Degan. 10 mg. 2 ml. 25 ampules
Degan. 10 mg. 2 ml. 25 ampules
Degan WHAT IS AND WHAT IT IS USED
Degan antiemetic . It contains metoclopramide. It works to a certain place in your brain by preventing nausea and vomiting.
Dagan is used in adults :
For the prevention of nausea and vomiting which may occur after the operation ;
For the treatment of nausea and vomiting , including nausea and vomiting which may occur in migraine ;
To prevent nausea and vomiting caused by radiotherapy .
Dagan use in children (aged 1-18 years) only if other treatments are not effective or can be administered :
To prevent appearing later nausea and vomiting after chemotherapy ;
For the treatment of nausea and vomiting that occur after surgery.
2 . WHAT YOU SHOULD KNOW BEFORE YOU USE Degan
You should not be applied Dagan if:
you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in Section 6) ;
have bleeding , occlusion or rupture of the stomach or intestines ;
have a rare tumor of the adrenal gland, which is located near the kidney ( phaeochromocytoma)
ever had involuntary muscle spasms ( tardive dyskinesia ) during drug treatment ;
have epilepsy ;
suffer from Parkinson's disease ;
taking levodopa ( a drug for the treatment of Parkinson's disease ) or dopaminergic agonists ( see below " Other drugs and Dagan " ) ;
ever had abnormal blood pigments ( methemoglobinemia ) or deficiency of NADH cytochrome - b5.
Do not apply Dagan of children aged less than 1 year ( see below " Children and Youth " ) .
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Dagan if:
have a history of abnormal heart rhythm ( QT prolongation ), or other heart problems ;
have problems with the levels of salts in the blood , such as potassium, sodium, and magnesium;
taking other drugs that are known to affect the heart rhythm
have a neurological (brain ) disease;
have liver disease or kidney. The dose may be reduced (see section 3 ) .
Your doctor may do blood tests to check the amount of blood pigments. In case of abnormal levels ( methemoglobinemia ) , treatment should be stopped immediately .
Children and adolescents
Uncontrollable movements ( extrapyramidal disorder ) can occur in children and adolescents. This medicine should not be used in children under the age of one year due to an increased risk of uncontrollable movements ( see above "Do not take if Dagan " ) .
Other medicines and Dagan
Tell your doctor, pharmacist or nurse if you are taking , have recently taken or might take other medicines. This is because some drugs can affect the action of Dagan Dagan or may affect how other medicines work . These drugs include the following :
Levodopa or other medicines for the treatment of Parkinson's disease ( see above "Do not take if Dagan " ) ;
Anticholinergic drugs ( drugs that relieve stomach cramps or spasms)
Morphine derivatives (drugs for the relief of pain ) ;
Medicines used to treat mental health problems ;
Digoxin (a medicine to treat heart failure) ;
Ciclosporin (a medicine to treat certain problems with the immune system) ;
mivakurium and suxamethonium (drugs for muscle relaxation ) ;
fluoxetine and paroxetine ( medicines for the treatment of depression ) .
Taking Dagan food , beverages and alcohol
It is not recommended to drink alcohol during treatment with metoclopramide , because alcohol can increase the sedative effect of Dagan .
Since Dagan affect transit time of food through the gastrointestinal tract and thereby the rate of resorption may be necessary to adjust the dose of oral antidiabetic agents and insulin .
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine. If necessary, Indigestion can be taken during pregnancy . Your doctor will decide whether to prescribe this medication .
Not recommended intake Dagan while breastfeeding because metokloperamid can pass into breast milk and harm your baby.
Driving and using machines
You may feel drowsy , dizzy or have uncontrollable twitching , spasms or convulsions and abnormal muscle tone causing distortion of the body, after use of Dagan . This can impair your vision and also interferes with the ability to drive and use machines.
3 . HOW TO USE Degas
The drug was administered by a physician or nurse , slow intravenous ( for not less than 3 minutes ) or intramuscularly.
In adult patients
For the treatment of nausea and vomiting , including nausea and vomiting which may occur in migraine and for the prevention of nausea and vomiting induced by radiotherapy : the recommended unit dose is 10 mg, taken up to three times a day.
The maximum recommended dose is 30 mg per day or 0,5 mg / kg body weight.
For the prevention of nausea and vomiting after surgery, it is recommended that a single dose of 10 mg.
All therapeutic indications ( pediatric patients aged 1-18 years)
The recommended dosage is 0.1 to 0,15 mg / kg of body weight, taken up to 3 times a day , affixed by slow injection into a vein.
The maximum dose per 24 hours is 0,5 mg / kg body weight.
Dosing table .
Age Body Weight Dose Frequency
1-3 years, 10-14 kg 1 mg to 3 times per day
3-5 years, 15-19 kg 2 mg to 3 times per day
5-9 years, 20-29 kg 2.5 mg 3 times per day
9-18 years 30-60 kg 5 mg 3 times per day
15-18 Over 60 kg 10 mg 3 times daily
Treatment of nausea and vomiting occurring after surgery should not exceed 48 hours.
Treatment of emerging later nausea and vomiting after chemotherapy should not last more than 5 days.
You may need dose reduction , depending on the problems with the kidneys, liver and overall health .
Adults with kidney problems
Tell your doctor if you have kidney problems . The dose should be reduced if you have moderate or severe renal impairment.
Adults with kidney problems
Tell your doctor if you have liver problems . The dose should be reduced if you have severe liver damage.
Children and adolescents
Metoclopramide should not be used in children aged less than 1 year (see section 2 ) .
If you use more than the amount of Dagan
Immediately contact your doctor or pharmacist. You may have uncontrolled movements ( extrapyramidal disorder ) may feel sleepy, have depressed consciousness to be confused, have hallucinations and cardiac disorders. If necessary, your doctor may prescribe treatment for these symptoms.
If you forget to use Dagan
If you think you do not dose Dagan , ask your doctor or the rest of the medical staff immediately . Do not apply a double dose to make up the missed dose.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, Indigestion can cause side effects, although not everybody gets them .
Stop treatment immediately and tell your doctor , pharmacist or nurse if you have any of these signs while taking this medicine :
Uncontrolled movements (often involving the head or neck ) . They may occur in children and young people , and especially when used at high doses. These signs usually appear early in treatment and even after a single administration . These movements will stop after appropriate treatment;
High temperature, high blood pressure , convulsions , sweating, salivation. These may be signs of a condition called neuroleptic malignant syndrome;
Itching or skin rash , swelling of the face, lips or throat, difficulty breathing. These may be symptoms of allergic reaction which may be severe .
Assessment of adverse reactions based on the frequency
Common: affects 1 to 10 users in 100 ;
Uncommon: affects 1 to 10 users in 1000 ;
Rare: affects 1 to 10 users in 10,000 ;
Very rare: affects less than 1 user in 10 000 ;
Not known: frequency can not be estimated from the available data.
Very common ( may affect more than 1 in 10 people):
Feeling drowsy .
Common ( may affect up to 1 in 10 people):
uncontrolled movements such as twitching , shaking, twisting movements or muscle contracture ( stiffness, muscle rigidity ) ;
Symptoms similar to Parkinson's disease ( rigidity, tremor) ;
low blood pressure (especially intravenous ) ;
a feeling of weakness .
Uncommon ( may affect up to 1 in 100 people):
elevated blood levels of a hormone called prolactin, which may cause : separation of the milk in men and women who are not breast-feeding ;
irregular menstruation ;
depressed level of consciousness ;
slow heartbeat ( especially intravenous ) ;
Rare (may affect up to 1 in 1000 people):
confusional state ;
convulsions (especially in patients with epilepsy) .
Not known (frequency can not be estimated from the available data):
variation in the levels of blood pigments : you can change the color of your skin ;
breast enlargement in men ( gynecomastia ) ;
involuntary muscle spasms after prolonged use , especially in elderly patients ;
fever, high blood pressure , convulsions , sweating , salivation . These may be signs of a condition called neuroleptic malignant syndrome;
changes in heart rate , which can be seen in the ECG analysis;
heart failure (especially intravenous ) ;
shock (severe lowering of blood pressure) (especially intravenous ) ;
Fainting (especially intravenous ) ;
Allergic reaction that can be severe (especially intravenous ) ;
Very high blood pressure .
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet .
Adverse event reporting
If you get any side effects , tell your doctor. This includes all listed in this leaflet . You can also report side effects directly through the national system for reporting to the BDA , "Damian Gruev " ? 8 , 1303 Sofia, tel : +35928903417 , Website : www.bda.bg. As reported side effects , you can do your bit to get more information on the safety of this medicine.
5 . HOW TO STORE Degan
Keep out of reach of children.
Store below 25 ° C, protected from light
Do not use this medicine after the expiry date stated on the packaging.
Method of allocation :
Dagan is taken only on prescription , and the solution is made only in a hospital setting.
Exceptionally, the solution can be prepared at home with continued therapy after the patient was discharged from the hospital.
6 . PACKAGE CONTENTS AND ADDITIONAL INFORMATION
The active substance is metoklopramidov hydrochloride.
Each 2 ml of solution for injection ( 1 vial ) containing 10 mg metoklopramidov hydrochloride monohydrate).
Other ingredients are: hydrochloric acid (to adjust pH ), water for injections.
Dagan looks like and contents of pack
Cartons of 10, 25 or 50 ampoules of injectable solution containing 10 mg / 2 ml of metoclopramide hydrochloride monohydrate.