500 mg/500 mg powder for infusion solution
imipenem/cilastatin
What Tienam is and what it is used for
Tienam belongs to a group of medicines called carbapenem antibiotics. It kills a large number of different bacteria that cause infection in different parts of the body in adults and children 1 year and older.
Treatment
Your doctor has prescribed Tienam because you have one (or more) of the following types of infection:
- Complicated abdominal infections
- Infection affecting the lungs ( pneumonia )
- Infections you can get during or after childbirth
- Complicated urinary tract infections
- Complicated skin and soft tissue infections
Tienam can be used to treat patients with low white blood cell counts who have a fever suspected to be caused by a bacterial infection.
Tienam can be used to treat bacterial infections in the blood that may be a result of any of the infections mentioned above.
What you need to know before using Tienam
Do not use Tienam
- if you are allergic to imipenem, cilastatin, or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems
Warnings and precautions
Tell your doctor about any medical conditions you have or have had including:
- allergy to other medicines, even antibiotics (sudden life-threatening allergic reaction requires immediate medical attention)
- colitis ( inflammation of the colon) or other diseases of the gastrointestinal tract
- kidney or urinary tract problems, including impaired kidney function (the levels of Tienam in the blood increase in patients with impaired kidney function). Side effects in the central nervous system may occur if the dose is not adjusted according to kidney function)
- any disease of the central nervous system such as localized tremor or epileptic seizures
- liver problems
You may get a positive test result on the Coombs test, which indicates that you have antibodies that can destroy red blood cells. Your doctor will discuss this with you.
Children
Tienam is not recommended for children younger than one year or children with kidney problems.
Other medicines and Tienam
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking ganciclovir, which is used to treat certain viral infections.
Also tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia) or any blood thinners such as warfarin.
Your doctor will decide whether you should use Tienam together with these medicines.
Pregnancy and breastfeeding
You must tell your doctor if you are pregnant or plan to become pregnant before receiving Tienam. Tienam has not been studied in pregnant women. Tienam should only be given during pregnancy if the potential benefit of treatment to the mother outweighs the possible risk to the fetus.
You must tell your doctor if you are breastfeeding or if you intend to breastfeed before receiving Tienam. Small amounts of this medicine may pass into breast milk and may affect the baby. Your doctor will therefore decide whether you should use Tienam while you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
There are some side effects associated with this product (such as seeing, hearing, or feeling something that is not there (hallucinations), dizziness, tiredness, and a spinning sensation) which may affect some patients’ ability to drive or use machines (see section 4 ).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Tienam contains sodium
This medicine contains 37.6 mg of sodium (the main ingredient in common/table salt) per vial. This corresponds to 1.9% of the maximum recommended daily intake of sodium for adults.
How to use Tienam
Tienam will be prepared and given to you by a doctor or other healthcare professional. Your doctor will decide how much Tienam you need.
Use for adults and adolescents
The recommended dose for adults and adolescents is 500 mg/500 mg every 6 hours or 1000 mg/1000 mg every 6 or 8 hours. If you have kidney problems, your doctor may lower your dose.
Use for children
The recommended dose for children 1 year of age or older is 15/15 or 25/25 mg/kg body weight and the dose every 6 hours. Tienam is not recommended for children younger than one year and children with kidney problems.
Mode of administration
Tienam is given intravenously (into a vein) over 20-30 minutes for a dose of ≤500 mg/500 mg or 40-60 minutes for a dose of >500 mg/500 mg. In case of nausea, the infusion rate can be reduced.
If you have used too much Tienam
Symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood pressure, and slow pulse.
If you are worried that you have ingested too much Tienam or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forgot to use Tienam
If you are concerned that you have missed a dose, contact your doctor or another healthcare professional immediately.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are divided according to the following frequency groups:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- less common: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- frequency not known: cannot be estimated from available data
The following side effects may occur in rare cases. If these side effects occur while you are taking or after taking Tienam, you should immediately stop using the medicine and contact your doctor immediately.
- allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat (with difficulty breathing or swallowing), and/or low blood pressure
- skin flaking ( toxic epidermal necrolysis )
- severe skin reactions ( Stevens-Johnson syndrome and erythema multiforme)
- severe skin rash with skin and hair loss (exfoliative dermatitis )
Other possible side effects:
Usual
- nausea, vomiting, diarrhea. Nausea and vomiting occur more often in patients with low white blood cell counts
- swelling and redness along a vein that is extremely tender to the touch
- rash
- abnormal liver function detected by analysis of blood samples
- increase in certain white blood cells
Less common
- local skin redness
- local pain and formation of hard swelling at the injection site
- skin itching
- hives
- fever
- blood diseases that affect the blood cells. This is usually detected by blood test analysis (symptoms can be fatigue, pale skin, and prolonged bruising after injuries)
- abnormal kidney, liver, and blood function detected by blood test analysis
- tremors and uncontrolled muscle twitching
- convulsions
- mental disorders (such as mood swings and impaired judgment)
- hallucinations (seeing, hearing, or feeling something that is not there)
- confusion
- dizziness, drowsiness
- low blood pressure
Rare
- fungal infection (candida infection)
- discoloration of teeth and/or tongue
- inflammation of the colon with severe diarrhea
- taste impact
- impaired liver function
- liver inflammation
- impaired kidney function
- changes in the amount of urine, changes in the color of the urine
- brain disorders, tingling sensation (numbness), limited tremors
- hearing loss
Very rare
- severe liver dysfunction due to inflammation ( fulminant hepatitis )
- inflammation of the stomach or intestines ( gastroenteritis )
- inflammation of the intestines with bloody diarrhea ( hemorrhagic colitis )
- red swollen tongue, overgrowth on the surface of the tongue giving it a hairy appearance, heartburn, sore throat, increased salivation
- stomach pain
- spinning sensation (dizziness, vertigo), headache
- ringing in the ears ( tinnitus )
- pain in several joints, weakness
- irregular heartbeat, the heart beats forcefully or rapidly
- chest discomfort, difficulty breathing, abnormally fast and shallow breathing, pain in the upper part of the spine
- redness, bluish discoloration of the face and lips, changes in the texture of the skin, excessive sweating
- genital itching in women
- changes in the amount of blood cells are
- worsening of a rare disease with muscle weakness ( myasthenia gravis )
No known frequency
- abnormal movements
- indignation
How to store Tienam
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the vial. The expiration date is the last day of the specified month.
Store at a maximum of 25 ºC.
After preparation:
A ready-made solutions should be used immediately. The time interval between the start of preparation and the end of the intravenous infusion should not exceed two hours.
Diluted solution must not be frozen.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are imipenem and cilastatin. One vial contains imipenem monohydrate equivalent to 500 mg imipenem and cilastatin sodium equivalent to 500 mg cilastatin.
- Another ingredient is sodium bicarbonate.
Appearance and package sizes of the medicine
Tienam is a white to light yellow powder for infusion, solution in a glass vial. Pack sizes: 1, 10 or 25 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Sharp & Dohme BV
PO Box 581
2031 BN, 2003 PC Haarlem
Netherlands
Manufacturer
FAREVA Mirabel
Route de Marsat – Riom
63963 Clermont-Ferrand Cedex 9
France
Information provided by
Merck Sharp & Dohme (Sweden) AB
Box 45192
104 30 Stockholm
Phone: 077 570 04 88
This medicine is approved in the European Economic Area under the names:
Austria: Zienam
Bulgaria: Tienam
Cyprus: Tienam
Czech Republic: Tienam
France: TIENAM
Germany: ZIENAM
Greece: Primaxin
Hungary: Tienam
Ireland: Primaxin IV
The Netherlands: TIENAM
Norway: Tienam
Portugal: Tienam IV
Sweden: Tienam
UK: Primaxin IV