Invanz
ertapenem
ertapenem
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, nurse or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What INVANZ is and what it is used for
What you need to know before you are given INVANZ
How to use INVANZ
Possible side effects
How to store INVANZ
Contents of the pack and other information
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.
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).
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.
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.
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.
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.
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.
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 concerned that you may have been given too much INVANZ, contact your doctor or another healthcare professional immediately.
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.
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.
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)
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 25C
The active ingredient of INVANZ is ertapenem 1 g.
The other ingredients are: sodium bicarbonate (E500) and sodium hydroxide (E524).
INVANZ is a white to 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:
UAB Merck Sharp & Dohme Tel. + 370 5 278 02 47
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
MSD Belgium
Tél/Tel: +32(0)27766211
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111
MSD Pharma Hungary Kft. Tel.: +361 888 53 00
MSD Danmark ApS Tlf: +45 44 82 40 00
Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558)
INFECTOPHARM
Arzneimittel und Consilium GmbH Tel. +49 (0)6252 / 95-7000
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 (0)23 5153153)
Merck Sharp & Dohme OÜ Tel.: +372 6144 200
MSD (Norge) AS Tlf: +47 32 20 73 00
MSD Α.Φ.Β.Ε.Ε.
Τηλ: + 30 210 98 97 300
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00
MSD Polska Sp.z o.o. Tel.: +48 22 549 51 00
MSD France
Tél: + 33 (0) 1 80 46 40 40
Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333
Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204201
Vistor hf.
Sími: +354 535 7000
Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com
MSD Finland Oy
Puh/Tel: +358 (0) 9 804650
Merck Sharp & Dohme Cyprus Limited
Τηλ.: 80000 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB Tel: +46 (0)77 5700488
SIA Merck Sharp & Dohme Latvija Tel: +371 67364 224
Tel: +353 (0)1 2998700
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Instructions of how to reconstitute and dilute INVANZ: For single use only. Preparation for intravenous administration:
Adult 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.