ertapenem: package leaflet

INVANZ 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.
INVANZ can be given to persons 3 months of age and older.
Treatment:
Your doctor has prescribed INVANZ 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.

Do not use INVANZ
- if you are allergic to the active substance (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 taking INVANZ.
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 INVANZ 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 INVANZ. 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 INVANZ below).
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.
Children and adolescents (3 months to 17 years of age)
Experience with INVANZ 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 INVANZ
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 INVANZ can affect the way some other medicines work. Your doctor will decide whether you should use INVANZ 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.
INVANZ has not been studied in pregnant women. INVANZ should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the foetus.
Women who are receiving INVANZ 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 INVANZ, which may affect some patients’ ability to drive or operate machinery.
INVANZ contains sodium
This medicine contains approximately 137 mg sodium (main component of cooking / table salt) in each 1.0 g dose. This is equivalent to 6.85 % of the recommended maximum daily dietary intake of sodium for an adult.

INVANZ will always be prepared and given to you intravenously (into a vein) by a doctor or another healthcare professional.

The recommended dose of INVANZ for adults and adolescents 13 years of age and older is 1 gram (g) given once a day. The recommended dose for children 3 months to 12 years of age is 15 mg/kg given twice daily (not to exceed 1 g/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 INVANZ is 1 g administered as a single intravenous dose 1 hour before surgery.
It is very important that you continue to receive INVANZ for as long as your doctor prescribes it.
If you are given more INVANZ than you should
If you are concerned that you may have been given too much INVANZ, contact your doctor or another healthcare professional immediately.
If you miss a dose of INVANZ
If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adults 18 years of age and older:
Since the drug 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) side effects are:
- 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) side effects are:
- 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) side effects are:
- 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
Side effects reported with frequency not known (frequency cannot be estimated from the available data) are:
- 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) side effects are:
- 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) side effects are:
- 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
Side effects reported with frequency not known (frequency cannot be estimated from the available data) are:
- 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 national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 container.
The first 2 numbers indicate the month; the next 4 numbers indicate the year.
Do not store above 25 C

What INVANZ contains
The active ingredient of INVANZ is ertapenem 1 g.
The other ingredients are: sodium bicarbonate (E500) and sodium hydroxide (E524).
What INVANZ looks like and contents of the pack
INVANZ is a white to yellowish off-white, freeze-dried powder for concentrate for solution for infusion.
Solutions of INVANZ range from colourless to pale yellow. Variations of colour within this range do not affect potency.
INVANZ is supplied in packs of 1 vial or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Manufacturer
FAREVA Mirabel
Route de Marsat, Riom
63963 Clermont-Ferrand Cedex 9
France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Lietuva
UAB Merck Sharp & Dohme
Tel. +370 5 2780 247 dpoc_lithuania@msd.com
България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737 info-msdbg@msd.com
Luxembourg/Luxemburg
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com

Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 277 050 000 dpoc_czechslovak@msd.com
Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300 hungary_msd@msd.com
Danmark
MSD Danmark ApS
Tlf.: +45 4482 4000 dkmail@msd.com
Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558) dpoccyprus@msd.com
Deutschland
INFECTOPHARM Arzneimittel und
Consilium GmbH
Tel.: +49 (0)6252 / 95-7000 kontakt@infectopharm.com
Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153) medicalinfo.nl@msd.com
Eesti
Merck Sharp & Dohme OÜ
Tel: +372 614 4200 dpoc.estonia@msd.com
Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00 medinfo.norway@msd.com
Eλλάδα
MSD Α.Φ.Ε.Ε.
Τηλ: +30 210 98 97 300 dpoc.greece@msd.com
Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044 dpoc_austria@msd.com
España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00 msd_info@msd.com
Polska
MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00 msdpolska@msd.com
France
MSD France
Tél: +33 (0)1 80 46 40 40
Portugal
Merck Sharp & Dohme, Lda
Tel.: +351 21 4465700 inform_pt@msd.com
Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 6611 333 dpoc.croatia@msd.com
România
Merck Sharp & Dohme Romania S.R.L.
Tel.: +40 21 529 29 00 msdromania@msd.com
Ireland
Merck Sharp & Dohme Ireland (Human
Health) Limited
Tel: +353 (0)1 2998700 medinfo_ireland@msd.com
Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 520 4201 msd.slovenia@msd.com
Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010 dpoc_czechslovak@msd.com
Ιtalia
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911) dpoc.italy@msd.com
Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650 info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700) dpoccyprus@msd.com
Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488 medicinskinfo@msd.com
Latvija
SIA Merck Sharp & Dohme Latvija
Tel.: +371 67025300 dpoc.latvia@msd.com
This leaflet was last revised in{MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.
--------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Instructions of how to reconstitute and dilute INVANZ:
For single use only.
Preparation for intravenous administration:
INVANZ must be reconstituted and then diluted prior to administration.
Adults and adolescents (13 to 17 years of age)
Reconstitution
Reconstitute the contents of a 1 g vial of INVANZ with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution 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; 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 and discard. Transfer the contents of the reconstituted 1 g vial of INVANZ to the 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution.
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 INVANZ with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution to yield a reconstituted solution of approximately 100 mg/mL.
Shake well to dissolve.
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 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 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. If not used immediately, in use storage times 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 at 2 to 8°C (in a refrigerator). Solutions should be used within 4 hours of their removal from the refrigerator. Do not freeze the reconstituted solutions.
The reconstituted solutions should be inspected visually for particulate matter and discolouration prior to administration, whenever the container permits. Solutions of INVANZ 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.