Ertapenem Qilu 1 g powder for concentrate for solution for infusion EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Ertapenem Qilu 1g powder for concentrate for solution for infusion EFG
ertapenem
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these adverse effects are not listed in this leaflet. See section 4.
Contents of this leaflet
- What Ertapenem Qilu is and what it is used for
- What you need to know before using Ertapenem Qilu
- How to use Ertapenem Qilu
- Possible side effects
- How to store Ertapenem Qilu
- 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 has the ability to destroy a wide range of bacteria (microorganisms) that cause infections in different parts of the body.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste. |
This medicine can be administered to individuals from 3 months of age onwards.
Treatment:
Your doctor has prescribed Ertapenem Qilu because you or your child have one (or more) of the following types of infection:
- Abdominal infection
- Infection affecting the lungs (pneumonia)
- Gynecological infections
- Skin infections in the foot of diabetic patients
Prevention:
- Prevention of surgical wound infections in adults after colon or rectal surgery.
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 (used to treat various infections).
Warnings and precautions
Talk to your doctor, nurse, or pharmacist before starting to use Ertapenem Qilu.
If during treatment 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.
Although antibiotics, including Ertapenem Qilu, destroy certain bacteria, other bacteria and fungi may continue to grow excessively. This is known as bacterial overgrowth. Your doctor will monitor for bacterial overgrowth and treat you if necessary.
It is important that you inform your doctor if you have diarrhea before, during, or after your treatment with Ertapenem Qilu. This may be due to a condition known as colitis (inflammation of the intestine). Do not take any medication for diarrhea without first consulting your doctor.
Inform your doctor if you are taking medicines called valproic acid or sodium valproate (see below Other medicines and Ertapenem Qilu).
Tell your doctor about any other medical conditions you have or have had, including:
- Kidney disease. It is especially important that your doctor knows if you have kidney disease and if you are receiving dialysis treatment.
- Allergies to any medicines, including antibiotics.
- Disorders of the central nervous system, such as localized tremors or seizures (fits).
Children and adolescents (from 3 months to 17 years of age)
Experience with Ertapenem Qilu in children under two years of age is limited. For this age group, your doctor will decide on the potential benefit of its use. 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 need to take any other medicines.
Tell your doctor, pharmacist, or nurse 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 may affect how other medicines work. Your doctor will decide whether Ertapenem Qilu should be used in combination with these medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using 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 benefit justifies the potential risk to the fetus.
Women receiving Ertapenem Qilu should not breastfeed, as it has been detected in breast milk and may therefore affect the breastfed infant.
Driving and using machines
Do not drive or operate any tools or machinery until you know how this medicine affects you.
Certain adverse effects such as dizziness and somnolence have been reported with Ertapenem Qilu, which may affect patients' ability to drive or use machines.
Ertapenem Qilu contains sodium
This medicine contains approximately 137 mg of sodium (a main component of cooking/table salt) in each 1.0 g dose. This corresponds to 6.85% of the maximum daily recommended sodium intake 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 Ertapenem Qilu for adults and adolescents aged 13 years and older is 1 gram (g) given once daily.
Use in children
The recommended dose for children aged 3 months to 12 years is 15 mg/kg, administered twice daily (without exceeding 1 g per day).
Your doctor will decide how many days of treatment you need.
To prevent surgical site infections following colon or rectal surgery, the recommended dose of this medicine is 1 g given as a single intravenous dose 1 hour before surgery.
If you are given more Ertapenem Qilu than you should
If you are concerned that you may have been given too much medicine, consult your doctor or other healthcare professional immediately.
If you forget to use Ertapenem Qilu
If you are concerned that a dose has been missed, consult your doctor or other healthcare professional immediately.
If you stop using Ertapenem Qilu
It is very important that you continue receiving Ertapenem Qilu for the full 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 adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adults aged 18 years and older:
Since this medicine has been marketed, serious allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions such as: 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.
Frequent adverse effects (may affect up to 1 in 10 people) are:
- Headache
- Diarrhea, nausea, vomiting
- Skin rash, itching
- Problems with the vein where the medicine is administered (including inflammation, formation of a lump, swelling at the injection site, or leakage of fluid into the surrounding tissue and skin at the injection site)
- Increased platelet count
- Changes in liver function tests
Uncommon adverse effects (may affect up to 1 in 100 people) are:
- Dizziness, drowsiness, insomnia, confusion, seizures
- Low blood pressure, slow heart rate
- Difficulty breathing, sore throat
- Constipation, oral yeast infection, antibiotic-associated diarrhea, acid reflux, dry mouth, indigestion, loss of appetite
- Skin redness
- Vaginal discharge and irritation
- Abdominal pain, fatigue, fungal infection, fever, edema/swelling, chest pain, altered taste
- Abnormalities in certain urine and blood tests
Rare adverse effects (may affect up to 1 in 1,000 people) are:
- Decreased white blood cells, decreased number of platelets in the blood
- Low blood sugar levels
- Irritability, anxiety, depression, tremor
- Irregular heart rate, increased blood pressure, bleeding, rapid heart rate
- Nasal congestion, cough, nosebleeds, pneumonia, unusual breathing sounds and wheezing
- Inflammation of the gallbladder, difficulty swallowing, fecal incontinence, yellowing of the skin (jaundice), liver disorder
- Skin inflammation, fungal skin infection, skin peeling, wound infection after surgery
- Muscle cramps, shoulder pain
- Urinary tract infection, kidney failure
- Abortion, genital bleeding
- Allergic reaction, malaise, pelvic peritonitis, changes in the white part of the eye, fainting
- Skin may harden at the injection site
- Swelling of blood vessels in the skin
Adverse effects with frequency not known (cannot be estimated from available data):
- Hallucinations
- Decreased level of consciousness
- Altered mental state (including aggression, delirium, disorientation, changes in mental status)
- Abnormal movements
- Muscle weakness
- Unsteady gait
- Stained teeth
Changes in certain parameters measured in blood tests have also been reported.
If you develop fluid-filled or raised spots on your skin over a wide area of your body, inform your doctor or nurse immediately.
Children and adolescents (from 3 months to 17 years of age):
Frequent adverse effects (may affect up to 1 in 10 people) are:
- Diarrhea
- Diaper dermatitis
- Pain at the infusion site
- Changes in white blood cell count
- Changes in liver function tests
Uncommon adverse effects (may affect up to 1 in 100 people) are:
- Headache
- Hot flushes, high blood pressure, small smooth red or purple spots under the skin
- Pale-colored stools, black tarry stools
- Skin redness, skin rash
- Burning, itching, redness, and warmth at the infusion site, redness at the injection site
- Increased platelet count
- Changes in certain blood tests
Adverse effects with frequency not known (cannot be estimated from available data):
- Hallucinations
- Altered mental state (including aggression)
Reporting of adverse effects
If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 label of the container and vial after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25 °C.
After reconstitution:
Reconstituted solutions should be used immediately.
After dilution:
Chemical and physical in-use stability has been demonstrated for diluted solutions (approximately 1 mg/ml and 20 mg/ml) for 6 hours at 25 °C, or for 24 hours between 2 and 8 °C (in a refrigerator). Solutions should 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 process excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the duration and conditions of in-use storage are the user's responsibility.
6. Contents of the container and other information
Composition of Ertapenem Qilu
The active substance is ertapenem. Ertapenem Qilu 1 g powder for concentrate for solution for infusion EFG contains 1 g of ertapenem.
The other components are: sodium hydrogen carbonate (for pH adjustment) and sodium hydroxide (for pH adjustment).
Appearance of the product and contents of the container
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. Colour variations within this range do not affect efficacy.
Ertapenem Qilu is available in packs containing 1 vial or 10 vials.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
QILU PHARMA SPAIN S.L.
Paseo de la Castellana 40,
8th floor, Madrid - 28046
Spain
Manufacturer
KYMOS, S.L.
Ronda de Can Fatjó,
7B (Parc Tecnològic del Vallès),
Cerdanyola del Vallès, 08290 Barcelona,
Spain
or
Eurofins Analytical Services Hungary Kft
Anonymus u. 6.
Budapest, H-1045
Hungary
Local representative:
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya, 53-55
08007 Barcelona
Spain
Tel.: +34 93 342 7890
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Lithuania | Ertapenem Qilu 1 g powder for concentrate for infusion solution |
Denmark | Ertapenem Qilu |
Estonia | Ertapenem Qilu |
Spain | Ertapenem Qilu 1 g powder for concentrate for perfusion solution EFG |
Finland | Ertapenem Qilu 1 g powder for concentrate for infusion solution, solution |
France | Ertapenem Qilu 1 g, powder for solution to be diluted for infusion |
Italy | Ertapenem Qilu |
Latvia | Ertapenem Qilu 1 g powder for preparation of infusion concentrate |
Norway | Ertapenem Qilu |
Sweden | Ertapenem Qilu 1 g powder for concentrate for infusion solution, solution |
Date of the most recent review of this summary: February 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)
This information is intended for healthcare professionals only:
Instructions for reconstitution and dilution of Ertapenem Qilu:
For single use only.
Preparation for intravenous administration:
Ertapenem Qilu must be reconstituted and then diluted prior to administration.
Adults and adolescents (aged 13 to 17 years)
Reconstitution:
Reconstitute the contents of the 1 g vial of Ertapenem Qilu with 10 ml of water for injections or 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, remove 10 ml from a 50 ml vial of 9 mg/ml (0.9 %) sodium chloride injection solution and discard. Transfer the 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
Infuse over a period of 30 minutes.
Children (aged 3 months to 12 years)
Reconstitution
Reconstitute the contents of the 1 g vial of Ertapenem Qilu with 10 ml of water for injections or 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 equivalent to 15 mg/kg body weight (not exceeding 1 g/day) into a bag of 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 equivalent to 15 mg/kg body weight (not exceeding 1 g/day) into a vial of 9 mg/ml (0.9 %) sodium chloride injection solution, to achieve a final concentration of 20 mg/ml or less.
Infusion
Infuse over a period of 30 minutes.
The reconstituted solution must be immediately diluted in 9 mg/ml (0.9 %) sodium chloride injection solution after preparation. For shelf life after reconstitution and dilution, see section 5.
Whenever possible, reconstituted solutions should be inspected visually for particulate matter or discoloration prior to administration. Solutions of Ertapenem Qilu may range from colorless to pale yellow. Variation in color within this range does not affect efficacy. Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.