Ertapenem Steriscience

Package leaflet: Information for the user

Ertapenem Steriscience 1 g powder for concentrate for solution for infusion

ertapenem
Generic medicine
Read this leaflet carefully before you take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Ertapenem Steriscience is and what it is used for

Ertapenem Steriscience contains ertapenem, which is an antibiotic belonging to the beta-lactam group. It is effective against a wide range of bacteria (microorganisms) that cause infections in various parts of the body.
Ertapenem Steriscience can be administered to individuals aged 3 months and older.
Treatment:
Your doctor has prescribed Ertapenem Steriscience for you or for the child to treat one (or more) of the following types of infection:

• Abdominal infections
• Lung infection (pneumonia)
• Gynecological infections
• Foot skin infections in diabetic patients

Prevention:

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

2. What you need to know before using Ertapenem Steriscience

Do not use Ertapenem Steriscience

• 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 (which are used to treat various types of infections).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ertapenem Steriscience.
During treatment, if 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 require
urgent medical treatment.
While antibiotics, including Ertapenem Steriscience, are effective against certain bacteria, other
bacteria and fungi may grow more than usual. This phenomenon is called overgrowth. Your doctor will
monitor you for overgrowth and treat you if necessary.
It is important that you inform your doctor if you develop diarrhoea before, during, or after treatment
with Ertapenem Steriscience. This is because you may have a condition known as colitis (an inflammation
of the intestine). Do not use any medicine to treat diarrhoea without first consulting your doctor.
Inform your doctor if you are taking medicines containing valproic acid or sodium valproate (see below
Other medicines and Ertapenem Steriscience).
Inform your doctor about any medical conditions you currently have or have had in the past, including:

• Kidney disease. It is very important that your doctor knows if you have kidney disease and if you are undergoing dialysis treatment.
• Allergies to any medicines, including antibiotics.
• Disorders of the central nervous system, such as localized tremors or seizures.

Children and adolescents (aged between 3 months and 17 years)
Experience with Ertapenem Steriscience is limited in children under two years of age. In this age group,
the doctor must decide whether the potential benefit of using the medicine outweighs the risks. There is
no experience with children under 3 months of age.

Other medicines and Ertapenem Steriscience
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Inform your doctor, nurse, or pharmacist if you are taking medicines containing valproic acid or
sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia). This is because
Ertapenem Steriscience may affect the way some other medicines work. Your doctor will decide whether
you should use Ertapenem Steriscience together with these other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult
your doctor before taking this medicine.
Ertapenem Steriscience has not been studied in pregnant women. Ertapenem Steriscience should not
be used during pregnancy unless your doctor decides that the potential benefits justify the possible risks
to the fetus.
Women being treated with Ertapenem Steriscience should not breastfeed, as the medicine has been
detected in breast milk and the infant could therefore be affected.

Driving and using machines
Do not drive or operate machinery until you know how this medicine affects you.
When using Ertapenem Steriscience, certain side effects such as dizziness and drowsiness have been
reported; in some patients, these effects may impair the ability to drive or operate machinery.

Ertapenem Steriscience contains sodium
This medicine contains approximately 137 mg of sodium (a key component of table salt) per vial. This
amount is equivalent to 6.85% of the maximum daily dietary intake recommended for an adult.

3. How to use Ertapenem Steriscience

Ertapenem Steriscience must always be prepared and administered intravenously (into a vein) by a doctor or another healthcare professional.
The recommended dose of Ertapenem Steriscience for adults and adolescents aged 13 years and older is 1 gram (g) once daily. The recommended dose for children from 3 months to 12 years of age is 15 mg/kg administered twice daily (not exceeding 1 g per day). Your doctor will decide the necessary duration of treatment.
The recommended dose of Ertapenem Steriscience for the prevention of surgical site infections following colorectal surgery is 1 g administered as a single intravenous dose 1 hour before surgical incision.
It is very important to continue using Ertapenem Steriscience for the entire period prescribed by your doctor.
If you use more Ertapenem Steriscience than you should
If you think you have used too much Ertapenem Steriscience, contact your doctor or a healthcare professional immediately.
If you forget to use Ertapenem Steriscience
If you think you have missed a dose, contact your doctor or a healthcare professional immediately.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Adults from 18 years onwards:
Since the medicine was placed on the market, serious allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions including rash, fever, abnormal blood tests) have been reported. Early signs of a serious allergic reaction may include swelling of the face and/or throat. If these symptoms occur, inform your doctor immediately, as you may require urgent medical treatment.
Common side effects (may affect up to 1 in 10 people) are:

• Headache
• Diarrhoea, nausea, vomiting
• Rash, itching
• Problems at the vein where the medicine was injected (including inflammation, swelling, injection site swelling, fluid leakage into the tissues and skin around the injection site)
• Increased platelet count
• Changes in liver function tests

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

• Dizziness, drowsiness, insomnia, confusion, convulsions
• Low blood pressure, slowed heart rate
• Shortness of breath, sore throat
• Constipation, fungal 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, altered taste
• Changes in certain blood and urine laboratory tests

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

• Decreased white blood cells, decreased platelets
• Low blood sugar levels
• Agitation, anxiety, depression, tremor
• Irregular heartbeat, increased blood pressure, bleeding, rapid heartbeat
• Nasal congestion, cough, nosebleeds, pneumonia, abnormal breathing sounds, wheezing
• Gallbladder inflammation, difficulty swallowing, faecal incontinence, yellowing of the skin and mucous membranes, liver disorders
• Skin inflammation, fungal skin infection, skin peeling, surgical wound infection
• Muscle cramps, shoulder pain
• Urinary tract infections, kidney dysfunction
• Abortion, genital bleeding
• Allergic reaction, malaise, pelvic peritonitis, changes in the white part of the eye, fainting
• The skin may become hard at the injection site
• Swelling of blood vessels in the skin

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

• Hallucinations
• Reduced consciousness
• Altered mental state (including aggression, delirium, disorientation, changes in mental status)
• Abnormal movements
• Muscle weakness
• Unsteady gait
• Discoloration of teeth

Changes in blood tests have also been reported.
Inform your doctor or nurse immediately if you develop raised or fluid-filled skin lesions over a large area of the body.
Children and adolescents (from 3 months to 17 years):
Common side effects (may affect up to 1 in 10 people) are:

• Diarrhoea
• 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
• Hot flushes, high blood pressure, flat, pinpoint red or red-purple spots under the skin
• Change in stool colour, black stools
• Skin redness, rash
• Burning, itching, redness and warmth at the infusion site, redness at the injection site
• Increased platelet count in blood tests
• Changes in certain laboratory blood tests

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

• Hallucinations
• Altered mental state (including aggression)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ertapenem Steriscience 1 g powder for concentrate for solution for

infusion
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and the outer packaging following EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
After reconstitution/dilution:
Diluted solutions must be used immediately. If not used immediately, the storage times during use are the responsibility of the user. Diluted solutions (approximately 20 mg ertapenem/mL) are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours between 2°C and 8°C (refrigerated). Solutions must be used within 4 hours after removal from the refrigerator. Do not freeze Ertapenem Steriscience solutions.

6. Package Contents and Other Information

What Ertapenem Steriscience Contains

• The active substance is ertapenem. Each vial contains: 1.0 g of ertapenem (as ertapenem sodium).
• The other components are: sodium bicarbonate (E500) and sodium hydroxide (E524) (to adjust pH).

Description of the Appearance of Ertapenem Steriscience and Package Contents

Ertapenem Steriscience is a lyophilized powder or cake, white to pale yellow in colour. Solutions of Ertapenem Steriscience range from colourless to pale yellow. Colour variations within this range do not affect the potency of the drug.
Ertapenem Steriscience is supplied in packages containing either 1 vial or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Steriscience B.V.
Kingsfordweg 151,
1043GR Amsterdam,
The Netherlands

Manufacturer:
Pharma Revolta s.r.o.
Rybne Namestie 1,
81102 Stare Mesto Bratislava
Slovakia

The following information is intended exclusively for physicians and healthcare professionals:

Instructions for Reconstituting and Diluting Ertapenem Steriscience 1 g Powder for Concentrate for Solution for Infusion:
For single use only.

Preparation for Intravenous Administration:
Ertapenem Steriscience 1 g powder for concentrate for solution for infusion must be reconstituted and subsequently diluted before administration.

Adults and Adolescents (13 to 17 years of age)

Reconstitution
Reconstitute the contents of one 1 g Ertapenem Steriscience vial with 10 mL of water for injections or with 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 infusion bag: Immediately transfer the entire contents of the reconstituted vial into a 50 mL bag containing 9 mg/mL (0.9%) sodium chloride solution for a 1 g dose;
or,
For a 50 mL diluent vial: Remove and discard 10 mL from a 50 mL vial of 9 mg/mL (0.9%) sodium chloride solution. Then transfer the entire contents of the reconstituted 1 g Ertapenem Steriscience vial into the 50 mL vial of 9 mg/mL (0.9%) sodium chloride solution.

Infusion
Administer the infusion over 30 minutes.

Children (3 months to 12 years of age)

Reconstitution
Reconstitute the contents of one 1 g Ertapenem Steriscience vial with 10 mL of water for injections or with 9 mg/mL (0.9%) sodium chloride solution to obtain a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve.

Dilution
For an infusion bag: Transfer a volume corresponding to 15 mg/kg body weight (not exceeding 1 g/day) into an infusion bag containing 9 mg/mL (0.9%) sodium chloride solution, to achieve a final concentration of 20 mg/mL or less;
or,
For a diluent vial: Transfer a volume corresponding to 15 mg/kg body weight (not exceeding 1 g/day) into a vial containing 9 mg/mL (0.9%) sodium chloride solution, to achieve a final concentration of 20 mg/mL or less.

Infusion
Infuse over 30 minutes.

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

Reconstituted solutions should be inspected visually before administration for the presence of particulate matter or discoloration, whenever the container allows. Solutions of Ertapenem Steriscience range from colourless to pale yellow. Colour variations within this range do not affect the potency.

Any unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.

Incompatibilities:
Do not use solvents or infusion fluids containing dextrose to reconstitute or administer ertapenem.