INVANZ 1 g POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use INVANZ

Do not useINVANZ

• if you are allergic to the active substance (ertapenem) or to 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 precautions

Consult your doctor, pharmacist, or nurse before starting treatment with INVANZ.

If during treatment you experience an allergic reaction (such as swelling of the face, tongue, or throat, difficulty breathing or swallowing, skin rash), 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 normal. This is called bacterial overgrowth. Your doctor will monitor bacterial overgrowth and treat it if necessary.

It is essential that you inform your doctor if you have diarrhea before, during, or after your treatment with INVANZ. This is because you may be suffering from a disease 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 below Use of INVANZ with other medicines).

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

• Kidney disease. It is especially important that your doctor knows 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 convulsions.

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

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 medicines and INVANZ

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

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 medicines work. Your doctor will decide if INVANZ should be used in combination with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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

Driving and using machines

Do not drive or use any tools or machines until you know how the medicine affects you.

Certain side effects have been reported with INVANZ, such as dizziness and somnolence, which may affect patients' ability to drive or use machines.

INVANZ contains sodium

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

3. How to use INVANZ

INVANZ will always be prepared and administered intravenously (in a vein) by a doctor or other healthcare professional.

The recommended dose of INVANZ for adults and adolescents aged 13 years and older is 1 gram (g) administered once a day. The recommended dose for children aged 3 months to 12 years is 15 mg/kg, administered twice a day (not exceeding 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 duration 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 forget to use INVANZ

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

4. Possible side effects

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

Adults aged 18years and older:

Since the drug was marketed, serious 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.

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

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

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

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

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

• Decrease in white blood cells, decrease in platelet count
• Low blood sugar
• Irritation, anxiety, depression, tremor
• Irregular heart rate, increased blood pressure, bleeding, rapid heart rate
• Nasal congestion, cough, nosebleed, pneumonia, unusual breathing sounds and wheezing
• Gallbladder inflammation, difficulty swallowing, fecal incontinence, yellowing of the skin (jaundice), liver disorder
• Skin inflammation, fungal skin infection, skin peeling, surgical wound infection
• Muscle cramps, shoulder pain
• Urinary tract infection, kidney failure
• Abortion, genital bleeding
• Allergy, discomfort, pelvic peritonitis, changes in the white part of the eye, fainting.
• The skin may become hardened at the injection site
• Swelling of the blood vessels in the skin

Side effects with unknown frequency (cannot be estimated from the 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
• Discolored teeth

Changes in some parameters measured in blood tests have also been reported.

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

Children and adolescents (from 3monthsto17years of age):

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

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

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

• Headache
• Flushing, high blood pressure, small, smooth, red or purple spots under the skin
• Discolored stools, black tarry stools
• Redness of the skin, skin rash
• Itching, burning, redness, and warmth at the infusion site, redness at the injection site
• Increased platelet count
• Changes in some blood tests

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

• Hallucinations
• Altered mental state (including aggression)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of INVANZ

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

Do not use this medicine after the expiry date which is stated on the carton.

The first two numbers indicate the month; the next four numbers indicate the year.

Do not store above 25°C.

6. Container contents and additional information

Composition ofINVANZ

• The active ingredient is ertapenem 1 g.
• The other components are: sodium bicarbonate (E-500) and sodium hydroxide (E-524).

Appearance of the product and container contents

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

The solutions of INVANZ range from colorless to pale yellow. Color variations within this range do not affect efficacy.

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

Only some pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Manufacturer

FAREVA Mirabel

Route de Marsat, Riom

63963 Clermont-Ferrand Cedex 9

France

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

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

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

Instructions for reconstitution and dilution of INVANZ:

For single use.

Preparation for intravenous administration:

INVANZ must be reconstituted and then diluted before administration.

Adults and adolescents (13 to 17 years of age)

Reconstitution:

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

Dilution

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

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

Infusion

Infuse over a period of 30 minutes.

Children (3 months to 12 years of age)

Reconstitution

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

Dilution

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

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

Infusion

Infuse over a period of 30 minutes.

The reconstituted solution must be diluted in 9 mg/ml (0.9%) sodium chloride solution immediately after preparation. The diluted solutions should be used immediately. If not used immediately, the in-use storage times are the responsibility of the user. The diluted solutions (approximately 20 mg/ml of ertapenem) are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours between 2 and 8°C (in the refrigerator). Once removed from the refrigerator, the solutions should be used within 4 hours. Do not freeze the reconstituted solutions.

Whenever possible, the reconstituted solutions should be inspected visually for particulate matter or discoloration prior to administration. The solutions of INVANZ range from colorless to pale yellow. A color variation within this range does not affect efficacy.

Disposal of unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.