1 g of powder to concentrate for infusion solution 
ertapenem

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • 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. See section 4.

In this leaflet you will find information about: 
1. What Ertapenem Fresenius Kabi is and what it is used for 
2. What you need to know before you get Ertapenem Fresenius Kabi 
3. How to use Ertapenem Fresenius Kabi 
4. Possible side effects 
5. How Ertapenem Fresenius Kabi to be stored 
6. Contents of the packaging and other information 

1. What Ertapenem Fresenius Kabi is and what it is used for

Ertapenem Fresenius Kabi contains ertapenem, an antibiotic belonging to the beta-lactam group. It has the ability to kill a large number of different bacteria ( microorganisms ) that cause infection in different parts of the body.

Ertapenem Fresenius Kabi can be given to individuals who are three months and older.

Treatment:

Your doctor has prescribed Ertapenem Fresenius Kabi for you or your child to have one (or more) of the following types of infections:

  • Infection of the abdomen
  • Infection affecting the lungs ( pneumonia )
  • Gynecological infection er
  • Skin infections of the foot in diabetics

Prophylaxis:

  • Prophylaxis against infection in adults in the area where the surgery was performed after surgery in the colon or rectum.

Ertapenem contained in Ertapenem Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you get Ertapenem Fresenius Kabi

Do not use Ertapenem Fresenius Kabi

  • if you are allergic to the active substance (ertapenem) or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to antibiotics such as penicillins, cephalosporins, or carbapenems (used to treat various infections ).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Ertapenem Fresenius Kabi:

If you get an allergic reaction during treatment (such as swelling of the face, tongue, or throat, difficulty breathing or swallowing, rash), you should contact your doctor as soon as possible as you may need medical treatment immediately.

Although antibiotics including Ertapenem Fresenius Kabi kill some bacteria, other bacteria and fungi can continue to grow more than normal. This is called overgrowth. Your doctor will monitor you for overgrowth and, if necessary, give you treatment.

You must tell your doctor if you have diarrhea before, during, or after your treatment with Ertapenem Fresenius Kabi. This is because you may have a condition called colitis (inflammation of the colon). Do not take any medicine to treat diarrhea without first discussing it with your doctor.

Tell your doctor if you are taking the medicines valproic acid or sodium valproate (see Other medicines and Ertapenem Fresenius Kabi below).

Tell your doctor about the diseases you have or have had:

  • Kidney disease. Your doctor must know if you have kidney disease and if you are undergoing dialysis treatment.
  • Drug allergies, including antibiotics.
  • Diseases of the central nervous system, such as limited tremors or seizures.

Children and adolescents (3 months to 17 years of age)

Experience with Ertapenem Fresenius Kabi in children younger than two years is limited. For this age group, the doctor assesses the possible benefits of the treatment. There is no experience in children under 3 months of age.

Other medicines and Ertapenem Fresenius Kabi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Tell your doctor, nurse, or pharmacist if you are taking medicines containing valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, and schizophrenia). This is because Ertapenem Fresenius Kabi can affect the way other medicines work. Your doctor will decide if you should use Ertapenem Fresenius Kabi at the same time as any of these medicines.

Pregnancy and breastfeeding

You must tell your doctor if you are pregnant or planning to become pregnant before receiving Ertapenem Fresenius Kabi.

Ertapenem Fresenius Kabi has not been studied in pregnant women. Ertapenem Fresenius Kabi should not be used during pregnancy unless your doctor considers that the potential benefit outweighs the potential risk to the fetus.

Before you are treated with Ertapenem Fresenius Kabi, you must tell your doctor if you are breast-feeding or planning to start breast-feeding.

Because Ertapenem Fresenius Kabi has been found in breast milk, women receiving Ertapenem Fresenius Kabi should not breast-feed as the breast-fed baby may be affected.

Driving and using machines

Do not drive or use machines until you know how you react to the medicine. Certain side effects, such as dizziness and drowsiness, have been reported with Ertapenem Fresenius Kabi, which may affect some patients’ ability to drive or use machines.

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.

Ertapenem Fresenius Kabi contains sodium

This medicine contains 137 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 6.9% of the maximum recommended daily sodium intake for adults.

How to use Ertapenem Fresenius Kabi

Ertapenem Fresenius Kabi will always be mixed and given intravenously (into a vein) by a doctor or other healthcare professional.

The recommended dose of Ertapenem Fresenius Kabi for adults and adolescents 13 years of age or older is 1 gram (g) once daily. The recommended dose for children between 3 months and 12 years of age is 15 mg/kg given twice daily (1 g / day must not be exceeded). Your doctor will decide how many days you need to receive treatment.

In the prophylaxis of infection in the area where the surgery was performed after surgery in the colon or rectum, the usual dose is 1 g and is given intravenously as a single dose one hour before the operation.

You must continue to receive Ertapenem Fresenius Kabi for as long as your doctor prescribes it.

If you take more Ertapenem Fresenius Kabi then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have missed a dose of Ertapenem Fresenius Kabi 

If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adults 18 years or older

Since the drug was introduced to the market, severe allergic reactions ( anaphylaxis ) and hypersensitivity syndromes (allergic reactions with rash, fever, and abnormal blood tests) have been reported. The first signs of a severe allergic reaction may be swelling of the face and/or throat. If these signs of illness occur, contact your doctor as soon as possible as you may need medical treatment immediately.

Common (may affect up to 1 in 10 people) side effects are:

  • Headache
  • Diarrhea, nausea, vomiting
  • Rash, itching
  • Problems with the vein in which the medicine is given (including inflammation, the formation of a lump, swelling at the injection site, or leakage of fluid into the tissue and skin around the injection site)
  • Increased platelet count
  • Altered liver function values.

Uncommon (may affect up to 1 in 100 people) side effects are:

  • Dizziness, drowsiness, difficulty sleeping, confusion, seizures
  • Low blood pressure, slow heart rate
  • Shortness of breath, sore throat
  • Constipation, yeast infection in the mouth, diarrhea associated with antibiotic treatment, acid reflux, dry mouth, impaired digestion, loss of appetite
  • Reddening of the skin
  • Discharges and irritation in the abdomen
  • Stomach pain, fatigue, fungal infection, fever, edema/swelling, chest pain, altered taste sensation
  • Alteration of certain blood and urine samples.

Rare (may affect up to 1 in 1,000 people) side effects are:

  • Decreased white blood cell count, decreased platelet count
  • Low blood sugar
  • Upset, anxiety, depression, tremors
  • Irregular heartbeat, high blood pressure, bleeding, fast heartbeat
  • Nasal congestion, cough, nosebleeds, pneumonia, altered breathing sounds, wheezing
  • Inflammation of the gallbladder, difficulty swallowing, fecal incontinence, jaundice, liver disease
  • Skin inflammation, fungal infection of the skin, skin flaking, infection of the wound after surgery
  • Muscle cramps, shoulder pain
  • Urinary tract infection, kidney problems
  • Miscarriage, abdominal bleeding
  • Allergy malaise, inflammation of the pelvic floor, changes in the white part of the eye, fainting.

No known frequency (cannot be calculated from the available data): 

  • Hallucinations
  • Decreased level of consciousness
  • Changed mood (including aggression, delirium, disorientation, changes in mood)
  • Abnormal movements
  • Muscle weakness
  • Unsteady gait
  • Discoloration of teeth.

There have also been reports of changes in certain laboratory values.

If you experience raised or fluid-filled skin spots all over your body, talk to your doctor or nurse immediately.

Children and adolescents (3 months to 17 years old)

Common (may affect up to 1 in 10 people) side effects are:

  • Diarrhea
  • Diaper rash
  • Pain at the infusion site
  • Change in the number of white blood cells
  • Altered liver function values.

Uncommon (may affect up to 1 in 100 people) side effects are:

  • Headache
  • Hot flashes, high blood pressure, red or reddish-purple flat dots as big as pinheads under the skin
  • Discolored stools, black tar-like stools
  • Reddening of the skin, itchy skin
  • Burning sensation, itching, redness, and heat at the infusion site, redness at the injection site
  • Increased platelet count
  • Alteration of certain blood samples.

No known frequency (frequency can not be calculated from the available data): 

  • Hallucinations
  • Changed mood (including aggression).

5. How to store Ertapenem Fresenius Kabi

Keep this medicine out of the sight and reach of children.

Use before the expiry date which is stated on the vial. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

After reconstitution: Reconstituted solutions should be used immediately.

After dilution: Dilute solutions (approximately 20 mg/ml ertapenem) are physically and chemically stable for 6 hours at 25 ° C or 24 hours at 2 ° C – 8 ° C (in a refrigerator). The solution should be used within 4 hours after removal from the refrigerator. Ertapenem Fresenius Kabi solution must not be frozen.

From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage time and storage conditions and these should not normally exceed 24 hours at 2-8 ° C unless preparation/dilution (etc) has taken place under controlled and validated conditions.

Do not use this medicine if you notice particles and discoloration in the reconstituted solution.

Medicines 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 substance is ertapenem 1 g.
  • The other ingredients are Sodium bicarbonate (E500) and sodium hydroxide (E524).

What the medicine looks like and the contents of the pack

Ertapenem Fresenius Kabi is a white to yellowish lyophilized powder for concentrate for solution for infusion.

The color of solutions of Ertapenem Fresenius Kabi ranges from colorless to pale yellow. Variations within this color scale do not affect the strength of the drug.

Ertapenem Fresenius Kabi is supplied in packs of 10 vials.

Not all pack sizes may be marketed.

Manufacturer

ACS Dobfar SpA

Nucleo Industriale S.Atto

64100 Teramo

Italy

Muhammad Nadeem

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