1 g of powder to concentrate for infusion solution
ertapenem
1. WHAT INVANCE IS AND WHAT IT IS USED FOR
INVANZ contains ertapenem, an antibiotic belonging to the beta-lactam group. It has the ability to kill a large number of different bacteria ( microorganisms ) that cause infection in different parts of the body.
INVANZ can be given to individuals who are three months and older.
Treatment:
Your doctor has prescribed INVANZ because you or your child have one (or more) of the following types of infections:
- Infection of the abdomen
- Infection affecting the lungs ( pneumonia )
- Gynecological infection er.
- Skin infections of the foot in diabetics.
Prophylaxis:
- Prophylaxis against infection is in adults in the area where the surgery was performed after surgery in the colon or rectum.
2. What you need to know before you get INVANZ
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 (used to treat various infections ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking INVANZ
If you get an allergic reaction during treatment (such as swelling of the face, tongue, or throat, difficulty breathing or swallowing, rash), you should contact your doctor as soon as possible as you may need medical treatment immediately.
Although antibiotics, including INVANZ, kill certain bacteria, other bacteria and fungi can continue to grow more than normal. This is called overgrowth. Your doctor will monitor you for overgrowth and, if necessary, give you treatment.
It is important that you tell your doctor if you have diarrhea before, during, or after your treatment with INVANZ. This is because you may have a condition called colitis (inflammation of the colon). Do not take any medicine to treat diarrhea without first discussing it with your doctor.
Tell your doctor if you are taking the medicines valproic acid or sodium valproate (see Other medicines and INVANZ below).
Tell your doctor about the diseases you have or have had:
- Kidney disease. It is especially important that your doctor knows if you have kidney disease and if you are undergoing dialysis treatment.
- Drug allergies, including to antibiotics .
- Diseases of the central nervous system , such as limited tremors or seizures.
Children and adolescents (3 months to 17 years of age)
Experience with INVANZ in children younger than two years is limited. For this age group, the doctor makes an assessment of the possible benefits of the treatment. There is no experience in children under 3 months of age.
Other medicines and INVANZ
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor, nurse, or pharmacist if you are taking medicines containing valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, and schizophrenia). This is because INVANZ can affect the way other medicines work. Your doctor will decide if you should use INVANZ at the same time as any of these medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
INVANZ has not been studied in pregnant women. INVANZ should not be used during pregnancy unless your doctor considers that the potential benefit outweighs the potential risk to the fetus.
Because INVANZ has been found in breast milk, women receiving INVANZ should not breastfeed as the breast-fed baby may be affected.
Driving and using machines
Do not drive or use machines until you know how you react to the medicine. Certain side effects, such as dizziness and drowsiness, have been reported with INVANZ, which may affect some patients’ ability to drive or use machines.
INVANZ contains sodium
This medicine contains approximately 137 mg of sodium (the main ingredient in table salt/table salt) per dose of 1.0 g. This corresponds to 6.85% of the maximum recommended daily intake of sodium for adults.
3. How to use INVANZ
INVANZ will always be mixed and given to you intravenously (into a vein) by a doctor or other healthcare professional.
The recommended dose of INVANZ for adults and adolescents 13 years of age or older is 1 gram (g) once daily. The recommended dose for children between 3 months and 12 years of age is 15 mg/kg given twice daily (1 g / day must not be exceeded). Your doctor will decide how many days you need to receive treatment.
In prophylaxis against infection in the area where the surgery was performed after surgery in the colon or rectum, the usual dose is 1 g and is given intravenously as a single dose one hour before the operation.
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 received too much INVANZ, contact your doctor or other 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 other healthcare professional immediately.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adults 18 years or older
Since the drug was introduced to the market, severe allergic reactions ( anaphylaxis ) and hypersensitivity syndromes (allergic reactions with rash, fever, and abnormal blood tests) have been reported. The first signs of a severe allergic reaction may be swelling of the face and/or throat. If these signs of illness occur, contact your doctor as soon as possible as you may need medical treatment immediately.
Common (may affect up to 1 in 10 people) side effects are:
- Headache
- Diarrhea, nausea, vomiting
- Rash, itching
- Problems with the vein in which the medicine is given (including inflammation , lump formation, swelling at the injection site or leakage of fluid into the tissue and skin around the injection site).
- Increased platelet count
- Altered liver function values.
Uncommon (may affect up to 1 in 100 people) side effects are:
- Dizziness, drowsiness, difficulty sleeping, confusion, seizures
- Low blood pressure , slow heart rate
- Shortness of breath, sore throat
- Constipation, yeast infection in the mouth, diarrhea associated with antibiotic treatment, acid reflux, dry mouth , impaired digestion, loss of appetite
- Reddening of the skin
- Discharges and irritation in the abdomen
- Stomach pain, fatigue, fungal infection, fever, edema / swelling, chest pain, altered taste experience.
- Alteration of certain blood and urine samples.
Rare (may affect up to 1 in 1,000 people) side effects are:
- Decreased white blood cell count , decreased platelet count
- Low blood sugar
- Upset, anxiety, depression, tremors
- Irregular heartbeat, high blood pressure , bleeding, fast heartbeat
- Nasal congestion, cough, nosebleeds, pneumonia , altered breathing sounds, wheezing
- Inflammation of the gallbladder, difficulty swallowing, fecal incontinence, jaundice, liver disease
- Skin inflammation, fungal infection of the skin, skin flaking, infection of the wound after surgery
- Muscle cramps, shoulder pain
- Urinary tract infection, kidney problems
- Miscarriage, abdominal bleeding
- Allergy , malaise, inflammation of the pelvic floor, changes in the white part of the eye, fainting
- The skin may become hard at the injection site
- Swollen blood vessels in the skin.
Adverse reactions reported without known frequency (frequency can not be calculated from the available data) are:
- Hallucinations
- Decreased level of consciousness
- Changed mood (including aggression, delirium , disorientation, changes in mood)
- Abnormal movements
- Muscle weakness
- Unsteady gait
- Discoloration of teeth.
There have also been reports of changes in certain laboratory values.
If you experience raised or fluid-filled skin spots all over your body, talk to your doctor or nurse immediately.
Children and adolescents (3 months to 17 years old)
Common (may affect up to 1 in 10 people) side effects are:
- Diarrhea
- Diaper rash
- Pain at the infusion site
- Change in the number of white blood cells
- Altered liver function values.
Uncommon (may affect up to 1 in 100 people) side effects are:
- Headache
- Hot flashes, high blood pressure , red or reddish-purple flat dots as big as pinheads under the skin
- Discolored stools, black tar-like stools
- Reddening of the skin, itchy skin
- Burning sensation, itching , redness and heat at the infusion site , redness at the injection site
- Increased platelet count
- Alteration of certain blood samples.
Adverse reactions reported without known frequency (frequency can not be calculated from the available data) are:
- Hallucinations
- Changed mood (including aggression).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store INVANZ
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 carton. The first 2 digits show the month and the following 4 digits show the year.
Do not store above 25 ° C.
6. Contents of the packaging and other information
Content declaration
The active substance in INVANZ is ertapenem 1 g.
The other ingredients are Sodium bicarbonate (E500) and sodium hydroxide (E524).
What the medicine looks like and contents of the pack
INVANZ is a white to off-white lyophilised powder for concentrate for solution for infusion.
The color of INVANZ solutions ranges from colorless to pale yellow. Variations within this color scale do not affect the strength of the drug.
INVANZ is supplied in packs of 1 vial or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem The
Netherlands
Manufacturer
FAREVA Mirabel
Route de Marsat, Riom
63963 Clermont-Ferrand Cedex 9
France
Contact the representative of the marketing authorization holder to find out more about this medicine:
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