TRANSMETIL 500 mg. 5 ampoules

Abbott
TRANSMETIL 500 mg. 5 ampoules
€ 45.00
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WHAT TRANSMETIL AND WHAT IT IS USED
Your medicine is said TRANSMETIL. Its active ingredient normally found in several organs and tissues of the human body and plays an important role in many biological processes. In the liver ademethionine maintain mechanisms to address the emergence of cholestasis (retention of bile). When hepatic cirrhosis found a significant decrease in ademethionine in the liver, which in turn poses a risk of onset of cholestasis. Implementation of ademethionine in patients with cirrhosis leads to recovery of the quantity and therefore prevents the stagnation of bile (bile).

TRANSMETAL apply to:
treatment of liver stagnation of bile in patients with cirrhosis and pretsirotichno state;
treatment of hepatic congestion bile during pregnancy.

2. BEFORE YOU TAKE TRANSMETIL
You should not take this medicine if you have hypersensitivity to the active substance (ademethionine) or to any of the excipients of the solvent.
Ademethionine is contraindicated in patients with genetic defects affecting the methionine cycle and / or causing homocystinuria, and / or hiperhomotsisteinuriya (cystathionine-beta-synthase deficiency, a defect in the metabolism of vitamin B12).

Take special care with TRANSMETIL
In pretsirotichni and cirrhotic conditions with elevated levels of ammonia in the blood, treatment should be carried out under the supervision of a physician when performing certain studies.
Powder for solution to be mixed with the appropriate solvent prior to application.
Intravenous injection (injection into a vein) must be carried out very slowly.
If the powder for injection is colored in another color other than white to yellowish, which may be due to microscopic violating the integrity of the package and hence contamination or exposure to high temperature, it is necessary to return the entire package and replacing it with another .
Some patients may appear dizziness when applying ademethionine. Patients should be advised not to drive or operate machinery during treatment until it is sure that the product does not affect their ability to perform these activities.

Taking other medicines
No data on the interaction of TRANSMETIL with other medicines. However, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Caution is advised when concomitant intake of ademethionine with selective inhibitors of serotonin reuptake (SSRT), tricyclic antidepressants (such as clomipramine) and medicines obtained without a prescription containing tryptophan.

Pregnancy and lactation
The administration of high doses ademethionine in women in the last three months of pregnancy did not result in adverse effects. It is recommended to apply in the first three months of pregnancy only if absolutely necessary.
Ademethionine should be used during breast-feeding only if the potential benefit outweighs the risk to the infant.

Driving and using machines
Some patients may appear dizziness when applying ademethionine. Patients should be advised not to drive or operate machinery during treatment until it is sure that the product does not affect their ability to perform these activities.

3. HOW TO USE TRANSMETIL
Treatment may be initiated with the application of the injectable formulation and to continue administration of the tablets or to start directly with the tablet formulation of the product.
Ademethionine lyophilized powder and solvent in a vial 500 mg / 5 ml for intravenous and intramuscular injections. The lyophilised powder should be reconstituted with the solvent before use.
Ademethionine must not be mixed with the alkali metal or calcium ion containing solutions. If the lyophilized powder with a different color other than white (the integrity of the vial or exposure to high temperatures), the product should not be applied.
The intravenous form of ademethionine should be administered slowly intravenously.

Cholestasis in the liver (intrahepatic cholestasis)
The recommended dose is 5-12 mg / kg per day intravenously or intramuscularly. The starting dose is 500 mg per day intravenously or intramuscularly, the total daily dose should not exceed 800 mg for two weeks.
Maintenance treatment - 1000 - 1500 mg daily taken orally.

Elderly
Dose selection for an elderly patient should be approached cautiously, as you usually have to start from low doses in view of the greater frequency of decreased hepatic, renal or cardiac function, concomitant disease or other therapy.

Children
There were no efficacy and safety of ademethionine in children.
Hepatic impairment
There is no difference in the parameters between healthy subjects and patients with chronic liver diseases are similar.

Renal impairment
No studies have been conducted in patients with renal impairment. Therefore, it is recommended to administer the product with caution.

If you are given more than you should TRANSMETIL
There is no information on overdose of this medicine.

If you forget to take a dose TRANSMETIL
Please tell your doctor if you forget to take this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
As with all medicines, while taking ademethionine may experience side effects. This table includes reactions observed in clinical trials of the product.
Class Adverse reaction
Infections and infestations Urinary tract infections
Psychiatric disorders Confusion
Insomnia
Nervous system disorders Dizziness
Headache
Chills
Cardiac disorders Cardiovascular disorders
Vascular disorders Hot flushes
Superficial phlebitis
Gastrointestinal disorders Abdominal distension of the bowel
Abdominal pain
Diarrhea
Dry mouth
Heartburn
Inflammation of the lining of the esophagus
Flatulence
Pain of the gastrointestinal tract
Bleeding from the gastrointestinal tract
Nausea
Vomiting
Hepatobiliary disorders Biliary colic
Liver cirrhosis
Skin and subcutaneous tissue disorders Increased sweating
Persistent itching
Skin reactions
Musculoskeletal and connective tissue disorders Joint pain
Muscle spasms
General disorders and administration site Weight Loss
Creeps
Reactions at the injection site
Influenza-like illness
Indisposition
Peripheral edema
Fever
Effects observed after the release of the product:
Immune system disorders - hypersensitivity, anaphylactic or anaphylactoid reactions (eg., Flushing, shortness of breath, difficulty breathing or wheezing, back pain, chest discomfort, changes in blood pressure (high or low blood pressure) or heart rate (fast or slow heartbeat )).
Psychiatric disorders - anxiety.
Respiratory, thoracic and mediastinal disorders - laryngeal edema.
Skin and subcutaneous tissue - reaction at the injection site (very rare skin necrosis), swelling of the face or throat, allergic skin reactions (eg. Rash, itching, hives, redness).

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE TRANSMETIL
Keep out of reach of children.
This medicinal product must not be stored above 25 ° C.
TRANSMETIL should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of that month. Dissolved product remains stable until 6:00.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What TRANSMETIL
The active substance is ademethionine. Each bottle with powder for solution for injection contains 949 mg ademethionine (ademetionine), which corresponds to 500 mg ionic substance.
The other components of the solvent are: sodium hydroxide, L-lysine, and water for injection.

TRANSMETIL looks like and contents of the pack
The reconstituted solution of TRANSMETIL a white liquid.
Each box contains 5 glass bottles, sealed (with a rubber stopper, aluminum seal and polypropylene cap) + 5 vials containing 5 ml of solvent.

Opening the ampoule of solvent:
Opening the ampoule of solvent is done by grasping the bottle with both hands and push with your thumb on top of the vial on the color point.
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