegaly and pituitary gigantism

Pituitary gigantism, Acromegaly, Dysfunction of growth hormone secretion

T88.9 Complication of surgical and medical care, unspecified

Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after the removal of hemorrhoids, Pain in the application of excimer laser, Pain with injuries and after surgical interventions, Pain syndromes in the dental practice, Painful diagnostic intervention, Painful diagnostic manipulations, Painful instrumental diagnostic procedures, Painful instrumental manipulation, Painful treatments, Painful manipulations, Painful dressings, Painful therapeutic interventions, Pain in the area of the surgical wound, Pain in the postoperative period, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain during diagnostic procedures, Pain during therapeutic procedures, Pain in orthopedics, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, The pain after dental surgery, postoperative Pain, Pain postoperative and posttraumatic, The pain of tooth extraction, Inflammation after surgery or injury, Inflammation after orthopedic surgery, Inflammation after surgery, The inflammatory syndrome after surgery, Festering postoperative fistula, Operating wound, Complications after tooth extraction

Composition

Liofilizate for the preparation of a suspension for intramuscular administration of prolonged action 1 fl.

Lanreotide acetate 0.04 g

(Corresponding to 0.03 g of lanreotide)

Auxiliary substances: copolymers (lactide-glycolide and lactide-glycolic); Mannitol; Sodium carboxymethylcellulose; Polysorbate 80

Composition of the solvent in the ampoule: mannitol; water for injections

In vials (complete with a solvent in the ampoule, syringe, needles); In a pack of cardboard 1 set.

pharmachologic effect

The pharmacological action is somatostatin-like.

Dosing and Administration

In / m, only in specialized institutions and in strict accordance with the instructions given below.

Treatment begins with a trial injection (in case of ineffectiveness, its further therapy is impractical) and evaluate the response (dynamics of growth hormone secretion, symptoms associated with a carcinoid tumor).

Dosing regimen and duration of therapy are set individually for each patient.

Assign 30 mg of the drug in / m 1 time in 14 days. If there is insufficient effectiveness, you can increase the frequency of the drug to 1 injection every 10 days.

Instructions for preparation and administration of the drug

Mixing of the lyophilizate with the applied solvent should be performed immediately before the injection by shaking the contents of the vial with smooth movements, rotating the bottle 20-30 times between the fingers until a homogeneous suspension of white or white with a creamy hue is obtained.

Suspension should not be mixed with other drugs.

Procedure for performing the manipulation

1. Remove the cap from the needle with a pink nozzle and attach it to the syringe.

2. Collect all the solvent from the ampoule into the syringe.

3. Remove the lid from the lyophilisate vial by removing the blue plastic cover.

4. Insert the needle through the cap of chlorobutyl rubber and transfer the solvent into the vial.

5. Gently shake the contents, rotating the bottle 20-30 times between the fingers until a uniform suspension is obtained. Do not pour into the bottle and back.

6. Without turning the vial, dial into the syringe the entire suspension.

7. Remove the needle from the syringe. Press the syringe onto the piston so that all air is out.

8. Attach another needle (with a pink nozzle). Injection should always be done in / m.

9. Injection should be done immediately.

Storage conditions

At a temperature of 2-8 ° C. In a refrigerator.

Keep out of the reach of children.

Shelf life

2 years. Shelf life of the preparation after mixing with the solvent and ready for use is 6 hours when stored under normal conditions (room temperature).

Do not use after the expiry date printed on the package.