Piperacillin/Tazobactam 2g/0.25g Powder For Solution For Infusion.
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Piperacillin/Tazobactam 2 g / 0.25 g powder for solution for infusion Piperacillin/Tazobactam 4 g / 0.5 g powder for solution for infusion
Piperacillin/Tazobactam
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 pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are 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 pharmacist.
In this leaflet:
1. What Piperacillin/Tazobactam is and what it is used for
2. Before you are given Piperacillin /Tazobactam
3. How Piperacillin/Tazobactam is given
4. Possible side effects
5. How to store Piperacillin/Tazobactam
6. Further information
1. WHAT PIPERACILLIN/TAZOBACTAM 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 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 may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
Piperacillin/Tazobactam 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.
In certain serious infections, your doctor may consider using Piperacillin/Tazobactam in combination with other antibiotics.
2. BEFORE YOU ARE GIVEN PIPERACILLIN/TAZOBACTAM
Do not use Piperacillin/Tazobactam
- if you are allergic (hypersensitive) to piperacillin or tazobactam or any of the other ingredients of Piperacillin/Tazobactam .
- if you are allergic (hypersensitive) to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam.
Take special care with Piperacillin/Tazobactam
- 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 avoid an excess of blood clotting (see also Using other medicines 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 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.
Using other medicines
Please tell your doctor or pharmacist 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 (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. tablets enhancing urination or some medicines for cancer).
- Medicines containing the other antibiotics tobramycin or gentamycin. Tell your doctor if you have kidney problems.
Effect on laboratory tests
Tell the doctor or laboratory staff that you are taking Piperacillin/Tazobactam if you have to provide a blood or urine sample.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are trying to become pregnant, tell your doctor or other healthcare professional before receiving this product. Your doctor will decide if Piperacillin/Tazobactam 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 is right for you.
Driving and using machines
The use of Piperacillin/Tazobactam is not expected to affect the ability to drive or use machines.
Important information about some of the ingredients of this product
Piperacillin/Tazobactam 2a/0.25a
This medicinal product contains 4.7 mmol (or 108 mg) of sodium per vial of powder for solution for infusion.
This should be taken into consideration if you are on a controlled sodium diet.
Piperacillin/Tazobactam 4a/0.5a
This medicinal product contains 9.4 mmol (or 216 mg) of sodium per vial of powder for solution for infusion.
This should be taken into consideration if you are on a controlled sodium diet.
3. HOW PIPERACILLIN/TAZOBACTAM IS GIVEN
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.
Adults and adolescents aged 12 years or older
The usual dose is 4 g / 0.5 g of piperacillin / tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream).
Children aged 2 to 12 years
The usual 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 .
You will be given Piperacillin/Tazobactam until the sign of infection has gone completely (5 to 14 days).
Patients with kidney problems
Your doctor may need to reduce the dose of Piperacillin/Tazobactam 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.
The following information is intended for medical or healthcare professionals only:
Piperacillin/Tazobactam 2 g/0.25 g Piperacillin/Tazobactam 4 g/0.5 g
powder for solution for infusion
This is an extract from the Summary of Product Characteristics to assist in the administration of Piperacillin/Tazobactam. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the SPC.
For slow intravenous infusion.
Incompatibilities with diluents and other medicinal products . LACTATED RINGER'S (HARTMAN'S) SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN / TAZOBACTAM.
. WHEN USED CONCURENTLY WITH ANOTHER ANTIBIOTICS [E.G. AMINIGLYCOSIDES], PIPERACILLIN/TAZOBACTAM MUST BE ADMINISTERED SEPARATELY. MIXING OF PERACILLIN/ TAZOBACTAM WITH AN AMINOGLYCOSIDE IN VITRO CAN CAUSE INACTIVATION OF THE AMINOGLYCOSIDE.
. PIPERACILLIN/TAZOBACTAM SHOULD NOT BE MIXED WITH OTHER DRUGS IN A SYRINGE OR INFUSION BOTTLE SINCE COMPATIBILITY HAS NOT BEEN ESTABLISHED.
. DUE TO CHEMICAL INSTABILITY, PIPERACILLIN/TAZOBACTAM SHOULD NOT BE USED IN SOLUTION THAT CONTAIN SODIUM BICARBONATE.
. PIPERACILLIN/TAZOBACTAM SHOULD NOT BE ADDED TO BLOOD PRODUCTS OR ALBUMIN HYDROLYSATES.
INSTRUCTIONS FOR USE AND HANDLING AND DISPOSAL
The reconstitution/dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.
For single use only. Discard any unused solution.
Any unused product or waste material should be discarded in accordance with local requirements.
Sterile diluents for preparation of the reconstituted solution:
• Sterile Water for Injection
• 9 mg/ml (0.9%) Sodium Chloride for Injection
• Dextrose 50 mg/ml (5%) in water
• Dextrose 50 mg/ml (5%) in sodium chloride 9 mg/ml (0.9%) solution
Dilution directions (for intravenous infusion)
Each vial Piperacillin/Tazobactam 2 g/0.25 g should be reconstituted with 10 ml of the above diluents.
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If you are given more Piperacillin/Tazobactam than you should
As you will receive Piperacillin/Tazobactam 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
If you think you have not been given a dose of Piperacillin/Tazobactam, tell your doctor or other healthcare professional Immediately.
If you have any further questions on the use of this product, ask your doctor or healthcare professional.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Piperacillin/Tazobactam can cause side effects,
although not everybody gets them.
The serious side effects of PiDeracillin/Tazobactam are:
- swelling of the face, lips, tongue or other parts of the body
- shortness of breath, wheezing or trouble breathing
- severe rash, itching or hives on the skin
- yellowing of the eyes or skin
- damage to blood cells (the signs include: being breathless when you do not expect it, red or brown urine, nosebleeds and bruising)
If you notice any of the above, see a doctor straight away. For frequency of
these reactions, refer to the information below.
Possible side effects are listed according to the following categories:
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
Common side effects
• diarrhoea, vomiting, nausea
• skin rashes
Uncommon side effects
• thrush
• (abnormal) decrease in white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia)
• allergic reaction
• headache, sleeplessness
• low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area)
• jaundice (yellowing staining of the skin or whites of the eyes), inflammation of the mucous lining of the mouth, constipation, indigestion, stomach upset
• increase of certain enzymes in the blood (alanine aminotransferase increased, aspartate aminotransferase increased)
• itching, nettle rash
• increase of muscle metabolism product in the blood (blood creatinine increased)
• fever, injection site reaction
• yeast infection (candidal superinfection)
Rare side effects (affecting less than 1 in 1, 000 patients but more than 1
in 10,000) are:
• (abnormal) decrease of red blood cells or blood pigment / haemoglobin, (abnormal) decrease of red blood cells due to premature breakdown (degradation) (haemolytic anaemia), small spot bruising (purpura), bleeding of the nose (epistaxis) and bleeding time prolonged, (abnormal) increase of a specific type of white blood cells (eosinophilia)
• severe allergic reaction (anaphylactic/anaphylactoid reaction, including shock)
• flushed red skin
• a certain form of infection of the colon (pseudomembranous colitis), abdominal pain
• inflammation of the liver (hepatitis), increase of a blood pigments breakdown product (bilirubin), increase of certain enzymes in the blood (blood alkaline phosphatase increased, gamma-glutamyltransferase increased)
• skin reactions with redness and formation of skin lesions (exanthema, erythema multiforme), skin reactions with blistering (bullous dermatitis)
• joint and muscle pain
• poor kidney functions and kidney problems
• rigors chill / rigidity
Very rare side effects:
• severe decrease of granular white blood cells (agranulocytosis), severe decrease of red blood cells, white blood cells and platelets (pancytopenia)
• prolonged time for blood clot formation (prolonged partial thromboplastin time, prothrombin time prolonged), abnormal lab test (positive direct Coombs), increase of platelets (thrombocythaemia)
• decrease of potassium in the blood (hypokalaemia), decrease of blood sugar (glucose), decrease of the blood protein albumin, decrease of blood total protein
• detachment of the top layer of the skin all over the body (toxic epidermal necrolysis), serious bodywide allergic reaction with skin and mucous lining rashes and various skin eruptions (Stevens-Johnson Syndrome)
• blood urea nitrogen increased
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients. 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 nurse.
5. STORING PIPERACILLIN/TAZOBACTAM
Keep out of the reach and sight of children.
Do not use Piperacillin/Tazobactam after the expiry date which is stated on the carton and the vials after EXP. The expiry date refers to the last day of that month.
Powder:
Store in the original package in order to protect from light.
Store below 25°C.
For single use only.
Discard any unused solution.
Reconstituted and/or diluted Piperacillin/Tazobactam should be used immediately.
From a microbiological point of view, the product should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose off medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Piperacillin/Tazobactam contains
The active substances are piperacillin and tazobactam.
Each vial contains piperacillin sodium corresponding to 2 g piperacillin and tazobactam sodium corresponding to 0.25 g tazobactam.
Each vial contains piperacillin sodium corresponding to 4 g piperacillin and tazobactam sodium corresponding to 0.5 g tazobactam.
There are no other ingredients.
What Piperacillin/Tazobactam looks like and contents of the pack
Powder for solution for injection or infusion White to off-white powder.
Piperacillin/Tazobactam is supplied in packs of 1 or 12 vials and enclosed in a carton with a package leaflet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom
Manufacturer
Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom
or
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
This leaflet was last approved in 11/2011.
Each vial Piperacillin/Tazobactam 4 g/0.5 g should be reconstituted with 20 ml of the above diluents.
Swirl until dissolved.
The reconstituted solution may be further diluted to 50 ml to 100 ml with one of the reconstitution diluents or with dextran 60 mg/ml (6%) in sodium chloride 9 mg/ml (0.9%) solution.
Intravenous infusion should be given over 20-30 minutes.
SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from light Store below 25°C.
Reconstituted and/or diluted Piperacillin/Tazobactam should be used immediately.
From a microbiological point of view, once opened, the product should be used immediately.