500 mg / 500 mg powder for infusion solution
Active substances: imipenem and cilastatin
1. What Imipenem / Cilastatin Fresenius Kabi is and what it is used for
Imipenem / Cilastatin Fresenius Kabi 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 who are 1 year and older.
Treatment
Your doctor has prescribed Imipenem / Cilastatin Fresenius Kabi because you have one (or more) of the following types of infection:
- Complicated abdominal infections
- Infection affecting the lungs ( pneumonia )
- Infection you can get during or after childbirth
- Complicated urinary tract infections
- Complicated skin and soft tissue infections
Imipenem / Cilastatin Fresenius Kabi can be used to treat patients with low white blood cell counts who have a fever suspected of being a bacterial infection.
Imipenem / Cilastatin Fresenius Kabi can be used to treat bacterial infections in the blood that may be due to any of the infections mentioned above.
What you need to know before you use Imipenem / Cilastatin Fresenius Kabi
Do not use Imipenem / Cilastatin Fresenius Kabi
- 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 cautions
Talk to your doctor or nurse before using Imipenem / Cilastatin Fresenius Kabi
- if you have allergies to other medicines, including antibiotics (sudden life-threatening allergic reaction that requires immediate medical attention)
- if you have colitis ( inflammation of the colon) or other diseases of the gastrointestinal tract
- if you have kidney or urinary tract, including renal impairment (levels of imipenem / cilastatin Kabi in the blood are increased in patients with impaired renal function. The adverse event is in the central nervous system can occur if the dose one is not adjusted for renal function).
- if you have any diseases of the central nervous system such as localized tremor or epileptic seizures
- if you have liver problems
You can get a positive test result on Coomb’s test which indicates that you have antibodies that can destroy red blood cells. Your doctor will discuss this with you.
Children
Imipenem / Cilastatin Fresenius Kabi is not recommended for children under one year of age or for children with kidney problems.
Other medicines and Imipenem / Cilastatin Fresenius Kabi
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 that 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 thinner such as warfarin.
Your doctor will decide if you should use Imipenem / Cilastatin Fresenius Kabi with these medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is important that you tell your doctor if you are pregnant or planning to become pregnant before receiving Imipenem / Cilastatin Fresenius Kabi. Imipenem / Cilastatin Fresenius Kabi has not been studied in pregnant women. Imipenem / Cilastatin Fresenius Kabi should only be given during pregnancy if the potential benefit of treatment to the mother outweighs the potential risk to the fetus.
It is important that you tell your doctor if you are breastfeeding or if you intend to breastfeed before receiving Imipenem / Cilastatin Fresenius Kabi. Small amounts of this medicine may pass into breast milk and it may affect the baby. Your doctor will therefore decide if you should use Imipenem / Cilastatin Fresenius Kabi while you are breastfeeding.
Driving and using machines
There are some side effects associated with this product (such as seeing, hearing, or feeling something that does not exist (hallucinations), dizziness, tiredness, and a tingling sensation) that 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 sharpened 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Imipenem / Cilastatin Fresenius Kabi contains sodium
This medicine contains 37.7 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 1.9% of the maximum recommended daily sodium intake for adults.
How to use Imipenem / Cilastatin Fresenius Kabi
Imipenem / Cilastatin Fresenius Kabi will be prepared and given to you by a doctor or other healthcare professional. Your doctor will decide how much Imipenem / Cilastatin Fresenius Kabi you need.
Use in adults and adolescents
The recommended dose for adults and adolescents is 500 mg / 500 mg every 6 hours or 1,000 mg / 1,000 mg every 6 or 8 hours. If you have kidney problems, your doctor may lower your dose.
Use in children
The recommended dose for children aged 1 year or older is 15/15 or 25/25 mg/kg body weight and dose every 6 hours. Imipenem / Cilastatin Fresenius Kabi is not recommended for children under one year of age and for children with kidney problems.
Method of administration Imipenem / Cilastatin Fresenius Kabi is given intravenously (into a vein) for 20-30 minutes for a dose of ≤500 mg / 500 mg or 40-60 minutes for a dose of> 500 mg / 500 mg. The infusion rate can be reduced if you feel unwell.
If you use more Imipenem / Cilastatin Fresenius Kabi than you should
Symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood pressure, and slow heart rate. If you are concerned that you have received too much Imipenem / Cilastatin Fresenius Kabi, contact your doctor or another healthcare professional immediately.
If you forget to use Imipenem / Cilastatin Fresenius Kabi
If you are concerned that you have missed a dose, contact your doctor or another healthcare professional immediately.
Do not take a double dose to make up for a forgotten dose.
If you stop using Imipenem / Cilastatin Fresenius Kabi
Do not stop taking Imipenem / Cilastatin Fresenius Kabi unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, Imipenem / Cilastatin Fresenius Kabi can cause side effects, although not everybody gets them.
The following side effects are rare, but if these side effects occur while you are taking or after taking Imipenem / Cilastatin Fresenius Kabi, you should stop using the medicine as soon as possible and contact your doctor immediately.
- allergic reactions with rash, swelling of the face, lips, tongue and / or throat (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:
Common (may affect up to 1 in 10 people)
- nausea, vomiting, diarrhea. Nausea and vomiting are more common in patients with low white blood cell count
- swelling and redness along a blood vessel that is extremely tender to the touch
- rash
- abnormal liver function detected during analysis of blood samples
- increase in certain white blood cells
Uncommon (may affect up to 1 in 100 people)
- local skin redness
- local pain and formation of severe swelling at the injection site
- skin itching
- hives
- fever
- blood diseases that affect the blood cells . This is usually detected by blood test (symptoms may include fatigue, pale skin and prolonged bruising after injuries)
- abnormal kidney, liver and blood function detected during blood test analysis
- tremor (tremors) and uncontrolled muscle twitching
- seizures
- mental disorders (such as mood swings and impaired judgment)
- hallucinations (seeing, hearing or feeling something that does not exist)
- confusion
- dizziness, drowsiness
- low blood pressure
Rare (may affect up to 1 in 1000 people)
- fungal infection (candida infection)
- discoloration of teeth and / or tongue
- inflammation of the colon with severe diarrhea
- taste influence
- hepatic impairment
- hepatitis
- renal impairment
- change in urine output, changes in urine color
- brain diseases, stinging sensation (numbness), limited tremors
- hearing loss
Very rare (may affect up to 1 in 10,000 people)
- severe hepatic impairment 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 that gives it a hairy appearance, heartburn, sore throat, increased salivation
- abdominal pain
- tingling sensation (dizziness, dizziness), headache
- tinnitus ( tinnitus )
- pain in several joints, weakness
- irregular heartbeat, the heart beats powerfully or fast
- Chest discomfort, difficulty breathing, abnormally fast and shallow breathing, pain in the upper spine
- itching of the genitals in women
- changes in the amount of blood is
- exacerbation of a rare disease with muscle weakness ( myasthenia gravis )
No known frequency (can not be calculated from the available data)
- Abnormal movements
- Indignation
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Imipenem / Cilastatin Fresenius Kabi
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial after “EXP” and on the outer carton after “EXP”. The expiration date is the last day of the specified month.
Before opening the package:
Do not store above 25 ° C.
Opened / reconstituted product:
Reconstituted/diluted solutions should be used immediately. The time interval between the preparation begins and that the intravenous infusion, end must not exceed two hours.
Diluted solution must not be frozen.
The medicine 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. Contents of the packaging and other information
Content declaration
- The active substances are 500 mg imipenem (in the form of 530 mg of imipenem monohydrate) and 500 mg of cilastatin (in the form of 530 mg of the sodium salt of cilastatin).
- The other ingredient is sodium bicarbonate.
What the medicine looks like and contents of the pack
Imipenem / Cilastatin Fresenius Kabi 500 mg imipenem and 500 mg cilastatin is a white to off-white or yellow powder supplied in 20 ml glass vials and 100 ml glass vials.
Imipenem / Cilastatin Fresenius Kabi 500 mg / 500 mg is supplied in packs containing 10 glass vials and 10 powder vials, respectively, sealed with a rubber stopper, aluminum cap, and flip-off cap.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Fresenius Kabi AB
Uppsala
Manufacturer:
ACS Dobfar SpA, Nucleo Industriale S. atto, S. Nicolo a Tordino, Teramo, Italy
For any information about this medicine, please contact the Marketing Authorization Holder.