about the product
Lyophilizate for preparation of a solution for subcutaneous administration.
Lyophilizate
White powder or white porous mass condensed into a tablet (whole or
crumbled).
Solvent
Colorless transparent liquid.
Specifications
use
Always use the drug in full accordance with the recommendations of your doctor.
If in doubt, consult your doctor.
Recommended dose
The recommended dose of Glutegris is 0.05 mg / kg body weight once a day
daily. The dose is expressed in milliliters (ml) of solution.
Your doctor will select the appropriate dose for you, taking into account your body weight. If in doubt
, consult your doctor.
Use in children and adolescents
The dosage regimen in children and adolescents aged 1 to 17 years inclusive does not
differ from the dosage regimen in adults.
The doctor will select the appropriate dose based on body weight. If in doubt
, consult your doctor.
Route and (or) method of administration
The drug solution should be administered subcutaneously once a day, daily, alternating
injection sites in the four quadrants of the abdominal wall. If the injection of the drug into the abdomen
is complicated by pain, scarring, or thickening of the tissue,
the thigh area can be used for injection.
Glutegris should not be administered intravenously or intramuscularly.
The injection can be done by yourself or it can be done by another person, for example,
a doctor, his assistant or a nurse.
Before you administer the drug yourself, you or your caregivers should
You should receive appropriate training from your doctor or nurse.
Instructions for the preparation and administration of a solution of the drug Glutegris are
given at the end of this leaflet.
Help
Package leaflet
Short bowel syndrome is a disorder that occurs due to impaired absorption of nutrients and fluids in the intestine. Most often, such disorders are caused by surgical removal of the entire small intestine or part of it. The drug Glutegris, reproducing the effects of GLP-2, improves the absorption of nutrients and fluids from the remaining intestine. If there is no improvement or you feel worse, you should consult a doctor.
The drug Glutegrisi is used in adults and children over the age of 1 year with short bowel syndrome (CCC).
Patients should be in stable condition after a period of intestinal adaptation after surgery.
If you have used the drug Glutegris more than you should have
If you have injected more of the drug Glutegris than you should, consult your doctor. In case
of overdose, your doctor should carefully monitor your condition.
If you forgot to apply the drug Glutegris
If you forgot to administer the drug Glutegris at the usual time, administer the drug
as early as possible on the same day.
Do not use a double dose to compensate for the missed dose.
Like all medications, the drug Glutegris can cause
undesirable reactions, however, do not occur in everyone.
Seek medical attention immediately., if you have any problems
signs of the following adverse reactions:
Frequently (may occur in no more than 1 people out of 10):
− congestive heart failure, the signs of which may be fatigue,
shortness of breath or swelling of the legs or feet, or swelling of the face
− inflammation of the pancreas (pancreatitis), which is manifested by severe
abdominal pain and fever
− intestinal obstruction, the signs of which may be severe
abdominal pain, vomiting, and constipation
− violation of the outflow of bile from the gallbladder and/ or inflammation of the gallbladder
(cholecystitis), signs of which may include jaundice of the skin and whites of the eyes,
itching of the skin, darkening of urine and discoloration of feces, pain in the upper right or left
the middle part of the abdomen
Infrequently (may occur in no more than 1 The man from 100):
− fainting (syncope). If your heart rate and breathing are normal, and you
come to your senses quickly, consult your doctor. In other cases, please contact
Get help as soon as possible
Other undesirable reactions:
Very common (may occur in more than 1 person out of 10):
− respiratory tract infections (nasopharyngitis, influenza, upper respiratory tract infections
respiratory tract and lower respiratory tract infections)
− headache
− bloating of the abdomen
− abdominal pain
− nausea
− vomiting
− injection site reactions (redness, pain, swelling, bruise (hematoma),
hemorrhage)
− complications from the gastrointestinal stoma (intestinal orifice,
formed surgically after removal of all or part of the intestine,
designed to drain the contents of the intestine)
Do not use the drug Glutegris:
− If you are allergic to teduglutide or any other components of the drug listed in section 6 of the leaflet;
− If you have or suspect a malignant neoplasm (cancer);
− If you have had cancer of the gastrointestinal
tract, including the liver, gallbladder or bile ducts, as well as the pancreas, in the last 5 years
.
Tell your doctor that you are using, have recently used, or may start using any other medications. The drug Glutegris may increase the absorption of concomitantly administered medications.
The holder of the registration certificate
Russian Federation
PROMOMED RUS LLC
13 Mira Avenue, building 1, office 13, Moscow, 129090
Phone: +7 (495) 640-25-28
Email: reception@promomed.pro
Manufacturer
Russian Federation
JSC "Biochemist"
15A Vasenko St., Saransk, 430030, Republic of Mordovia
For any information about the drug, as well as in cases of claims
You should contact the local representative of the registration holder.
identification cards:
The Russian Federation and the Republic of Armenia
PROMOMED RUS LLC
Address: 13 Mira Avenue, building 1, Moscow, 129090, Russian Federation,
office 13
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro, armenia@drugsafety.ru
Keep the drug out of the reach of the child so that the child cannot see it.
Do not use the drug after the expiration date (shelf life) indicated on the cardboard pack after "Good before".
The expiration date is the last day of the given month.
The drug should not be stored at temperatures above 25 ° C. Store in the original packaging (pack) to protect from light. Do not freeze.
The prepared solution should be transparent or opalescent, colorless.
If the solution is cloudy or contains foreign particles, do not use it.
The prepared solution should be stored at a temperature of no more than 25 ° C for no more than 3 hours.
Do not dispose of the medicine in the sewer. Ask the pharmacy employee how to dispose of the drug that is no longer needed. These measures will help protect the environment.
All needles and syringes should be disposed of in a container for disposal of sharp objects after using the drug.
If you are pregnant or breastfeeding, think you are pregnant, or plan to become pregnant, consult your doctor before using the drug.
During pregnancy and lactation, the use of Glutegris is not recommended.
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