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Profile Pharma Limited

Suite 3 Ground Floor, Bicentennial Building, Southern Gate, Chichester, West Sussex, PO19 8EZ
Telephone: +44 (0)1243 859 000
Fax: +44 (0)1243 859 001
WWW: http://www.profilepharma.com
Medical Information Direct Line: +44 (0)800 0288 942
Medical Information Direct Line: +44 (0)800 0288 942 (Out of Hours)
Medical Information e-mail: info.profilepharma@zambongroup.com
Summary of Product Characteristics last updated on medicines.ie: 12/01/2018
SPC Promixin 1 million International Units (IU) Powder for Nebuliser Solution

When a pharmaceutical company changes an SPC or PIL, 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 12/01/2018 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-Dec-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Previously in section 4.2 there was only 1 table (detailing data on 1MIU doses), however this has been deleted and replaced by 2 tables that show data on low ("1 MIU)" and high "(2 MIU) doses both with different nebulisers.

The following table has been deleted:

Characteristic

Nebuliser system

Respironics

I-neb AAD

Pari LC plus with Pari TurboBoy S compressor

Respironics Sidestream with Portaneb compressor

With 0.3 mL

(grey) medication chamber

With 0.5 mL

(lilac) medication chamber

(a)

Droplet Size Distribution

(µm)

Median Particle Size:     d50

4.34

4.81

4.78

3.32

(b)

Total Drug Delivered from Nebuliser mouthpiece

(Million IU)

0.333

0.579

0.407

0.239

(c)

Fine Particle Fraction

 (% < 5µm)

59.55

53.01

52.67

76.07

(d)

Total Drug Delivered to patient

(Million IU < 5 µm)

0.198

0.307

0.214

0.182

(e)

Delivery Time 

3 minutes,

36 seconds

8 minutes,

29 seconds

7 minutes,

4 seconds

5 minutes,

18 seconds

(f)

Drug Delivery Rate to patient

(Million IU/minute)

0.055

0.036

0.030

0.034

·      Measured using 1 million IU of Promixin reconstituted using 1mL (I-neb AAD) and 3mL (Pari LC plus and Sidestream) of a 50:50 mixture of WFI and 0.9% saline to the recommended volume for each nebuliser   system.

·      TurboBoy S operated at 1.2 bar pressure, 4.5 L/min flow rate. Portaneb operated at: 0.8 bar pressure, 6 L/min flow rate

·      (d) is calculated from (b) / 100 x (c) 

·      (f)  = (d) / (e)

 

 

 

 

 

 

 

 

It has been replaced by the two tables shown below:

Characteristic

Nebuliser system

Respironics I-neb AAD with 0.3mL (grey) medication chamber

 Pari eflow rapid

Pari LC Sprint with Pari Boy SX compressor

Promixin dose placed in nebuliser system

1 million IU

in 1mL

1 million IU

in 3mL

1 million IU

in 3mL

(a)

Droplet Size Distribution;

Median Particle Size:  d50

(µm)

4.34

4.56

4.37

(b)

Total Drug Delivered from Nebuliser mouthpiece #

(Million IU)

0.333

0.277

0.385

(c)

Fine Particle Fraction

 (% < 5µm)

59.55

58.19

57.73

(d)

Fine Particle Dose Delivered from Nebuliser mouthpiece #

(Million IU < 5 µm)

0.198

0.161

0.222

(e)

Delivery Time # 

 3 minutes,

 36 seconds

5 minutes,

0 seconds

6 minutes,

40 seconds

(f)

Drug Delivery Rate from Nebuliser mouthpiece #

(Million IU/minute)

0.055

0.032

0.033

#  Measured using a simulated inhalation: exhalation (I:E) ratio of 1:1, a tidal volume of 500mL and 15 breathes per minute.

•   All Promixin reconstituted with a 50:50 mixture of WFI and 0.9% saline to the recommended volume for each nebuliser system.

•   Pari Boy SX operated at 1.6 bar pressure, 5.1L/min flow rate.

•   (d) is calculated from (b) / 100 x (c) 

•   (f)  = (d) / (e)

 

 

 

 

 

 

 

 

 



Characteristic

Nebuliser system

Respironics I-neb AAD with 0.5mL

(lilac) medication chamber

Pari eflow rapid

Pari LC Sprint with Pari Boy SX compressor

Promixin dose placed in nebuliser system

1 million IU

in 1mL

2 million IU

in 4mL

2 million IU

in 4mL

(a)

Droplet Size Distribution;

Median Particle Size:   d50

(µm)

4.81

4.31

4.35

(b)

Total Drug Delivered from Nebuliser mouthpiece #

(Million IU)

0.579

0.601

0.861

(c)

Fine Particle Fraction

 (% < 5µm)

53.01

63.11

57.73

(d)

Fine Particle Dose Delivered from Nebuliser mouthpiece #

(Million IU < 5 µm)

0.307

0.379

0.497

(e)

Delivery Time #

 8 minutes,

 29 seconds

6 minutes,

38 seconds

11 minutes,

32 seconds

(f)

Drug Delivery Rate from Nebuliser mouthpiece #

(Million IU/minute)

0.036

0.057

0.043

#  Measured using a simulated inhalation: exhalation (I:E) ratio of 1:1, a tidal volume of 500mL and 15 breathes per minute.

•   All Promixin reconstituted with a 50:50 mixture of WFI and 0.9% saline to the recommended volume for each nebuliser system.

•   Pari Boy SX operated at 1.6 bar pressure, 5.1L/min flow rate.

•   (d) is calculated from (b) / 100 x (c) 

•   (f)  = (d) / (e)

In section 10, the date of the revision of the text has changed from:

December 2015

To:

December 2017
Updated on 03/02/2016 and displayed until 12/01/2018
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11-Dec-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Summarised Changes

RED FONT – added text

BLUE FONT – deleted text
BLACK FONT - no change

 

4.8      Undesirable effects

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

IMB Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie


6.3     Shelf life

Unopened: 2 years.

After reconstitution:

Chemical and physical in-use stability of solution reconstituted in the original vial has been demonstrated for up to 24 hours at 2 to 8ºCroom temperature. Patients self-treating with nebulised antibiotic should be advised to use solutions immediately after preparation. If this is not possible, solutions should not be stored for longer than 24hrs in a refrigerator.

6.5     Nature and contents of container

The product is supplied in a clear type I glass 10R ISO vials (nominal volume 10mL) sealed with a siliconised chlorobutyl type I rubber stopper and protected by a 20 mm aluminium tear-off cap incorporating a red flip-up central plastic top. The product is supplied in packs of 30 vials. In member states where the I-neb is in use, eEach pack also contains a Promixin Disc to enable use with the I-neb AAD System.

6.6     Special precautions for disposal and other handlingInstructions for use, handling and disposal

Promixin may be reconstituted to produce a clear colourless to pale yellow solution,with either Water for Injections (WFI) to produce a clear colourless to pale yellow hypotonic solution, or a 50:50 mixture of WFI and 0.9% sodium chloride saline to produce an clear colourless to pale yellow isotonic solution, or with 0.9% sodium chloride to produce a hypertonic solution. The volume used for reconstitution should be in accordance with the instructions for use provided with the nebuliser device, and is normally not more than 4ml.  During reconstitution swirl gently to avoid frothing. When reconstituted, Promixin may be used with any conventional nebuliser suitable for delivery of antibiotic solutions.

Solutions should be used immediately after reconstitution, however if this is not possible solutions must be used within 24 hours and stored in a refrigerator.  Any unused solution remaining in the nebuliser must be discarded following treatment. Promixin is supplied with a Promixin Disc, for use with the I-neb AAD System. For instructions on the use of Promixin with the I-neb AAD System, please refer to detailed instructions provided with the device.

Conventional nebulisers operate on a continuous flow basis and it is likely that some nebulised drug will be released into the local environment. When used with a conventional nebuliser, Promixin should be administered in a well-ventilated room, particularly in hospitals where several patients may be using nebulisers at the same time. Tubing or filters may be used to prevent waste aerosol from entering the environment.

10.     Date of revision of the text

JuneDecember 2015

Updated on 23/06/2015 and displayed until 03/02/2016
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Jun-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Changes implemented as requested by the European Commission following conclusion of the CHMP Article 31 referral on colistimethate sodium products. 

 

As the EMEA recognise that colistimethate sodium/colistin is a crucial therapeutic option in the treatment of infections caused by multi-drug resistant Gram-negative pathogens this referral was to seek the CHMP to evaluate the benefit-risk of polymyxin-based products and whether and further regulatory measures need to be taken to ensure its correct use.    

the main 3 changes being that the wording of the indication has been amended (not significantly); deleting the lower age limit and  adding specific dosing recommendations for use in children under 2 years of age; and adding a dosing conversion table has been added to explain the different expressions of potency currently in use. 
Updated on 26/01/2015 and displayed until 23/06/2015
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   07-Mar-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 6.3:

Unopened: 2 years.

After reconstitution:

Chemical and physical in-use stability has been demonstrated for up to 24 hours at room temperature. Patients self-treating with nebulised antibiotic should be advised to use solutions immediately after preparation. If this is not possible, solutions should not be stored for longer than 24hrs in a refrigerator.


Section 6.7:

Solutions should be used immediately after reconstitution, however if this is not possible solutions must be used within 24 hours and stored in a refrigerator.  Any unused solution remaining in the nebuliser must be discarded following treatment.
Updated on 20/07/2011 and displayed until 26/01/2015
Reasons for adding or 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Text in blue or grey is pre-existing text. Added or deleted text is in black.

NEWLY ADDED TEXT (IN BLACK)

4.2 POSOLOGY & METHOD OF ADMINISTRATION

Children < 2 years: The safety and efficacy of Promixin has not been demonstrated in patients less than 2 years of age.

Mode of administration

Promixin for nebulisation is intended for administration by nebulisation using a suitable nebuliser. 

Drug delivery characteristics from in vitro studies with different nebuliser systems are detailed below:

Characteristic

Nebuliser system

Respironics

I-neb AAD

Pari LC plus with Pari TurboBoy S compressor

Respironics Sidestream with Portaneb compressor

With 0.3 mL

(grey) medication chamber

With 0.5 mL

(lilac) medication chamber

(a)

Droplet Size Distribution

(µm)

Median Particle Size:  d50

4.34

4.81

4.78

3.32

(b)

Total Drug Delivered from Nebuliser mouthpiece

(Million IU)

0.333

0.579

0.407

0.239

(c)

Fine Particle Fraction

 (% < 5µm)

59.55

53.01

52.67

76.07

(d)

Total Drug Delivered to patient

(Million IU < 5 µm)

0.198

0.307

0.214

0.182

(e)

Delivery Time 

3 minutes,

36 seconds

8 minutes,

29 seconds

7 minutes,

4 seconds

5 minutes,

18 seconds

(f)

Drug Delivery Rate to patient

(Million IU/minute)

0.055

0.036

0.030

0.034

·      Measured using 1 million IU of Promixin reconstituted using 1mL (I-neb AAD) and 3mL (Pari LC plus and Sidestream) of a 50:50 mixture of WFI and 0.9% saline to the recommended volume for each nebuliser   system.

·      TurboBoy S operated at 1.2 bar pressure, 4.5 L/min flow rate. Portaneb operated at: 0.8 bar pressure, 6 L/min flow rate

·      (d) is calculated from (b) / 100 x (c) 

·      (f)  = (d) / (e)

































































For special precautions for disposal and handling of reconstituted solutions, see Section 6.6.  

4.3 CONTRAINDICATIONS

Promixin is contraindicated in patients with known hypersensitivity to colistimethate sodium or other polymyxins.

4.4 SPECIAL WARNINGS & PRECAUTIONS FOR USE

Renal impairment

Colistimethate sodium is renally excreted and is nephrotoxic if high serum concentrations are achieved.  Whilst this is unlikely during inhalation therapy, serum concentration estimations are recommended especially in patients with renal impairment.

Microbial Resistance

Colistimethate sodium acquired resistance in mucoid Pseudomonas aeruginosa during clinical use has been reported. Susceptibility testing should be performed on patients who are treated on a long term basis, at regular clinic visits, and whenever a patient experiences an exacerbation (see Section 5.1).

4.6 FERTILITY, PREGNANCY & LACTATION

Animal studies do not indicate a teratogenic potential.

5.1 PHARMACODYNAMIC PROPERTIES

Mode of action

Colistimethate sodium is a prodrug of colistin, a polymyxin antibiotic , (belonging to the polymyxin E group). It is a polypeptide structure and is derived from Bacillus polymyxa var. colistinus.

PK/PD relationship

Polymyxins have been reported to have a concentration-dependent bactericidal effect on susceptible bacteria.

Mechanisms of resistance

Resistance develops due to modifications of lipopolysaccharide (LPS) or other components in the bacterial cell membrane.

Susceptibility

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.  As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Species for which acquired resistance may be a problem

Stenotrophomonas maltophilia

Achromobacter xylosoxidans (formerly Alcaligenes xylosoxidans)

Inherently resistant organisms

Burkholderia cepacia and related species

Proteus spp

Providencia spp

Serratia spp

Resistance

Colistimethate sodium acquired resistance in mucoid Pseudomonas aeruginosa has been reported to be approximately 3%. However, local rates of resistance may vary including higher rates (see Section 4.4).

5.2 PHARMACOKINETIC PROPERTIES

Pharmacokinetics

A study in healthy volunteers, who inhaled colistimethate sodium, demonstrated the Cmax of polymyxin E1 (the active moiety) varied between 40.0 and 69.9 ng/mL and the AUC varied between 350 and 668 ng/mL/h depending on the nebuliser and the fill volume and concentration, which varied the dose from 0.3 million IU to 2 million IU. The half-life was approximately 5.2 hours.  The absolute bioavailability was calculated to vary between 5% and 18% depending on the nebuliser.  The AUC following an intravenous dose of 0.5 million IU was 3,352 ng/ml/h and the Cmax was 1,232 ng/mL.

Elimination

Following i.v. administration excretion is primarily renal with 62% of a parenteral dose recovered in the urine within 8 hours and around 80% in 24 hours.

5.3 PRE-CLINICAL SAFETY DATA

Animal studies with colistimethate do not indicate adverse effects on fertility or embryo-foetal development. Peri-postnatal studies have not been conducted.

Data on potential genotoxicity and carcinogenicity for colistimethate sodium are lacking. Colistin has been shown to induce chromosomal aberrations in human lymphocytes in vitro an effect that might be related to a reduction in mitotic index, which was also observed. Colistin was not mutagenic in a set of other tests.

6.2 INCOMPATIBILITIES

This medicinal product should not be mixed with other medicinal products except those mentioned in section 6.6.

10 DATE OF REVISION OF TEXT

June 2011

 

REMOVED TEXT (IN BLACK)

4.2 POSOLOGY & METHOD OF ADMINISTRATION

The dosage is determined by the severity and type of infection, and renal function of the patient.

Colistimethate sodium is renally excreted and is nephrotoxic if high serum concentrations are achieved.  Whilst this is unlikely during inhalation therapy, serum concentration estimations are recommended especially in patients with renal impairment.

Where there is renal impairment, excretion may be delayed and the daily dosage (magnitude of dose and dose interval) must be adjusted in relation to renal function to prevent accumulation of colistimethate sodium as indicated in the table.

Suggested modification of dosage of Promixin for patients with impaired renal function

 

Degree of Renal Impairment

Normal

Mild

Moderate

Severe

Creatinine

(mmol/L)

60 – 105

106 - 129

130 - 214

215 – 340

Creatinine Clearance

(% of normal)

76 to 100

40 to 75

25 to 40

Less than 25

Dose

 

 

 

 

Unit dose

(Million IU)

1.3  to 2

1 to 1.5

1

1 to 1.5

Frequency

(Times per day)

3

2

1 or 2

Every 36 hours

Total Daily Dose (Million IU)

4 to 6

2 to 3

1 to 2

0.6 to 1

Promixin is administered by nebulisation using a suitable nebuliser.  For instructions on reconstitution of the product before administration see section 6.6.  Once reconstituted use immediately.

4.4 SPECIAL WARNINGS & PRECAUTIONS FOR USE

Use with caution in renal impairment as colistimethate sodium is renally excreted.

4.6 FERTILITY, PREGNANCY & LACTATION

Animal studies are insufficient with respect to effects on reproduction.

5.1 PHARMACODYNAMIC PROPERTIES

General properties

Colistimethate sodium is a polymyxin antibiotic and is derived from Bacillus polymyxa var. colistinus. It is a polypeptide and is active against a number of aerobic, Gram-negative bacteria.

Breakpoints

Susceptible (S) ≤ 4 mg/L    Resistant (R) ³ 8 mg/L

Susceptibility

The table below lists bacterial species which are regarded as susceptible to colistimethate sodium. Bacterial resistance may vary according to region and information on resistant species in a specific area is desirable, particularly when treating severe infections. Only bacteria likely to be relevant to the clinical indication are listed.

SUSCEPTIBLE BACTERIA

RESISTANT BACTERIA

Acinetobacter species

Haemophilus influenzae

Klebsiella species

Pseudomonas aeruginosa

Brucella species

Burkholderia cepacia and related species

Serratia species

Proteus mirabilis

Resistance

Colistimethate sodium acquired resistance in mucoid Pseudomonas aeruginosa has been reported to be approximately 3%. Susceptibility testing should be performed on patients who are treated on a long term basis.

Cross resistance

Polymyxins including colistimethate sodium differ in their mechanism of action compared with other antibiotics and there is evidence to show that Gram-negative bacteria resistant to other antibiotics may be susceptible to colistimethate sodium.  The resistance to polymyxins is not crossed with other antibiotic families.

5.2 PHARMACOKINETIC PROPERTIES

Absorption

Gastrointestinal absorption is negligible hence the swallowing of colistimethate sodium deposited in the nasopharynx is unlikely to add to the systemic exposure. Absorption following lung administration appears to be variable and clinical work has shown that resultant serum concentrations may range from undetectable to rarely exceeding 4 mg/L (50,000 IU/L) compared to serum concentrations of 10–20 mg/L (approx. 125,000-250,000 IU/L) following intravenous use. Absorption following lung administration is influenced by the nebuliser system, aerosol droplet size and disease state of the lungs. A study in cystic fibrosis patients showed that colistimethate sodium was undetectable in the urine after 1 million IU were inhaled twice daily for 3 months. This is despite the fact that excretion is known to be primarily via the urine.

Distribution

Colistimethate sodium shows a low level of protein binding. Polymyxin antibiotics are known to persist in muscle tissue, liver, kidney, heart and brain.

Pharmacokinetics

Serum concentrations and pharmacokinetics in 5 patients receiving inhaled colistimethate sodium

Parameter

160 mg (Approximately 2 million IU) Nebulised Colistimethate Sodium

AUC0-4 (h/mg/L)

165.9 ± 76.5

Cmax (mg/L)

0.051 ± 0.0244

Tmax (h)

1.9 ± 1.2

Ka (h-1)

3.0 ± 1.8

t½ (h)

10.4 ± 3.6

Cl/F

0.27 ± 0.15

Volume of distribution has been calculated to be 0.09 L/Kg in a single study in patients with cystic fibrosis (CF).

Biotransformation

Colistimethate sodium undergoes conversion to its base in vivo. Approximately 80% of the parenteral dose is recoverable unchanged in the urine. There is no biliary excretion.

Elimination

There is no information on the elimination of colistimethate sodium following nebulisation.

Following i.v. administration excretion is primarily renal with 40% of a parenteral dose recovered in the urine within 8 hours and around 80% in 24 hours. It follows that dose should be reduced in the renally impaired in order to prevent accumulation. Refer to Section 4.2.

The elimination half-life is approximately 1.5 hours following i.v. administration to healthy adults. This compares with an elimination half-life of 3.4 ± 1.4 hours when CF patients were given a single 30 minute i.v. infusion.

Colistimethate sodium kinetics appear to be similar in all patient groups provided renal function is normal.

5.3 PRE-CLINICAL SAFETY DATA

Animal studies are insufficient with respect to effects on reproduction.

Data on potential genotoxicity are limited and carcinogenicity data for colistimethate sodium are lacking. Colistimethate sodium has been shown to induce chromosomal aberrations in human lymphocytes, in vitroThis effect may be related to a reduction in mitotic index, which was also observed.

10 DATE OF REVISION OF TEXT

January 2009

Updated on 29/06/2009 and displayed until 20/07/2011
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   01-Jan-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

4.4 Nephrotoxicity or neurotoxicity may rarely occur especially if the recommended dose is exceeded (see also section 4.5).
4.8 Impairment of renal function has been reported, usually following use of higher than recommended i.v. or i.m. doses in patients with normal renal function, or failure to reduce the i.v. or i.m dosage in patients with renal impairment or when used concomitantly with other nephrotoxic antibiotics. The effect is usually reversible on discontinuation of therapy.High serum concentrations of colistimethate sodium, which may be associated with overdosage or failure to reduce the dosage in patients with renal impairment, have been known to lead to neurotoxicity. Concomitant use with either curariform agents or antibiotics with similar neurotoxic effects can also lead to neurotoxicity. Dose reduction of colistimethate sodium may relieve symptoms. Neurotoxic effects that have been reported include: vertigo, transient facial paraesthesia, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea.
10. Date of revision of the textNovember 2006 September 2008
Updated on 26/02/2007 and displayed until 29/06/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder address
  • Change to MA holder contact details
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 7: Change of address, telephone and fax number for the MA holder.

Section 10: Date of revision of text changed to January 2007

Updated on 07/03/2006 and displayed until 26/02/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Colistimethate Sodium