INVANZ 1 g powder for concentrate for solution for infusion
(ertapenem)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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 your pharmacist.
In this leaflet:
1. What INVANZ is and what it is used for
2. Before you take INVANZ
3. How to take INVANZ
4. Possible side effects
5. How to store INVANZ
6. Further information
What Invanz Is And What It Is Used For
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.
Before You Take Invanz
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 gastro-intestinal disease.
- Central nervous system disorders, such as localised 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 6.0 mEq (approximately 137 mg) of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.
How To Take Invanz
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.
Possible Side Effects
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.
How To Store Invanz
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
Further Information
What INVANZ contains
The active ingredient of INVANZ is ertapenem 1g.
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
Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
medinfo_uk@merck.com
This leaflet was last approved in July 2010
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
© Merck Sharp & Dohme Limited 2010. All rights reserved.
PIL.IVZ.10.UK/IRL.3304 (II-032)
No comments:
Post a Comment