Fomicyt

Main information

  • Trade name:
  • Fomicyt 2g powder for solution for infusion vials
  • Pharmaceutical form:
  • Powder for solution for infusion (385231004)
  • Administration route:
  • Intravenous (47625008)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fomicyt 2g powder for solution for infusion vials
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF code: 05010700

Other information

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15011/0017
  • Last update:
  • 23-06-2018

Summary of Product characteristics: dosage,interactions,side effects

Object 1

Fomicyt 40mg/ml Powder for Solution for

Infusion

Summary of Product Characteristics Updated 11-Dec-2017 | Nordic Pharma Limited

1. Name of the medicinal product

Fomicyt 40 mg/ml powder for solution for infusion

2. Qualitative and quantitative composition

One ml of reconstituted solution contains 40 mg fosfomycin.

Each bottle with 2.69 g of powder contains 2.64 g disodium fosfomycin, corresponding to 2 g fosfomycin

and 0.64 g sodium, for reconstitution in 50 ml of solvent.

Each bottle with 5.38 g of powder contains 5.28 g disodium fosfomycin, corresponding to 4 g fosfomycin

and 1.28 g sodium, for reconstitution in 100 ml of solvent.

Each bottle with 10.76 g of powder contains 10.56 g disodium fosfomycin, corresponding to 8 g

fosfomycin and 2.56 g sodium, for reconstitution in 200 ml of solvent.

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Powder for solution for infusion.

White to cream-coloured powder.

4. Clinical particulars

4.1 Therapeutic indications

Fosfomycin is indicated for the treatment of the following infections in adults and children including

neonates (see section 5.1):

- Osteomyelitis

- Complicated urinary tract infections

- Nosocomial lower respiratory tract infections

- Bacterial meningitis

- Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections

listed above

Fosfomycin should be used only when it is considered inappropriate to use antibacterial agents that are

commonly recommended for the initial treatment of the infections listed above, or when these alternative

antibacterial agents have failed to demonstrate efficacy.

For information regarding the combination with other antibiotics see section 4.4 and 4.5.

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

4.2 Posology and method of administration

The daily dose of fosfomycin is determined based on the indication, severity and site of the infection,

susceptibility of the pathogen(s) to fosfomycin and the renal function. In children, it is also determined by

age and body weight.

Adults and adolescents ≥ 12 years of age (> 40 kg):

Fosfomycin is primarily excreted renally unchanged. The general dosage guidelines for adults with

estimated creatinine clearance > 80 ml/min are as follows:

Indication

Daily dose

Osteomyelitis

12–24 g

in 2–3 divided doses

Complicated urinary tract infection

12–16 g in 2–3 divided doses

Nosocomial lower respiratory tract infection

12–24 g

in 2–3 divided doses

Bacterial meningitis

16–24 g

in 3–4 divided doses

Individual doses must not exceed 8 g.

The high-dose regimen in 3 divided doses should be used in severe infections expected or known to be

caused by less susceptible bacteria.

There are limited safety data in particular for doses in excess of 16 g/day. Special caution is advised when

such doses are prescribed.

Dosage in renal insufficiency

The dose recommendations for patients with renal impairment are based on pharmacokinetic modelling

and limited clinical data; safety and efficacy have not yet been evaluated in clinical trials.

It is unclear if dose reductions are necessary for patients with an estimated creatinine clearance between

40–80 ml/min. Great caution should be exercised in these cases, particularly if doses at the higher end of

the recommended range are considered.

In patients with impaired renal function the dose of fosfomycin must be adjusted to the degree of renal

impairment.

Dose titration should be based on creatinine clearance values. In adults, creatinine clearance may be

calculated according to the following formula by Cockroft and Gault:

In order to calculate CL

in women, the result of this formula is multiplied by 0.85.

Dosage table for patients with impaired renal function:

CR patient

CR patient

/ CL

CR normal

Daily dosage recommended

40 ml/min

0.333

70% (in 2–3 divided doses)

30 ml/min

0.250

60% (in 2–3 divided doses)

20 ml/min

0.167

40% (in 2–3 divided doses)

10 ml/min

0.083

20% (in 1–2 divided doses)

The dose is expressed as a proportion of the dose that would have been considered appropriate if the

patient's renal function were normal

The first dose should be increased by 100% (loading dose), but must not exceed 8 g.

Patients undergoing renal replacement therapy

Patients undergoing chronic intermittent dialysis (every 48 hours) should receive 2 g of fosfomycin at the

end of each dialysis session.

During continuous veno-venous hemofiltration (post-dilution CVVHF), fosfomycin is effectively

eliminated. Patients undergoing post-dilution CVVHF will not require any dose adjustment (see section

5.2).

No clinical data exist for intravenous fosfomycin in patients undergoing pre-dilution CVVHF or other

forms of renal replacement therapy.

Hepatic impairment

There are no data indicating that dose adjustment is necessary in patients with hepatic impairment.

Elderly patients

The recommended doses for adults should be used in elderly patients. Caution is advised when

considering the use of doses at the higher end of the recommended range (see also recommendations on

dosage for patients with impaired renal function).

Paediatric population

Dose recommendations are based on very limited data.

Neonates, infants and children < 12 years of age (< 40 kg)

The dosage of fosfomycin in children should be based on age and body weight (BW):

Age/weight

Daily dose

Premature neonates

(age

< 40 weeks)

100 mg/kg BW in 2 divided doses

Neonates

200 mg/kg BW in 3 divided doses

(age

40–44 weeks)

Infants 1–12 months

(up to 10 kg BW)

200–300

mg/kg BW in 3 divided doses

Infants and children aged 1–12 years

(10–40 kg BW)

200–400

mg/kg BW in 3–4 divided doses

Sum of gestational and postnatal age.

The high-dose regimen may be considered for severe infections and or serious infections (such as

meningitis), in particular when known or suspected to be caused by organisms with moderate

susceptibility.

No dose recommendations can be made for children with renal impairment.

Method and duration of administration

Method of administration

Disodium fosfomycin is intended for intravenous administration. The duration of infusion should be at

least 15 minutes for the 2 g pack size, at least 30 minutes for the 4 g pack size and at least 60 minutes for

the 8 g pack size.

Use only clear solutions.

As damaging effects can result from inadvertent intra-arterial administration of products not specifically

recommended for intra-arterial therapy, it is essential to ensure that fosfomycin is only administered into

veins.

For preparation of the solution for infusion see section 6.6.

Duration of treatment

Treatment duration should take into account the type of infection, the severity of the infection as well as

the patient's clinical response. Relevant therapeutic guidelines should be adhered to when deciding

treatment duration.

4.3 Contraindications

- Hypersensitivity to the active substance, fosfomycin, or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Consideration should be given to co-administering intravenous fosfomycin with another antibacterial

agent, taking into account the remaining susceptibilities of the pathogen(s) under treatment. As it is

unknown whether the development of resistance to intravenous fosfomycin is higher when it is used as a

monotherapy, co-administration with other antibacterials should also be considered in order to prevent the

emergence of resistance.

1 g fosfomycin (equivalent to 1.32 g disodium fosfomycin) contains 14 mmol (320 mg) sodium. One

bottle with 2 g of fosfomycin contains 28 mmol (640 mg) sodium, one bottle with 4 g fosfomycin

contains 56 mmol (1280 mg) sodium and one bottle with 8 g of fosfomycin contains 111 mmol (2560 mg)

sodium.

A high sodium load associated with the use of fosfomycin may result in decreased levels of potassium in

serum or plasma. A low-sodium diet is recommended during treatment. The substitution of potassium

may be necessary in some cases. Serum electrolyte levels and water balance must be monitored during

therapy. Caution is advised when fosfomycin is used in patients with cardiac insufficiency, hypertension,

hyperaldosteronism, hypernatraemia or pulmonary oedema.

Acute, potentially life-threatening hypersensitivity reactions (anaphylactic shock) may occur in very rare

cases. At the first signs (including sweating, nausea, cyanosis), the infusion of fosfomycin must be

immediately discontinued. The intravenous line should be left in place. Depending upon the clinical

situation, appropriate emergency measures may need to be initiated.

Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all

antibacterial agents including fosfomycin, and may range in severity from mild to life-threatening.

Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or

subsequent to the administration of fosfomycin. Discontinuation of therapy with fosfomycin and the

administration of specific treatment for Clostridium difficile should be considered. Medicinal products

that inhibit peristalsis should not be given.

In patients with severe renal insufficiency (creatinine clearance ≤ 40ml/min), the elimination of

fosfomycin is substantially slowed. See section 4.2 for appropriate dosing of fosfomycin in renal

insufficiency.

4.5 Interaction with other medicinal products and other forms of interaction

No drug-drug interaction studies have been performed with fosfomycin. To date, no clinically relevant

pharmacological interactions between fosfomycin and other agents (drugs, stimulants or foodstuffs) have

been reported.

Combination with other antibiotics

In-vitro tests have shown that the combination of fosfomycin with a β-lactam antibiotic such as penicillin,

ampicillin, cefazolin or the class of carbapenems, usually shows an additive to synergistic effect. The

same applies to the combination of fosfomycin with most anti-staphylococcal (linezolid,

quinupristin/dalfopristin, moxifloxacin) agents in the treatment of staphylococcal infections. The

combination of fosfomycin with aminoglycosides has predominantly indifferent to additive effects.

4.6 Fertility, pregnancy and lactation

Fertility

To date, in humans no reduction in fertility after therapy with fosfomycin has been reported. In male and

female rats, reduced fertility was observed after the oral administration of fosfomycin at supra-therapeutic

doses (see section 5.3.).

Pregnancy

For fosfomycin, no clinical data on pregnancies are available. Animal studies do not indicate direct or

indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal

development (see section 5.3). Fosfomycin should therefore not be prescribed to pregnant women unless

the benefit outweighs the risk.

Lactation

After the administration of fosfomycin, low quantities of fosfomycin were found in human milk.

Fosfomycin should therefore not be administered during lactation, unless the benefit outweighs the risk.

4.7 Effects on ability to drive and use machines

Occasionally, even if the product is correctly administered, side effects may occur which impair the

ability to drive and use machines (see also section 4.8).

4.8 Undesirable effects

Summary of the safety profile

The most commonly reported adverse reactions during treatment are gastrointestinal disturbances and

injection site reactions. Other important adverse reactions include hypokalaemia and/or hypernatraemia.

Tabulated list of adverse reactions

Undesirable effects are listed by body system and frequency in accordance with the following

classification:

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

Very rare:

< 1/10,000

Not known:

cannot be estimated from the available data

System Organ Class

Frequency

Category

Adverse Drug Reactions

Blood and lymphatic

system disorders

Rare

Aplastic anaemia, eosinophilia

Frequency not

known

Agranulocytosis, granulocytopenia, leucopenia,

pancytopenia, thrombocytopenia, neutropenia

Immune system

disorders

Very rare

Anaphylactic shock (see section 4.4)

Metabolism and

nutrition disorders

Uncommon

Decreased appetite, hypernatraemia and/or hypokalaemia

(see section 4.4), oedema

Psychiatric disorders

Frequency not

known

Confusion

Nervous system

disorders

Uncommon

Dysgeusia, headache

Eye disorders

Very rare

Visual impairment

Ear and labyrinth

disorders

Uncommon

Vertigo

Cardiac disorders

Frequency not

known

Tachycardia

Respiratory, thoracic

and mediastinal

disorders

Uncommon

Dyspnoea

Frequency not

known

Asthmatic attack

Gastrointestinal

disorders

Common

Retching, stomach ache

Uncommon

Nausea, vomiting, diarrhoea

Frequency not

known

Pseudomembranous colitis (see section 4.4)

Hepatobiliary

disorders

Uncommon

Blood alkaline phosphatase, aspartate aminotransferase and

alanine aminotransferase increased (transient)

Very rare

Fatty liver (completely reversible after discontinuation of

fosfomycin)

Frequency not

known

Hepatitis, cholestatic hepatitis, icterus

Skin and subcutaneous

tissue disorders

Uncommon

Rash

Frequency not

known

Angioedema, facial oedema, pruritus, urticaria

General disorders and

administration site

conditions

Common

Injection site phlebitis

Uncommon

Fatigue

Description of selected adverse reactions

Hypokalaemia may result in diffuse symptoms such as weakness, tiredness or oedema and/or muscle

twitching. Severe forms may cause hyporeflexia and cardiac arrhythmia. Hypernatraemia may be

associated with hypertension and signs of fluid overload such as oedema (see section 4.4).

Paediatric population

Limited safety information is available from the paediatric population. Frequency, type and severity of

adverse reactions may be expected to be similar to the adult population.

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 the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

4.9 Overdose

To date, no cases of accidental overdose with clinically relevant intolerances have been reported. If an

overdose is believed to have taken place, the patient must be monitored (particularly for plasma/serum

electrolyte levels) and treated symptomatically. Fosfomycin is effectively cleared from the body by

haemodialysis with a mean elimination half-life of approximately 4 hours.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antibiotics for systemic use, other antibacterials

ATC-Code: J01XX01

Mode of action

Fosfomycin exerts a bactericidal effect on proliferating pathogens by preventing the enzymatic synthesis

of the bacterial cell wall. Fosfomycin inhibits the first stage of intracellular bacterial cell wall synthesis by

blocking peptidoglycan synthesis.

Fosfomycin is actively transported into the bacterial cell via two different transport systems (the sn-

glycerol-3-phosphate and hexose-6 transport systems).

Pharmacokinetic (PK)/pharmacodynamic (PD) relationship

Limited data indicate that fosfomycin most likely acts in a time-dependent manner.

Resistance mechanism

Main mechanism of resistance is a chromosomal mutation causing an alteration of the bacterial

fosfomycin transport systems. Further resistance mechanisms, which are plasmid- or transposon-borne,

cause enzymatic inactivation of fosfomycin by binding the molecule to glutathione or by cleavage of the

carbon-phosphorus-bond in the fosfomycin molecule, respectively.

Cross-resistance

The mode of action of fosfomycin differs from that of all other antibiotic classes. Fosfomycin was

generally found to be active in-vitro against clinical isolates of methicillin-resistant staphylococci,

vancomycin-resistant enterococci, penicillin- and erythromycin-resistant streptococci and multiresistant

Pseudomonas.

Antimicrobial spectrum of fosfomycin (in vitro)

The data predict only the probability of micro-organism susceptibility to fosfomycin.

For intravenous fosfomycin, the susceptibility breakpoints established by the European Committee on

Antimicrobial Susceptibility Testing are as follows (EUCAST breakpoint table version 5.0, 2015):

Species

susceptible

resistant

Enterobacteriaceae

≤ 32 mg/l

> 32 mg/l

Staphylococcus spp.

≤ 32 mg/l

> 32 mg/l

The prevalence of acquired resistance of individual species may vary geographically and over time. Local

information about the resistance situation is therefore necessary, particularly in order to ensure

appropriate treatment of severe infections.

In-vitro activity spectrum of fosfomycin and resistance

The following table is based on the breakpoint according to EUCAST and comprises organisms relevant

for the approved indications:

Commonly susceptible species

Aerobic Gram-positive microorganisms

Staphylococcus aureus

Streptococcus pyogenes

Streptococcus pneumoniae

Aerobic Gram-negative microorganisms

Citrobacter spp.

Edwardsiella spp.

Enterobacter cancerogenus

Escherichia coli

Haemophilus influenzae

Klebsiella oxytoca

Neisseria spp.

Proteus mirabilis

Proteus penneri

Providencia rettgeri

Anaerobic microorganisms

Peptococcus spp.

Peptostreptococcus spp.

Species in which acquired resistance may be a problem

Gram-positive microorganisms

Enterococcus faecalis

Staphylococcus epidermidis

Gram-negative microorganisms

Enterobacter cloacae

Klebsiella pneumonia

Proteus inconstans

Pseudomonas aeruginosa

Serratia marcescens

Inherently resistant species

Gram-negative microorganisms

Morganella morganii

Anaerobic microorganisms

Bacteroides spp.

The physiologically important apathogenic anaerobic species, Lactobacillus and Bifidobacterium, are not

susceptible to fosfomycin.

5.2 Pharmacokinetic properties

Pharmacokinetics

A single intravenous infusion of 4 g and 8 g of fosfomycin in young healthy males resulted in maximum

serum concentrations (C

) of approx. 200 and 400 μg/ml, respectively. The serum half-life was approx.

2 hours. In elderly and/or critically ill male and female subjects, single intravenous doses of 8 g of

fosfomycin resulted in mean C

and half-lives in plasma of approximately 350–380 µg/ml and 3.6–3.8

h, respectively.

Distribution

The apparent volume of distribution of fosfomycin is approx. 0.30 l/kg body weight. Fosfomycin is

distributed well to tissues. High concentrations are reached in eyes, bones, wound secretions,

musculature, cutis, subcutis, lungs and bile. In patients with inflamed meninges, cerebrospinal fluid

concentrations reach approx. 20–50% of the corresponding serum levels. Fosfomycin passes the placental

barrier. Low quantities were found in human milk (about 8 % of the serum concentrations). The plasma

protein binding is negligible.

Metabolism

Fosfomycin is not metabolised by the liver and does not undergo enterohepatic circulation. No

accumulation is therefore to be expected in patients with hepatic impairment.

Elimination

80–90% of the quantity of fosfomycin administered to healthy adults is eliminated renally within 10 hours

after a single intravenous administration. Fosfomycin is not metabolised, i.e. the biologically active

compound is eliminated. In patients with normal or mildly to moderately impaired renal function

(creatinine clearance ≥ 40 ml/min), approximately 50–60% of the overall dose is excreted within the first

3-4 hours.

Linearity

Fosfomycin shows linear pharmacokinetic behaviour after intravenous infusion of therapeutically used

doses.

Special populations

Very limited data are available in special populations.

Elderly

No dose adjustment is necessary based on age alone. However, renal function should be assessed and the

dose should be reduced if there is evidence of renal impairment (see section 4.2).

Paediatric population

The pharmacokinetics of fosfomycin in children and adolescents aged 3–15 years as well as in term

newborns with normal renal function are generally similar to those of healthy adult subjects. However, in

renally healthy neonates and infants up to 12 months, the glomerular filtration rate is physiologically

decreased compared to older children and adults. This is associated with a prolongation of the elimination

half-life of fosfomycin in dependence on the stage of renal maturation.

Renal insufficiency

In patients with impaired renal function, the elimination half-life is increased proportionally to the degree

of renal insufficiency. Patients with creatinine clearance values of 40 ml/min or less require dose

adjustments (see also section 4.2. “Dosage in renal insufficiency” for further details).

In a study investigating 12 patients under CVVHF customary polyethylene sulfone haemofilters with a

membrane surface of 1.2 m

and a mean ultrafiltration rate of 25 ml/min were employed. In this clinical

setting, the mean values of plasma clearance and elimination half-life in plasma were 100 ml/min, and

12h, respectively.

Hepatic insufficiency

There is no requirement for dosage adjustments in patients with hepatic insufficiency since the

pharmacokinetics of fosfomycin remains unaffected in this patient group.

5.3 Preclinical safety data

Subacute and chronic toxicity

The toxicity of fosfomycin following repeated administration for up to 6 months was evaluated in rats,

dogs, rabbits and monkeys. At high intra-peritoneal doses of fosfomycin (> 500 mg/kg /day), rats

developed respiratory arrest, tetanic cramps, anaemia, a reduction of blood protein levels, increased serum

cholesterol and reduced blood glucose. Furthermore, dogs and monkeys experienced diarrhoea due to

antibiotic-related changes in the intestinal flora following intravenous administration of doses of higher

than 250 mg/kg /day and 500 mg/kg /day, respectively. In the rabbit, no toxicity was observed following

intravenous administration of 400 mg/kg /day for a period of 1 month.

Reproductive toxicity

Fertility

In male and female rats, following repeated administration (via a pharyngeal tube) of up to 1400 mg/kg

/day reduced fertility was observed at the maximum dose tested.

Teratogenicity

Fosfomycin was administered to mice, rats and rabbits via pharyngeal tube at maximum doses of 2 x 120

mg/kg /day, 1400 mg/kg /day and 420 mg/kg /day, respectively or intravenously to mice and rabbits at

55.3 mg/kg /day, and up to 250 mg/kg /day, respectively. There was no evidence of embryotoxicity or

teratogenicity.

Perinatal and postnatal toxicity

In rats, a maximum dose of 2800 mg/kg /day was administered via a pharyngeal tube. There was no

evidence of foetal or peri- and postnatal toxicity.

Mutagenicity

In-vitro tests were performed to test the alkylating capacity and the mutagenic effect of fosfomycin.

Fosfomycin showed no alkylating effect. In the Ames test, no mutagenic effect was seen in test strains of

Salmonella typhimurium (TA 98, TA 100, TA 1535, TA 1537 and TA 1538, with and without addition of

rat-liver homogenate) after exposure to fosfomycin at up to 1600 µg/ml.

6. Pharmaceutical particulars

6.1 List of excipients

Succinic acid.

6.2 Incompatibilities

Although no chemical/pharmaceutical incompatibilities have been found, Fomicyt solutions should not be

mixed together with other parenteral preparations with the exception of those listed in section 6.6.

6.3 Shelf life

4 years.

Chemical and physical in-use stability of the reconstituted solution that has been produced under aseptic

conditions has been demonstrated for 24 hours at 25 °C if protected from light.

From a microbiological point of view, the product should be used immediately. If not used immediately,

in-use storage times and conditions prior to use are the responsibility of the user and would normally not

be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated

aseptic conditions.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

For storage of the reconstituted solution see section 6.3.

6.5 Nature and contents of container

Clear type-II glass bottles with a rubber stopper (bromobutyl rubber) and pull-off cap containing 2 g (in

100 ml bottle), 4 g (in 100 ml bottle) or 8 g (in 250 ml bottle) of Fomicyt, respectively, in packs of 10

bottles each.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

For single use only.

Any unused product or waste material should be disposed of in accordance with local requirements.

Preparation of the solution for infusion

In order to prepare the solution for infusion:

Fomicyt 2 g should be dissolved in 50 ml of Water for Injections, Glucose Infusion 50 mg/ml (5 %) or

Glucose Infusion 100 mg/ml (10 %).

Fomicyt 4 g should be dissolved in 100 ml of Water for Injections, Glucose Infusion 50 mg/ml (5 %) or

Glucose Infusion 100 mg/ml (10 %).

Fomicyt 8 g should be dissolved in 200 ml of Water for Injections, Glucose Infusion 50 mg/ml (5 %) or

Glucose Infusion 100 mg/ml (10 %).

A slight degree of warming occurs when the powder is dissolved.

The reconstituted solution is clear and colourless to slightly yellowish.

Displacement value

The displacement values for the reconstituted solutions are 1 ml for the 2 g pack size, 2 ml for the 4 g

pack size and 4 ml for the 8 g pack size.

These volumes are equivalent to an increase of volume of 2 %. This has to be considered when preparing

the final solution in case of not using the entire content of the bottle.

7. Marketing authorisation holder

INFECTOPHARM Arzneimittel und Consilium GmbH

Von-Humboldt-Str. 1

64646 Heppenheim

Germany

Distributor

Nordic Pharma UK Ltd

Abbey House

1650 Arlington Business Park

Theale

Berkshire

RG7 4SA

8. Marketing authorisation number(s)

PL 15011/0017

9. Date of first authorisation/renewal of the authorisation

19/06/2015

10. Date of revision of the text

11/06/2017

Company Contact Details

Nordic Pharma Limited

Address

3 Commerce Park, Brunel Road, Theale, Reading, Berkshire, RG7 4AB

+44 (0) 118 207 9161

Medical Information e-mail

[email

protected]

Stock Availability

[email

protected]

Telephone

+44 (0) 118 207 9160

Medical Information Direct Line

+44 (0) 800 121 8924

Medical Information Fax

+44 (0) 44 1748 828801

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Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

25-5-2018

Orphan designation:  Treprostinil sodium,  for the: Treatment of chronic thromboembolic pulmonary hypertension

Orphan designation: Treprostinil sodium, for the: Treatment of chronic thromboembolic pulmonary hypertension

On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Europe - EMA - European Medicines Agency

4-2-2019

Elmiron (bene-Arzneimittel GmbH)

Elmiron (bene-Arzneimittel GmbH)

Elmiron (Active substance: pentosan polysulfate sodium) - Centralised - Yearly update - Commission Decision (2019)848 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Europe - EMA - European Medicines Agency

24-1-2019


Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Europe - EMA - European Medicines Agency

21-1-2019

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names (Active substance: Diclofenac sodium) - Community Referrals - Art 29 - Commission Decision (2019)589 of Mon, 21 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1467

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety