Imipenem 500 mg. 20 ml. 5 vials

HOSPIRA
Imipenem 500 mg. 20 ml. 5 vials
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What is imipenem / cilastatin Hospira and what it is used
Imipenem / cilastatin Hospira belongs to a group of medicines called carbapenem antibiotics. It kills a wide spectrum of bacteria (microorganisms) that cause infections in various parts of the body in adults and children aged 1 year and more.

Treatment
Your doctor has prescribed imipenem / cilastatin Hospira, because you have one (or more) of the following types of infection:
Complicated infections of the abdomen;
Infections of the lungs (pneumonia);
Infections that you received during or after birth;
Complicated urinary tract infections;
Complicated infections of skin and soft tissues.
Imipenem / cilastatin Hospira can be used in the treatment of patients with low levels of white blood cells that have fever that is suspected to be due to bacterial infection.
Imipenem / Cilastatin Hospira can be used to treat bacterial infections of the blood, which may be related to the type of infection mentioned above.

2. What you need to know before taking imipenem / cilastatin Hospira
Do not take imipenem / cilastatin Hospira:
if you are allergic (hypersensitive) to imipenem cilastatin or any of the other ingredients of this medicine (listed in section 6);
if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins or carbapenems.
Warnings and Precautions
Talk to your doctor before using imipenem / cilastatin Hospira. Tell your doctor about any medical conditions that you have or have had including:
allergies to medicines, including antibiotic (sudden life-threatening allergic reactions require immediate treatment);
colitis or other gastrointestinal disorder;
disease of the central nervous system such as tremors or localized epileptic seizures;
problems with liver, kidney or urinary tract.
You may have positive test (test of Coombs), indicating the presence of antibodies that may 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. Other medicines and imipenem / cilastatin Hospira below).

Children
Imipenem / cilastatin Hospira is not recommended in children under one year of age or children with kidney problems.

Other medicines and imipenem / cilastatin Hospira
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Contact your doctor if taking ganciclovir which is used for the treatment of certain 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 drugs blood thinners such as warfarin.
Your doctor will decide whether you should use imipenem / cilastatin Hospira in combination with these medicines.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Imipenem / cilastatin Hospira has not been studied in pregnant women. Imipenem / cilastatin Hospira should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the fetus.
If you are breastfeeding or plan to breastfeed, it is important to tell your doctor about this before you start receiving imipenem / cilastatin Hospira. Small amounts of the medicine can pass into breast milk and affect the baby. Therefore your doctor will decide whether you should use imipenem / cilastatin Hospira 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 imipenem / cilastatin Hospira
This medicinal product contains 1,6 mmol (or 37,5 mg) of sodium per dose of 500 mg, this should be taken into consideration for patients on a diet with a controlled intake of sodium.

3. How to take imipenem / cilastatin Hospira
Imipenem / cilastatin Hospira will be prepared and will be administered by a doctor or other medical professional. Your doctor will decide what dose of imipenem / cilastatin Hospira need.

Adults and adolescents
In adults and adolescents usual dose of imipenem / cilastatin Hospira 500 mg / 500 mg every 6 hours or 1,000 mg / 1,000 mg every 6 or 8 hours. If you have kidney problems, or if you weigh less than 70 kg, your doctor may reduce your dose.

Method of administration
Imipenem / cilastatin Hospira is 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.

Use in children
For children over the age of one year, the usual dose is 15/15 or 25/25 mg / kg / dose every 6 hours. Not recommended use of imipenem / cilastatin Hospira in children aged 1 year and children with kidney problems.

If you use more than the amount of imipenem / cilastatin Hospira
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 imipenem / cilastatin Hospira, immediately contact your doctor or other healthcare professional.

If you forget to use imipenem / cilastatin Hospira
If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional.
Do not take a double dose to make up the missed dose.

If you stop use of imipenem / cilastatin Hospira
Do not stop the use of imipenem / cilastatin Hospira, unless your doctor tells you to stop.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines imipenem / cilastatin Hospira 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 patient in 10;
Common: affects 1 to 10 patients in 100;
Uncommon: affects 1 to 10 patients in 1000;
rare: affects 1 to 10 patients per 10 000;
very rare: affects less than 1 in 10,000;
Not known: from the available data can not be estimated.
Common:
Nausea, vomiting, diarrhea. Nausea and vomiting occur more frequently in patients with low white blood cell counts;
Highly painful to the touch swelling and redness along the vein;
Rash;
Liver function abnormalities, which were found in a blood test;
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;
Hives;
Fever;
Blood disorders affecting blood cells, which are usually detected in a blood test (symptoms may be tiredness, pale skin and delayed delivery of bruises formed by injury);
Violations of the function of kidneys and liver, and abnormal blood tests that detected in a blood test;
Tremors and uncontrollable muscle twitching;
Seizures;
Psychiatric disorders (such as mood swings and impaired judgment);
Seeing, hearing or feeling things that are not there (hallucinations);
Confusion;
Dizziness, drowsiness;
Lowering blood pressure.
Rare:
Allergic reactions including rash, swelling of face, lips, tongue and / or throat (with difficulty in breathing or swallowing), and / or low blood pressure. If these events occur during or after administration of imipenem / cilastatin Hospira, the drug should be discontinued immediately and contact your doctor;
Peeling of skin (toxic epidermal necrolysis);
Severe skin reactions (Stevens-Johnson and erythema multiforme);
Severe skin reactions with peeling skin and hair (exfoliative dermatitis);
Fungal infection (candidiasis);
Staining of teeth and / or tongue;
Inflammation of the colon with severe diarrhea;
Taste disorders;
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 the urine;
Brain damage, numbness (pins and needles), localized tremor;
Hearing loss.
Very rare:
Severe impairment of liver function due to inflammation (fulminant hepatitis);
Inflammation of the stomach or intestines (gastroenteritis);
Inflammatory bowel disease with bloody diarrhea (hemorrhagic colitis);
Red, swollen tongue, expansion of the normal bumps on the tongue, which gives him the "hairy" appearance, heartburn, sore throat, increased saliva production;
Abdominal pain;
Feelings of dizziness (vertigo), headache;
Ringing in the ears (tinnitus);
Pain in several joints, weakness;
Irregular heartbeat, fast or too strong heartbeat;
Chest discomfort, difficulty breathing, an unusually rapid and shallow breathing, pain in the upper part of the spine;
Redness, bruising to the face and lips, change in the skin, increased sweating;
Vaginal itching in women;
Changes in the number of blood cells;
Worsening of a rare disease associated with muscle weakness (worsening of myasthenia gravis).
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet.

5. How to store imipenem / cilastatin Hospira
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the bottle label and carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions prior to reconstitution or dilution.
The reconstituted solution should be used immediately. The time from the beginning of reconstitution by the end of intravenous administration should not exceed two hours. The reconstituted solution should be refrigerated.
Unused medicines should not be disposed of 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. Contents of the pack and further information
What imipenem / cilastatin Hospira
The active substances are imipenem and cilastatin. Each vial contains 500 mg of imipenem and cilastatin 500 mg.
The other ingredient is sodium bicarbonate.

How does imipenem / cilastatin Hospira and contents of the pack
This medicine is dark white to light yellow hygroscopic powder for solution for infusion in a glass vial.
Packs of 20 ml vial containing 5 vials in a carton.
Packs of 100 ml vials containing 1 vial in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The holder of the marketing authorization of imipenem / cilastatin Hospira is:
Hospira UK Limited, UK.

The manufacturer (responsible for batch release of the product in the European Economic Area) is:
Hospira UK Limited, UK.

The following information is intended for healthcare professionals:
Preparation of the intravenous solution
Medicinal product is supplied as a dry sterile powder in vials containing the equivalent of 500 mg of imipenem and 500 mg cilastatin.
The product is buffered with sodium hydrogen carbonate to give a pH of the solution between 6.5 and 8.5. No significant change in pH when the solution is prepared and used as indicated. The product contains 37,5 mg sodium (1,6 mmol).
For single use only. Discard any unused solution.
Reconstitution of the powder must be carried out under aseptic conditions, using described below diluents. The solution should be inspected visually for particulate matter and discoloration immediately prior to administration. The solution should be used only if it is clear and without particles.
The stability of the reconstituted solution is set to 0.9% sodium chloride and sterile water for injection.
Reconstituted and diluted solutions should be used immediately.

Reconstitution of vials 100 ml
Sterile powder should be reconstituted as directed below. Must be shaken until a clear solution, the dissolution of the powder takes about 3-4 minutes. Differences in color from colorless to yellow does not affect the efficacy of the product.

Dose (imipenem in mg) Volume of solvent to be added (ml) Mean approximate concentration of product (mg / ml imipenem)
500 100 5
Reconstitution of 20 ml vial
The contents of the vial should be transferred to 100 ml of an appropriate infusion. It is advisable to add approximately 10 ml of a suitable infusion solution in the vial. Shake well and transfer the resulting suspension in court with the infusion solution.

Caution: the suspension is not for direct infusion.
Repeat the procedure with another 10 ml of infusion solution to ensure that the entire contents of the vial is transferred to the infusion solution. The resulting mixture must be shaken until clear.
Any unused product or waste material should be disposed of in accordance with local requirements.

Incompatibility
The product is chemically incompatible with lactate and should not be dissolved in solvents, which contain lactate. However, the product can be administered via an intravenous drip, through which the infused solution containing lactate.
The product should not be mixed or physically added to other antibiotics.

After reconstitution and dilution
After reconstitution and dilution, the solution should be used immediately. The time from the beginning of reconstitution by the end of intravenous administration should not exceed two hours.
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