Amikin Injection 100 mg / 2 ml

  • Name:

    Amikin Injection 100 mg / 2 ml

  • Company:
    info
  • Active Ingredients:

    Amikacin Sulfate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/05/18

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 19/6/2019

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Bristol-Myers Squibb Pharmaceuticals uc

Bristol-Myers Squibb Pharmaceuticals uc

Company Products

Medicine NameActive Ingredients
Medicine Name Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 1ml Active Ingredients Triamcinolone Acetonide
Medicine Name Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 5ml Active Ingredients Triamcinolone Acetonide
Medicine Name Amikin Injection 100 mg / 2 ml Active Ingredients Amikacin Sulfate
Medicine Name Azactam 1g and 2g Powder for Solution for Injection or Infusion Active Ingredients Aztreonam
Medicine Name Hydrea 500 mg Hard Capsules Active Ingredients Hydroxycarbamide
1 - 0 of 5 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 19 June 2019 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 6 June 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
  • Change to MA holder contact details

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

Updated on 16 May 2018

Updated on 24 April 2018 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 19 April 2018 PIL

Reasons for updating

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

Updated on 23 December 2014 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 December 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Addition of ADR agreed wording in section 4.8 and updated revision date in section 10.

Updated on 19 December 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 December 2014 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 3 February 2014 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 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • 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

 

This grouped application proposes to align the summary of product characteristics (SmPC) to the Core Safety profile (CSP), approved 25th January 2013, during the harmonised PSUR application and the company core data sheet (CCDS). The associated changes have also been proposed to the patient information leaflet (PIL), as applicable.

 

In addition, the opportunity has been taken to align the SmPC and patient information leaflet to the current QRD template, excipients guideline and International naming nomenclature (INN) for ingredients amikin sulfate and sodium bisulphite and to correct typographical errors.

Updated on 24 January 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 26 June 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 2 has been revised to the following:

Each 2ml vial contains amikacin sulphate equivalent to amikacin activity 100mg (100,000 international units) in 2ml (50mg/ml).

Updated on 15 May 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 3 April 2012 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Due to the numerous changes made to the SmPC, it is not possible to list them all here.

Updated on 30 March 2012 PIL

Reasons for updating

  • PIL retired pending re-submission
  • 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

Updated on 31 January 2012 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

In section 4.2 under 'Children 4 weeks to 12 years', it says 7,5mg/kg rather than 7.5mg/kg.

In section 7, 'Holdings' has now been placed in brackets.

Updated on 27 January 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 3 March 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 2 March 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 25 January 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

The following changes have been made to the SPC:

Section 4.1

Consideration should be given to official guidance on the appropriate use of

antibacterial agents

Section 4.2:

Adults and children over 12 years:

The recommended intramuscular or intravenous dosage for adults and adolescents

with normal renal function (creatinine clearance

 

50 ml/min) is 15 mg/kg/day which

 

may be administered as a single daily dose or divided into 2 equal doses i.e. 7.5 mg/kg

q 12 h. The total daily dose should not exceed 1.5 g. In endocarditis and in febrile

neutropenic patients dosing should be twice daily, as there is not enough data to

support once daily dosing.

Children 4 weeks to 12 years:

The recommended intramuscular or intravenous (slow intravenous infusion) dose in

children with normal renal function is 15-20 mg/kg/day which may be administered as

15-20 mg/kg, once a day; or as 7,5 mg/kg q 12 h. In endocarditis and in febrile

neutropenic patients dosing should be twice daily, as there is not enough data to

support once daily dosing.

Neonates:

An initial loading dose of 10 mg/kg followed by 7.5 mg/kg q 12 h (see

sections 4.4 and 5.2).

Premature infants:

The recommended dose in prematures is 7.5 mg/kg in every 12 hours (see sections 4.4

and 5.2).

Specific recommendation for intravenous administration

In paediatric patients the amount of diluents used will depend on the amount of

amikacin tolerated by the patient. The solution should normally be infused over a 30 to

60 minute period. Infants should receive a 1 to 2 hour infusion.

 

 

Section 4.4:

Paediatric use

Aminoglycosides should be used with caution in premature and neonatal infants

because of the renal immaturity of these patients and the resulting prolongation of

serum half-life of these drugs.

Section 4.6:

There are limited data on use of aminoglycosides in pregnancy.

Aminoglycosides can cause foetal harm. Aminoglycosides cross the placenta

and there have been reports of total, irreversible, bilateral congenital deafness in

children whose mothers received streptomycin during pregnancy. Although

adverse effects on the foetus or newborns have not been reported in pregnant

women treated with other aminoglycosides, the potential for harm exists. In

reproduction toxicity studies in mice and rats no effects on fertility or foetal

toxicity were reported. If amikacin is used during pregnancy or if the patient

becomes pregnant while taking this drug, the patient should be apprised of the

potential hazard to the foetus.

It is not known whether amikacin is excreted in human milk. A decision should be made whether to discontinue breast-feeding or to discontinue therapy.

Amikacin should be administered to pregnant women and neonatal infants only

when clearly needed and under medical supervision (see section 4.4).

Section 5.2:

Data from multiple daily dose trials show that spinal fluid levels in normal infants are

approximately 10 to 20% of the serum concentrations and may reach 50% in meningitis.

Intramuscular and intravenous administration

In neonates and particularly in premature babies, the renal elimination of amikacin is reduced.

In a single study in newborns (1-6 days of post natal age) grouped according to birthweights

(<2000, 2000-3000 and >3000g). Amikacin was administered

 

 

intramuscularly and/or

 

intravenously at a dose of 7.5 mg/kg. Clearance in neonates >3000 g was 0.84 ml/min/kg and

terminal half-life was about 7 hours. In this group, the initial volume of distribution and

volume of distribution at steady state was 0.3 ml/kg and 0.5 mg/kg, respectively. In the groups

with lower birth weight clearance/kg was lower and half-life longer. Repeated dosing every 12

hours in all the above groups did not demonstrate accumulation after 5 days.

 

 



Updated on 19 January 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to information about pregnancy or lactation

Updated on 18 February 2010 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

None provided

Updated on 11 February 2010 PIL

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)