Albumex 20

Main information

  • Trade name:
  • Albumex 20 20% w/v Solution for infusion
  • Dosage:
  • 20% w/v
  • Pharmaceutical form:
  • Solution for infusion
  • Units in package:
  • Vial, glass, bottle, 10 mL
  • Class:
  • General sale
  • Prescription type:
  • General sale
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • CSL Behring (Australia) Pty Ltd

Documents

Localization

  • Available in:
  • Albumex 20 20% w/v Solution for infusion
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Hypoproteinaemia in the acutely ill patient; Albumex® 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 7573
  • Authorization date:
  • 25-08-1995
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

Albumex 20 NZ DS 15.00

Page 1 of 11

New Zealand Data Sheet

Albumex

®

20

Human Albumin 20% (200 g/L)

NAME OF THE MEDICINE

Human albumin, solution for intravenous infusion.

DESCRIPTION

Albumex

20 is manufactured from human plasma donated by New Zealand’s voluntary and

non-remunerated donors. Albumex

20 is a clear, slightly viscous liquid; it is almost

colourless, yellow, amber or green. It is prepared by a combination of the Cohn cold-ethanol

fractionation process and chromatographic techniques. It is a sterile, preservative free

20% w/v human albumin solution. It is hyperoncotic and hypo-osmotic compared to human

serum. It has a nominal osmolality of 130 mOsm/kg, is hypotonic and the pH is 6.7 to 7.3.

The manufacturing process for Albumex

20 contains dedicated steps to reduce the

possibility of virus transmission, including pasteurisation (60°C for 10 hours) and incubation

at low pH to inactivate viruses. The composition of Albumex

20 is as follows:

Human Albumin

200 g/Litre

Sodium

48 to 100 mmol/Litre

Octanoate

32 mmol/Litre

PHARMACOLOGY

Albumin accounts quantitatively for more than half of the total protein in the plasma and

represents about 10% of the protein synthesis activity of the liver. The metabolic half-life of

albumin

in vivo

is about 19 days and the turnover in an adult is approximately 15 g per day.

There is rapid interchange of albumin between the intra- and extravascular spaces.

Albumex

20 is hyperoncotic with human serum and supplies the oncotic equivalence of

approximately four times its volume of human plasma. Albumex

20 has two main functions:

maintenance of plasma colloid osmotic pressure and carriage of intermediate products in the

transport and exchange of tissue metabolites.

Albumex 20 NZ DS 15.00

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INDICATIONS

Hypoproteinaemia in the acutely ill patient

Albumex

20 is administered when there are existing or anticipated clinical problems or

complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy.

Shock

Albumex

20 may be used for the resuscitation of patients in shock due to acute loss of blood

or plasma, but 4% human albumin is preferred when available.

Burns

Extensive burns are followed by sequential shifts in the distribution of body water, salt and

proteins resulting in hypovolaemic shock and circulatory failure.

Initially (during the first 24 hours) there is an increased vascular permeability leading to loss

of water and proteins into the extravascular compartment, and haemoconcentration. Large

volumes of crystalloid solutions should be infused to restore the constricted intravascular

fluid space, and smaller amounts of Albumex

20 are required to maintain adequate plasma

volume and colloid osmotic pressure.

Adult respiratory distress syndrome

The clinical syndrome is characterised by inadequate oxygenation secondary to pulmonary

interstitial oedema, complicating shock and postoperative states resulting in a decreased

central venous pressure, decreased plasma albumin concentration, rising blood pressure,

reduced cardiac output, lowered pulse rate and a falling renal output.

The acute condition can be controlled by diuretics and Albumex

20 in amounts sufficient to

maintain vital signs.

In patients who have undergone abdominal surgery, the intravenous (IV) administration of

albumin solution (20%) immediately after the operation has been shown to improve lung

compliance and gaseous exchange.

Haemodialysis

Albumex

20 may be used to assist with the rapid removal of excess extravascular fluid and

to maintain perfusion pressure.

Albumex 20 NZ DS 15.00

Page 3 of 11

Therapeutic plasma exchange

Therapeutic plasma exchange is a procedure in which approximately one plasma volume is

exchanged with a colloid replacement solution. The choice of replacement fluid and its

concentration are determined by the particular clinical situation and the frequency of the

procedure.

Iso-oncotic albumin solution is the preferred replacement material. If the patient’s serum

albumin level is not maintained, concentrated albumin (20%) may be indicated. If exchange

occurs less frequently than once a week, less concentrated colloids may be appropriate.

CONTRAINDICATIONS

Albumex

20 must not be used if there is a history of allergy to this product. Albumin is

contraindicated in patients with cardiac failure, pulmonary oedema or severe anaemia.

The infusion of Albumex

20 is not justified in hypoproteinaemic states associated with

chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency or

undernutrition.

In chronic nephrosis, infused albumin solution (20%) is promptly excreted by the kidneys

with no relief of the chronic oedema.

PRECAUTIONS

The sodium levels in this product are 48 to 100 mmol/L. This should be noted when the

product is used in patients requiring sodium restriction.

The colloid osmotic effect of Albumex

20 is approximately four times that of plasma.

Therefore, patients should always be monitored carefully in order to guard against the

possibility of circulatory overload. Patients with cardiac failure, renal insufficiency or

stabilised chronic anaemia often have an increased circulatory plasma volume and are

therefore at special risk of developing circulatory overload. As Albumex

20 is hyperoncotic,

albumin must be given with (see

Dilution of concentrated albumin 20%

) or followed by

crystalloid solution in the presence of dehydration.

Administration of albumin can aggravate myocardial depression when present in patients

with shock. A paradoxical effect of refractory oliguria has been reported in burns patients

receiving albumin, possibly because of insufficient accompanying crystalloids. True

anaphylactic reactions occur rarely. Should an anaphylactic reaction to Albumex

20 develop,

Albumex 20 NZ DS 15.00

Page 4 of 11

the infusion should be stopped and treatment instituted with adrenaline, hydrocortisone and

antihistamines, as appropriate.

The use of albumin for fluid resuscitation of patients with traumatic brain injury is not

recommended.

In chronic nephrosis, infused albumin solution (20%) is promptly excreted by the kidneys

with no relief of the chronic oedema.

Albumex

20 contains trace amounts of aluminium (≤200 µg/L). Accumulation of aluminium

in patients with chronic renal insufficiency has led to toxic manifestations such as

hypercalcaemia, vitamin D-refractory osteodystrophy, anaemia and severe progressive

encephalopathy. Therefore, when large volumes of albumin are contemplated for

administration to such patients, serious consideration of these potential risks relative to the

anticipated benefits should be given.

Hypertension

The rise in blood pressure which may follow rapid administration of albumin necessitates

observation of the injured patient to detect bleeding points which failed to bleed at the lower

blood pressure; otherwise, new haemorrhage and shock may occur.

Pathogen safety

This product is made from human plasma. Products made from human plasma may contain

infectious agents such as viruses and theoretically Creutzfeldt-Jakob Disease (CJD) agents,

that can cause disease. The risk that such products will transmit an infectious agent has been

reduced by screening plasma donors for prior exposure to certain infectious agents and by

testing for the presence of certain viral markers.

In addition, virus inactivation/removal procedures are included in the manufacturing process.

The current process and procedures applied in the manufacture of this product are effective

against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus

(HBV) and hepatitis C virus (HCV), and the non-enveloped virus, hepatitis A virus (HAV).

These procedures may be of limited value against the non-enveloped virus, parvovirus B19.

Despite these measures, such products may still potentially transmit disease. There is also the

possibility that other known or unknown infectious agents may be present in such products.

Vaccination for patients in receipt of medicinal products from human plasma should be

considered where appropriate.

Albumex 20 NZ DS 15.00

Page 5 of 11

Effects on fertility

No studies examining the effect of Albumex

20 on fertility have been conducted.

Use in pregnancy

The safety of this medicinal product for use in human pregnancy has not been established in

controlled clinical trials; therefore, it should be given to pregnant women only if clearly

needed.

Use in lactation

No information available.

Paediatric use

There have been no specific clinical studies of Albumex

20 in children.

Use in the elderly

There have been no specific clinical studies of Albumex

20 in the elderly.

Genotoxicity

No genotoxicity studies have been conducted with Albumex

Carcinogenicity

No carcinogenicity studies have been conducted with Albumex

Effect on laboratory tests

Albumin is an endogenous plasma protein so no specific effects on laboratory tests are

anticipated.

INTERACTIONS WITH OTHER MEDICINES

Hypotension has been reported in patients given albumin who are on Angiotensin Converting

Enzyme (ACE) inhibitors, (see

Compatibility with other fluids

ADVERSE EFFECTS

Adverse reactions reported with albumin solutions in general may include chills, fever,

flushing, headache, dyspnoea, nausea, vomiting, increased salivation and allergic reactions

(hypotension, urticaria, skin rashes, anaphylaxis).

Albumex 20 NZ DS 15.00

Page 6 of 11

Adverse reactions to albumin solutions are uncommon and are usually mild and transient.

More serious events may include rigors, hypotension, lowered serum electrolyte levels

(potassium, calcium, bicarbonate), lowered total serum protein levels, low platelet count and

increased prothrombin time.

DOSAGE AND ADMINISTRATION

Dosage

Hypoproteinaemia in the acutely ill patient

The usual daily dose is 50–75 g. The rate of administration should not exceed 2 mL per

minute, as more rapid infusion may precipitate circulatory overload and pulmonary oedema.

In some cases a dose of albumin is added to a suitable crystalloid solution in the proportion of

1 mL Albumex

20 to 4 mL crystalloid solution (see

PRECAUTIONS, Dilution of

concentrated albumin 20%

) and administered by the usual intravenous technique.

Shock

If concentrated albumin (>4–5%) is given, it should be accompanied by the intravenous

infusion of a crystalloid solution. Failure to supply this additional fluid may lead to

dehydration of the tissues.

The precise nature and strength of the crystalloid solution will depend on the requirements of

the patient for electrolytes and fluid.

The patient’s haemodynamic response should be monitored and the usual precautions against

circulatory overload observed.

The dose should be determined by the patient’s condition and response to treatment. The

usual initial dose of 20 g may be administered as a blood volume expander at a rate of 2 to

4 mL per minute. The rate of infusion may be increased in emergencies and repeated in 15 to

30 minutes if necessary. The total dose should not exceed the level of albumin found in the

normal individual i.e. about 2 g per kg body weight in the absence of active bleeding.

Albumex 20 NZ DS 15.00

Page 7 of 11

Burns

The usual dose is 20 to 80 g human albumin given daily at the rate of about 1 mL per minute.

Beyond 24 hours, Albumex

20 can be used to maintain plasma colloid osmotic pressure. A

reasonable goal is the maintenance of a plasma albumin concentration of 25 g/L or a colloid

osmotic pressure of 20 mmHg.

The continuing need for albumin is occasioned by losses from denuded areas and decreased

albumin synthesis.

Adult respiratory distress syndrome

Commence with a dose of 50 g human albumin (equivalent to 250 mL of Albumex

20) over

the first 24 hours together with diuretic therapy. Thereafter the dose is adjusted to maintain

vital signs, particularly central venous pressure, urine output and plasma albumin

concentration.

Haemodialysis

Patients with significant fluid overload may benefit from the administration of 100–200 mL

of Albumex

20 at the end of the dialysis procedure.

Therapeutic plasma exchange

Replace albumin removed on a gram-for-gram basis, e.g. removal of 2.5 litres of plasma

should be accompanied by replacement of 125 g of human albumin (625 mL of

Albumex

20), either prediluted (see

PRECAUTIONS, Dilution of concentrated albumin

20%

) or followed by 4–5 volumes of an appropriate crystalloid solution.

Monitoring advice

It is recommended that blood pressure is monitored during administration of Albumex

To avoid circulatory overload the rate and volume of infusion should be monitored

frequently.

Myocardial function should also be monitored e.g. central venous pressure, arterial pressure

and pulse rate.

Albumex 20 NZ DS 15.00

Page 8 of 11

Myocardial function (in shock), serum potassium (when pretreatment concentrations are

low), platelet count (when pretreatment values are low) and prothrombin times (when these

are prolonged before exchange) should also be monitored.

In the treatment of shock, monitor blood pressure frequently. Widening of the pulse pressure

is correlated with an increase in stroke volume or cardiac output.

Administration

CAUTION: Albumex

®

20 contains no antimicrobial preservative. It must, therefore, be

used immediately after opening the bottle. Any unused solution should be discarded

appropriately. Use in one patient on one occasion only.

Albumex

20 is normally clear or slightly opalescent. If it appears to be turbid by transmitted

light, it must not be used and the bottle should be returned unopened to the New Zealand

Blood Service.

Albumex

20 should always be administered by intravenous infusion through a standard IV

infusion giving set.

Dilution of concentrated albumin 20%

Albumex

20 can be diluted to an iso-oncotic protein concentration (4–5% albumin) prior to

administration, in the proportion of 1 mL of Albumex

20 to 4 mL of suitable crystalloid

solution and administered by the usual intravenous technique. Under no circumstances should

water be used since the lower tonicity will lead to intravascular haemolysis.

If the product was stored in the refrigerator it should be allowed to reach room temperature or

body temperature before administration. Do not use if the solution has been frozen.

The following procedure is recommended for the 100 mL pack size:

Remove the plastic cover from the seal.

Apply a suitable antiseptic to the exposed part of the rubber stopper and allow to dry.

Stand the bottle upright and insert the air vent needle vertically in one of the indentations

of the stopper. It is preferable to use a long airway needle fitted with a filter. If not

available, a short needle attached to a non-wettable filter may be used.

Clamp the tubing of the giving set and insert the perforator vertically through one of the

other indentations of the stopper.

Should the stopper become dislodged, do not use this

bottle and discard the solution appropriately.

Albumex 20 NZ DS 15.00

Page 9 of 11

Invert the bottle and attach the hanger to a support approximately one metre above the

patient.

Allow the tubing to fill by adjusting the clamp. Insert the giving set needle into a vein and

adjust the rate of flow.

When the bottle is empty, clamp the tubing and transfer the air vent needle and the needle

at the upper end of the giving set to a further bottle of Albumex

20 or to a bottle

containing a crystalloid solution, according to requirements.

Should leakage become evident during administration, cease the infusion and

discard the solution appropriately. Recommence the infusion with a new bottle and

giving set.

The following procedure is recommended for the 10 mL (paediatric) pack size:

Remove the plastic cover from the seal.

Apply a suitable antiseptic to the exposed part of the rubber stopper and allow to dry.

Stand the bottle upright, insert the needle vertically in the stopper and draw up the

product.

Infuse the product into appropriate chamber as required e.g. infusion set.

Compatibility with other fluids

Albumex

20 should not be mixed with protein hydrolysates, amino acid solutions, solutions

containing alcohol, or solutions containing medicines that bind to albumin e.g. calcium

channel blockers.

OVERDOSAGE

Excess human albumin may lead to circulatory overload (see

PRECAUTIONS

PRESENTATION AND STORAGE CONDITIONS

Albumex

20 is issued in two sizes:

2 g of human albumin in 10 mL of electrolyte solution

20 g of human albumin in 100 mL of electrolyte solution.

10 mL: Store at 2°C to 8°C (Refrigerate. Do not freeze).

100 mL: Store below 30°C (Do not freeze).

Albumex 20 NZ DS 15.00

Page 10 of 11

Protect from light. Do not use after the expiry date.

NAME AND ADDRESS OF THE SPONSOR

CSL Behring (NZ) Ltd

666 Great South Road

Penrose

Auckland

New Zealand

NAME AND ADDRESS OF THE MANUFACTURER

CSL Behring (Australia) Pty Ltd

189–209 Camp Road

Broadmeadows VIC 3047

Australia

NAME AND ADDRESS OF THE DISTRIBUTOR

New Zealand Blood Service

71 Great South Road

Epsom

Auckland

New Zealand

MEDICINE CLASSIFICATION

General Sale Medicine

DATE OF PREPARATION

14 December 2015

Albumex is the registered trademark of CSL Limited

For Medical/Technical Enquiries

+61 3 9389 1932

For Customer Service Enquiries

+61 3 9246 5231

Albumex 20 NZ DS 15.00

Page 11 of 11

customerservice@cslbehring.com.au

www.cslbehring.com.au

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Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-12-2018

The red palm weevil

The red palm weevil

What is the red palm weevil? The red palm weevil (Rhynchophorus ferrugineus) is a beetle that is a particular menace to palm trees. Originally from South and South-east Asia, it is now found in more than 60 countries, where it threatens date palms, ornamental palms and coconut palms. It has been present in France since 2006; it was first detected in the Provence-Alpes-Côte d'Azur region (French Riviera) and has now become established in the Occitanie region and Corsica.

France - Agence Nationale du Médicament Vétérinaire

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Peer review of the pesticide risk assessment of the active substance propanil

Peer review of the pesticide risk assessment of the active substance propanil

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) 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 t...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Published on: Wed, 19 Dec 2018 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applican...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

The red palm weevil:  combating the loss of palm trees on the Mediterranean coast

The red palm weevil: combating the loss of palm trees on the Mediterranean coast

The palm weevil is one of the most damaging insect pests of palm trees, and is a threat to plant biodiversity in many countries. This insect has spread rapidly along the Mediterranean coast in the last ten years or more, and is classified as a regulated quarantine pest and a major danger to plant health in France. It is therefore subject to compulsory control measures. In order to curb the spread of the pest, which was introduced into the country in 2006, control strategies are being implemented at local...

France - Agence Nationale du Médicament Vétérinaire

18-12-2018

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

17-12-2018


Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Thu, 13 Dec 2018 Following a request from the European Commission, EFSA was asked to review the comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments originating from the applicant (Han‐Biotech GmbH) were submitted to EFSA via the E...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

Europe - EMA - European Medicines Agency

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

Enforcement Report for the Week of November 21, 2018

Enforcement Report for the Week of November 21, 2018

Recently Updated Records for the Week of November 21, 2018 Last Modified Date: Tuesday, November 20, 2018

FDA - U.S. Food and Drug Administration

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

11-1-2019


Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Europe - EMA - European Medicines Agency

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Europe - EMA - European Medicines Agency

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Europe - EMA - European Medicines Agency

6-12-2018


Ex ante publicity of a negotiated procedure: bank accounts for the deposit of surplus funds in euro

Ex ante publicity of a negotiated procedure: bank accounts for the deposit of surplus funds in euro

Ex ante publicity of a negotiated procedure: bank accounts for the deposit of surplus funds in euro

Europe - EMA - European Medicines Agency

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Europe - EMA - European Medicines Agency

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

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

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Active substance: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor) - Orphan designation - Commission Decision (2018)7798 of Wed, 21 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Active substance: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast) - Orphan designation - Commission Decision (2018)7797 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/134/18

Europe -DG Health and Food Safety