2 g / 0.25 g and 4 g / 0.5 g powder for solution for infusion piperacillin
/ tazobactam
What Piperacillin / Tazobactam Stragen 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 more types of bacteria are killed when piperacillin and tazobactam are given together.
Piperacillin / Tazobactam Stragen 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 Stragen can be used to treat bacterial infections in patients with low white blood cell count (reduced resistance to infections ).
Piperacillin / Tazobactam Stragen 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), an infection of the gallbladder. Piperacillin / Tazobactam Stragen 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 Stragen in combination with other antibiotics.
Piperacillin/tazobactam contained in Piperacillin / Tazobactam Stragen may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 are given Piperacillin / Tazobactam Stragen
Do not use Piperacillin / Tazobactam Stragen
- if you are allergic to piperacillin or tazobactam or any of the other ingredients of Piperacillin / Tazobactam Stragen.
- if you are allergic to antibiotics called penicillins, cephalosporins, or other beta-lactamase inhibitors, as you may be allergic to Piperacillin / Tazobactam Stragen
Warnings and cautions
Talk to your doctor or nurse before taking Piperacillin / Tazobactam Stragen
- if you have allergies. If you have multiple 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 Using other medicines 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.
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, leading 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
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 Stragen
Tell your doctor 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 acetylsalicylic acid ).
- drugs used as muscle relaxants during surgeries. Tell your doctor if you are going to be anesthetized.
- methotrexate (a medicine used to treat cancer, arthritis, or psoriasis ). Piperacillin and tazobactam may prolong 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 Stragen if you have to take a blood or urine sample.
Pregnancy and breastfeeding
Piperacillin and tazobactam can pass into a fetus or pass into breast milk. If you are pregnant or breastfeeding, think you may be pregnant, or are trying to get pregnant, tell your doctor before taking this medicine. Your doctor will decide if Piperacillin / Tazobactam Stragen is right for you.
Driving and using machines
The use of Piperacillin / Tazobactam Stragen 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 vigilance. 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 Stragen contains sodium
Piperacillin / Tazobactam Stragen 2 g / 0.25 g: This medicine contains 108 mg of sodium (the main ingredient in table salt / table salt) per bottle. This corresponds to 5.4% of the maximum recommended daily intake of sodium for adults.
Piperacillin / Tazobactam Stragen 4 g / 0.5 g: This medicine contains 216 mg of sodium (the main ingredient in table salt / table salt) per bottle. This corresponds to 10.8% of the highest recommended daily intake of sodium for adults.
The maximum recommended daily dose of one of these medicines contains 864 mg of sodium (found in table salt). This corresponds to 43.2% of the WHO’s highest recommended daily intake of sodium for adults.
Talk to your doctor or pharmacist if you need to use Piperacillin / Tazobactam Stragen daily for a long period, especially if you have been prescribed a low-salt (sodium-poor) diet.
How to take Piperacillin / Tazobactam Stragen
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.
You will be given Piperacillin / Tazobactam Stragen until all signs of infection have completely disappeared (5 to 14 days).
Adults and adolescents from 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 aged 2 to 12 years
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 Stragen.
Patients with kidney problems
Your doctor may need to reduce the dose of Piperacillin / Tazobactam Stragen or how often you take 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 Stragen than you should
Because you are being given Piperacillin / Tazobactam Stragen 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 cramps or if you think you have had too much, tell your doctor immediately.
If you miss a dose of Piperacillin / Tazobactam Stragen
If you think you have not been given a dose of Piperacillin / Tazobactam Stragen, 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately if you experience any of these potentially serious side effects of Piperacillin / Tazobactam Stragen:
The serious side effects (frequency in brackets) of Piperacillin / Tazobactam Stragen are:
- severe skin rash [Stevens-Johnson syndrome, bullous dermatitis (no known frequency), exfoliative dermatitis (no known frequency), toxic epidermal necrolysis (rare)] that first appear as reddish target-like dots or round spots, often with central blisters on the body. Additional signs may include sores in the mouth, throat, nose, arms, legs, genitals, and conjunctivitis (red and swollen eyes). The rash can develop into widespread blistering or flaking of the skin and can be life-threatening.
- severe, potentially fatal allergic reaction [(drug reaction with eosinophilia and systemic symptoms (no known frequency)] that may affect the skin and, more severely, other organs under the skin such as the kidneys and liver
- skin condition AGEP [( acute generalized exanthematous pustulosis (no known frequency)] accompanied by fever and manifests as a large number of small fluid-filled blisters on large areas of swollen, reddened skin
- swelling of the face, lips, tongue, or other parts of the body (no known frequency)
- shortness of breath, wheezing, or difficulty breathing (no known frequency)
- severe skin rash or hives (uncommon), itching or rash (common)
- whites of the eyes or skin yellow (no known frequency)
- damage to blood cells, such as decreased platelet count ( thrombocytopenia ), decreased red blood cell count ( anemia, hemolytic anemia ) or decreased blood pigment/hemoglobin (common), greatly reduced white blood cell count [neutropenia, leukopenia (uncommon)]. Signs of this may be that you become short of breath for no reason, that the urine turns red or brown, and nosebleeds or bruises with small dots.
- severe colon infection, including severe or persistent diarrhea accompanied by fever or weakness (rare)
Other side effects:
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 healthcare professional.
Very common side effects ( affects more than 1 user in 10) :
- diarrhea
Common side effects ( affects up to 1 in 10 people):
- yeast infection
- deviating results in laboratory tests (positive direct Coombs), prolonged time until blood clot forms (prolonged activated partial thromboplastin time)
- decrease in protein in the blood
- headache, insomnia
- abdominal pain, vomiting, nausea, constipation, upset stomach
- increase in liver enzymes in the blood
- abnormal results in blood tests that measure kidney function
- fever, injection site reaction
Uncommon side effects ( affects up to 1 in 100 people):
- prolonged time until a blood clot forms (prolonged prothrombin time)
- decrease in potassium in the blood, decrease in blood sugar
- low blood pressure, inflammation of the veins (feels like tenderness or redness in the affected area), redness of the skin
- increase in a degradation product from blood pigments ( bilirubin )
- skin reactions with redness, sores on the skin, hives
- joint and muscle pain
- frostbite
Rare side effects ( affects up to 1 in 1,000 people):
- inflammation of the oral mucosa
No known frequency (can not be calculated from the available data):
- prolonged bleeding time, increased number of platelets ( thrombocytosis ), increased number of a certain type of white blood cell ( eosinophilia )
- allergic reaction and severe allergic reaction
- hepatitis
- renal impairment and kidney problems
- a type of lung disease that involves elevated levels of eosinophils (a type of white blood cell ) in the lungs
Treatment with piperacillin has been associated with an increased incidence of fever and rash in patients with cystic fibrosis.
How to store Piperacillin / Tazobactam Stragen
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 vial and carton label after “EXP”. The expiration date is the last day of the specified month.
Powder:
Do not store above 25 ° C
After reconstitution / dilution:
For storage conditions of the reconstituted/diluted product, see section “The following information is intended for healthcare professionals only” at the end of this leaflet.
Medicines should not be disposed of via wastewater. 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
Each vial contains:
- 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt) respectively
- 4 g piperacillin (as sodium salt) and 0.5 g 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 Stragen is a white to off-white powder for solution for infusion, packaged in glass vials, packaged in cartons containing 1, 5, 10, or 12 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder Stragen
Nordic A / S
Helsingørsgade 8C
3400 Hillerød
Denmark
Tel: +45 48 10 88 10
Email: info@stragen.dk
Manufacturer:
Maritim Srl
Via Cacciamali 34-38
25125 Brescia
Italy
This medicinal product is authorized under the European Economic Area under the names:
| Denmark, Finland, Norway, Sweden, Germany: | Piperacillin / Tazobactam Stragen |
| Netherlands: | Piperacillin / Tazobactam Stragen |