Imipenem + cilastatin aptapharma

Package leaflet: Information for the patient

Imipenem + Cilastatin AptaPharma, 500 mg + 500 mg, powder for solution for infusion
Imipenemum + Cilastatinum
Please read this leaflet carefully before using this medicine, as it contains important information for the patient.
Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor.
This medicine has been prescribed for a specific individual. Do not give it to others.
The medicine may harm another person, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor. See section 4.
Contents of the leaflet

1. What Imipenem + Cilastatin AptaPharma is and what it is 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 pack and other information

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

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

Treatment
Your doctor has prescribed Imipenem + Cilastatin AptaPharma because you have been diagnosed with at least one of the following infections:

• Complicated intra-abdominal infections
• 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 low white blood cell counts who have developed fever likely caused by a bacterial infection.
Imipenem + Cilastatin AptaPharma may also be used to treat bacterial blood infections, which 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

• if the patient is allergic to imipenem, cilastatin, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems.

Warnings and precautions
Tell your doctor about any medical conditions the patient currently has or has had in the past, including:

• allergies to any medicines, including antibiotics (sudden, life-threatening allergic reactions requiring immediate medical attention),
• colitis or any other gastrointestinal disease,
• kidney or urinary tract problems, including impaired kidney function (in patients with impaired kidney function, increased blood levels of Imipenem + Cilastatin AptaPharma may occur; if the dose is not adjusted according to kidney function, adverse reactions affecting the central nervous system may occur),
• any disorders of the central nervous system, such as localised tremors or seizures,
• liver problems.

The result of a blood test detecting antibodies that can destroy red blood cells (Coombs test) may be positive. Your doctor will discuss this issue with you.

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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

If the patient is taking ganciclovir, used to treat certain viral infections, tell your doctor.

You should also inform your doctor if the patient is taking valproic acid or sodium valproate (medicines used for epilepsy, bipolar affective disorders, migraine, or schizophrenia) or any anticoagulant medicines such as warfarin.

Your doctor will decide whether the patient can receive Imipenem + Cilastatin AptaPharma together with these medicines.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or planning to become pregnant, she should inform her doctor before starting Imipenem + Cilastatin AptaPharma. The use of Imipenem + Cilastatin AptaPharma in pregnant women has not been studied. Imipenem + Cilastatin AptaPharma should not be used during pregnancy unless the doctor decides that the potential benefits of treatment outweigh the risks to the unborn child.

If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before starting Imipenem + Cilastatin AptaPharma.

The medicine may pass into human milk in small amounts and may affect the breastfed infant. Therefore, your doctor will decide whether Imipenem + Cilastatin AptaPharma can be used during breastfeeding.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Some adverse effects associated with this medicine (such as hallucinations – seeing, feeling, or hearing things that are not real; loss of balance, drowsiness, and dizziness) may affect the ability of some patients to drive or operate machinery (see section 4).

Imipenem + Cilastatin AptaPharma contains sodium
This medicine contains 37.5 mg of sodium (the main component of table salt) per vial. This corresponds 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 healthcare professional. The doctor will decide how much Imipenem + Cilastatin AptaPharma should be given to the patient.

Use in 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. In patients with kidney disease, the doctor may reduce the dose.

Use in children
The recommended dose for children aged one year and older 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:
a dose ≤ (500 mg + 500 mg) is given over 20–30 minutes,
and a dose > (500 mg + 500 mg) is given over 40–60 minutes.
If the patient experiences nausea, the infusion rate may be reduced.

Use of a higher than recommended dose of Imipenem + Cilastatin AptaPharma
Symptoms of overdose may include: seizures (epileptic fits), feeling disoriented, tremor, nausea, vomiting, low blood pressure, and slow heart rate. If there is concern that an excessive dose of Imipenem + Cilastatin AptaPharma has been administered, contact a doctor or other healthcare professional immediately.

Missed dose of Imipenem + Cilastatin AptaPharma
If there is concern that a dose of Imipenem + Cilastatin AptaPharma has been missed, contact a doctor or other healthcare professional immediately.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During or after administration of Imipenem + Cilastatin AptaPharma, the following adverse reactions have been reported rarely; however, if they occur, the treatment must be discontinued immediately and medical advice must be sought without delay.

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

Other possible adverse reactions:
Common (less than 1 in 10 people)

• Nausea, vomiting, diarrhoea. Nausea and vomiting appear to occur more frequently in patients with low white blood cell counts.
• Swelling and redness along the vein, maximally tender to 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 hard lumps at the injection site
• Itching of the skin
• Urticaria (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
• Tremor and uncontrolled muscle twitching
• Seizures (epileptic fits)
• Psychiatric disturbances (such as mood swings and impaired judgment)
• Hallucinations, i.e. seeing, hearing or feeling things that do not exist
• Feeling of disorientation
• Dizziness, drowsiness
• Low blood pressure

Rare (less than 1 in 1,000 people)

• Fungal infection (candidiasis)
• Discoloration of teeth and (or) tongue
• Colitis (inflammation of the large intestine) with severe diarrhoea
• Taste disturbances
• Liver function disorders
• Hepatitis (liver inflammation)
• Kidney function disorders
• Changes in the amount and colour of urine
• Brain function disturbances, sensation of tingling (numbness and tingling), local tremor
• Hearing loss

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

• Severe liver dysfunction due to hepatitis (fulminant hepatitis)
• Inflammation of the stomach or intestines
• Enterocolitis with bloody diarrhoea (haemorrhagic colitis)
• Redness and swelling of the tongue, overgrowth of tongue papillae giving it a "hairy" appearance, heartburn, sore throat, increased salivation
• Stomach pain
• Sensation of spinning (disturbance of balance), headache
• Ringing in the ears (tinnitus)
• Joint pain, weakness
• Irregular heartbeat, rapid heartbeat or strong palpitations
• Chest discomfort, difficulty breathing, abnormally fast or shallow breathing, pain in the upper spine
• Hot flushes with facial redness, bluish discoloration of the face and lips, skin texture changes, excessive sweating
• Itching of the vulva in women
• Changes in blood cell counts
• Worsening of symptoms of a rare condition causing muscle weakness (exacerbation of myasthenia gravis symptoms)

Frequency not known (cannot be estimated from available data)

• Abnormal movements
• Restlessness

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Imipenem + Cilastatin AptaPharma

Keep this 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 stated month.
Do not store above 25°C.
Reconstituted solution:
The reconstituted solution should be used immediately. The time from the beginning of reconstitution to the end of intravenous infusion should not exceed two hours.
Do not freeze the reconstituted solution.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Imipenem + Cilastatin AptaPharma contains
The active substances are imipenem and cilastatin. Each vial contains imipenem monohydrate
equivalent to 500 mg of imipenem and sodium cilastatin equivalent to 500 mg of cilastatin.
Other ingredient: sodium hydrogen carbonate.
What Imipenem + Cilastatin AptaPharma looks like and contents of the pack
Imipenem + Cilastatin AptaPharma is a white to slightly yellowish powder in 20 mL vials made of
colourless glass type III, closed with a bromobutyl rubber stopper and a flip-off seal.
The pack contains 10 vials.
Marketing Authorisation Holder
Apta Medica Internacional d.o.o.
Likozarjeva 6
1000 Ljubljana
Slovenia
Tel.: 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 medicinal product is authorised in the Member States of the European Economic Area
under the following names:

The following information is intended exclusively for healthcare professionals

Healthcare personnel only
Each vial is for single use only.

Preparation of the solution
The contents of each vial should be transferred into 100 mL of an appropriate infusion solution (see sections "Incompatibility" and "Prepared solution"): 0.9% sodium chloride solution. In exceptional circumstances, if for clinical reasons 0.9% sodium chloride solution cannot be used, 5% glucose solution may be used instead.

According to the recommended procedure, approximately 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 into the infusion container.

NOTE: THE MIXTURE IS NOT INTENDED FOR DIRECT INFUSION.

The procedure should be repeated by adding another 10 mL of the infusion solution to ensure that the entire contents of the vial have been transferred into the infusion solution. The resulting mixture should be shaken until it becomes clear.

Both imipenem and cilastatin concentrations in the solution prepared according to the above procedure are approximately 5 mg/mL.

Variations in color (from colorless to yellow) do not affect the potency of the product.

Incompatibility
Chemical incompatibility of the medicinal product with lactates occurs; therefore, solvents containing lactates should not be used for reconstitution or dilution of this medicinal product. However, the medicinal product may be administered through an infusion set used for administering lactate-containing solutions.

The medicinal product must not be mixed with other medicinal products except as specified in the section "Preparation of the solution".

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