2 g / 0.25g and 4g / 0.5g powder for solution for infusion Piperacillin / tazobactam
What Piperacillin / Tazobactam Reig Jofre is and what it is used for
Piperacillin belongs to a group of medicines called penicillin-type broad-spectrum 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 simultaneously.
Piperacillin / Tazobactam Reig Jofre is used in adults and adolescents over 12 years of age to treat bacterial infections such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin, or blood.
Piperacillin / Tazobactam Reig Jofre can be used to treat bacterial infections in patients with low white blood cell count (reduced resistance to infections ).
Piperacillin / Tazobactam Reig Jofre is used in children aged 2-12 years to treat infections in the abdomen such as appendicitis, peritonitis ( infection of the fluid and mucous membranes of the abdominal organs), an infection of the gallbladder. Piperacillin / Tazobactam Reig Jofre can be used to treat bacterial infections in patients with low white blood cell count (reduced resistance to infections ).
For some serious infections, your doctor may consider using Piperacillin / Tazobactam Reig Jofre in combination with other antibiotics.
Piperacillin/tazobactam contained in Piperacillin / Tazobactam Reig Jofre 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 Reig Jofre
Do not use Piperacillin / Tazobactam Reig Jofre
- 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 other penicillin or cephalosporin or other beta-lactamase inhibitors, you may be allergic to Piperacillin / Tazobactam Reig Jofre.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Piperacillin / Tazobactam Reig Jofre
- if you have allergies. If you have several allergies, tell your doctor or another healthcare professional before taking this medicine.
- if you have diarrhea or get diarrhea during or after treatment. In such cases, you must 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 do regular blood tests during treatment.
- if you have kidney or liver problems or if you have hemodialysis. Your doctor may want to check your kidneys before taking this medicine and want to do regular blood tests during treatment.
- if you are taking blood-thinning medicines (so-called anticoagulants ) (see also Other medicines and Piperacillin / Tazobactam Reig Jofre in this leaflet) or if you experience any unexpected bleeding during treatment. In this case, you should inform your doctor or another healthcare professional immediately.
- if you get cramps during treatment. In this case, you should inform your doctor or other healthcare professional.
- if you think you have a new or worsening infection. In this case, you should inform your doctor or other healthcare professional.
Children
Piperacillin/tazobactam is not recommended for use in children under 2 years of age due to insufficient data on safety and efficacy.
Other medicines and Piperacillin / Tazobactam Reig Jofre
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 affect and be affected by piperacillin and tazobactam.
These include:
- medicines for gout (probenecid). This medicine may take longer for piperacillin and tazobactam to leave your body.
- blood thinners or anticoagulants (for example heparin, warfarin, or acetylsalicylic acid ).
- muscle relaxants are used during surgeries. Tell your doctor if you are going to be anesthetized.
- methotrexate (medicines for cancer, arthritis ( rheumatoid arthritis ), or psoriasis ). Piperacillin and tazobactam may make it longer for methotrexate to leave the body.
- medicines that reduce the level of potassium in the blood (eg diuretics or certain cancer medicines)
- other antibiotics such as tobramycin, gentamicin, or vancomycin. Tell your doctor if you have kidney problems.
Impact on laboratory tests
Tell your doctor or laboratory staff that you are taking Piperacillin / Tazobactam Reig Jofre if you are going to have a blood or urine sample.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or other healthcare professional for advice before taking this medicine. Your doctor will decide if Piperacillin / Tazobactam Reig Jofre is right for you.
Piperacillin and tazobactam can pass to the baby in the womb or through breast milk. If you are pregnant or breastfeeding, your doctor will decide if Piperacillin / Tazobactam Reig Jofre is right for you.
Driving and using machines
The use of Piperacillin / Tazobactam Reig Jofre 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. Discuss with your doctor if you are unsure.
Piperacillin / Tazobactam Reig Jofre contains sodium
Piperacillin / Tazobactam Reig Jofre 2 g / 0.25 g
This medicine contains 4.72 mmol (108 mg) sodium per vial of powder for solution for infusion.
Piperacillin / Tazobactam Reig Jofre 4 g / 0.5 g
This medicine contains 9.44 mmol (217 mg) sodium per vial of powder for solution for infusion.
This should be considered by patients on a low-salt diet.
How to use Piperacillin / Tazobactam Reig Jofre
Your doctor or other healthcare professional will give you this medicine as an infusion (via a drip for 30 minutes) into one of your veins. The dose you receive depends on what you are being treated for, how old you are and if you have any kidney problems.
Dosage
The usual dose is 4 g / 0.5 g piperacillin/tazobactam, which is given every 6-8 hours, given in one of your veins (directly into the bloodstream).
Children aged 2-12 years
The usual dose for children with an infection in the abdomen is 100 mg / 12.5 mg/kg body weight of piperacillin/tazobactam given every 8 hours in a vein (directly in the blood). The usual dose for children with low white blood cell count is 80 mg / 10 mg/kg body weight of piperacillin/tazobactam given every 6 hours in a vein (directly in the blood).
Doctors calculate a dose depending on the weight of the child, but each dose will not exceed 4 g / 0.5 g Piperacillin / TazobactamReig Jofre.
You will receive Piperacillin / Tazobactam Reig Jofre until the symptoms of infection have completely disappeared (5 to 14 days).
Patients with kidney problems
Doctors may need to reduce the dose of Piperacillin / Tazobactam Reig Jofre or how often you get it. Your doctor may also want to take blood samples to make sure you are being treated with the right dose, especially if you have to take the medicine for a long time.
If you take more Piperacillin / Tazobactam Reig Jofre than you should
Because you will be given Piperacillin / Tazobactam Reig Jofre by a doctor or other healthcare professional, it is unlikely that you will receive the wrong dose. However, if you get side effects, such as seizures, or think you have been given too much medicine, talk to a doctor immediately.
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.
If you forget to take a dose of Piperacillin / Tazobactam Reig Jofre
If you think you have missed a dose of Piperacillin / Tazobactam Reig Jofre talk to your doctor immediately.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical advice immediately if you get any of these potentially serious side effects from Piperacillin / Tazobactam Reig Jofre:
The serious side effects (with frequency in brackets) of Piperacillin / Tazobactam Reig Jofre are:
- severe skin rash [Stevens-Johnson syndrome, bullous dermatosis (unknown frequency), toxic epidermal necrolysis (rare)] that first appear as reddish, target-like, or round spots, often with blisters in the middle, on the torso. Other signs include sores in the mouth, pharynx, nose, extremities, 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, possibly fatal allergic reaction (drug reaction with eosinophilia and systemic symptoms) which may include the skin, but most importantly other organs in the body such as the kidneys and liver
- a skin condition ( acute generalized exanthematous pustulosis ) accompanied by fever, which manifests itself as many small fluid-filled blisters over large areas of swollen and reddened skin
- swelling of the face, lips, tongue, or other parts of the body (frequency unknown)
- shortness of breath, wheezing, or difficulty breathing (unknown frequency)
- severe rash or hives (unknown frequency), itching or rash (common)
- yellowing of eyes or skin (frequency unknown)
- damage to blood cells [symptoms may include: shortness of breath without cause, red or brown urine (frequency unknown), nosebleeds (rare) and small bruises (unknown frequency)], severe decrease in white blood cells (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 (may affect more than 1 in 10 people):
- diarrhea
Common (may affect up to 1 in 10 people):
- fungal infection
- decrease in platelets, decrease in red blood cells or blood pigments/hemoglobin, abnormal laboratory tests (positive result from direct antiglobulin test), prolonged blood coagulation time (prolonged activated partial thromboplastin time)
- reduction of blood protein
- headache, insomnia
- abdominal pain, vomiting, nausea, constipation, stomach upset
- increase in liver enzymes in the blood
- rash, itching
- abnormal kidney blood tests
- fever, injection site reaction
Uncommon (may affect up to 1 in 100 people):
- decrease in white blood cells ( leukopenia ), prolonged blood coagulation time (prolonged prothrombin time)
- decrease in potassium in the blood lowered blood sugar
- low blood pressure, inflammation of the veins (feels like tenderness or redness in the affected area), skin redness
- increase in a degradation product of blood pigments ( bilirubin )
- skin reactions with redness, skin damage, hives
- joint pain and muscle pain
- overindulge
Rare (may affect up to 1 in 1,000 people):
- a sharp decrease in white blood cells (agranulocytosis), nosebleeds
- severe infection of the colon, inflammation of the oral mucosa
- loosening of the top layer of skin over the whole body ( toxic epidermal necrolysis )
Unknown frequency (frequency can not be determined from available data):
- severe decrease in red blood cells, white blood cells, and platelets (pancytopenia), decrease in white blood cells ( neutropenia ), decrease in red blood cells due to premature degradation, small bruises, prolonged bleeding time, increase in 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 affecting the whole body with rash on the skin and mucous membranes, blisters and various skin rashes ( Stevens-Johnson syndrome ), a severe allergic condition involving the skin and other organs such as kidneys and liver (drug reaction with eosinophilia and systemic symptoms), many small fluid-filled blisters in large areas of swollen and reddened skin accompanied by fever ( acute generalized exanthematous pustulosis ), skin reactions with blistering (bullous dermatosis ), purpura
- renal impairment and kidney problems
- a type of lung disease with an increased number 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 Reig Jofre
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and 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 unused solutions.
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.
- Piperacillin / Tazobactam Reig Jofre 2g / 0.25g powder for solution for infusion : Each vial contains 2 g piperacillin (as piperacillin sodium) and 0.25 g tazobactam (as tazobactam sodium). The product does not contain any other substances.
- Piperacillin / Tazobactam Reig Jofre 4g / 0.5g powder for solution for infusion: Each vial contains 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 Reig Jofre powder for solution for infusion is supplied in packs containing a vial of powder to be dissolved into a solution before being given to you as an infusion (a slow drip) into a vein.
Pack sizes: 1, 10 (hospital pack), 50 (hospital pack) and 100 (hospital pack) vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Marketing Authorisation Holder
Laboratory Reig Jofre SA
Grand Captain, 10
08970 Sant Joan Despi – Barcelona
Spain
Local representative
Bioglan AB
Box 50310
202 13 Malmö
Manufacturer
Laboratory Reig Jofre SA
C / Jarama 111 Pol.Ind
45007, Toledo
Spain
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Piperacillin / Tazobactam Reig Jofre
Finland: Piperacillin / Tazobactam Reig Jofre
England: Piperacillin / Tazobactam