2 g / 0.25 g and 4 g / 0.5 g powder for solution for infusion piperacillin
/ tazobactam
What Piperacillin / Tazobactam Fresenius Kabi is and what it is used for
Piperacillin belongs to a group of medicines called ‘broad-spectrum penicillin antibiotics’. It can kill many types of bacteria. Tazobactam may prevent certain resistant bacteria from surviving the effects of piperacillin. This means that several types of bacteria are killed when piperacillin and tazobactam are given together.
Piperacillin / Tazobactam Fresenius Kabi is used in adults and adolescents to treat bacterial infections such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin, or blood.
Piperacillin / Tazobactam Fresenius Kabi can be used to treat bacterial infections in patients with low white blood cell count (reduced resistance to infections ).
Piperacillin / Tazobactam Fresenius Kabi is used in children aged 2-12 years to treat infections in the abdomen, such as appendicitis, peritonitis ( infection of the fluid and the lining of the abdominal organs), and infection of the gallbladder.
Piperacillin / Tazobactam Fresenius Kabi can be used to treat bacterial infections in patients with low white blood cell count (reduced resistance to infections ).
In case of some serious infection, your doctor may consider using Piperacillin / Tazobactam Fresenius Kabi in combination with other antibiotics.
Piperacillin/tazobactam contained in Piperacillin / Tazobactam Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor or another healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Piperacillin / Tazobactam Fresenius Kabi
Do not use Piperacillin / Tazobactam Fresenius Kabi
- if you are allergic to piperacillin or tazobactam or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to antibiotics called for penicillins, cephalosporins, or other beta-lactamase inhibitors, you may be allergic to Piperacillin / Tazobactam Fresenius Kabi.
Warnings and cautions
Talk to your doctor or nurse before using Piperacillin / Tazobactam Fresenius Kabi:
- if you have allergies is. If you have several allergies, be sure to tell your doctor or another healthcare provider before receiving this product.
- if you have diarrhea before, or if you get diarrhea during or after treatment. In this case, be sure to tell your doctor or another healthcare professional immediately. Do not take any medicine for diarrhea without first checking with your doctor.
- if you have low potassium levels in your blood. Your doctor may want to check your kidneys before taking this medicine and he/she may perform regular blood tests during treatment.
- if you have any kidney or liver problems or receive hemodialysis. Your doctor may want to check your kidneys before taking this medicine and he/she may perform regular blood tests during treatment.
- if you are taking certain medicines (called anticoagulants) to avoid excessive blood clotting (see also Other medicines and Piperacillin / Tazobactam Fresenius Kabi in this information) or if any unexpected bleeding occurs during treatment. In this case, tell your doctor or another healthcare professional immediately.
- if you get cramps during treatment. In this case, tell your doctor or other healthcare professional about it.
- if you think you have a new or worsening infection. In this case, tell your doctor or other healthcare professional about it.
- if you get severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP). Stop using Piperacillin / Tazobactam Fresenius Kabi and seek medical attention immediately if you notice any of the symptoms described in section 4.
Hemophagocytic lymphohistiocytosis
There have been reports of a disease in which the immune system produces too many of the otherwise normal white blood cells, so-called histiocytes, and lymphocytes, which leads to inflammation (hemophagocytic lymphohistiocytosis). This condition can be life-threatening if not diagnosed and treated early. If you get several symptoms, e.g. fever, swollen glands, feeling weak, feeling dizzy, shortness of breath, bruising, or rash, you should contact your doctor immediately.
Children under 2 years
The use of piperacillin/tazobactam is not recommended for use in children below 2 years of age due to insufficient data on safety and efficacy.
Other medicines and Piperacillin / Tazobactam Fresenius Kabi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may affect or be affected by piperacillin and tazobactam.
These include:
- medicines for gout (probenecid). This can increase the time it takes for piperacillin and tazobactam to leave the body.
- drugs that thin the blood or treat blood clots (eg heparin, warfarin, or aspirin).
- medicines used to relax your muscles during surgery. Tell your doctor if you are going to be anesthetized.
- methotrexate (a medicine used to treat cancer, arthritis, or psoriasis ). Piperacillin and tazobactam may increase the time it takes for methotrexate to leave the body.
- medicines that lower the level of potassium in the blood (eg tablets that increase urination or certain medicines for cancer).
- medicines containing the other antibiotics tobramycin, gentamycin, or vancomycin. Tell your doctor if you have kidney problems.
Effects on laboratory tests
Tell your doctor or laboratory staff that you are taking Piperacillin / Tazobactam Fresenius Kabi if you have to take a blood or urine sample.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if Piperacillin / Tazobactam Fresenius Kabi is right for you.
Piperacillin and tazobactam can pass into a fetus or be excreted in human milk. If you are breastfeeding, your doctor will decide if Piperacillin / Tazobactam Fresenius Kabi is right for you.
Driving and using machines
The use of Piperacillin / Tazobactam Fresenius Kabi is not expected to affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Piperacillin / Tazobactam Fresenius Kabi contains sodium
Piperacillin / Tazobactam Fresenius Kabi 2 g / 0.25 g contains 112 mg sodium (the main ingredient in table salt / table salt) per vial . This corresponds to 5.6% of the maximum recommended daily intake of sodium for adults.
Piperacillin / Tazobactam Fresenius Kabi 4 g / 0.5 g contains
224 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 11.2% of the highest recommended daily intake of sodium for adults.
How to use Piperacillin / Tazobactam Fresenius Kabi
Your doctor or other healthcare professional will give you this medicine by infusion (a 30-minute drip) into one of your veins.
The dose of medicine you are given depends on what you are being treated for, your age, and whether you have kidney problems or not.
Adults and adolescents 12 years of age and older
The recommended dose is 4 g / 0.5 g piperacillin/tazobactam given every 6 to 8 hours as an infusion into one of your veins (directly into the bloodstream).
Children 2 to 12 years of age
The recommended dose for children with abdominal infections is 100 mg / 12.5 mg piperacillin/tazobactam per kg body weight given every 8 hours in a vein (directly in the bloodstream). The usual dose for children with low white blood cell count is 80 mg / 10 mg piperacillin/tazobactam per kg body weight given every 6 hours in a vein (directly in the bloodstream).
Your doctor will calculate a dose depending on your child’s body weight, but each dose should not exceed 4 g / 0.5 g piperacillin/tazobactam.
You will be given Piperacillin / Tazobactam Fresenius Kabi until the signs of infection have completely disappeared (5 to 14 days).
Patients with kidney problems Your
the doctor may need to reduce the dose of Piperacillin / Tazobactam Fresenius Kabi or how often you get it. Your doctor may also want to test your blood to ensure that the treatment is given at the right dose, especially if you have to take the medicine for a long time.
If you take more Piperacillin / Tazobactam Fresenius Kabi than you should
Because you are being given Piperacillin / Tazobactam Fresenius Kabi by a doctor or other healthcare professional, it is unlikely that you will be given the wrong dose. However, if you experience side effects such as seizures or if you think you have had too much, tell your doctor immediately.
If you forget to take a dose of Piperacillin / Tazobactam Fresenius Kabi
If you think you have not received a dose of Piperacillin / Tazobactam Fresenius Kabi tell your doctor or another healthcare professional immediately.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to your doctor immediately if you experience any of these potentially serious side effects from Piperacillin / Tazobactam Fresenius Kabi:
Serious adverse reactions (in brackets) from Piperacillin / Tazobactam Fresenius Kabi are:
- severe skin rash ( Stevens-Johnson syndrome, bullous dermatitis (reported), exfoliative dermatitis (reported), toxic epidermal necrolysis (rare)) that first appear as reddish spots or round spots, often with blisters in the middle, on the torso. Additional signs are blisters in the mouth, throat, nose, arms, legs, and genitals and eye inflammation (red and swollen eyes). The rash may develop into widespread blistering or scaling of the skin and may be a life-threatening, serious potentially life-threatening allergic condition (drug reaction with eosinophilia and systemic symptoms, DRESS) which may include the skin and, more importantly, other organs under the skin such as kidneys and liver
- a skin condition ( acute generalized exanthematous pustulosis ) with fever, consisting of many small fluid-filled blisters that appear in large areas of swollen and reddened skin
- swelling of the face, lips, tongue, or other parts of the body (has been reported).
- shortness of breath, wheezing, or difficulty breathing (have been reported).
- severe rash or hives (uncommon), itching or rash on the skin (common)
- yellowed eyes or skin (has been reported)
- damaged blood cells (signs include: being short of breath when you do not expect it, red or brown urine (has been reported), nosebleeds (rare) and small bruises (have been reported), greatly reduced white blood cell count (rare))
- severe or persistent diarrhea accompanied by fever or weakness (rare)
If any of the following side effects get worse or if you notice any side effects not listed in this leaflet, please tell your doctor or healthcare professional.
Very common side effects (affects more than 1 user in 10):
- diarrhea
Common side effects (may affect up to 1 in 10 people):
- fungal infection
- reduction in platelet counts and reduction in red blood cells or blood pigments/hemoglobin, abnormal laboratory test results (positive direct Coombs), prolonged coagulation time (prolonged partial thromboplastin time),
- decreased blood protein content
- headache, insomnia
- abdominal pain, vomiting, nausea, constipation, stomach upset
- increased levels of liver enzymes in the blood
- rash, itching
- abnormal blood tests regarding kidney function
- fever, injection site reaction
Uncommon side effects (may affect up to 1 in 100 people):
- decrease in white blood cell count ( leukopenia ), prolonged coagulation time (prolonged prothrombin time)
- decreased blood potassium lowered blood sugar
- convulsions (convulsions), mainly in people who take high doses or who have kidney problems
- low blood pressure, inflammation of the veins (feels like tenderness or redness in the affected area), skin redness
- increased content of a degradation product of blood pigments ( bilirubin )
- skin reactions with redness, skin changes, hives, and muscle aches
- overindulge
Rare side effects (may affect up to 1 in 1,000 people):
- severe decrease in white blood cells ( agranulocytosis ), nosebleeds
- severe inflammation of the colon, inflammation of the lining of the mouth
- extensive flaking of the skin
Has been reported (occurs in an unknown number of people) :
- severe decrease in red blood cells, white blood cells, and platelets (pancytopenia), decrease in white blood cells ( neutropenia ), decreased number of red blood cells due to premature degradation, small bruises, prolonged bleeding time, increase in the number of platelets, increase in a certain type of white blood cells ( eosinophilia )
- allergic reaction and severe allergic reaction
- hepatitis, yellowing of the skin or whites of the eyes
- severe allergic reaction with rash usually in the form of blisters or sores in the oral cavity and eyes and other mucous membranes (Stevens-Johnson syndrome), a severe allergic condition that can affect the skin and internal organs, such as kidneys and liver (drug reaction with eosinophilia and systemic symptoms), a large number of small fluid-filled blisters on large parts of the skin in areas that are swollen and red along with fever ( acute generalized exanthematous pustulosis ), dermatitis with blistering (bullous dermatitis )
- renal impairment and kidney problems
- a form of lung disease in which the number of eosinophils (a type of white blood cell ) in the lung increases
- acute state of confusion ( delirium )
Treatment with piperacillin has been associated with an increased incidence of fever and rash in patients with cystic fibrosis.
Beta-lactam antibiotics, including piperacillin/tazobactam, may lead to the manifestation of encephalopathy (brain damage or brain disease) and convulsions
How to store Piperacillin / Tazobactam Fresenius Kabi
Keep this medicine out of the sight and reach of children.
Store the vials in the outer carton.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. and on the vial after “EXP”.
The expiration date is the last day of the specified month.
Unopened vials: Do not store above 25 ° C.
For single use only. Discard any unused solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
The active substances are piperacillin and tazobactam.
Each vial contains 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt).
Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of tazobactam (as sodium salt).
The product does not contain any other substances.
What the medicine looks like and the contents of the pack
Piperacillin / Tazobactam Fresenius Kabi 2 g / 0.25 g and 4 g / 0.5 g are a white to off-white lyophilized powder for solution for infusion
Piperacillin / Tazobactam Fresenius Kabi 2 g / 0.25 g are available in 15 ml and 50 g ml vials of stained glass (type II) closed with a gray chlorobutyl rubber stopper.
Piperacillin / Tazobactam Fresenius Kabi 4 g / 0.5 g are available in 50 ml stained glass vials (type II) closed with a gray chlorobutyl rubber stopper.
Pack sizes: 1, 5, and 10 vials.
Not all sizes may be marketed.
Marketing Authorisation Holder:
Fresenius Kabi AB, SE-751 74 Uppsala, Sweden
Manufacturer:
LABESFAL – Laboratórios Almiro SA
FRESENIUS KABI GROUP
3465-157 Santiago de Besteiros
Portugal
and
For Piperacillin / Tazobactam Fresenius Kabi 4 g / 0.5 g:
MITIM Srl
Via Cacciamali no 34-36-38
25125 Brescia
Italy