The active substances are imipenem and cilastatin. Each vial contains 530mg imipenem monohydrate equivalent to 500 mg imipenem and 530 mg cilastatin sodium equivalent to 500 mg cilastatin.
Excipients/Inactive Ingredients: The other ingredient is sodium bicarbonate.
ImiCila belongs to a group of medicines called carbapenem antibiotics. It kills a wide range of bacteria (germs) that cause infections in various parts of the body in adults and children one year of age and above.
The doctor has prescribed ImiCila because the patient has one (or more) of the following types of infection: Complicated infections in the abdomen.
Infection affecting the lungs (pneumonia).
Infections that the patient can catch during or after the delivery of the baby.
Complicated urinary tract infections.
Complicated skin and soft tissue infections.
ImiCila may be used in the management of patients with low white blood cell counts, who have fever that is suspected to be due to a bacterial infection.
ImiCila may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned previously.
ImiCila will be prepared and given to the patient by a doctor or another health care professional. The doctor will decide how much ImiCila the patient needs.
Adults and adolescents: The usual dose of ImiCila for adults and adolescents is 500 mg/500mg every 6 hours or 1,000 mg/1,000 mg every 6 or 8 hours. If the patient has kidney problems or weighs less than 70 kg, the doctor may lower the dose.
Children: The usual dose for children one year of age or older is 15/15 or 25/25 mg/kg/dose every 6 hours. ImiCila is not recommended in children under one year of age and children with kidney problems.
Method of administration: ImiCila 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/500mg. The rate of infusion may be slowed if the patient feels sick.
If the patient is given more ImiCila than they should: Symptoms of overdose may include seizures (fits), confusion, tremors, nausea, vomiting, low blood pressure and slow heart rate. If the patient is concerned that the patient may have been given too much ImiCila, contact the doctor or another healthcare professional immediately.
If the patient misses a dose of ImiCila: If the patient is concerned that the patient may have missed a dose, contact the doctor or another healthcare professional immediately.
If the patient has any further questions on the use of this medicine, ask the doctor, pharmacist or nurse.
Do not use ImiCila: If the patient is allergic to imipenem, cilastatin or any of the other ingredients of this medicine (listed in Description); If the patient is allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems.
Talk to the doctor, pharmacist or nurse before the patient is given ImiCila: If the patient has or has had allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require immediate medical treatment).
If the patient has or has had colitis or any other gastrointestinal disease.
If the patient has or has had kidney or urinary problems, including reduced kidney function (ImiCila blood levels increase in patient with reduced kidney function. Central nervous system adverse reactions may occur if the dose is not adjusted to the kidney function).
If the patient has or has had any central nervous system disorders such as localized tremor or epileptic seizures (fits).
If the patient has or has had liver problems.
The patient may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. The doctor will discuss this with the patient.
Tell the doctor if the patient is taking medicines called valproic acid or sodium valproate (see Interactions).
ImiCila contains sodium: This medicine product contains approximately 20 mg of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.
Driving and using machines: There are some side effects associated with this product (such as seeing, hearing, or feeling something that is not there, dizziness, sleepiness, and a spinning sensation) that may affect some patients' ability to drive or operate machinery (see Side Effects).
Use in Children: ImiCila is not recommended in children less than one year of age or children with kidney problems.
It is important that the patient tells the doctor if she is pregnant or is planning to become pregnant before receiving this medicine. ImiCila has not been studied in pregnant women. This medicine should not be used during pregnancy unless the doctor decided the potential benefit justifies the potential risk to the developing baby.
It is important that the patient tells the doctor if she is breast-feeding or if she intends to breast-feed before receiving ImiCila. Small amounts of this medicine may pass into breast milk and it may affect the baby. Therefore, the doctor will decide whether the patient should use ImiCila while breast-feeding.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side-effects occur rarely, however if they do occur, while receiving or after receiving ImiCila, the medicine must be stopped and the doctor contacted immediately.
Allergic reactions including rash, swelling of the face, lips, tongue, and/or throat (with difficulty in breathing or swallowing), and/or low blood pressure.
Skin peeling (toxic epidermal necrolysis).
Severe skin reactions (Stevens- Johnson syndrome and erythema multiforme).
Severe skin rash with loss of skin and hair (exfoliative dermatitis).
Other possible side effects: Common (may affect up to 1 in 10 people): Nausea, vomiting, diarrhea. Nausea and vomiting appear to occur more frequently in patients with low number of white blood cells.
Swelling and redness along a vein which is extremely tender when touched.
Rash.
Abnormal liver function detected by blood tests.
Increase in some white blood cells.
Uncommon (may affect up to 1 in 100 people): Local skin redness.
Local pain and formation of a firm lump at the injection site.
Skin itchiness.
Hives.
Fever.
Blood disorders affecting the cell components of the blood and usually detected by blood tests (symptoms may be tiredness, paleness of skin, and prolonged bruising after injury).
Abnormal kidney, liver and blood function detected by blood tests.
Tremors and uncontrolled twitching or muscles.
Seizures (fits).
Psychic disturbances (such as mood swings and impaired judgment).
Seeing, hearing or feeling something that is not there (hallucinations).
Confusion.
Dizziness, sleepiness.
Low blood pressure.
Rare (may affect up to 1 in 1,000 people): Fungal infection (candidiasis).
Staining of the teeth and / or tongue.
Inflammation of the colon with severe diarrhea.
Disturbances in taste.
Inability of the kidney to perform normal function.
Changes in the amount of urine, changes in urine colour.
Disease of the brain, tingling sensation (pins and needles), localized tremor.
Hearing loss.
Very rare (may affect up to 1 in 10,000 people): Severe loss of liver function due to inflammation (fulminant hepatitis).
Inflammation of stomach or intestine (gastro-enteritis).
Inflammation of intestine with bloody diarrhea (haemorrhagic colitis).
Red swollen tongue, overgrowth of the normal projections on the tongue giving it a hairy appearances, heartburn, sore throat, increase in the production of saliva.
Stomach pain.
A spinning sensation (vertigo), headache.
Ringing in the ears (tinnitus).
Pain in several joints, weakness.
Irregular heartbeat, the heart beating forcefully or rapidly.
Chest discomfort, difficulty breathing, abnormally fast and superficial breathing, pain in the upper spine.
Flushing, bluish discoloration of the face and lips, skin texture changes, excessive sweating.
Itching of the vulva in women.
Changes in the amounts of blood cells.
Worsening of a rare disease associated with muscle weakness (aggravation of myasthenia gravis).
If any of the side effect gets serious, or if the patient notices any side effects not listed in this monograph, tell the doctor or pharmacist.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
Tell the doctor if the patient is taking ganciclovir which is used to treat some viral infections.
Also, tell the doctor if the patient is taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia) or any blood thinners such as warfarin.
The doctor will decide whether the patient should use ImiCila in combination with these medicines.
The following information is intended for healthcare professionals only.
ImiCila powder for solution for infusion: Each vial is for single use only.
Reconstitution: Contents of each vial must be transferred to 50ml of an appropriate infusion solution (see Presentation and Description): 0.9% sodium chloride injection, 10% glucose injection, 5% glucose and 0.9% sodium chloride injection, 5% glucose injection with 0.45% saline solution, 5% glucose injection with 0.15% potassium chloride solution, Mannitol 5%, Mannitol 10%.
A suggested procedure is to add approximately 10 ml of the appropriate infusion solution to the vial. Shake well and transfer the resulting mixture to the infusion solution container.
CAUTION: THE MIXTURE IS NOT FOR DIRECT INFUSION.
Repeat with an additional 10ml of infusion solution to ensure complete transfer of vial contents to the infusion solution. The resulting mixture should be agitated until clear.
The concentration of the reconstituted solution following the previously mentioned procedure is approximately 10mg/ml for both imipenem and cilastatin.
Variations of colour, from colourless to yellow, do not affect the potency of the product.
Incompatibility: This medicinal product is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. However, it can be administered into an I.V system through which a lactate solution is being infused.
This medicinal product must not be mixed with other medicinal products except those mentioned under Reconstitution.
After reconstitution: Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed 4 hours at 25°C or 24 hours under refrigeration (5°C ± 3°C).
Do not throw away any medicine via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help protect the environment.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Refer to the Summary of Product Characteristics (SmPC) for further information about ImiCila powder for solution for infusion.
J01DH51 - imipenem and cilastatin ; Belongs to the class of carbapenems. Used in the systemic treatment of infections.
Powd for soln for infusion (vial) [white to almost white or light (pale) yellow powder] 10's.
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