Package Insert: Information for the User

INVANZ 1g powder for concentrate for solution for infusion

ertapenem

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section4.

INVANZ contains ertapenem, which is a beta-lactamic antibiotic. It has the ability to destroy a wide variety of bacteria (microorganisms) that cause infections in different parts of the body.

INVANZ can be administered to individuals aged 3 months and above.

Treatment:

Your doctor has prescribed INVANZ because you or your child suffer from one (or more) of the following types of infection:

• Abdominal infection
• Pneumonia (infection affecting the lungs)
• Gynecological infections
• Foot skin infections in diabetic patients

Prevention:

• Prevention of surgical wound infections in adults after colon or rectal surgery.

Do not useINVANZ

• if you are allergic to the active ingredient (ertapenem) or any of the other components of this medication (listed in section6).
• if you are allergic to antibiotics such as penicillins, cephalosporins, or carbapenems (used to treat various infections).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use INVANZ.

If you experience an allergic reaction (such as swelling of the face, tongue, or throat, difficulty breathing or swallowing, skin rash) during treatment, inform your doctor immediately, as you may need urgent medical treatment.

Although antibiotics, including INVANZ, destroy certain bacteria, other bacteria and fungi may continue to grow more than usual. This is known as bacterial overgrowth. Your doctor will monitor bacterial overgrowth and treat you if necessary.

It is essential to inform your doctor if you have diarrhea before, during, or after treatment with INVANZ. This is because you may develop a condition known as colitis (inflammation of the intestine). Do not take any medication to treat diarrhea without consulting your doctor first.

Inform your doctor if you are using medications called valproic acid or sodium valproate (see belowUse of INVANZ with other medications).

Inform your doctor of any other medical condition you have or have had, including:

• kidney disease. It is especially important for your doctor to know if you have kidney disease and if you are receiving dialysis treatment.
• allergies to any medication, including antibiotics.
• central nervous system disorders, such as localized tremors or seizures.

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

The experience with INVANZ in children under two years is limited. For this age group, your doctor will decide on the possible benefit of its use. There is no experience in children under 3 months of age.

Other medications and INVANZ

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor, pharmacist, or nurse if you are taking medications called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). This is because INVANZ may affect how other medications work. Your doctor will decide whether to use INVANZ in combination with these medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

INVANZ has not been studied in pregnant women. INVANZ should not be used during pregnancy unless your doctor decides that the potential benefit justifies the potential risk to the fetus.

Women receiving INVANZ should not breastfeed because it has been found in breast milk and may affect the infant.

Driving and operating machinery

Do not drive or use any tools or machines until you know how you react to the medication.

Certain adverse effects, such as dizziness and somnolence, associated with INVANZ may affect patients' ability to drive or operate machinery.

INVANZ contains sodium

This medication contains approximately 137 mg of sodium (main component of table salt/for cooking) in each 1.0 g dose. This is equivalent to 6.85% of the recommended daily maximum sodium intake for an adult.

INVANZ will always be prepared and administered by a doctor or other healthcare professional via intravenous (into a vein) route.

The recommended dose of INVANZ for adults and adolescents 13 years of age and older is 1 gram (g) administered once a day. The recommended dose for children 3 months to 12 years of age is 15 mg/kg, administered twice a day (not to exceed 1 g/day). Your doctor will decide how many days of treatment you need.

To prevent surgical wound infections after colon or rectal surgery, the recommended dose of INVANZ is 1 g administered as a single intravenous dose 1 hour before surgery.

It is very important that you continue to receive INVANZ for the entire time your doctor has told you.

If you use more INVANZ than you should

If you are concerned that you may have been given too much INVANZ, consult your doctor or other healthcare professional immediately.

If you forgot to use INVANZ

If you are concerned that you may have forgotten a dose, consult your doctor or other healthcare professional immediately.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Adults aged 18 years and older:

Since the drug was marketed, severe allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions such as: skin rash, fever, abnormal blood tests) have been reported. The first signs of a severe allergic reaction may include swelling of the face and/or throat. If these symptoms appear, inform your doctor immediately as you may need urgent medical treatment.

Frequent side effects (can affect up to 1 in 10 people) are:

• Headache
• Diarrhea, nausea, vomiting
• Skin rash, itching
• Problems with the vein in which the medicine is administered (including inflammation, lump formation, swelling at the injection site, or leakage of liquid into the surrounding tissue and skin)
• Increased platelet count
• Changes in liver function tests

Less frequent side effects (can affect up to 1 in 100 people) are:

• Dizziness, drowsiness, insomnia, confusion, seizures
• Low blood pressure, slow heart rate
• Difficulty breathing, sore throat
• Constipation, oral thrush infection, antibiotic-associated diarrhea, acid reflux, dry mouth, indigestion, loss of appetite
• Redness of the skin
• Vaginal discharge and irritation
• Abdominal pain, fatigue, fungal infection, fever, edema/swelling, chest pain, altered taste.
• Alterations in some urine and blood tests

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

• Decreased white blood cell count, decreased platelet count in the blood
• Low blood sugar
• Irritation, anxiety, depression, tremor
• Irregular heart rate, increased blood pressure, bleeding, rapid heart rate
• Runny nose, cough, nasal bleeding, pneumonia, unusual breathing sounds and pings
• Bile duct inflammation, difficulty swallowing, fecal incontinence, yellowing of the skin (jaundice), liver disorder
• Skin inflammation, fungal skin infection, skin peeling, wound infection after surgery
• Muscle cramps, shoulder pain
• Urinary tract infection, kidney insufficiency
• Abortion, genital bleeding
• Allergy, discomfort, pelvic peritonitis, changes in the white part of the eye, fainting.
• The skin may harden at the injection site
• Swelling of blood vessels in the skin

Side effects with unknown frequency (cannot be estimated from available data) are:

• Hallucinations
• Decreased level of consciousness
• Altered mental state (including aggression, delirium, disorientation, changes in mental state)
• Abnormal movements
• Muscle weakness
• Unstable gait
• Stained teeth

Also, changes in some blood parameters measured in blood tests have been reported.

If you experience blisters filled with fluid or raised over a large area of your body, inform your doctor or nurse immediately.

Children and adolescents (3 months to 17 years old):

Frequent side effects (can affect up to 1 in 10 people) are:

• Diarrhea
• Diaper rash
• Pain at the perfusion site
• Changes in white blood cell count
• Changes in liver function tests

Less frequent side effects (can affect up to 1 in 100 people) are:

• Headache
• Flushes, high blood pressure, small, smooth, red or purple spots under the skin
• Colored stools, black stools like tar
• Redness of the skin, skin rash
• Itching, prickling, redness, and warmth at the perfusion site, redness at the injection site
• Increased platelet count
• Changes in some blood tests

Side effects with unknown frequency (cannot be estimated from available data) are:

• Hallucinations
• Altered mental state (including aggression)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging.

The first 2numbers indicate the month; the next 4numbers indicate the year.

Do not store at a temperature above 25°C.

Composition ofINVANZ

-The active ingredient is ertapenem 1g.

-The other components are: sodium bicarbonate (E‑500) and sodium hydroxide (E‑524).

Appearance of the product and contents of the container

INVANZ is a lyophilized powder for concentrate solution for intravenous infusion, white to off-white in color.

The INVANZ solutions vary from colorless to pale yellow. Variations in color within this range do not affect efficacy.

INVANZ is presented in vials of 1vial or 10vials.

Only some sizes of containers may be marketed.

Marketing Authorization Holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Responsible for manufacturing

FAREVA Mirabel

Route de Marsat, Riom

63963 Clermont-Ferrand Cedex 9

France

For more information about this medicinal product, please consult the representative of the marketing authorization holder in your country:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

--------------------------------------------------------------------------------------------------------------------------This information is intended for healthcare professionals only:

Instructions for reconstituting and diluting INVANZ:

For single use.

Preparation for intravenous administration:

INVANZ must be reconstituted and then diluted before administration.

Adults and adolescents (13to 17years of age)

Reconstitution:

Reconstitute the contents of the 1g vial of INVANZ with 10ml of water for injection or 9mg/ml (0.9%) sodium chloride solution to obtain a reconstituted solution of approximately 100mg/ml. Shake well to dissolve.

Dilution

For a 50ml diluent bag:For a dose of 1g, transfer the contents of the reconstituted vial immediately to a 50ml bag of 9mg/ml (0.9%) sodium chloride solution; or

For a 50ml diluent vial:For a dose of 1g, remove 10ml from a 50ml vial of 9mg/ml (0.9%) sodium chloride solution and discard. Transfer the contents of the 1g vial of INVANZ reconstituted to the 50ml vial of 9mg/ml (0.9%) sodium chloride solution.

Infusion

Infuse over a period of 30minutes.

Children (3months to 12years of age)

Reconstitution

Reconstitute the contents of the 1g vial of INVANZ with 10ml of water for injection or 9mg/ml (0.9%) sodium chloride solution to obtain a reconstituted solution of approximately 100mg/ml. Shake well to dissolve.

Dilution

For a diluent bag: transfer a volume equivalent to 15mg/kg of body weight (not to exceed 1g/day) to a bag of 9mg/ml (0.9%) sodium chloride solution, to a final concentration of 20mg/ml or less; or

For a diluent vial: transfer a volume equivalent to 15mg/kg of body weight (not to exceed 1g/day) to a vial of 9mg/ml (0.9%) sodium chloride solution, to a final concentration of 20mg/ml or less.

Infusion

Infuse over a period of 30minutes.

The reconstituted solution must be diluted in 9mg/ml (0.9%) sodium chloride solution immediately after preparation. The diluted solutions must be used immediately. If not used immediately, the storage times in use are the responsibility of the user. The diluted solutions (approximately 20mg/mlof ertapenem) are physically and chemically stable for 6hours at room temperature (25°C) or for 24hours between 2and8°C (in refrigerator). Once removed from the refrigerator, the solutions must be used within the 4hours that follow. Do not freeze the reconstituted solutions.

Whenever the container permits, the reconstituted solutions must be visually inspected before administration for the presence of particles or discoloration. The INVANZ solutions vary from colorless to pale yellow. A variation in color within this range does not affect efficacy.

The disposal of unused medicinal product and of all materials that have been in contact with it, must be in accordance with local requirements.