ERTAPENEM 1 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

1. what ertapenem is and what it is used for

This medicine contains ertapenem (as ertapenem sodium) which is an antibiotic of the beta-lactam group. It has the ability to kill a wide range of bacteria (germs) that cause infections in various parts of the body.

Ertapenem can be given to persons 3 months of age and older.

Treatment:

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

• Infection in the abdomen
• Infection affecting the lungs (pneumonia)
• Gynaecological infections
• Skin infections of the foot in diabetic patients.

Prevention:

• Prevention of surgical site infections in adults following surgery of the colon or rectum.

2. what you need to know before you are given ertapenem

Do not use Ertapenem

• 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 Ertapenem.

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 Ertapenem 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 Ertapenem. 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 Ertapenem 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 Ertapenem 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 ofage.

Other medicines and Ertapenem

Tell your doctor if you are taking, have recently taken or might take any other medicines, 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 Ertapenem can affect the way some other medicines work. Your doctor will decide whether you should use Ertapenem in combination with these other medicines.

Pregnancy and breast-feeding

It is important that you tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

Women who are receiving Ertapenem 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 Ertapenem, which may affect some patients’ ability to drive or operate machinery.

Ertapenem contains sodium

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

3. how to use ertapenem

Ertapenem will always be prepared and given to you intravenously (into a vein) by a doctor or another healthcare professional.

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

For prevention of surgical site infections following surgery of the colon or rectum, the recommended dose of Ertapenem is 1g administered as a single intravenous dose 1 hour before surgery.

It is very important that you continue to receive Ertapenem for as long as your doctor prescribes it.

If you are given more Ertapenem than you should

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

If you miss a dose of Ertapenem

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.

The following information is intended for healthcare professionals only:

Instructions of how to reconstitute and dilute Ertapenem:

For single use only.

Preparation for intravenous administration:

Ertapenem must be reconstituted and then diluted prior to administration.

Adult and adolescents (13 to 17 years of age)

Reconstitution

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

Dilution

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

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

Infusion

Infuse over a period of 30 minutes.

Children (3 months to 12 years of age)

Reconstitution

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

Aspire

1010418-P3.1 PHARMA

L164GBERTA100

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.

Common (may affect up to 1 in 10 people) 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

Uncommon (may affect up to 1 in 100 people) 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

Rare (may affect up to 1 in 1,000 people) side effects 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, bleedingfrom 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
• The skin may become hard at the site of injection
• Swelling ofthe skin blood vessels

Not known (frequency cannot be estimated from the available data) side effects 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):

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

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

Uncommon (may affect up to 1 in 100 people) 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

Not known ( frequency cannot be estimated from the available data) side effects are:

• Hallucinations
• Altered mental status (including aggression)

5. how to store ertapenem

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 vial label and carton. The first 2 numbers indicate the month; the next 4 numbers indicate the year. The expiry date refers to the last day of that month.

Do not store above 25°C and store in original package.

After reconstitution: Reconstituted solutions should be used immediately.

After dilution: Chemical and physical in-use stability for diluted solutions (approximately 20mg/ml ertapenem) has been demonstrated for 6 hours at 25°C or for 24 hours at 2 to 8°C (in a refrigerator). Solutions should be used within 4 hours of their removal from the refrigerator.

Do not freeze solutions of ertapenem.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/di­lution (etc.) has taken place in controlled and validated aseptic conditions.

If only part of a vial is used, the remainder should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Ertapenem contains

The active ingredient of this medicine is ertapenem sodium.

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

What Ertapenem looks like and contents of the pack

Ertapenem is a white to yellowish, freeze-dried powder for concentrate for solution for infusion. Solutions of Ertapenem range from colourless to pale yellow. Variations of colour within this range do not affect potency.

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

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aspire Pharma Ltd

Unit 4, Rotherbrook Court, Bedford Rd, Petersfield

Hampshire, GU32 3QG, United Kingdom

Manufacturer

ACS Dobfar S.p.A

Nucleo Industriale S. Atto, S. Nicolo a Tordino

64100, Teramo

Italy

This leaflet was last revised

in 09/2021

Aspire

1010418-P3.1 PHARMA

L164GBERTA100

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.

Common (may affect up to 1 in 10 people) 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

Uncommon (may affect up to 1 in 100 people) 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

Rare (may affect up to 1 in 1,000 people) side effects 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, bleedingfrom 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
• The skin may become hard at the site of injection
• Swelling ofthe skin blood vessels

Not known (frequency cannot be estimated from the available data) side effects 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):

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

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

Uncommon (may affect up to 1 in 100 people) 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

Not known ( frequency cannot be estimated from the available data) side effects are:

• Hallucinations
• Altered mental status (including aggression)