INVANZ 1g powder for concentrate for solution for infusion

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What INVANZ is and what it is used for
2. What you need to know before you are given INVANZ
3. How to use INVANZ
4. Possible side effects
5. How to store INVANZ
6. Contents of the pack and other information

Do not use INVANZ

• 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 (which are used to treat various infections).

Warnings and precautions

Talk to your doctor, nurse or pharmacist before taking INVANZ.

During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), tell your doctor straight away as you may need urgent medical treatment.

While antibiotics including INVANZ kill certain bacteria, other bacteria and fungi may continue to grow more than normal. This is called overgrowth. Your doctor will monitor you for overgrowth and treat you if necessary.

It is important that you tell your doctor if you have diarrhoea before, during or after your treatment with INVANZ. This is because you may have a condition known as colitis (an inflammation of the bowel). Do not take any medicine to treat diarrhoea without first checking with your doctor.

Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Other medicines and INVANZ below).

Tell your doctor about any medical condition you have or have had including:

• Kidney disease. It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.
• Allergies to any medicines, including antibiotics.
• Central nervous system disorders, such as localised tremors, or seizures.

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

Experience with INVANZ is limited in children less than two years of age. In this age group your doctor will decide on the potential benefit of its use. There is no experience in children under 3 months of age.

Other medicines and INVANZ

Always tell your doctor about all medicines that you are taking or plan to take, including those obtained without a prescription.

Tell your doctor, nurse or pharmacist if you are taking medicines called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). This is because INVANZ can affect the way some other medicines work. Your doctor will decide whether you should use INVANZ in combination with these other medicines.

Pregnancy and breast-feeding

It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving INVANZ.

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

It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving INVANZ.

Women who are receiving INVANZ should not breast-feed, because it has been found in human milk and the breast-fed baby may therefore be affected.

Driving and using machines

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

Certain side effects, such as dizziness and sleepiness, have been reported with INVANZ, which may affect some patients’ ability to drive or operate machinery.

INVANZ contains sodium

This medicine contains approximately 6.0 mEq (approximately 137 mg) of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.

If you are given more INVANZ than you should

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

If you miss a dose of INVANZ

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

Adults 18 years of age and older:

Since the drug has been marketed, severe allergic reactions (anaphylaxis), hypersensitivity syndromes (allergic reactions including 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 occur tell your doctor straight away as you may need urgent medical treatment.

The most common (more than 1 in 100 patients and less than 1 in 10 patients) side effects are:

• Headache
• Diarrhoea, nausea, vomiting
• Rash, itching
• Problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site, or leaking of fluid into the tissue and skin around the injection site)
• Increase in platelet count
• Changes in liver function tests

Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) side effects are:

• Dizziness, sleepiness, sleeplessness, confusion, seizure
• Low blood pressure, slow heart rate
• Shortness of breath, sore throat
• Constipation, yeast infection of the mouth, antibiotic-associated diarrhoea, acid regurgitation, dry mouth, indigestion, loss of appetite
• Skin redness
• Vaginal discharge and irritation
• Abdominal pain, fatigue, fungal infection, fever, oedema/swelling, chest pain, abnormal taste
• Changes in some laboratory blood and urine tests

Side effects reported rarely (more than 1 in 10,000 patients and less than 1 in 1,000 patients) are:

• Decrease in white blood cells, decrease in blood platelet count
• Low blood sugar
• Agitation, anxiety, depression, tremor
• Irregular heart rate, increased blood pressure, bleeding, fast heart rate
• Nasal congestion, cough, bleeding from the nose, pneumonia, abnormal breathing sounds, wheezing
• Inflammation of the gall bladder, difficulty in swallowing, faecal incontinence, jaundice, liver disorder
• Inflammation of the skin, fungal infection of the skin, skin peeling, infection of the wound after an operation
• Muscle cramp, shoulder pain
• Urinary tract infection, kidney impairment
• Miscarriage, genital bleeding
• Allergy, feeling unwell, pelvic peritonitis, changes to the white part of the eye, fainting.

Side effects reported (frequency not known) since the drug has been marketed are:

• hallucinations
• decreased consciousness
• altered mental status (including aggression, delirium, disorientation, mental status changes)
• abnormal movements
• muscle weakness
• unsteady walking
• teeth staining

There have also been reports of changes in some laboratory blood tests.

If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.

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

The most common (more than 1 in 100 patients and less than 1 in 10 patients) side effects are:

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

Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) side effects are:

• Headache
• Hot flush, high blood pressure, red or purple, flat, pinhead spots under the skin
• Discoloured faeces, black tar-like faeces
• Skin redness, skin rash
• Burning, itching, redness and warmth at infusion site, redness at injection site
• Increase in platelet count
• Changes in some laboratory blood tests

Side effects reported (frequency not known) since the drug has been marketed are:

• Hallucinations
• Altered mental status (including aggression)

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What INVANZ contains

The active ingredient of INVANZ is ertapenem 1g.

The other ingredients are: sodium bicarbonate (E500) and sodium hydroxide (E524).

What INVANZ looks like and contents of the pack

INVANZ is a white to off-white, freeze-dried powder for concentrate for solution for infusion.

Solutions of INVANZ range from colourless to pale yellow. Variations of colour within this range do not affect potency.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: