Ertapenem Acs Dobfar

Package leaflet: Information for the user

Ertapenem ACS Dobfar 1 g powder for concentrate for solution for infusion

Ertapenem
Equivalent medicine
Please read all of 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 you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Ertapenem ACS Dobfar is and what it is used for

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

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

Ertapenem ACS Dobfar may also be used to prevent surgical site infection in adults following surgery on the colon or rectum.

2. What you should know before taking Ertapenem ACS Dobfar

Do not use Ertapenem ACS Dobfar

• 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 ACS Dobfar.
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 ACS Dobfar, are effective against certain bacteria, other
bacteria and fungi may grow excessively. This phenomenon is known as overgrowth. Your doctor will
monitor you for any overgrowth and treat it if necessary.
It is important that you inform your doctor if you have diarrhea before, during, or after treatment with
Ertapenem ACS Dobfar. This is because you may have a condition known as colitis (inflammation of the
intestine). Do not take any medicine for diarrhea 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 ACS Dobfar).
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
• 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 ACS Dobfar is limited in children under two years of age. In this age group, the doctor must evaluate the potential benefit of using the medicine. There is no experience with children under 3 months of age.
Other medicines and Ertapenem ACS Dobfar
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 disorders, migraine, or schizophrenia). This is
because Ertapenem ACS Dobfar may affect the way some other medicines work. Your doctor will decide whether you should use Ertapenem ACS Dobfar in combination with these other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Ertapenem ACS Dobfar has not been studied in pregnant women. Ertapenem ACS Dobfar should not be used during pregnancy unless your doctor decides that the potential benefits outweigh the possible risks to the fetus.
Women being treated with Ertapenem ACS Dobfar should not breastfeed, as the medicine has been found in breast milk and the infant could therefore be affected.
Driving and using machines
Dizziness and drowsiness have been reported with the use of Ertapenem ACS Dobfar, which may impair your ability to drive or operate machinery.
Do not drive or operate machinery until you know how you react to the medicine.
Ertapenem ACS Dobfar contains sodium
This medicine contains approximately 137 mg of sodium (a main 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 ACS Dobfar

This medicinal product must always be prepared and administered intravenously ( into a vein ) by a
doctor or other healthcare professional.
Recommended dose:

• Adults and adolescents from the age of 13 years: 1 gram (g) once daily.
• Children from 3 months to 12 years of age: 15 mg/kg administered twice daily (do not exceed 1 g per day).

Your doctor will decide the number of days of treatment required. It is very important to continue
taking Ertapenem ACS Dobfar for the entire duration prescribed by your doctor.

• For the prevention of surgical site infections following colorectal surgery, the recommended dose is 1 g given as a single intravenous dose 1 hour before surgery.

If you take more Ertapenem ACS Dobfar than you should
If you think you have taken too much Ertapenem ACS Dobfar, contact your doctor or a
healthcare professional immediately.
If you forget to take Ertapenem ACS Dobfar
If you think you have missed a dose, contact your doctor or a healthcare professional immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Since the medicine was placed on the market, severe allergic reactions (anaphylaxis) and hypersensitivity syndromes (including allergic reactions such as rash, fever, abnormal blood tests) have been reported. Early signs of a severe 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.

Adults aged 18 years and older:
Common side effects (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, swelling, injection site swelling or leakage of fluid 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):

• Dizziness, drowsiness, insomnia, confusion, seizures
• Low blood pressure, slow heart rate
• Shortness of breath, sore throat
• Constipation, fungal infection of the mouth, antibiotic-associated diarrhoea, acid regurgitation, dry mouth, digestive difficulties, 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):

• Decrease in white blood cells, decrease in 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
• Inflammation of the gallbladder, difficulty swallowing, faecal incontinence, yellowing of the skin and mucous membranes, 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 hardened at the injection site
• Swelling of blood vessels in the skin

Side effects with unknown frequency (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
• Discolouration 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.

Side effects in children and adolescents (from 3 months to 17 years of age):
Common side effects (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 side effects (may affect up to 1 in 100 people):

• Headache
• Hot flushes, high blood pressure, flat red or red-purple pinpoint 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 with unknown 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:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ertapenem ACS Dobfar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
Store below 25°C in the original packaging to protect the medicine from moisture.
After dilution: Diluted solutions (approximately 20 mg ertapenem/mL) are physically and chemically stable for 6 hours at 25°C or for 24 hours between 2°C and 8°C (in a refrigerator).
Solutions must be used within 4 hours after removal from the refrigerator.
Do not freeze Ertapenem ACS Dobfar solutions.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage during use are the responsibility of the user.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ertapenem ACS Dobfar contains
The active substance is ertapenem 1 g (as ertapenem sodium).
The other components are: sodium bicarbonate and sodium hydroxide.

Description of the appearance of Ertapenem ACS Dobfar and contents of the pack
Ertapenem ACS Dobfar is a white to yellowish lyophilized powder for concentrate for solution for infusion.
Ertapenem ACS Dobfar is supplied in packs of 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder
ACS Dobfar S.p.A.
Viale Addetta 4/12
20067 Tribiano (MI), Italy

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

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Ertapenem ACS Dobfar 1 g, poudre pour solution à diluer pour perfusion
Netherlands: Ertapenem Added Pharma 1 g poeder voor concentraat voor oplossing voor infusie
Italy: Ertapenem ACS Dobfar
Romania: Ertapenem ACS Dobfar 1 g pulbere pentru concentrat pentru soluţie perfuzabilă

The following information is intended exclusively for physicians and healthcare professionals:
Instructions for reconstituting and diluting Ertapenem ACS Dobfar:

For single use only.
Preparation for intravenous administration:
Preparation for intravenous administration:
Adults and adolescents (13 to 17 years of age)
Reconstitution
Reconstitute the contents of one 1 g vial with 10 mL of water for injections or with sodium chloride solution 9 mg/mL (0.9%) 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 sodium chloride solution 9 mg/mL (0.9%); or
For a 50 mL diluent vial: For a 1 g dose, withdraw 10 mL from a 50 mL vial of sodium chloride solution 9 mg/mL (0.9%) and discard. Transfer the contents of the reconstituted Ertapenem ACS Dobfar 1 g vial into the 50 mL vial of sodium chloride solution 9 mg/mL (0.9%).
Infusion
Infuse over 30 minutes.
Children (3 months to 12 years of age)
Reconstitution
Reconstitute the contents of one 1 g vial with 10 mL of water for injections or with sodium chloride solution 9 mg/mL (0.9%) 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 per day) into a bag containing sodium chloride solution 9 mg/mL (0.9%) 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 per day) into a vial containing sodium chloride solution 9 mg/mL (0.9%) to achieve a final concentration of 20 mg/mL or less.
Infusion
Infuse over 30 minutes.
The reconstituted solution must be diluted in sodium chloride solution 9 mg/mL (0.9%) immediately 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/mL ertapenem) 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.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage during use are the responsibility of the user.
Reconstituted solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution clarity and container permit. Ertapenem ACS Dobfar solutions range from colourless to pale yellow. Colour 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.