Ertapenem aptapharma

Package leaflet: Information for the user

Ertapenem AptaPharma, 1 g, powder for solution for infusion concentrate
Ertapenemum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, nurse, or pharmacist. See section 4.

Contents of the leaflet

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

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

Ertapenem AptaPharma contains ertapenem, an antibiotic belonging to the beta-lactam group. It is a medicine that kills many types of bacteria (microorganisms) causing infections in various parts of the body.
Ertapenem AptaPharma may be administered to patients aged 3 months and older.

Treatment:
Your doctor has prescribed Ertapenem AptaPharma because they have diagnosed in an adult patient or child at least one of the following infections:

• Intra-abdominal infection;
• Lung infection (pneumonia);
• Gynecological infection;
• Foot skin infections in diabetic patients.

Prevention:

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

2. Important information before using Ertapenem AptaPharma

When not to use Ertapenem AptaPharma

• if the patient is allergic to the active substance (ertapenem) or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to antibiotics such as penicillins, cephalosporins, or carbapenems (used to treat various types of infections).

Warnings and precautions
Before starting treatment with Ertapenem AptaPharma, discuss this with your doctor, nurse,
or pharmacist.
If allergic reactions occur during treatment (such as swelling of the face, tongue, or throat, difficulty
breathing or swallowing, skin rash), seek immediate medical advice, as immediate medical assistance
may be required.
Although antibiotics such as Ertapenem AptaPharma kill certain types of bacteria, other bacteria
and fungi may continue to overgrow. This phenomenon is known as overgrowth. Your doctor will
monitor you and, if necessary, initiate appropriate treatment.
If diarrhoea develops before, during, or after treatment with Ertapenem AptaPharma, inform your doctor
immediately, as this may indicate a condition called colitis (inflammation of the large intestine). Do not
take any anti-diarrhoeal medicines before consulting your doctor.
Inform your doctor if you are taking medicines containing valproic acid or sodium valproate (see below:
Ertapenem AptaPharma and other medicines).
Inform your doctor about any previous or current medical conditions, including:

• kidney disease. It is especially important to inform your doctor about existing kidney problems or if you are undergoing dialysis;
• allergies to any medicines, including antibiotics;
• disorders of the central nervous system, such as partial tremors or seizures.

Children and adolescents (aged 3 months to 17 years)
Experience with the use of Ertapenem AptaPharma in children under 2 years of age is limited. The doctor will decide whether to use the medicine in this age group, weighing the expected benefits. There is no experience with the use of this medicine in children under 3 months of age.

Ertapenem AptaPharma and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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), because Ertapenem AptaPharma may affect the way some other medicines work. Your doctor will decide whether Ertapenem AptaPharma should be used together with these medicines.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using Ertapenem AptaPharma.
Studies on the use of Ertapenem AptaPharma in pregnant women have not been conducted. Ertapenem AptaPharma should not be used during pregnancy unless your doctor considers that the expected benefit justifies the potential risk to the fetus.
It is important that you inform your doctor if you are breastfeeding or intend to breastfeed before starting treatment with Ertapenem AptaPharma.
Women taking Ertapenem AptaPharma should not breastfeed, as the medicine passes into human milk and may have adverse effects on the infant.

Driving and using machines
Do not drive or operate machinery until you know how this medicine affects you.
During treatment with Ertapenem AptaPharma, adverse effects such as dizziness and drowsiness have been reported. These may affect your ability to drive or operate machinery.

Ertapenem AptaPharma contains sodium
This medicine contains approximately 137 mg of sodium (the main component of table salt) in each 1 g dose. This corresponds to 7% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Ertapenem AptaPharma

Ertapenem AptaPharma must always be prepared and administered intravenously by a physician or
another qualified healthcare professional.
The recommended dose of Ertapenem AptaPharma in adults and adolescents aged 13 years and older is
1 g once daily. The recommended dose in children aged 3 months to 12 years is 15 mg/kg body weight
administered twice daily (the total daily dose should not exceed 1 g). The duration of treatment will be
determined by the physician.
To prevent surgical site infections following procedures involving the colon or rectum, the recommended
dose of Ertapenem AptaPharma is 1 g, given as a single intravenous dose administered 1 hour before
surgery.
It is very important that the patient receives Ertapenem AptaPharma for as long as the physician has prescribed.
Overdose of Ertapenem AptaPharma
If there is concern that a higher than recommended dose of Ertapenem AptaPharma has been administered,
immediately inform the physician or another qualified healthcare professional.
Missed dose of Ertapenem AptaPharma
If there is concern that a dose of the medicine has been missed, immediately inform the physician or
another qualified healthcare professional.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Adult patients aged 18 years and older:
Since the medicine was introduced to the market, severe allergic reactions (anaphylactic reactions) and hypersensitivity syndromes (allergic reactions presenting with rash, fever, and abnormal blood test results) have been reported. Initial symptoms of a severe allergic reaction may include swelling of the face and (or) throat. If such symptoms occur, seek immediate medical attention, as emergency medical treatment may be required.

Common (may occur in up to 1 in 10 people):

• headache;
• diarrhoea, nausea, vomiting;
• rash, itching;
• complications at the vein where the medicine was administered (including inflammation, formation of lumps, swelling at the injection site, or leakage of fluid into surrounding tissues and skin);
• increased platelet count;
• changes in liver function test results.

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

• dizziness, drowsiness, insomnia, confusion, seizure;
• low blood pressure, slowed heart rate;
• shortness of breath, sore throat;
• constipation, fungal infections of the mouth, antibiotic-associated diarrhoea, regurgitation of acidic stomach contents, dry mouth, indigestion, loss of appetite;
• skin redness;
• vaginal discharge and irritation;
• abdominal pain, fatigue, fungal infection, fever, swelling and (or) puffiness, chest pain, taste disturbances;
• changes in results of certain blood and urine laboratory tests.

Rare (may occur in up to 1 in 1000 people):

• decreased number of white blood cells, decreased number of platelets;
• low blood glucose levels;
• restlessness, anxiety, depression, tremor;
• heart rhythm disturbances, high blood pressure, bleeding, rapid heart rate;
• nasal congestion, cough, nosebleeds, pneumonia, abnormal breath sounds, wheezing;
• gallbladder inflammation, difficulty swallowing, faecal incontinence, jaundice, liver function disturbances;
• skin inflammation, fungal skin infections, skin peeling, postoperative wound infections;
• muscle spasms, shoulder pain;
• urinary tract infection, kidney function disorder;
• miscarriage, genital bleeding;
• hypersensitivity, general malaise, pelvic peritonitis, changes in the sclera of the eye, fainting;
• skin at the injection site may become hard;
• swelling of blood vessels in the skin.

Frequency not known (frequency cannot be estimated from available data):

• hallucinations;
• disturbances in consciousness;
• changes in mental status (including aggressive behaviour, delirium, disorientation, other mental changes);
• abnormal movements;
• muscle weakness;
• unsteady gait;
• tooth discoloration.

Cases of changes in certain blood laboratory test results have also been reported.

If a rash or fluid-filled blisters over a large area of the skin occur, seek immediate medical advice from a doctor or nurse.

Children and adolescents (aged 3 months to 17 years):
Common (may occur in up to 1 in 10 people):

• diarrhoea;
• diaper dermatitis;
• pain at infusion site;
• changes in white blood cell count;
• changes in liver function test results.

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

• headache;
• episodes of facial flushing, high blood pressure, red or purple flat, tiny subcutaneous spots;
• stools of altered colour, black tarry stools;
• skin redness, skin rash;
• burning, itching, redness, and warmth at infusion site, redness at injection site;
• increased platelet count;
• changes in results of certain blood laboratory tests.

Frequency not known (frequency cannot be estimated from available data):

• hallucinations;
• changes in mental status (including aggressive behaviour).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ertapenem AptaPharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton label following: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
After reconstitution: The reconstituted solution should be used immediately.
After dilution: Chemical and physical stability of diluted ertapenem solutions (approximately 20 mg/mL) has been demonstrated for 6 hours at 25°C or for 24 hours at 2 to 8°C (in a refrigerator). After removal from the refrigerator, the solution should be used within 4 hours.
Solutions of Ertapenem AptaPharma must not be frozen.
From a microbiological point of view, the medicine should be used immediately, unless the method of reconstitution and dilution excludes the risk of microbiological contamination. If the medicine is not used immediately, the responsibility for storage conditions and duration prior to administration lies with the user.
Do not use this medicine if particulate matter or discoloration is observed in the reconstituted solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ertapenem AptaPharma contains
The active substance in Ertapenem AptaPharma is 1 g of ertapenem.
The other ingredients are: sodium hydrogen carbonate, sodium hydroxide.

What Ertapenem AptaPharma looks like and contents of the pack
Ertapenem AptaPharma is a white to yellowish, lyophilized powder for solution for infusion concentrate.
The solution of Ertapenem AptaPharma is colourless to pale yellow. A change in colour within the stated range does not affect the efficacy of the medicinal product.
Ertapenem AptaPharma is available in packs containing 10 vials.

Marketing Authorisation Holder
Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]

Manufacturer
ACS Dobfar S.p.A.
Nucleo Industriale S. Atto
S. Nicolò a Tordino
64100 Teramo
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:

Information intended exclusively for healthcare professionals:

Instructions for reconstitution and dilution of Ertapenem AptaPharma: For single use only.
Preparation of solution for intravenous administration
Before administration, Ertapenem AptaPharma must be dissolved and then diluted.

Adults and adolescents (aged 13 to 17 years)
Reconstitution
The contents of a vial containing 1 g of Ertapenem AptaPharma should be dissolved in 10 mL of water for injections or 9 mg/mL (0.9%) sodium chloride solution to obtain a concentrate of approximately 100 mg/mL. Shake well to ensure complete dissolution of the powder.

Dilution
Bags containing 50 mL diluent: To obtain a 1 g dose, immediately transfer the reconstituted vial contents into a bag containing 50 mL of 9 mg/mL (0.9%) sodium chloride solution; or
Vials containing 50 mL diluent: To obtain a 1 g dose, remove 10 mL from a 50 mL vial containing 9 mg/mL (0.9%) sodium chloride solution. Transfer the reconstituted contents of the vial containing 1 g of Ertapenem AptaPharma into the 50 mL vial containing 9 mg/mL (0.9%) sodium chloride solution.

Infusion
Administer by 30-minute infusion.

Children (aged 3 months to 12 years)
Reconstitution
The contents of a vial containing 1 g of Ertapenem AptaPharma should be dissolved in 10 mL of water for injections or 9 mg/mL (0.9%) sodium chloride solution to obtain a concentrate of approximately 100 mg/mL. Shake well to ensure complete dissolution of the powder.

Dilution
Diluent bag: To achieve a final concentration of 20 mg/mL or less, transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g per day) into a bag containing 9 mg/mL (0.9%) sodium chloride solution; or
Diluent vial: To achieve a final concentration of 20 mg/mL or less, transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g per day) into a vial containing 9 mg/mL (0.9%) sodium chloride solution.

Infusion
Administer by 30-minute infusion.

The reconstituted solution should be diluted with 9 mg/mL (0.9%) sodium chloride solution immediately after preparation. The resulting solution should be administered immediately.
If the solution is not administered immediately after preparation, the person administering the medicinal product is responsible for the storage period and conditions. The infusion solution (approximately 20 mg/mL ertapenem) maintains physical and chemical stability for 6 hours at room temperature (25°C) or for 24 hours at 2° to 8°C (refrigerated). After removal from the refrigerator, the solution should be used within 4 hours. Reconstituted Ertapenem AptaPharma solution must not be frozen.

Reconstituted solutions should be inspected visually for particulate matter or discoloration prior to administration, if the solution and container permit. The Ertapenem AptaPharma solution should be colorless or pale yellow. A color change within the specified range does not affect the efficacy of the medicinal product.

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Shelf-life after reconstitution: The reconstituted solution should be used immediately.

Shelf-life after dilution: Chemical and physical stability of diluted ertapenem solutions (approximately 20 mg/mL) has been demonstrated for 6 hours at 25°C or for 24 hours at 2–8°C (refrigerated). After removal from the refrigerator, the solution should be used within 4 hours. Ertapenem AptaPharma solutions should not be frozen.

From a microbiological standpoint, the medicinal product should be used immediately, unless the reconstitution and dilution methods exclude the risk of microbiological contamination. If not used immediately, the user is responsible for the storage period and conditions prior to administration.