TRANSMETIL 300 mg /5 Ml Порошок И Раствор Для Инъекционного Раствора
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Инструкция по применению TRANSMETIL
Содержание инструкции
TRANSMETIL 300 mg/5ml powder and solvent for injectable solution, 500 mg/5ml powder and solvent for injectable solution, 300 mg gastro-resistant tablets, 500 mg gastro-resistant tablets
Ademetionine
Read this leaflet carefully before you use this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What TRANSMETIL is and what it is used for
- 2. What you need to know before you use TRANSMETIL
- 3. How to use TRANSMETIL
- 4. Possible side effects
- 5. How to store TRANSMETIL
- 6. Contents of the pack and other information
1. What is TRANSMETIL and what is it used for
This medicine contains an active ingredient called ademetionine. Ademetionine is a compound
naturally present in the body, which intervenes in many processes that occur within the
body.
TRANSMETIL is used in the treatment of cholestasis, a disease due to the obstruction of bile
inside the liver, caused by problems with the liver (precirrhotic and cirrhotic states) or pregnancy.
It manifests with itching, yellowish discoloration of the skin and eyes, dark urine and pale stools.
2. What you need to know before using TRANSMETIL
Do not use TRANSMETIL if:
- you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
- you have genetic diseases that cause alterations of certain protein components such as methionine or homocysteine (for example: cystathionine beta-synthase deficiency, vitamin B12 metabolism defects).
Warnings and precautions
Consult your doctor or pharmacist before using TRANSMETIL
Tell your doctor if:
- you have had increased levels of ammonia in the blood, after taking oral medications containing S-adenosylmethionine;
- you have liver or kidney disease;
- you suffer from bipolar disorder, depression or other psychiatric illnesses;
- you have a decrease in red blood cells (anemia);
- you have a vitamin deficiency due to illness or dietary habits (for example, you are vegan);
- you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”);
IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE THE NEED TO PERFORM
CHECK-UP EXAMINATIONS OR TO MODIFY THE THERAPY.
Consult your doctor if during treatment with TRANSMETIL:
- you experience a state of anxiety or your anxiety worsens, as it may be necessary to re-evaluate your therapy;
- you experience a high level of homocysteine in the blood, which may be caused by therapy with TRANSMETIL (false positive);
- you experience dizziness.
Children and adolescents
TRANSMETIL is not suitable for children and adolescents.
Other medicines and TRANSMETIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine
In particular, tell your doctor if you are taking:
- medicines against depression called selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants (example clomipramine);
- medicines and supplements that contain an amino acid (a component of proteins) called tryptophan.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor for advice before using this medicine.
During the first three months of pregnancy and during breastfeeding, TRANSMETIL should only be used in
cases of actual need and under direct medical supervision.
Driving and operating machinery
TRANSMETIL can cause dizziness: make sure you do not experience this side effect before
driving vehicles or using machinery.
TRANSMETIL 300 mg/5ml powder and solvent for injectable solution powder and solvent for
injectable solutioncontains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically “sodium-free”.
TRANSMETIL 500 mg/5ml powder and solvent for injectable solution powder and solvent for
injectable solutioncontains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically “sodium-free”.
TRANSMETIL 300 mg gastro-resistant tabletscontains less than 1 mmol (23 mg) of sodium per
tablet, i.e. essentially “sodium-free”.
TRANSMETIL 500 mg gastro-resistant tabletscontains less than 1 mmol (23 mg) of sodium per
tablet, i.e. essentially “sodium-free”.
3. How to use TRANSMETIL
Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Initial dose
TRANSMETIL powder and solvent for injectable solution: 500 mg per day, for 2 weeks. The doctor
may establish a different dose calculating it based on your weight: from 5 to 12 mg per day for each kilo
of body weight.
The maximum dose is 800 mg per day.
or
TRANSMETIL tablets: 800 mg per day. The doctor may establish a different dose calculating it based on
your weight from 10 to 25 mg per day for each kilo of body weight.
The maximum dose is 1600 mg per day.
Dose for maintenance therapy
TRANSMETIL tablets: 800 – 1600 mg per day.
Elderly: the doctor may establish a lower dose than those indicated above.
Patients with renal impairment:
if you suffer from kidney problems, the doctor may decide to adopt particular caution when administering
TRANSMETIL.
Method of administration
TRANSMETIL tablets: must be taken by mouth (orally). Swallow the tablets whole,
without chewing and away from meals. The tablets must be removed from the blister (aluminum packaging)
immediately before use. Do not take TRANSMETIL if the tablets appear different from the white/yellowish color
(due to the presence of holes in the aluminum packaging).
TRANSMETIL powder and solvent for injectable solution: must be administered via an
injection into a vein (intravenously) or into a muscle (intramuscularly). Intravenous administration must
be performed slowly and exclusively by medical personnel.
The solution to be injected must
be prepared immediately
before use, dissolving the
powder contained in the
vial with the transparent
liquid (solvent) that
you find in the ampoule inside the
packaging. In case of
administration into a
vein, the dose must be further diluted in 250 ml of saline solution.
To prepare the injection solution:
- on the neck of the ampoule, there is a small colored dot. Gently tap the top
of the ampoule to remove any liquid residue present in the tip; position the ampoule as
indicated in figure 1;
- to open the ampoule, apply pressure with your thumb above the colored dotas indicated in figure 2;
- draw the solvent with a syringe and inject it into the vial containing the powder;
- when the powder has dissolved, draw the solution.
Use each vial only once and discard any remaining solution. Do not mix other
medicines into the solution. This is particularly important for alkaline solutions or those containing ions
of calcium. Do not use the powder if it has a color different from white/yellowish (due to damage to the
ampoule or exposure to heat).
If you take more TRANSMETIL than you should,contact your doctor immediately as
appropriate measures may be necessary.
If you forget to use TRANSMETIL
Do not take a double dose to make up for a missed dose.
If you stop taking TRANSMETIL
It is important that you take this medicine until the end of the treatment prescribed by your doctor. Do not
stop treatment just because you feel better, as your symptoms may return or
worsen.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop takingTRANSMETIL immediately and contact your doctor if any of the following occur:
- allergic reactions, even severe ones, which manifest with the more or less sudden appearance of skin lesions, for example, color changes in patches or widespread (rash, erythema), itching, hives, swelling (angioedema) of the face, eyes, lips and difficulty breathing (dyspnea, bronchospasm), back pain, chest pain or tightness, changes in blood pressure or heart rate (tachycardia, bradycardia);
- difficulty breathing due to swelling of the throat (laryngeal edema).
Tell your doctor if you notice any of the following during treatment with TRANSMETIL:
Common side effects(may affect up to 1 in 10 people)
- itching;
- headache;
- abdominal pain, diarrhea, nausea;
- anxiety, sleep disorders (insomnia).
Uncommon side effects(may affect up to 1 in 100 people)
- dry mouth, indigestion (dyspepsia), presence of intestinal gas (flatulence), pain or bleeding or other disorders in the stomach or intestines, vomiting;
- fatigue (asthenia), swelling (edema), fever, chills, reactions at the injection site;
- urinary tract infection;
- joint pain or muscle spasms, excessive sweating;
- dizziness, changes in sensitivity (paresthesia) or taste (dysgeusia), agitation, confusion;
- hot flashes, low blood pressure (hypotension), inflammation of the veins (phlebitis).
Rare side effects(may affect up to 1 in 1000 people)
- abdominal swelling, inflammation of the esophagus (esophagitis);
- malaise, suicidal ideation/behavior;
- very intense pain localized in the upper abdomen, radiating to the right flank and back and occurring suddenly after a fatty meal or during the night (biliary colic).
Side effects of unknown frequency(frequency cannot be estimated based on available data)
- liver problems due to a condition called cirrhosis;
- heart or blood vessel problems (cardiovascular disorders);
- flu-like symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store TRANSMETIL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month.
TRANSMETIL tablets: no special storage precautions are necessary.
TRANSMETIL powder and solvent for injectable solution: store at a temperature not exceeding
30°C. Use TRANSMETIL immediately after preparation of the solution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What TRANSMETIL contains
The active ingredient is: S-adenosylmethionine.
TRANSMETIL 300 mg/5ml powder and solvent for injectable solution
One vial of powder 300 mg contains: 300 mg of S-adenosylmethionine.
The other ingredients are:
- solvent vial: water for injections, L-lysine, sodium hydroxide.
TRANSMETIL 500 mg/5ml powder and solvent for injectable solution
One vial of powder 500 mg contains: 500 mg of S-adenosylmethionine.
The other ingredients are:
- solvent vial: water for injections, L-lysine, sodium hydroxide.
One tablet contains: 300 mg of S-adenosylmethionine.
The other ingredients are: microcrystalline cellulose, magnesium stearate, polyethylene glycol 6000,
polymethacrylates, polysorbates, colloidal silicon dioxide, emulsified silicone, sodium starch glycolate, talc.
TRANSMETIL 500 mg tablets
One tablet contains: 500 mg of S-adenosylmethionine.
The other ingredients are: microcrystalline cellulose, magnesium stearate, polyethylene glycol 6000,
polymethacrylates, polysorbates, colloidal silicon dioxide, sodium hydroxide, emulsified silicone, sodium starch glycolate,
talc.
Description of the appearance of TRANSMETIL and contents of the pack
TRANSMETIL 300 mg/5ml powder and solvent for injectable solution: is available in a pack
containing 5 vials of powder and 5 vials of solvent of 5 ml.
TRANSMETIL 500 mg/5ml powder and solvent for injectable solution: is available in a pack
containing 5 vials of powder and 5 vials of solvent of 5 ml.
TRANSMETIL 300 mg tablets: is available in a pack of 20 tablets.
TRANSMETIL 500 mg tablets: is available in a pack of 10 tablets.
Marketing Authorisation Holder
Mylan Italia S.r.l Via Vittor Pisani 20, 20124 Milano
Manufacturer
TRANSMETIL 300 mg gastroresistant tablets
Avara Liscate Pharmaceutical Services S.p.A. – Via Fosse Ardeatine 2, 20060 Liscate (Milano)
TRANSMETIL 500 mg gastroresistant tablets
AbbVie S.r.l. - S.R. 148 Pontina km 52 s.n.c Campoverde (LT)
TRANSMETIL 300 mg/5ml powder and solvent for injectable solution
Avara Liscate Pharmaceutical Services S.p.A. – Via Fosse Ardeatine 2, 20060 Liscate (Milano)
AbbVie S.r.l. – S.R. 148 Pontina km 52 s.n.c -Campoverde (LT)
TRANSMETIL 500 mg/5ml powder and solvent for injectable solution
AbbVie S.r.l. – S.R. 148 Pontina km 52 s.n.c -Campoverde (LT)
Delpharm Saint Remy - Rue de I’Isle Saint Remy Sur Avre, 28380 (France)
Biologici Italia Laboratories S.r.l. Via F. Serpero 2, 20060 Masate (Milano)
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- Страна регистрации
- Форма выпускаPowder and solvent for injectable solution, 300 MG/5 ML
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги TRANSMETILФорма выпуска: Coated tablet, <200 mgДействующее вещество: СилимаринПроизводитель: ELLEVA PHARMA SRLОтпускается по рецептуФорма выпуска: Granulate, 200 MGДействующее вещество: СилимаринПроизводитель: PHARMABER S.R.L.Отпускается по рецептуФорма выпуска: Hard capsule, 250 MGДействующее вещество: chenodeoxycholic acidПроизводитель: LEADIANT GMBHОтпускается по рецепту
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Аналог TRANSMETIL в Украина
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Часто задаваемые вопросы
TRANSMETIL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
TRANSMETIL производится компанией VIATRIS ITALIA S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения TRANSMETIL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить TRANSMETIL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом () включают SILIMARIN, SILMAR, AKIDO KENODESOSSIKOLIKO LEADIANT. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
