Piperacillin Tazobactam 4g/0.5g powder for solution for infusion

  • Name:

    Piperacillin Tazobactam 4g/0.5g powder for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Piperacillin sodium, Tazobactam sodium

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/12/18

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Summary of Product Characteristics last updated on medicines.ie: 21/12/2018

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Gerard Laboratories

Gerard Laboratories

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1 - 0 of 117 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 21 December 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 21 December 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 June 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 June 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 8 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 8 November 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Renal Impairment

Due to its potential nephrotoxicity (see section 4.8), piperacillin / tazobactam should be used with care in patients with renal impairment or in hemodialysis patients. Intravenous dosages and administration intervals should be adjusted to the degree of renal function impairment (see section 4.2).

In a secondary analysis using data from a large multicenter, randomized-controlled trial when glomerular filtration rate (GFR) was examined after administration of frequently used antibiotics in critically ill patients, the use of piperacillin/tazobactam was associated with a lower rate of reversible GFR improvement compared with the other antibiotics. This secondary analysis concluded that piperacillin/tazobactam was a cause of delayed renal recovery in these patients.

4.8 Undesirable effects

System Organ Class

Very common

≥ 1/10

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1,000 to < 1/100

Rare

≥ 1/10,000 to < 1/1,000

Frequency not known (cannot be estimated from available data)

Infections and infestations

 

candida infection*

 

pseudo-membranous colitis

 

Blood and lymphatic system disorders

 

thrombocytopenia, anaemia*
Coombs direct test positive, activated partial thromboplastin time prolonged

leukopenia
prothrombin time prolonged

agranulocytosis
epistaxis

pancytopenia*, neutropenia,
purpura, bleeding time prolonged, 
haemolytic anaemia*,
eosinophilia
thrombocytosis*, eosinophilia,*

Immune system disorders

 

 

 

 

anaphylactoid reaction*, anaphylactic reaction*,
anaphylactoid shock*, anaphylactic shock*, anaphylactoid reaction*, anaphylactic reaction*,
hypersensitivity*

Metabolism and nutrition disorders

 

blood albumin decreased, protein total decreased

hypokalaemia
blood glucose decreased

 

 

Psychiatric disorders

 

insomnia

 

 

 

Nervous system disorders

 

headache
insomnia

 

 

 

Vascular disorders

 

 

hypotension, phlebitis, thrombophlebitis,
 phlebitis flushing

 

 

Respiratory, thoracic and mediastinal disorders

 

 

 

epistaxis

eosinophilic pneumonia

Gastrointestinal disorders

diarrhoea

abdominal pain, vomiting, nausea, constipation, nausea, dyspepsia

 

pseudo-membranous colitis,
stomatitis

 

Hepatobiliary disorders

 

alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased

blood bilirubin increased

 

hepatitis*, jaundice
gamma-glutamyl-transferase increased

Skin and subcutaneous tissue disorders

 

rash, pruritus

erythema multiforme*, urticaria, rash maculopapular*

toxic epidermal necrolysis*

Stevens-Johnson syndrome*, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms (DRESS)*, acute generalised exanthematous pustulosis (AGEP)*, dermatitis bullous, purpura

Musculoskeletal and connective tissue disorders

 

 

arthralgia, myalgia

 

 

Renal and urinary disorders

 

blood creatinine increased, blood urea increased

 

 

renal failure, tubulointerstitial nephritis*

General disorders and administration site conditions

 

pyrexia,

injection-site reaction

chills

 

 

Investigations

 

alanine aminotransferase increased, aspartate aminotransferase increased, protein total decreased, blood albumin decreased, Coombs direct test positive, blood creatinine increased, blood alkaline phosphatase increased, blood urea increased, activated partial thromboplastin time prolonged

blood glucose decreased, blood bilirubin increased, prothrombin time prolonged

 

bleeding time prolonged, gamma-glutamyltransferase increased


6.6 Special precautions for disposal and other handling

The reconstitution and dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.
Intravenous use
Each injection vial of Piperacillin Tazobactam needs to be reconstituted by adding 50 ml to 150 ml of one of the following solutions:
• Sterile water for injection
• 0,9% (9 mg/ml) sodium chloride solution for injection
• Glucose 5%
In a first step, add the volume of solution indicated in the table below to each injection vial:

Content of the vial

Volume of solution to be added to the vial

2 g/0.25 g (2 g piperacillin and 0.25 g tazobactam)

10 ml

4 g/0.5 g (4 g piperacillin and 0.5 g tazobactam)

20 ml


Shake strongly the medicinal product during 1 to 2 minutes. The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with the same solvents. and following this step, add the same solution to make total volume to 50 ml.

Shake strongly the medicinal product again until it is completely dissolved.

10. DATE OF REVISION OF THE TEXT

December 2016July 2017

 

 

 

 

 

 

 

 

 

 

 

Updated on 7 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 November 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 3 January 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

The selection of piperacillin / tazobactam to treat an individual patient should take into account the appropriateness of using a broad-spectrum semi-synthetic penicillin based on factors such as the severity of the infection and the prevalence of resistance to other suitable antibacterial agents.

Before initiating therapy with piperacillin / tazobactam, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, other beta-lactam agents (e.g. cephalosporin, monobactam or carbapenem) and other allergens. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid [including shock]) reactions have been reported in patients receiving therapy with penicillins, including piperacillin / tazobactam. These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens. Serious hypersensitivity reactions require the discontinuation of the antibiotic, and may require administration of epinephrine and other emergency measures.

Therapy with piperacillin / tazobactam may cause severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalised exanthematous pustulosis Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in patients receiving piperacillin/tazobactam (see section 4.8).  If patients develop a skin rash they should be monitored closely and piperacillin/tazobactam discontinued if lesions progress.

4.5 Interaction with other medicinal products and other forms of interaction

Aminoglycosides
Piperacillin, either alone or with tazobactam, did not significantly alter the pharmacokinetics of tobramycin in subjects with normal renal function and with mild or moderate renal impairment. The pharmacokinetics of piperacillin, tazobactam, and the M1 metabolite were also not significantly altered by tobramycin administration.
The inactivation of tobramycin and gentamicin by piperacillin has been demonstrated in patients with severe renal impairment.
For information related to the administration of piperacillin / tazobactam with aminoglycosides please refer to sections 6.2 and 6.6.

Vancomycin
No pharmacokinetic interactions have been noted between piperacillin / tazobactam and vancomycin.

However, a limited number of retrospective studies have detected an increased incidence of acute kidney injury in patients concomitantly administered piperacillin / tazobactam and vancomycin as compared to vancomycin alone.

4.8 Undesirable effects

System Organ Class

Very common

≥ 1/10

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1,000 to < 1/100

Rare

≥ 1/10,000 to < 1/1,000

Frequency not known (cannot be estimated from available data)

Infections and infestations

 

Candidiasiscandida infection*

 

 

 

Blood and lymphatic system disorders

 

thrombocytopenia, anaemia*, Coombs direct test positive, activated partial thromboplastin time prolonged

leukopenia, prothrombin time prolonged

 agranulocytosis, epistaxis

pancytopenia*, neutropenia, purpura, bleeding time prolonged, haemolytic anaemia*, eosinophilia, thrombocytosis*

Immune system disorders

 

 

 

 

anaphylactoid reaction*, anaphylactic reaction*, anaphylactoid shock*, anaphylactic shock*, hypersensitivity*

Metabolism and nutrition disorders

 

blood albumin decreased, protein total decreased

hypokalaemia, blood glucose decreased

 

 

Nervous system disorders

 

headache, insomnia

 

 

 

Vascular disorders

 

 

hypotension, thrombophlebitis, phlebitis, flushing

 

 

Gastrointestinal disorders

diarrhoea

abdominal pain, vomiting, nausea, constipation, dyspepsia

 

pseudo-membranous colitis, stomatitis

 

Hepatobiliary disorders

 

alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased

blood bilirubin increased

 

hepatitis*, jaundice, gamma-glutamyl-transferase increased

Skin and subcutaneous tissue disorders

 

rash, pruritus

erythema multiforme*, urticaria, rash maculopapular*

toxic epidermal necrolysis*

Stevens-Johnson syndrome*,drug reaction with eosinophilia and systemic symptoms (DRESS)*, acute generalised exanthematous pustulosis (AGEP)*, dermatitis bullous

Musculoskeletal and connective tissue disorders

 

 

arthralgia, myalgia

 

 

Renal and urinary disorders

 

blood creatinine increased, blood urea increased

 

 

renal failure, tubulointerstitial nephritis*

General disorders and administration site conditions

 

pyrexia,

injection-site reaction

chills

 

 

* ADR identified post marketing

Updated on 22 December 2016 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 2 August 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

Dose in e Elderly patients
No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 40 ml/min.

4.3 Contraindications

Hypersensitivity to the active substances, or any other penicillin-antibacterial agent or to any of the excipients listed in section 6.1.
History of acute severe allergic reaction to any other beta-lactam active substances (e.g. cephalosporin, monobactam or carbapenem).

4.4 Special warnings and precautions for use

The selection of piperacillin / tazobactam to treat an individual patient should take into account the appropriateness of using a broad-spectrum semi-synthetic penicillin based on factors such as the severity of the infection and the prevalence of resistance to other suitable antibacterial agents.

Before initiating therapy with piperacillin / tazobactam, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, other beta-lactam agents (e.g. cephalosporin, monobactam or carbapenem) and other allergens. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid [including shock]) reactions have been reported in patients receiving therapy with penicillins, including piperacillin / tazobactam. These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens. Serious hypersensitivity reactions require the discontinuation of the antibiotic, and may require administration of epinephrine and other emergency measures.

Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in patients receiving piperacillin/tazobactam (see section 4.8).  If patients develop a skin rash they should be monitored closely and piperacillin/tazobactam discontinued if lesions progress.

4.8 Undesirable effects

The most commonly reported adverse reaction is diarrhoea (occurring in 1 patient out of 10)The most commonly reported adverse reactions (occurring in 1 to 10 patients in 100) are diarrhoea, vomiting, nausea and rash.

Among the most serious adverse reactions pseudo-membranous colitis and toxic epidermal necrolysis occur in 1 to 10 patients in 10,000. The frequencies for pancytopenia, anaphylactic shock and Stevens-Johnson syndrome cannot be estimated from the currently available data.

 

System Organ Class

 

Very common

≥ 1/10

 

 

 

Common

≥ 1/100 to < 1/10

 

 

Uncommon

≥ 1/1,000 to < 1/100

 

 

Rare

≥ 1/10,000 to < 1/1,000

 

 

Frequency not known (cannot be estimated from available data)

 

 

Infections and infestations

 

candidiasis

 

 

 

candidal superinfection

 

 

 

Blood and lymphatic system disorders

 

thrombocytopenia, anaemia, Coombs direct test positive, activated partial thromboplastin time prolonged

 

 

 

leukopenia,

 

neutropenia, thrombocytopeniaprothrombin time prolonged

anaemia, haemolytic anaemia,

purpura

 

 

agranulocytosis, epistaxis, bleeding time prolonged, eosinophilia

pancytopenia, neutropenia, purpura, bleeding time prolonged, haemolytic anaemia, eosinophilia, thrombocytosis

 

 

 

Immune system disorders

 

hypersensitivity

 

 

 

anaphylactic/

anaphylactoid reaction (including shock)

 

 

 

anaphylactoid reaction, anaphylactic reaction, anaphylactoid shock, anaphylactic shock, hypersensitivity

 

 

 

Metabolism and nutrition disorders

 

blood albumin decreased, protein total decreased

 

 

 

hypokalaemia, blood glucose decreased

 

 

 

Nervous system disorders

 

headache, insomnia

 

 

 

headache, insomnia

 

 

 

Vascular disorders

 

hypotension, thrombophlebitis, phlebitis

 

, flushing

flushing

 

 

 

Gastrointestinal disorders

 

diarrhoea

 

 

 

diarrhoea,

 

 

abdominal pain, vomiting, nausea, constipation, dyspepsia

jaundice, stomatitis, constipation, dyspepsia

 

 

 

pseudo-membranous colitis,

 

abdominal painstomatitis

Hepatobiliary disorders

 

alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased

 

 

 

alanine aminotransferase increased, aspartate aminotransferase increased

 

 

blood bilirubin increased

hepatitis, blood bilirubin increased, blood alkaline phosphatase increased, gamma-glutamyltrans-ferase increased

 

 

 

hepatitis, jaundice, gamma-glutamyl-transferase increased

 

 

 

Skin and subcutaneous tissue disorders

 

rash,

 

pruritusincluding maculopapular rash

erythema multiforme,

 

 

urticaria, rash maculopapularpruritus

toxic epidermal necrolysis

 

 

erythema multiforme, dermatitis bullous, exanthema

Stevens-Johnson syndrome, dermatitis bullous

 

 

 

Musculoskeletal and connective tissue disorders

 

arthralgia, myalgia

 

 

 

arthralgia, myalgia

 

 

 

Renal and urinary disorders

 

blood creatinine increased, blood urea increased

 

 

 

blood creatinine increased

 

 

 

renal failure, tubulointerstitial nephritis

 

 

 

renal failure, tubulointerstitial nephritis

 

 

 

General disorders and administration site conditions

 

pyrexia,

injection-site reaction

 

 

 

pyrexia,

injection-site reaction

 

 

chills

chills

 

 

 


5.2 Pharmacokinetic properties

 

Elderly patients
The mean half-life for piperacillin and tazobactam were 32% and 55% longer, respectively, in the elderly compared with younger subjects. This difference may be due to age-related changes in creatinine clearance.

Updated on 29 July 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 31 March 2016 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.6 Special precautions for disposal and other handling

The reconstitution and dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.

Intravenous use

Each injection vial of Piperacillin Tazobactam <Product Name> needs to be reconstituted by adding 50 ml of one of the following solutions:

  • Sterile water for injection
  • 0,9% (9 mg/ml) sodium chloride solution for injection
  • Glucose 5%

In a first step, add the volume of solution indicated in the table below to each injection vial:

Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. Swirl until dissolved. When swirled constantly, reconstitution generally occurs within 2 to 3 minutes (for details on handling, please see below).

Content of

the vial

Volume of

solvent* solution to be added to the vial

2 g/0.25 g (2 g piperacillin and 0.25 g tazobactam)

 

 

10 ml

 

 

4 g/0.5 g (4 g piperacillin and 0.5 g tazobactam)

 

 

20 ml

 

 

* Compatible solvents for reconstitution:
- 0.9% (9 mg/ml) sodium chloride solution for injection
- Sterile water for injections(1)
- Glucose 5%
(1) Maximum recommended volume of sterile water for injection per dose is 50 ml.


Shake strongly the medicinal product during 1 to 2 minutes and following this step, add the same solution to make total volume to 50 ml.

Shake strongly the medicinal product again until it is completely dissolved.

The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled amount of piperacillin and tazobactam.

The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:
- 0.9% (9 mg/ml) sodium chloride solution for injection
- Glucose 5%
- Dextrose 5% in water

Updated on 29 March 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change of special precautions for disposal

Updated on 14 September 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 9 September 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains piperacillin (as sodium salt) equivalent to 4 g and tazobactam (as sodium salt)

equivalent to 0.5 g.

Each vial of Piperacillin Tazobactam 4 g/0.5 g contains 9.4 mmol (216 mg) of sodium.

Excipients:

For a full list of excipients, see section 6.1.

4.2 Posology and Method of Administration

 

Route of administration

 

 

 

 

Piperacillin / tazobactam 4 g/0.5 g is administered by intravenous infusion (over 30 minutes).

For

 

instructions on reconstitution and dilution instructions of the medicinal product before

 

administration

 

 

, see section 6.6.


4.3 Contraindications

 

Hypersensitivity to the active substances, any other penicillin-antibacterial agent or to any of the

excipients

 

listed in section 6.1.

 

 

 

4.8 Undesirable Effects

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions

 

 

via HPRA Pharmacovigilance,

 

Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971 Fax: +353 1 6762517 Website:

www.hpra.ie; E-mail: medsafety@hpra.ie

6.4 Special Precautions for storage

 

 


 

For storage conditions

 

of the after reconstitutedreconstitution and dilutedion of the medicinal product,

 

see section 6.3.

6.5 Nature and Contents of the container

 




Not all the packs sizes may be marketed.

 

 

 

 

Updated on 15 October 2014 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 9 & 10 updated to include date of last renewal 28 February 2013 and Date of revision of text September 2014

Updated on 21 December 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 December 2011 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC now indivdual (was combined) and updated following article 30 referral.
Please note the method of administration has changed from injection to infusion only
As a consequence the name has changes from
'Piperacillin Tazobactam 4g/0.5g powder for solution for injection or infusion'
'Piperacillin Tazobactam 4g/0.5g powder for solution for infusion'