Piperacillin/Tazobactam 4g/0.5g Powder For Solution For Injection Or Infusion
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hospira
Read all of this leaflet carefully before you start using thi s medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
What is in this leaflet:
1. What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is and what it is used for
2. What you need to know before you use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion.
3. How to use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
4. Possible side effects
5. How to store Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
6. Contents of the pack and other information
1. What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is and what it is used for
Piperacillin belongs to the group of medicines known as “broad-spectrum penicillin antibiotics”. It can kill many kinds of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed.
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 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 4 g/0.5 g powder for solution for infusion may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is used in children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections. Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
In certain serious infections, your doctor may consider using Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion in combination with other antibiotics.
2. What you need to know before you use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Do not use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
• 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 known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion.
Warnings and precautions
Talk to your doctor before using Piperacillin/Tazobactam 4 g/0.5 g powder for solution
for infusion
• if you have allergies. If you have several allergies, make sure you tell your doctor or other healthcare professional before receiving this product.
• if you are suffering from diarrhoea before, or if you develop diarrhoea during or after your treatment. In this case, make sure you tell your doctor or other healthcare professional immediately. Do not take any medicine for the diarrhoea without first checking with
your doctor.
• if you have low levels of potassium in your blood. Your doctor may want to check your kidneys before you take this medicine and may perform regular blood tests during treatment.
• if you have kidney or liver problems, or are receiving haemodialysis. Your doctor may want to check your kidneys before you take this medicine, and may perform regular blood tests during treatment.
• if you are taking certain medicines (called anticoagulants) to prevent blood clots
(see also Other medicines and Piperacillin/Tazobactam in this leaflet) or any unexpected bleeding occurs during the treatment. In this case, you should inform your doctor or other healthcare professional immediately.
• if you develop convulsions (fits) during the treatment. In this case, you should inform your doctor or other healthcare professional.
• if you think you developed a new or worsening infection. In this case, you should inform your doctor or other healthcare professional.
Children below 2 years
Piperacillin/tazobactam is not recommended for use in children below the age of 2 years due to insufficient data on safety and effectiveness.
Other medicines and Piperacillin/Tazobactam
Tell your doctor or other healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may interact with piperacillin and tazobactam.
These include:
• medicines for gout (e.g. probenecid). This can increase the time it takes for piperacillin and tazobactam to leave your body.
• medicines to thin your blood or to treat blood clots (e.g. heparin, warfarin or aspirin).
• medicines used to relax your muscles during surgery. Tell your doctor if you are going to have a general anaesthetic.
• methotrexate (medicine used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam can increase the time it takes for methotrexate to leave your body.
• medicines that reduce the level of potassium in your blood (e.g. diuretics - medicines that increase the amount of urine you produce or some medicines for cancer).
• medicines containing the other antibiotics tobramycin or gentamicin. This is particularly important if you have kidney problems. Tell your doctor if this applies to you.
Effect on laboratory tests
Tell the doctor or laboratory staff that you are taking Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion if you have to provide a blood or urine sample.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or other healthcare professional before receiving this medicine. Your doctor will decide if Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is right for you.
Piperacillin and tazobactam can pass to a baby in the womb or through breast milk. If you are breast-feeding, your doctor will decide if Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is right for you.
Driving and using machines
The use of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is not expected to affect the ability to drive or use machines.
Important information about some of the ingredients of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion contains 9.44 mmol (217 mg) of sodium.
This should be taken into consideration if you are on a controlled-sodium diet.
3. How to use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Your doctor or other healthcare professional will give you this medicine through an infusion (a drip for 30 minutes) into one of your veins. The dose of medicine given to you depends on what you are being treated for, your age, and whether or not you have kidney problems.
Use in adults and adolescents aged 12 years or older
The recommended dose is 4 g/0.5 g piperacillin/tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream).
Use in children aged 2 to 12 years
The recommended dose for children with abdominal infections is 100 mg/12.5 mg/kg of body weight of piperacillin/tazobactam given every 8 hours into one of your veins (directly into the blood stream). The usual dose for children with low white blood cell counts is 80 mg/10 mg/kg of body weight of piperacillin/tazobactam given every 6 hours into one of your veins (directly into the blood stream).
Your doctor will calculate the dose depending on your child's weight but the daily dose will not exceed 4 g/0.5 g of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion.
You will be given Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion until the sign of infection has gone completely (5 to 14 days).
|
Content of vial |
Volume of solvent1 to be added to vial |
|
4 g/0.5 g (4 g piperacillin and 0.5 g tazobactam) |
20 ml |
The following information is intended for medical or healthcare professionals only:
Instructions for use
Piperacillin/tazobactam 4 g/0.5 g is administered by intravenous infusion (a drip for over 30 minutes).
Intravenous use
Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. Swirl until dissolved (for details on handling, please see below).
The reconstituted solution may be further diluted to desired volume (e.g. 50 ml to 150 ml) following compatible solvents:
• 0.9% (9 mg/ml) sodium chloride solution for injection
• Glucose 5%
This medicinal product must not be mixed with other medicinal products except those mentioned in above.
Whenever piperacillin/tazobactam is used concurrently with another antibiotic (e.g. aminoglycosides), the substances must be administered separately. The mixing of beta-lactam antibiotics with an aminoglycoside in vitro can result in substantial inactivation of the aminoglycoside.
Piperacillin/tazobactam should not be mixed with other substances in a syringe or infusion bottle since compatibility has not been established.
Piperacillin/tazobactam should be administered through an infusion set separately from any other drugs unless compatibility is proven.
Due to chemical instability, piperacillin/tazobactam should not be used in solutions containing only sodium bicarbonate.
Lactated Ringer's solution is not compatible with piperacillin/tazobactam.
Piperacillin/tazobactam should not be added to blood products or albumin hydrolysates.
Q79S5D
Use in patients with kidney problems
Your doctor may need to reduce the dose of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion or how often you are given it. Your doctor may also want to test your blood to make sure that your treatment is at the right dose, especially if you have to take this medicine for a long time.
If you receive more Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion than you should
As you will receive this medicine from a doctor or other healthcare professional, you are unlikely to be given the wrong dose. However, if you experience side effects, such as convulsions or think you have been given too much, tell your doctor immediately.
If you miss a dose of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
If you think you have not been given a dose of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion, tell your doctor or other healthcare professional immediately.
If you have any further questions on the use of this medicine, ask your doctor or other healthcare professional.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. See a doctor immediately if you experience any of these potentially serious side effects of Piperacillin/Tazobactam:
Uncommon: may affect up to 1 in 100 people
• severe rash or hives
Rare: may affect up to 1 in 1,000 people
• serious skin rashes [toxic epidermal necrolysis appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs include ulcers in the mouth, throat, nose, extremities, genitals and conjunctivitis
(red and swollen eyes). The rash may progress to widespread blistering or peeling of the skin and potentially may be life threatening].
• severe decrease in white blood cells and nosebleeds (signs of damage to blood cells)
• severe or persistent diarrhoea accompanied by a fever or weakness Not known: cannot be estimated from the available data
• swelling of the face, lips, tongue or other parts of the body
• serious skin rashes [Stevens-Johnson syndrome and dermatitis bullous appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs include ulcers in the mouth, throat, nose, extremities, genitals and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or peeling of the skin and potentially may be life threatening].
• shortness of breath, wheezing or trouble breathing
• yellowing of the eyes or skin
• being breathless when you do not expect it, red or brown urine and small spot bruising (signs of damage to blood cells)
Other side effects:
If any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or other healthcare professional
Very common: may affect more than 1 in 10 people
• diarrhoea
Common: may affect up to 1 in 10 people
• itching or rash on the skin
• yeast infection
• decrease in platelets and red blood cells
• prolonged blood clotting time
• abnormal lab test (positive direct Coombes)
• decrease in blood protein
• headache, sleeplessness
• abdominal pain, vomiting, nausea, constipation, upset stomach
• increase in blood liver enzymes
• abnormal kidney blood tests
• fever, injection site reaction Uncommon: may affect up to 1 in 100 people
• decrease in white blood cells
• decreased blood potassium, decreased blood sugar
• low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area), reddening of skin
• increase of blood pigment breakdown product (bilirubin)
• joint and muscle pain
• chills
Rare: may affect up to 1 in 1,000 people
• inflammation of the mucous lining of the mouth
Not known: cannot be estimated from the available data
• increase of platelets
• inflammation of the liver
• kidney failure, inflammation of the kidney
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
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 and vial label after “EXP”.
The expiry date refers to the last day of that month.
Unopened vials: This medicinal product does not require any special temperature storage conditions.
Keep the vials in the outer carton.
For single use only. Discard any unused solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion contains
• The active substances are piperacillin and tazobactam.
• Each vial contains 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt).
• There are no other ingredients.
What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion looks like and contents of the pack
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is a white to off-white powder for solution for infusion packaged in glass vials Packs containing 1 or 12 vials.
Marketing Authorisation Holder and Manufacturer:
Hospira UK Limited
Horizon, Honey Lane
Hurley
Maidenhead
SL6 6RJ
UK
This leaflet was last revised in 10/2016
Q796E0
compatible solvents for reconstitution:
• 0.9% (9 mg/ml) sodium chloride solution for injection
• Sterile water for injection111
• Glucose 5%
^Maximum recommended volume of sterile water for injection per dose is 50 ml The reconstituted solution should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelling amount of piperacillin and tazobactam.