TIENAM 500mg vial
TIENAM belongs to a group of medicines called "carbapenem antibiotics". For adults and children aged over one year it kills many bacteria (microorganisms) that cause infections in various parts of the body.
Your doctor has prescribed TIENAM , because you have one (or more) of the following infections:
• Complicated infections of the abdominal organs
• Infection affecting the lungs (pneumonia)
• Infection from which you acquired during or after the birth of your baby;
• Complicated urinary tract infection
• Complicated infection of the skin and soft tissues.
Tian can be used in the treatment of patients with low white blood cell count and fever, which is suspected to be due to bacterial infection.
Tien can be used to treat a bacterial infection of the blood, which can be connected to any of the infections mentioned above.
2. BEFORE YOU USE TIENAM
Do not use Tian
If you are allergic (hypersensitive) to imipenem, cilastatin or any of the other ingredients of Tian
If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins or carbapenems
Take special care with TIENAM
Tell your doctor about any medical conditions, including if you have any of the following:
- Allergies to any medicines, including antibiotic (sudden life-threatening allergic reactions require immediate medical treatment) Colitis or any other gastrointestinal disease Problems with kidney or urinary tract, including reduced renal function (elevated blood in Tian patients with reduced kidney function. If the dose is adjusted to renal function may experience undesirable effects associated with the central nervous system) Whatever disease of the central nervous system, focal tremors or epileptic seizures (fits) liver problems fraction
When you can study is positive (test of Coombs), which indicates the presence Hit antibodies that destroy red blood cells. Your doctor will discuss this with you.
Tell your doctor if you use medicines containing valproic acid or sodium valproate (see. Taking other medicines below).
Experience with the application of TIENAM in children under 1 year or children with kidney diseases is too limited to recommend its use in these patient groups.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are taking ganciclovir which is used to treat some viral infections.
Also tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines or schizophrenia) or anticoagulants - as warfarin.
Your doctor will decide whether you should use Tian in combination with these medicines.
Pregnancy and lactation
If you are pregnant or plan to become pregnant, it is important to tell your doctor about this before you start getting TIENAM. Application of Tian in pregnant women has not been studied. Tian should not be used during pregnancy unless your doctor decides that the expected benefit outweighs the potential risk to the developing baby.
If karmigte or intend to breastfeed, it is important to tell your doctor about this before you start getting Tian. Small amounts of this medicine may pass into breast milk and affect the baby. Therefore your doctor will decide whether you should use Tian while breastfeeding.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Some of the side effects associated with use of this product (such as seeing, hearing or feeling things that are not, dizziness, drowsiness and dizziness) may affect some patients' ability to drive or operate machinery (see. Section 4).
Important information about some of the ingredients of TIENAM
This medicinal product contains approximately 1.6 mEq (approximately 37,6 mg) of sodium per dose of 500 mg, which must be taken into consideration for patients on a controlled sodium diet.
3. HOW TO USE TIENAM ?
Tian will be prepared and will be administered by a doctor or other healthcare professional. Your doctor will decide how much Tian need.
Adults and adolescents
In adults, the usual dose of the thienyl is 500 mg / 500 mg every 6 hours or 1000 mg / 1 000 mg every 6 or 8 hours. If you have kidney problems, or if you weigh less than 70 kg, your doctor can decrease your dose.
In children aged over one year usual dose is 15/15 or 25/25 mg / kg / dose every 6 hours. Not recommended TIENAM in children aged under 1 year.
Method of administration
Tian will be administered intravenously (into a vein) for about 20-30 minutes for doses <500 mg / 500 mg or about 40-60 minutes for doses> 500 mg / 500 mg. Infusion rate may be reduced if you get sick.
If you use more than the amount of TIENAM
Symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood pressure and slow heart rate. If you are worried that you may have been given too much Tian, immediately contact your doctor or other healthcare professional.
If you forget to use TIENAM
If you are concerned that you may have missed a dose, contact your doctor or other healthcare professional.
Do not take a double dose to make up the missed dose.
If you stop using TIENAM
Do not stop using Tian until your doctor tells you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, TIENAM can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below are defined based on the following standard:
• Very common: affects more than 1 in 10
• 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: from the available data can not be estimated
The following side effects are rare, however, if they occur while receiving or after receiving Tian, the drug should be discontinued immediately and contact your doctor.
• Allergic reactions including rash, swelling of face, lips, tongue and / or throat (with difficulty in breathing or swallowing)
• Scaling of skin (toxic epidermal necrolysis)
• Severe skin reactions (syndrome of Stevens-Johnson and erythema multiforme)
• Severe skin rash with loss of skin and hair (exfoliative dermatitis)
Other possible side effects:
Common: Nausea, vomiting, diarrhea. It seems that nausea and vomiting developed more frequently in patients with low white blood cell count.
Strong swelling and redness along the vein, which is extremely painful to the touch, rash, abnormal liver function, which is found in blood tests Increase in certain white blood cells
Uncommon: Local redness of the skin
Local pain and form a solid lump at the site of injection
• Itchy skin
• Blood disorders affecting blood cells, which are typically found in a blood test (symptoms may be fatigue, pallor of the skin and hematoma formation with minimal trauma)
• Abnormal kidney function and liver, and abnormal blood tests, which are found in a blood test
• Tremors or involuntary muscle spasms
• Psychiatric disorders (such as mood swings and impaired judgment)
• Vision, hearing or feeling things that are not there (hallucinations)
• Dizziness, somnolence
• Lowering blood pressure
Rare: Allergic reactions including rash, swelling of the face, lips, tongue and / or throat (with difficulty in breathing or swallowing), and / or low blood pressure. If any of these side effects occur during or after the application of Tien, you should stop taking the drug and immediately contact your doctor.
Peeling of skin (toxic epidermal necrolysis)
Severe skin reactions (Stevens-Johnson and erythema multiforme)
Severe skin rash with loss of skin and hair (exfoliative dermatitis)
Fungal infections (thrush)
Staining of teeth and / or tongue
Inflammation of the colon with severe diarrhea
Inability of the liver to perform its functions Inflammation of the liver
Inability of the kidneys to perform their functions
Changes in the amount of urine you produce, discoloration of urine
Brain damage, numbness, localized tremor
Very rare: Severe impairment of liver function due to inflammation (fulminant hepatitis), inflammation of the stomach or intestines (gastroenteritis) Inflammation of intestine with bloody diarrhea (hemorrhagic colitis), redness or swelling of the tongue, expansion of the normal bumps on the tongue, which gives him a "hairy" appearance, heartburn, sore throat, increased saliva, stomach pain Dizziness, headache Tinnitus (tinnitus) pain in several joints, weakness, irregular heartbeat, rapid or too strong heartbeat , chest discomfort, difficulty breathing, an unusually rapid and shallow breathing, pain in the upper part of the spine
• Hot flushes, bruising of the face and lips, a change in the texture of the skin, increased sweating
• Vaginal itching in women
• Changes in the number of blood cells
• Worsening of a rare disease associated with muscle weakness (myasthenia gravis)
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 TIENAM?
Keep out of the reach and sight of children.
Do not use Tian after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 25 ° C.
The diluted solution should be used immediately. The time between the start of dissolution and the end of the intravenous infusion should not exceed two hours.
The reconstituted solution should not be frozen.
Do not dispose of medications in 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
The active substances are imipenem and cilastatin. Each vial contains imipenem monohydrate equivalent to 500 mg imipenem and cilastatin sodium equivalent to 500 mg cilastatin.
The other component is sodium bicarbonate.