Trifas 10 mg. / 2 ml. 5 ampules

What Trifas 10 mg / 2 ml is and what it is used for

Trifas 10 mg / 2 ml contains the active substance torasemide and is a drug of the loop diuretics group. Torasemide strengthens the formation and excretion of urine and lowers blood pressure.

Trifas 10 mg / 2 ml is used in adults to treat:
• Swelling (stagnation of fluid in the tissues) and / or
• effusion (collecting fluid in the cavities of the body),
as a result of impaired cardiac function, if intravenous treatment is needed (eg pulmonary edema due to acute heart failure).

2. What you need to know before using Trifas 10 mg / 2 ml

Do not take Trifas 10 mg / 2 ml:
> if you are allergic to:
the active substance torasemide;
- substances with a chemical structure similar to torasemide (sulfonylureas);
- any of the other ingredients of this medicine (listed in section 6);
> in kidney failure with urinary incontinence (anuria);
> in severely impaired hepatic function with impaired consciousness (liver coma or hepatic excess);
> low blood pressure (hypotension);
> reduced blood volume (hypovolaemia);
> in the absence of sodium or potassium (hyponatraemia, hypokalaemia);
> in case of serious urinary disorders (eg as a result of pathological enlargement of the prostate);
> if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Trifas ® 10 mg / 2 ml.

In the following cases, there is still insufficient experience with Triphas® 10 mg / 2 ml treatment. Therefore,  Trifas 10 mg / 2 ml should not be used in the following cases:
- gout;
- severe heart rhythm abnormalities, especially if the heart rate is very slow (high-grade heart rhythm-conduction disorders, eg SA block, second and third degree AV block);
- pathological changes in the alkaline-acid balance of the body;
- concomitant treatment with lithium (a medicine used to treat mood swings and some types of depression);
- concomitant treatment with certain antibiotics (aminoglycosides, cephalosporins) to treat infections;
- pathological changes in the blood picture (eg decreased platelet count or reduced red blood cell count in patients without impaired renal function);
- impaired renal function caused by kidney-damaging substances.

Children and adolescents under 18 years of age
Children and adolescents under 18 years of age should not take Triphas® 10 mg / 2 ml as there is still no therapeutic experience with children and adolescents below 18 years of age.

Effects on doping tests and doping abuse
The use of Triphas 10 mg / 2 ml may result in positive results in doping tests.
It is not possible to predict the health effects of Triphas® 10 mg / 2 ml in doping abuse, health risks can not be ruled out.

Other medicines and Triphas® 10 mg / 2 ml
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Triphas 10 mg / 2 ml may affect the effects of the following medicines
> Blood pressure lowering medicines, especially ACE inhibitors: If you are taking ACE inhibitors additionally or immediately after receiving Triphas® 10 mg / 2 ml, a strong decrease in blood pressure may occur.
> Theophylline (a medicine used to treat asthma): Triphas® 10 mg / 2 ml may enhance the effect of this medicine.
> Substances that are similar to the chemical structure of a curd: an enhanced muscle relaxant effect.
> Antidiabetic medicines (medicines to treat diabetes mellitus): Triphas® 10 mg / 2 ml may reduce the effect of these medicines.
> Drugs for pain and rheumatism: when treated with high doses of anti-pain and rheumatic drugs from the salicylate group, their effect on the central nervous system may be increased.
> Medicines for the treatment of circulatory disturbances and shock (eg adrenaline and noradrenaline): the effect of these medicines may be reduced by Triphas 10 mg / 2 ml.

• The effects of Trifas 10 mg / 2 ml are affected by the following medications
> Probenecid (a drug for treating gout): probenecid may reduce the effect of Triphas® 10 mg / 2 ml to enhance urinary excretion and to lower blood pressure.
> Some anti-inflammatory medicines (eg indomethacin, acetylsalicylic acid): these medicines may reduce the effect of  Trifas 10 mg / 2 ml to boost urine output and lower blood pressure.

• Particularly for high-dose treatment (see section 3), Triphas® 10 mg / 2 ml may lead to a worsening of the following effects
> Damage to hearing and kidneys with the use of so-called aminoglycoside antibiotics (eg kanamycin, gentamicin, tobramycin) to treat infections.
> Hearing and kidney damage when using medicines containing cisplatin (as an active substance for the treatment of malignancies).
> Kidney damage with the use of cephalosporins (antibiotics) to treat infections.

• Other interactions of Trifas 10 mg / 2 ml when used with other medicines
> Potassium deficiency caused by Triphas® 10 mg / 2 ml may
How to use Trifas 10 mg / 2 ml

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Dosage
The dosage is determined by the severity of renal function impairment.
The recommended dose is a single dose of 2 ml Triphas® 10 mg / 2 ml daily (equivalent to 10 mg of torasemide). If the effect is not sufficient, the dose may be increased to 4 ml of Triphas 10 mg / 2 ml (equivalent to 20 mg of torasemide). If the effect persists, a treatment of up to 8 ml of Triphas® 10 mg / 2 ml daily (equivalent to 40 mg of torasemide daily) may be attempted temporarily (up to 3 days).

In acute pulmonary edema, treatment should be initiated by intravenous administration of a single 4-ml dose of Trifas 10 mg / 2 ml (equivalent to 20 mg of torasemide). Depending on the success of the treatment, this dose may be repeated within half an hour; a maximum dose of 20 ml of Triphas® 10 mg / 2 ml (equivalent to 100 mg of torasemide) should not be exceeded within 24 hours.

• Patients with impaired hepatic function
If your liver function is impaired, treatment should be performed with caution. It may increase the level of torasemide in the blood.

• Elderly
A different elderly dose is not recommended.

Directions for use
Trifas 10 mg / 2 ml is administered intravenously; the intravenous injection should be administered slowly.

Only inject clear solutions!

Do not use intraarterially!

From a microbiological point of view, Triphas® 10 mg / 2 ml should be used immediately after first opening. If not used immediately, the person who is using it is responsible for the duration and storage conditions prior to use.

Trifas 10 mg / 2 ml should not be used together with other medicines mixed in one injection or infusion.

• Instruction
Note: Open the ampoules with a point-marked break point
It is not necessary to cut with a knife

The ampoule is pointing to you Allow the solution to descend from the neck to the bottom by lightly tapping or shaking the ampoule. The ampoule has the point to you Break the ampule neck by moving down.

Duration of use
Your doctor will evaluate the duration of use of  Trifas 10 mg / 2 ml.

Intravenous treatment with Trifas 10 mg / 2 ml should not last longer than one week.

In the case of prolonged treatment, an early switch from intravenous treatment to tablet administration is recommended.

During treatment with Trifas 10 mg / 2 ml, your doctor should closely monitor you.

If you use more than the required dose of Triphas® 10 mg / 2 ml

If you have used a large amount of Triphas® 10 mg / 2 ml, the following complaints may occur:
• Intensive, possibly hazardous salt and water release;
• disturbed consciousness;
• confusion;
• decrease in blood pressure;
• circulatory collapse;
• gastrointestinal complaints.
In this case, tell your doctor immediately. It will take all necessary measures.

If you have any further questions on 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 everyone gets them.

Common (may affect up to 1 in 10 people)
• disorders in the regulation of the alkaline-acid balance in the body (so-called metabolic alkalosis);
• muscle cramps (especially at the beginning of treatment);
• elevated levels of uric acid, glucose and lipids in the blood (triglycerides, cholesterol);
• Potassium deficiency (hypokalaemia) in combination with potassium-poor diet, vomiting, diarrhea, use of high doses of laxatives, chronic hepatic dysfunction;
• Depending on the dosage and duration of treatment, there may be impaired water-salt balance, e.g. loss of fluid (hypovolaemia), potassium and / or sodium deficiency (hypokalaemia, hyponatraemia);
• gastrointestinal complaints, especially at the beginning of treatment, e.g. lack of appetite, stomach pain, nausea, vomiting, diarrhea, constipation;
• increased concentrations of certain liver enzymes (gamma-GT) in the blood;
• headache, dizziness, fatigue, weakness, especially at the beginning of treatment.

Uncommon (may affect up to 1 in 100 people)
• increased urea and creatinine (muscle protein) levels in the blood, urinary retention may occur if urinary problems occur (eg in the case of enlargement of the prostate). In this case, urination is very difficult or totally impossible;
• dry mouth;
• feeling tingling and cold in the limbs (paraesthesia).

Very rare (may affect up to 1 in 10,000 people)
• reduced number of red and white blood cells (erythrocytes and leukocytes) and reduced number of blood clotting cells (platelets);
• allergic reactions, such as itching, skin rash (exanthema), sensitivity to light (photosensitivity), severe skin reactions.
Acute, potentially life-threatening hypersensitivity reactions
If you notice you have any of these side effects, tell your doctor straight away. He will assess the burden and decide what measures can be taken.
If any of the side effects gets serious, or if you notice any side effects, talk to your doctor straight away. This is important because some side effects can potentially become life-threatening. The doctor will decide what measures to take and whether treatment can continue.
At the first appearance of a sign of hypersensitivity (eg severe skin reaction), Trifas 10 mg / 2 ml should not be re-administered.

Measures in case of hypersensitivity reactions

Acute, potentially life-threatening hypersensitivity reactions (anaphylactic shock) may occur. This requires urgent action such as placing the body in an anti-shock condition (lying down with raised legs), cleaning the airways, applying oxygen, and, if necessary, artificial respiration, providing an intravenous route as well as intravenous administration of adrenaline, corticosteroids and, if necessary, volumetric treatment.

How to store Trifas 10 mg / 2 ml

Keep out of the reach and sight of children.
Store below 25 ° C.
Only inject clear solutions!
Use the injection solution immediately after first opening. The remaining quantity is discarded.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Trifas 10 mg / 2 ml contains
The active substance is torasemide. Each ampoule of 2 ml solution for injection contains 10,631 mg of torasemide sodium equivalent to 10 mg of torasemide.

Other ingredients: sodium hydroxide, trometamol, macrogol 400, water for injections. The pH of Trifas 10 mg / 2 ml is 8.5 to 9.5.

What Trifas 10 mg / 2 ml looks like and contents of the pack
Ampoules with a clear, colorless solution.
Trifas 10 mg / 2 ml is in packs of 5 or 25 ampoules, each with 2 ml of solution for injection.
Not all packs may be marketed.

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