INVANZ 1 g powder for concentrate for solution for infusion

INVANZ is an injectable antibiotic which will always be prepared and given to you by a doctor or another healthcare professional.

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.

Treatment:
Your doctor has prescribed INVANZ because you have 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 following surgery of the colon or rectum.

Do not take INVANZ

• if you are allergic to the active substance (ertapenem) or any of the other ingredients of INVANZ
• if you are allergic to antibiotics such as penicillins, cephalosporins or carbapenems.

Take special care with INVANZ

Tell your doctor about any medical condition you have or have had including:

• Kidney disease (see Patients with kidney disease)
• Allergies to any medicines, including antibiotics
• Colitis or any other gastrointestinal disease.
• Central nervous system disorders, such as localized tremors, or seizures.

During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must stop taking INVANZ immediately and seek medical advice.

Tell your doctor if you are taking medicines called valproic acid or sodium valproate. (see Taking other medicines below)

Patients with kidney disease

It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.

Children and adolescents (3 months to 17 years of age)
INVANZ can be given to children 3 months of age and older. 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.

Elderly
INVANZ works well and is well tolerated by most older and younger adult patients. The recommended dosage of INVANZ can be administered without regard to age.

Taking other medicines

Always tell your doctor about all medicines that you are taking or plan to take, including those obtained without a prescription.

Tell your doctor if you are taking medicines called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). Your doctor will decide whether you should use INVANZ in combination with these other medicines.

Pregnancy and breast-feeding

It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving INVANZ.
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.

It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving INVANZ.
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.

Important information about some of the ingredients of INVANZ : This medicinal product contains approximately 6.0mEq (approximately 137 mg) of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.

INVANZ will always be prepared and given to you by a doctor or another healthcare professional.

INVANZ is given intravenously (into a vein).

The normal dose of INVANZ for adults and adolescents 13 years of age and older is 1 gram (g) given once a day. The normal dose for children 3 months to 12 years of age is 15 mg/kg given twice daily (not to exceed 1 g/day). INVANZ is not recommended in children under 3 months of age, as no data are available. 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 take 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 forget to take INVANZ

If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.

Like all medicines, INVANZ can cause side effects, although not everybody gets them.

Adults 18 years of age and older:

The most common (more than 1 in 100 patients and less than 1 in 10 patients) 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).

Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) 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.

Side effects reported rarely (more than 1 in 10,000 patients and less than 1 in 1,000 patients) 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.

There have also been reports of changes in some laboratory blood tests.

Children and adolescents (3 months to 17 years of age):

The most common (more than 1 in 100 patients and less than 1 in 10 patients) side effects are:

• Diarrhoea
• Diaper rash
• Pain at the infusion site

Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) 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,

There have also been reports of changes in some laboratory blood tests

Since the drug has been marketed, severe allergic reactions (anaphylaxis), hypersensitivity syndromes (allergic reactions including rash, fever, abnormal blood tests), hallucinations, altered mental status (including aggression, delirium, disorientation, mental status changes), and abnormal movements have been reported. The first signs of a severe allergic reaction may include swelling of the face and/or throat. If these symptoms occur you must stop taking INVANZ immediately and inform your doctor or nurse immediately.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not use INVANZ 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 sterile, white to off-white, freeze-dried powder.
Solutions of INVANZ range from colourless to pale yellow. Variations of colour within this range do not affect potency.

INVANZ 1 g powder for concentrate for solution for infusion is supplied in packs of 1 vial or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Merck Sharp Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom Manufacturer Laboratoires Merck Sharp Dohme Chibret Route de Marsat - Riom F-63963 Clermont-Ferrand Cedex 9 France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiqueBelgiëBelgien Merck Sharp Dohme B.V. Succursale belgeBelgisch bijhuis TélTel 32 0 800 38693 MSDBelgiuminfomerck.com LuxembourgLuxemburg Merck Sharp Dohme B.V. Succursale belge Tél 32 0 800 38693 MSDBelgiuminfomerck.com

. 359 2 819 3740 info-msdbgmerck.com Magyarország MSD Magyarország Kft. Tel. 361 888 53 00 hungarymsdmerck.com

eská republika Merck Sharp Dohme IDEA, Inc., org. sl. Tel. 420 233 010 111 msdcrmerck.com Malta Merck Sharp Dohme Middle East LimitedTel 357 22866700 infocyprusmerck.com

Danmark Merck Sharp Dohme Tlf 45 43 28 77 66 dkmailmerck.com Nederland Merck Sharp Dohme B.V. Tel 31 0 23 5153153 msdbvnlmerck.com

Deutschland MSD SHARP DOHME GMBH Tel 49 0 89 4561 2612 Infocentermsd.de Norge MSD Norge AS Tlf 47 32 20 73 00 msdnorgemsd.no

Eesti Merck Sharp Dohme OÜ Tel. 372 613 9750 msdeestimerck.com Österreich Merck Sharp Dohme G.m.b.H. Tel 43 0 1 26 044 msd-medizinmerck.com

E BIANE . 3 0210 80091 11 Mailboxvianex.gr Polska MSD Polska Sp.z o.o. Tel. 48 22 549 51 00 msdpolskamerck.com

España Merck Sharp Dohme de España, S.A. Tel 34 91 321 06 00 Invanzmsd.es Portugal Merck Sharp Dohme, Lda Tel 351 21 4465700 informacaodoentemerck.com

France Laboratoires Merck Sharp Dohme Chibret Tél 33 0 1 47 54 87 00 contactmsd-france.com România Merck Sharp Dohme Romania S.R.L. Tel 4021 529 29 00 msdromaniamerck.com

Ireland Merck Sharp and Dohme Ireland Human Health Limited Tel 353 01 2998700 medinfoirelandmerck.com Slovenija Merck Sharp Dohme, inovativna zdravila d.o.o. Tel 386 1 5204201 msdsloveniamerck.com

Ísland Icepharma hf. Sími 354 540 8000 ISmailmerck.com Slovenská republika Merck Sharp Dohme IDEA, Inc. Tel. 421 2 58282010 msdskmerck.com

talia Merck Sharp Dohme Italia S.p.A. Tel 39 06 361911 doccenmerck.com SuomiFinland MSD Finland Oy PuhTel 358 0 9 804650 infomsd.fi

Merck Sharp Dohme Middle East Limited 357 22866700 infocyprusmerck.com Sverige Merck Sharp Dohme Sweden AB Tel 46 0 8 626 1400 medicinskinfomerck.com

Latvija SIA Merck Sharp Dohme Latvija Tel 371 67364 224 msdlvmerck.com United Kingdom Merck Sharp and Dohme Limited Tel 44 0 1992 467272 medinfoukmerck.com

Lietuva
UAB ?Merck Sharp & Dohme?
Tel.: +370 5 278 02 47msd_lietuva@merck.com

This leaflet was last approved in

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.

Adult and adolescents (13 to 17 years of age):

1. 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.

2. 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.

3. Infusion: Infuse over a period of 30 minutes.

Children (3 months to 12 years of age):

1. 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.

2. 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.

3. 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.