Patient leaflet - Ertapenem Qilu 1 g powder for concentrate for solution for infusion
1. What Ertapenem Qilu is and what it is used for
Ertapenem Qilu contains ertapenem 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.
This medicine can be given to persons 3 months of age and older.
Treatment:
Your doctor has prescribed Ertapenem Qilu 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 use Ertapenem Qilu
Do not use Ertapenem Qilu
- if you are allergic to 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 using Ertapenem Qilu.
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 Qilu. 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 Qilu”).
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 (fits).
Children and adolescents (3 months to 17 years of age)
Experience with Ertapenem Qilu 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 Ertapenem Qilu
Tell your doctor if you are taking, have recently taken or might take any other medicines.
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 Qilu can affect the way some other medicines work. Your doctor will decide whether you should use Ertapenem Qilu in combination with these other medicines.
Pregnancy and breast-feeding
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.
This medicine effect has not been studied in pregnant women. Ertapenem Qilu should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the foetus.
Women who are receiving this medicine 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 Qilu contains sodium
This medicine contains approximately 137 mg sodium (main component of cooking / table salt) in each 1 g dose. This is equivalent to 6.85 % of the recommended maximum daily dietary intake of sodium for an adult.
3. How to use Ertapenem Qilu
This medicine will always be prepared and given to you intravenously (into a vein) by a doctor or another healthcare professional.
The recommended dose of this medicine for adults and adolescents 13 years of age and older is 1 g (gram) given once a day.
Use in children
The recommended dose for children 3 months to 12 years of age is 15 mg/kg given twice daily (not to exceed 1 g per 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 this medicine is 1 g administered as a single intravenous dose 1 hour before surgery.
If you use more Ertapenem Qilu than you should
If you are concerned that you may have been given too much of this medicine, contact your doctor or another healthcare professional immediately.
If you forgot to use Ertapenem Qilu
If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.
If you stop using Ertapenem Qilu
It is very important that you continue to receive Ertapenem Qilu for as long as your doctor prescribes it.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adults 18 years of age and older:
Since this medicine 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)
- 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)
- 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)
- 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.
- the skin may become hard at the site of injection
- swelling of the skin blood vessels
Not known: frequency cannot be estimated from the available data
- 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)
- 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)
- 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
- 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.
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 which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
After reconstitution:
Reconstituted solutions should be used immediately.
After dilution:
Chemical and physical in-use stability of diluted solutions (approximately 1 mg/ml and 20 mg/ml) have 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 Qilu.
From a microbiological point of view, unless the method of reconstitution and dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6. Contents of the pack 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 ertapenem.
The other ingredients are: sodium hydrogen carbonate (for pH adjustment) and sodium hydroxide (for pH adjustment).
What Ertapenem Qilu looks like and contents of the pack
Ertapenem Qilu is a white to off-white, powder for concentrate for solution for infusion. Solutions of Ertapenem Qilu range from colourless to pale yellow. Variations of colour within this range do not affect potency.
Ertapenem Qilu is supplied in packs of 1 vial or 10 vials.
Not all pack sizes may be marketed.
The following information is intended for medical or healthcare professionals only:
Instructions of how to reconstitute and dilute Ertapenem Qilu:
For single use only.
Preparation for intravenous administration:
Ertapenem Qilu must be reconstituted and then diluted prior to administration.
Adult and adolescents (13 to 17 years of age)
Reconstitution
Reconstitute the contents of a 1 g vial of Ertapenem Qilu with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution for injection to yield a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve.
Dilution
For a 50 mL bag of diluent: For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 mL bag of sodium chloride 9 mg/mL (0.9 %) solution for injection; or
For a 50 mL vial of diluent: For a 1 g dose, withdraw 10 mL from a 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution for injection and discard. Transfer the contents of the reconstituted 1 g vial of Ertapenem Qilu to the 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Infusion
Infuse over a period of 30 minutes.
Children (3 months to 12 years of age)
Reconstitution
Reconstitute the contents of a 1 g vial of Ertapenem Qilu with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution for injection to yield a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve.
7mm
4.5mm 23.4mm
PN-07753 / UK-Ertapenem 1mg PIL_390x560mm_9pt_Rev.01_04.06.24 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, 08290, Barcelona,
Spain
This leaflet was last revised in 05/2024.
Dilution
For a bag of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a bag of sodium chloride 9 mg/mL (0.9 %) solution for injection for a final concentration of 20 mg/mL or less; or
For a vial of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a vial of sodium chloride 9 mg/mL (0.9 %) solution for injection for a final concentration of 20 mg/mL or less.
Infusion
Infuse over a period of 30 minutes.
The reconstituted solution should be diluted in sodium chloride 9 mg/mL (0.9 %) solution immediately after preparation. Diluted solutions should be used immediately. For Shelf-life after reconstitution and dilution: see section 5.
The reconstituted solutions should be inspected visually for particulate matter and discolouration prior to administration, whenever the container permits. Solutions of Ertapenem Qilu range from colourless to pale yellow. Variations of colour within this range do not affect potency.
Any unused product or waste material should be disposed of in accordance with local requirements.