Degan 10 mg. 2 ml. 50 ampoules

SANDOZ
Degan 10 mg. 2 ml. 50 ampoules
€ 45.00
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WHAT Degan AND WHAT IT IS USED
Degan is an antiemetic. It contains metoclopramide. It acts in a certain place in your brain by preventing nausea and vomiting.

adults
Degan 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.
Paediatric population
Degan use in children (aged 1-18 years) only if other treatment does not work 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 given Degan if:
you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6);
you have bleeding, blockage or rupture of the stomach or intestines;
have a rare tumor of the adrenal gland, which is located near the kidney (pheochromocytoma);
you have ever experienced involuntary muscle spasms (tardive dyskinesia) during treatment with the drug;
have epilepsy;
suffer from Parkinson's disease;
taking levodopa (a drug for the treatment of Parkinson's disease) or dopaminergic agonists (see below "Other medicines and Degan");
ever had abnormal levels of blood pigments (methemoglobinemia) or deficiency of NADH cytochrome - b5.
Do not use Degan of children under the age of 1 year (see below "Children and adolescents").

Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Degan 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 medications known to affect heart rhythm
have neurological (brain) disease;
damage to your liver or kidneys. The dose may be reduced (see section 3).
Your doctor may do blood tests to check the amount of blood pigments. In case of divergences in (methemoglobinemia), treatment should be stopped immediately.

Children and adolescents
Uncontrollable movements (extrapyramidal disorders) 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 Degan").

Other medicines and Degan
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some drugs can affect the action of Degan Degan or may affect the way other medicines. These drugs include the following:
Levodopa or other medicines for the treatment of Parkinson's disease (see above "Do not take if Degan");
Anticholinergic drugs (drugs that relieve stomach cramps or spasms);
Morphine derivatives (drugs to alleviate pain);
Sedatives;
Medicines used to treat mental health problems;
Digoxin (a medicine for the treatment of heart failure);
Ciclosporin (a medicine to treat certain problems with your immune system);
mivakurium and suxamethonium (drugs for muscle relaxation);
fluoxetine and paroxetine (medicines for depression).
Taking Degan of food, beverages and alcohol
It is not recommended to drink alcohol during treatment with metoclopramide, because alcohol may enhance the sedative effect of Degan.
As Degan affect the time of passage of food through the gastrointestinal tract, and thus rate of absorption may be necessary to adjust the dose of oral antidiabetic agents and insulin.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. If necessary, Degan can be taken during pregnancy. Your doctor will decide whether to prescribe this medicine.
Not recommended intake Degas 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 Degas. This can impair your vision and also interferes with the ability to drive and use machines.

3. HOW TO USE Degan
The medication is 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 dose is 0.1 to 0,15 mg / kg body weight, taken 3 times a day, placed 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 to 3 times a day
9-18 years 30-60 kg 5 mg 3 times per day
15-18 years More than 60 kg 10 mg to 3 times a day
Treatment of nausea and vomiting that occur after surgery should not exceed 48 hours.
Treatment of emerging later nausea and vomiting after chemotherapy should last more than five days.

Elderly
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 liver 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 under the age of 1 year (see. Point 2).

If you use more than the amount of Degan
Immediately contact your doctor or pharmacist. You may have uncontrolled movements (extrapyramidal disorders), you feel sleepy, have depressed consciousness to be confused, to have hallucinations and heart disorders. If necessary, your doctor may prescribe treatment for these symptoms.

If you forget to use Degan
If you think you do not dose Degan, ask your doctor or medical staff rest 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, Degan can cause side effects, although not everybody gets them.

Immediately stop the treatment 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 can occur in children and young people, and especially with the use of higher doses. These symptoms usually occur early in treatment and even after a single administration. These movements will stop after appropriate treatment;
Fever, 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 in 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: 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):
depression;
involuntary movements such as twitching, shaking, twisting movements or muscle contractures (numbness, muscle rigidity);
symptoms similar to Parkinson's disease (rigidity, tremor);
anxiety;
low blood pressure (especially intravenous);
diarrhea;
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 milk in men and women who are not breast fed;
irregular menstruation;
hallucinations;
reduced level of consciousness;
slow heartbeat (especially intravenous);
allergy.
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 levels of blood pigments that can change the color of your skin;
breast enlargement in men (gynecomastia)
involuntary muscle spasms after prolonged use, particularly in elderly patients;
fever, high blood pressure, convulsions, sweating, salivation. These may be signs of a condition called neuroleptic malignant syndrome;
changes in heart rhythm, which can be seen in the ECG examination;
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 any possible effects not listed in this leaflet.

Adverse event reporting
If you get any side effects, contact your doctor. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system to BDA Street. "Damyan Gruev" № 8, 1303 Sofia, tel .: +35928903417, website: www.bda.bg. As reported adverse reactions, 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.

Prescription:
Degan is taken only on prescription, and the solution is made only in a hospital setting.
Exceptionally solution can be prepared at home with continued therapy after the patient was discharged from the hospital.

6. CONTENTS OF THE PACKAGE AND ADDITIONAL INFORMATION
What Degan
The active substance is metoklopramidov hydrochloride.
Each 2 ml of solution for injection (1 ampoule) contains 10 mg metoklopramidov hydrochloride monohydrate).
Other ingredients are: hydrochloric acid (to adjust pH), water for injections.
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