IMIPENEM 500 mg/500 mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Imipenem + Cilastatin AptaPharma, 500 mg + 500 mg, powder for solution for infusion
   1. Table of contents of the leaflet
3. What is Imipenem + Cilastatin AptaPharma and what is it used for
   1. Treatment
4. Important information before using Imipenem + Cilastatin AptaPharma
   1. When not to use Imipenem + Cilastatin AptaPharma
   2. Warnings and precautions
   3. Imipenem + Cilastatin AptaPharma and other medicines
   4. Pregnancy, breastfeeding and fertility
   5. Driving and using machines
   6. Imipenem + Cilastatin AptaPharma contains sodium
5. How to use Imipenem + Cilastatin AptaPharma
   1. Using a higher dose of Imipenem + Cilastatin AptaPharma than recommended
   2. Missing a dose of Imipenem + Cilastatin AptaPharma
6. Possible side effects
   1. Uncommon (less than 1 in 100 people)
   2. Rare (less than 1 in 1000 people)
   3. Very rare (less than 1 in 10,000 people)
   4. Frequency not known (cannot be estimated from the available data)
   5. Reporting side effects
7. How to store Imipenem + Cilastatin AptaPharma
8. Contents of the packaging and other information
   1. What Imipenem + Cilastatin AptaPharma contains
   2. What Imipenem + Cilastatin AptaPharma looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:
   7. The following information is intended for medical staff or healthcare professionals only
   8. Reconstitution of the solution
   9. Incompatibility
   10. After reconstitution

Leaflet attached to the packaging: patient information

Imipenem + Cilastatin AptaPharma, 500 mg + 500 mg, powder for solution for infusion

Solution for infusion
Imipenem + Cilastatin
Read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.
Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Imipenem + Cilastatin AptaPharma and what is it used for
• 2. Important information before using Imipenem + Cilastatin AptaPharma
• 3. How to use Imipenem + Cilastatin AptaPharma
• 4. Possible side effects
• 5. How to store Imipenem + Cilastatin AptaPharma
• 6. Contents of the packaging and other information

1. What is Imipenem + Cilastatin AptaPharma and what is it used for

Imipenem + Cilastatin AptaPharma belongs to a group of medicines called carbapenem antibiotics.
This medicine destroys a wide range of bacteria (microorganisms) that cause infections in different parts of the body in adults and children over 1 year of age.

Treatment

The doctor has prescribed Imipenem + Cilastatin AptaPharma because the patient has been diagnosed with at least one of the following infections:

• complicated infections of the abdominal cavity
• lung infection (pneumonia)
• infections acquired during or after childbirth
• complicated urinary tract infections
• complicated skin and soft tissue infections.

Imipenem + Cilastatin AptaPharma may be used to treat patients with a reduced number of white blood cells who have developed a fever likely caused by a bacterial infection.
Imipenem + Cilastatin AptaPharma may be used to treat bacterial blood infections that may be associated with one of the types of infections listed above.

2. Important information before using Imipenem + Cilastatin AptaPharma

When not to use Imipenem + Cilastatin AptaPharma

Warnings and precautions

Tell your doctor about any diseases that the patient currently has or has had, including:

• allergies to any medicines, including antibiotics (sudden, life-threatening allergic reactions that require immediate medical attention),
• colitis or any other gastrointestinal disease,
• kidney or urinary tract problems, including impaired kidney function (in patients with impaired kidney function, the level of Imipenem + Cilastatin AptaPharma in the blood may increase; if the dose is not adjusted to kidney function, side effects from the central nervous system may occur);
• any central nervous system disorders, such as local tremors or seizures,
• liver problems.

The result of a test that detects antibodies in the blood that can destroy red blood cells (Coombs test) may be positive. The doctor will discuss this with the patient.
Children
Imipenem + Cilastatin AptaPharma is not recommended for use in children under 1 year of age or in children with kidney disease.

Imipenem + Cilastatin AptaPharma and other medicines

Tell your doctor or pharmacist about all medicines that are currently being taken or have been taken recently, as well as any medicines that the patient plans to take.
If the patient is taking ganciclovir, which is used to treat certain viral infections, they should tell their doctor.
They should also inform their doctor if they are taking valproic acid or sodium valproate (medicines used in epilepsy, bipolar affective disorders, migraine or schizophrenia) or any anticoagulant medicines, such as warfarin.
The doctor will decide whether the patient can receive Imipenem + Cilastatin AptaPharma with these medicines.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or plans to become pregnant, they should tell their doctor before starting to take Imipenem + Cilastatin AptaPharma. The use of Imipenem + Cilastatin AptaPharma has not been studied in pregnant women. Imipenem + Cilastatin AptaPharma should not be used in pregnant women unless the doctor decides that the potential benefits of using the medicine outweigh the risk to the fetus.
If the patient is breastfeeding or plans to breastfeed, they should tell their doctor before starting to take Imipenem + Cilastatin AptaPharma.
The medicine may pass into breast milk in small amounts and affect the breastfed baby. Therefore, the doctor will decide whether Imipenem + Cilastatin AptaPharma can be used during breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Some side effects associated with the use of this medicine (such as hallucinations - seeing, feeling or hearing things that do not exist; balance disorders, drowsiness and dizziness) may affect some patients' ability to drive or operate machinery (see section 4).

Imipenem + Cilastatin AptaPharma contains sodium

The medicine contains 37.5 mg of sodium (the main component of common salt) in each vial. This is equivalent to 1.9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Imipenem + Cilastatin AptaPharma

Imipenem + Cilastatin AptaPharma will be prepared and administered to the patient by a doctor or other qualified medical staff. The doctor will decide how much Imipenem + Cilastatin AptaPharma to administer to the patient.
Use in adults and adolescents
The recommended dose in adults and adolescents is 500 mg + 500 mg every 6 hours or 1000 mg + 1000 mg every 6 or 8 hours. In patients with kidney disease, the doctor may reduce the dose of the medicine.
Use in children
The recommended dose in children over 1 year of age is (15 mg + 15 mg) or (25 mg + 25 mg)/kg body weight every 6 hours. Imipenem + Cilastatin AptaPharma is not recommended for use in children under 1 year of age or in children with kidney disease.
Method of administration
Imipenem + Cilastatin AptaPharma is administered intravenously;
doses of ≤ (500 mg + 500 mg) are administered over 20-30 minutes,
and doses of > (500 mg + 500 mg) - over 40-60 minutes.
If the patient feels nauseous, the infusion rate can be reduced.

Using a higher dose of Imipenem + Cilastatin AptaPharma than recommended

Overdose symptoms may include: seizures (epileptic seizures), feeling disoriented, tremors, nausea, vomiting, low blood pressure and slow heart rate. If there is a suspicion that too much Imipenem + Cilastatin AptaPharma has been administered, contact a doctor or other qualified medical staff immediately.

Missing a dose of Imipenem + Cilastatin AptaPharma

If there is a suspicion that a dose of Imipenem + Cilastatin AptaPharma has been missed, contact a doctor or other qualified medical staff immediately.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During or after the administration of Imipenem + Cilastatin AptaPharma, the following side effects have occurred rarely, but if they occur, the use of the medicine should be stopped and a doctor should be contacted immediately.

• Allergic reactions, including rash, swelling of the face, lips, tongue and/or throat (causing breathing or swallowing problems) and/or low blood pressure
• Peeling of the skin (toxic epidermal necrolysis)
• Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme)
• Severe form of rash with peeling of the skin and hair loss (exfoliative dermatitis)

Other possible side effects:
Common (less than 1 in 10 people)

• Nausea, vomiting, diarrhea. It seems that nausea and vomiting occur more frequently in patients with a low white blood cell count.
• Swelling and redness along the vein, maximally sensitive to the touch
• Rash
• Abnormal liver function detected in blood tests
• Increased number of certain types of white blood cells

Uncommon (less than 1 in 100 people)

• Local redness of the skin
• Pain and formation of a hard lump at the injection site
• Itching of the skin
• Hives
• Fever
• Blood disorders affecting blood cells, usually detected during blood analysis (symptoms may include fatigue, pale skin and prolonged bruising after injury)
• Abnormal kidney, liver and blood function detected in blood tests
• Tremors and uncontrolled muscle twitching
• Seizures (epileptic seizures)
• Psychiatric disorders (such as mood swings and impaired judgment)
• Hallucinations, i.e. seeing, hearing and feeling things that do not exist
• Feeling disoriented
• Dizziness, drowsiness
• Low blood pressure

Rare (less than 1 in 1000 people)

• Fungal infection (candidiasis)
• Discoloration of teeth and/or tongue
• Colitis (inflammation of the large intestine) with severe diarrhea
• Taste disorders
• Liver function disorders
• Hepatitis
• Kidney function disorders
• Changes in the amount of urine excreted and changes in the color of urine
• Brain function disorders, feeling of tingling (numbness and tingling), local tremors
• Hearing loss

Very rare (less than 1 in 10,000 people)

• Severe liver function disorder due to hepatitis (fulminant hepatitis)
• Gastritis or enteritis
• Enteritis with bloody diarrhea (hemorrhagic colitis)
• Redness and swelling of the tongue, hypertrophy of papillae on the tongue giving it a "hairy" appearance, heartburn, sore throat, increased salivation
• Stomach pain
• Feeling of spinning (balance disorders), headaches
• Ringing in the ears (tinnitus)
• Pain in several joints, weakness
• Irregular heart rhythm, accelerated or strong heartbeat (palpitations)
• Discomfort in the chest, breathing difficulties, excessive acceleration or shallowness of breathing, pain in the upper back
• Hot flashes with facial redness, cyanotic discoloration of the face and lips, changes in skin structure, excessive sweating
• Vulvar itching in women
• Changes in blood cell count
• Worsening of symptoms of a rare disease in which muscle weakness occurs (worsening of myasthenia symptoms)

Frequency not known (cannot be estimated from the available data)

• Abnormal movements
• Agitation

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, consult a doctor or pharmacist. Side effects can also be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Imipenem + Cilastatin AptaPharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Reconstituted solution:
The reconstituted solution should be used immediately. The time from the start of reconstitution to the end of intravenous infusion should not exceed two hours.
Do not freeze the reconstituted solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Imipenem + Cilastatin AptaPharma contains

The active substances of the medicine are imipenem and cilastatin. Each vial contains imipenem monohydrate in an amount equivalent to 500 mg of imipenem and sodium cilastatin in an amount equivalent to 500 mg of cilastatin.
The other ingredient is: sodium bicarbonate.

What Imipenem + Cilastatin AptaPharma looks like and contents of the pack

Imipenem + Cilastatin AptaPharma is a white to light yellow powder in 20 mL vials made of colorless type III glass, closed with a bromobutyl rubber stopper and a flip-off cap.
The pack contains 10 vials.

Marketing authorization holder

Apta Medica Internacional d.o.o.
Likozarjeva 6
1000 Ljubljana
Slovenia
Phone: 00386 51 615 015
e-mail: [email protected]

Manufacturer

ACS Dobfar S.p.A.
Nucleo Industriale S. Atto, S. Nicolò a Tordino
64100 Teramo
Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:

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The following information is intended for medical staff or healthcare professionals only

Each vial is intended for single use only.

Reconstitution of the solution

The contents of each vial should be transferred to 100 mL of a suitable infusion solution (see sections "Incompatibility" "Reconstituted solution"): 0.9% sodium chloride solution. In exceptional circumstances, if 0.9% sodium chloride solution cannot be used for clinical reasons, 5% glucose solution may be used.
In accordance with the recommended procedure, about 10 mL of the 100 mL infusion solution should be added to the powder in the vial. The vial should be shaken vigorously, and the resulting mixture should be transferred to the infusion solution container.
NOTE: THE MIXTURE IS NOT INTENDED FOR DIRECT INFUSION.
The procedure should be repeated, adding another 10 mL of infusion solution to ensure that the entire contents of the vial are transferred to the infusion solution. The resulting mixture should be shaken until it becomes clear.
Both the concentration of imipenem and cilastatin in the reconstituted solution prepared according to the above procedure is approximately 5 mg/mL.
Differences in color (from colorless to yellow) do not affect the potency of the product.

Incompatibility

There is a chemical incompatibility of the medicinal product with lactates; therefore, solvents containing lactates should not be used to reconstitute and dilute this medicinal product. However, the medicinal product can be administered through an infusion set through which a solution containing lactates is administered.
The medicinal product should not be mixed with other medicinal products, except those mentioned in the section "Reconstitution of the solution".

After reconstitution

Diluted solutions should be used immediately after preparation.
The time from the start of reconstitution of the powder to the end of intravenous infusion should not exceed two hours.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.