Ertapenem Qilu

Package leaflet: Information for the user

Ertapenem Qilu 1 g powder for concentrate for solution for infusion

ertapenem
Generic medicine
Please read this leaflet carefully before taking 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 you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Ertapenem Qilu contains ertapenem, which is an antibiotic belonging to the beta-lactam group. It is effective against a wide spectrum of bacteria (microorganisms) that cause infections in various parts of the body.
This medicine can be administered to individuals aged 3 months and older.

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

• Abdominal infections
• Lung infection (pneumonia)
• Gynaecological infections
• Diabetic foot skin infections

Prevention:

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

2. What you need to know before using Ertapenem Qilu

Do not use Ertapenem Qilu

• if you are allergic to 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, nurse or pharmacist before taking Ertapenem Qilu.
During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat,
difficulty breathing or swallowing, rash), inform your doctor immediately, as you may require urgent
medical treatment.
While antibiotics, including Ertapenem Qilu, are effective against certain bacteria, other bacteria and
fungi may grow more than usual. This is known as overgrowth. Your doctor will monitor you for signs of
overgrowth and treat you if necessary.
It is important that you inform your doctor if you have diarrhoea before, during or after treatment with
Ertapenem Qilu. This is because you may have a condition known as colitis (inflammation of the
intestine). Do not take any medicine for 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 Qilu).
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 Qilu is limited in children under two years of age. In this age group, the doctor will decide whether the potential benefit of using the medicine outweighs the risks. There is no experience with Ertapenem Qilu in children under 3 months of age.

Other medicines and Ertapenem Qilu
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 Qilu may affect the way some other medicines work. Your doctor will decide whether Ertapenem Qilu should be used together with these other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
The effect of this medicine has not been studied in pregnant women. Ertapenem Qilu 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 Qilu must not breastfeed because the drug has been found in breast milk and the infant could be affected.

Driving and using machines
Do not drive or operate machinery until you know how this medicine affects you.
With the use of Ertapenem Qilu, certain side effects such as dizziness and somnolence have been reported. In some patients, these effects may impair the ability to drive or operate machinery.

Ertapenem Qilu contains sodium
This medicine contains approximately 137 mg of sodium (a component of table salt) per 1.0 g dose. This corresponds to 6.85% of the maximum daily dietary intake recommended for an adult.

3. How to use Ertapenem Qilu

This medicine will always be prepared and administered intravenously (into a vein) by a doctor or other healthcare professional.
The recommended dose of this medicine for adults and adolescents aged 13 years and older is 1 g (gram) once daily.
Use in children
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).
The doctor will decide the necessary duration of treatment.
The recommended dose of this medicine for the prevention of surgical site infections after surgery on the colon or rectum is 1 g administered as a single intravenous dose 1 hour before surgical incision.
If you use more Ertapenem Qilu than you should
If you think you have used too much of this medicine, contact your doctor or a healthcare professional immediately.
If you forget to use Ertapenem Qilu
If you think you have missed a dose, contact your doctor or a healthcare professional immediately.
If you stop treatment with Ertapenem Qilu
It is very important to continue using Ertapenem Qilu for the entire duration prescribed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Adults aged 18 years and older:
Since this medicine has been marketed, serious allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions including skin 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 (may affect up to 1 in 10 people):

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

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

• Dizziness, drowsiness, insomnia, confusion, epileptic seizures
• Low blood pressure, slowed heart rate
• Shortness of breath, sore throat
• Constipation, fungal infection of the mouth, antibiotic-associated diarrhoea, acid regurgitation, dry mouth, digestive problems, 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 (may affect up to 1 in 1,000 people):

• Decrease in white blood cells, decrease in platelet count
• 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
• Inflammation of the gallbladder, difficulty swallowing, faecal incontinence, yellowing of the skin and mucous membranes (jaundice), liver disorders
• Skin inflammation, fungal skin infection, skin peeling, infection of surgical wounds
• Muscle cramps, shoulder pain
• Urinary tract infections, kidney dysfunction
• Abortion, genital bleeding
• Allergic reactions, 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

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

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

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 wide area of the body.

Children and adolescents (from 3 months to 17 years of age):
Common (may affect up to 1 in 10 people):

• Diarrhoea
• Diaper dermatitis
• 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):

• 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 blood laboratory tests

Side effects reported with not known frequency (frequency cannot be estimated from the available data):

• Hallucinations
• Altered mental state (including aggression)

Reporting of side effects
If you get any side effects, including ones 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 Qilu

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the
vial after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C.
After reconstitution:
Reconstituted solutions must be used immediately.
After dilution:
Chemical and physical in-use stability of diluted solutions (approximately 1 mg/mL and 20 mg/mL) has been demonstrated for 6 hours at 25 °C or for 24 hours at 2-8 °C (refrigerated). Solutions must be used within 4 hours after removal from the refrigerator. Do not freeze Ertapenem Qilu solutions.
From a microbiological standpoint, unless the reconstitution and dilution methods exclude the risk of microbial contamination, the product should be used immediately. If not used immediately, the times and conditions of storage during use are the responsibility of the user.

6. Package contents and other information

What Ertapenem Qilu contains
The active substance is ertapenem. Each Ertapenem Qilu 1 g powder for concentrate for solution for
infusion contains 1 g of ertapenem.
The other excipients are: sodium bicarbonate (for pH adjustment) and sodium hydroxide (for pH
adjustment).
Description of the appearance of Ertapenem Qilu and contents of the pack
Ertapenem Qilu is a white to off-white lyophilized powder for concentrate for solution for infusion.
Solutions of Ertapenem Qilu range from colourless to pale yellow. Colour variations within this range do not affect the potency of the medicinal product.
Ertapenem Qilu is supplied in packs of 1 vial or 10 vials.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
QILU PHARMA SPAIN S.L.
Paseo de la Castellana 40, planta 8,
28046 Madrid,
Spain
Manufacturer
KYMOS, S.L.
Ronda de Can Fatjó,
7B (Parque Tecnológico del Vallès)
Cerdanyola del Vallès,
Barcelona, 08290
Spain
Eurofins Analytical Services Hungary Kft
Anonymus utca 6.,
Budapest, H-1045
Hungary
This medicinal product is authorised in the European Economic Area Member States
under the following names:

The following information is intended exclusively for healthcare professionals:

Instructions for reconstituting and diluting Ertapenem Qilu:
For single use only.
Preparation for intravenous administration:
Ertapenem Qilu 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 vial of Ertapenem Qilu with 10 mL of Water for Injections or with 9 mg/mL (0.9%) Sodium Chloride Injection solution to obtain a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve.
Dilution
For a 50 mL diluent bag: For a 1 g dose, immediately transfer the contents of the reconstituted vial into a 50 mL bag of 9 mg/mL (0.9%) Sodium Chloride Injection solution; or,
For a 50 mL diluent vial: For a 1 g dose, withdraw and discard 10 mL from a 50 mL vial of 9 mg/mL (0.9%) Sodium Chloride Injection solution. Transfer the entire contents of the reconstituted 1 g Ertapenem Qilu vial into the 50 mL vial of 9 mg/mL (0.9%) Sodium Chloride Injection solution.
Infusion
Administer by infusion over 30 minutes.
Children (3 months to 12 years of age)
Reconstitution
Reconstitute the contents of one 1 g vial of Ertapenem Qilu with 10 mL of Water for Injections or with 9 mg/mL (0.9%) Sodium Chloride Injection solution to obtain a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve.
Dilution
For a diluent bag: Transfer a volume corresponding to 15 mg/kg body weight (not exceeding 1 g/day) into a bag containing 9 mg/mL (0.9%) Sodium Chloride Injection 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 Injection solution to achieve a final concentration of 20 mg/mL or less.
Infusion
Infuse over 30 minutes.
The reconstituted solution must be diluted in 9 mg/mL (0.9%) Sodium Chloride solution immediately after preparation. Diluted solutions must be used immediately. For the shelf life after reconstitution and dilution, see section 5.
Reconstituted solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever the container allows. Ertapenem Qilu solutions range from colorless to pale yellow. Color variations within these limits do not affect potency.
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.