Armisarte (previously Pemetrexed Actavis)

Основна информация

  • Търговско наименование:
  • Armisarte (previously Pemetrexed Actavis)
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Armisarte (previously Pemetrexed Actavis)
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Antineoplastic agents,
  • Терапевтична област:
  • Carcinoma, Non-Small-Cell Lung, Mesothelioma
  • Терапевтични показания:
  • Malignant pleural mesotheliomaPemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
  • Каталог на резюме:
  • Revision: 5

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/004109
  • Дата Оторизация:
  • 17-01-2016
  • EMEA код:
  • EMEA/H/C/004109
  • Последна актуализация:
  • 29-03-2019

Доклад обществена оценка

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/87638/2016

EMEA/H/C/004109

EPAR summary for the public

Armisarte

pemetrexed

This is a summary of the European public assessment report (EPAR) for Armisarte. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Armisarte.

For practical information about using Armisarte, patients should read the package leaflet or contact

their doctor or pharmacist.

What is Armisarte and what is it used for?

Armisarte is a cancer medicine used to treat two types of lung cancer:

malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by

exposure to asbestos), where it is used together with cisplatin in patients who have not received

chemotherapy before and whose cancer cannot be removed by surgery;

advanced non-small-cell lung cancer of the kind known as ‘non-squamous’, where it is used either

in combination with cisplatin in previously untreated patients or on its own in patients who have

previously received cancer treatment. It can also be used as a maintenance treatment in patients

who have received a platinum-based chemotherapy.

Armisarte is a ‘hybrid medicine’. This means that Armisarte is similar to a ‘reference medicine’ already

authorised in the European Union (EU) called Alimta, but it is available in a different form. While Alimta

is available as a powder to be made up into a solution for infusion (drip) into a vein, Armisarte is

available as a concentrated liquid to be made up into a solution for infusion.

Armisarte contains the active substance pemetrexed.

Previously known as Pemetrexed Actavis.

Armisarte

EMA/87638/2016

Page 2/3

How is Armisarte used?

Armisarte is available as a concentrate for solution for infusion into a vein. The medicine can only be

obtained with a prescription and should only be given under the supervision of a doctor who is qualified

in the use of cancer medicines.

The recommended dose is 500 mg per square metre of body surface area (calculated using the

patient’s height and weight). It is given once every three weeks as an infusion lasting 10 minutes. To

reduce side effects, patients should take a corticosteroid (a type of medicine that reduces

inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment

with Armisarte. When Armisarte is given with cisplatin, an ‘anti-emetic’ medicine (to prevent vomiting)

and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.

Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are

abnormal or who have certain other side effects. For more information, see the summary of product

characteristics (also part of the EPAR).

How does Armisarte work?

The active substance in Armisarte, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that

are dividing, such as cancer cells), which belongs to the group ‘antimetabolites’. In the body,

pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved

in producing ‘nucleotides’ (the building blocks of DNA and RNA, the genetic material of cells). As a

result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells

from dividing and multiplying. The conversion of pemetrexed into its active form occurs more readily in

cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a

longer duration of action in cancer cells. This results in the division of cancer cells being reduced, while

normal cells are only slightly affected.

How has Armisarte been studied?

The company provided data from the published literature on pemetrexed. No additional studies were

needed as Armisarte is a hybrid medicine that is given by infusion and contains the same active

substance as the reference medicine, Alimta.

What are the benefits and risks of Armisarte?

Because Armisarte is a hybrid medicine that is given by infusion and contains the same active

substance as the reference medicine, its benefits and risks are taken as being the same as the

reference medicine’s.

Why is Armisarte approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance

with EU requirements, Armisarte has been shown to be comparable to Alimta. Therefore, the CHMP’s

view was that, as for Alimta, the benefit outweighs the identified risk. The Committee recommended

that Armisarte be approved for use in the EU.

Armisarte

EMA/87638/2016

Page 3/3

What measures are being taken to ensure the safe and effective use of

Armisarte?

A risk management plan has been developed to ensure that Armisarte is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Armisarte, including the appropriate precautions to be followed by healthcare

professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Armisarte

The European Commission granted a marketing authorisation valid throughout the European Union for

Pemetrexed Actavis on 18 January 2016. The name of the medicine was changed to Armisarte on 10

February 2016.

The full EPAR and risk management plan summary for Armisarte can be found on the Agency’s

website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For

more information about treatment with Armisarte, read the package leaflet (also part of the EPAR) or

contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

This summary was last updated in 02-2016.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Armisarte 25 mg/ml concentrate for solution for infusion

pemetrexed

Read all of this leaflet carefully before you start receiving this medicine because it contains

important information for you.

-

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If you get any side effects, talk to your doctor or nurse or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Armisarte is and what it is used for

What you need to know before you use Armisarte

How to use Armisarte

Possible side effects

How to store Armisarte

Contents of the pack and other information

1.

What Armisarte is and what it is used for

Armisarte is a medicine used in the treatment of cancer. It contains the active substance pemetrexed.

Pemetrexed belongs to a group of medicines known as folic acid analogues and disrupts processes that

are essential for cells to divide.

Armisarte is given in combination with cisplatin, another anti-cancer medicine, as treatment for

malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who

have not received prior chemotherapy.

Armisarte is also given in combination with cisplatin for the initial treatment of patients with advanced

stage of lung cancer.

Armisarte can be prescribed to you if you have lung cancer at an advanced stage if your disease has

responded to treatment or it remains largely unchanged after initial chemotherapy.

Armisarte is also a treatment for patients with advanced stage of lung cancer whose disease has

progressed after other initial chemotherapy has been used.

2.

What you need to know before you use Armisarte

Do not use Armisarte

if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in

section 6).

if you are breast-feeding; you must discontinue breast-feeding during treatment with Armisarte.

if you have recently received or are about to receive a vaccine against yellow fever.

Warnings and precautions

Talk to your doctor or hospital pharmacist before receiving Armisarte.

If you currently have or have previously had problems with your kidneys, talk to your doctor or

hospital pharmacist as you may not be able to receive Armisarte.

Before each infusion you will have samples of your blood taken to evaluate if you have sufficient

kidney and liver function and to check that you have enough blood cells to receive Armisarte. Your

doctor may decide to change the dose or delay treating you depending on your general condition and if

your blood cell counts are too low. If you are also receiving cisplatin, your doctor will make sure that

you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to

prevent vomiting.

If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early

or late radiation reaction with Armisarte.

If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects

with Armisarte.

If you have heart disease or a history of heart disease, please tell your doctor.

If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid

before giving you Armisarte.

Children and adolescents

There is no relevant use of Armisarte in the paediatric population

Other medicines and Armisarte

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicine for pain or inflammation (swelling), such as medicines called

“nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor’s

prescription (such as ibuprofen). There are many sorts of NSAIDs with different durations of activity.

Based on the planned date of your infusion of Armisarte and/or on the status of your kidney function,

your doctor needs to advise you on which medicines you can take and when you can take them. If you

are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.

Like other chemotherapy medicines Armisarte is not recommended with live attenuated vaccines.

Inactive vaccines should be used where possible.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. The

use of Armisarte should be avoided during pregnancy. Your doctor will discuss with you the potential

risk of taking Armisarte during pregnancy. Women must use effective contraception during treatment

with Armisarte.

Breast-feeding

If you are breast-feeding, tell your doctor.

Breast-feeding must be discontinued during Armisarte treatment.

Fertility

Men are advised not to father a child during and up to 6 months following treatment with Armisarte

and should therefore use effective contraception during treatment with Armisarte and for up to

6 months afterwards. If you would like to father a child during the treatment or in the 6 months

following receipt of treatment, seek advice from your doctor or pharmacist. You may want to seek

counselling on sperm storage before starting your therapy.

Driving and using machines

Armisarte may make you feel tired. Be careful when driving a car or using machines.

3.

How to use Armisarte

Armisarte 25 mg/ml concentrate for solution for infusion will always be given to you by a healthcare

professional. The dose of Armisarte is 500 milligrams for every square metre of your body’s surface

area. Your height and weight are measured to work out the surface area of your body. Your doctor will

use this body surface area to work out the right dose for you. This dose may be adjusted, or treatment

may be delayed depending on your blood cell counts and on your general condition. A hospital

pharmacist, nurse or doctor will have mixed the Armisarte concentrate with 5% glucose solution for

injection before it is given to you.

You will always receive Armisarte by infusion into one of your veins. The infusion will last

approximately 10 minutes.

When using Armisarte in combination with cisplatin:

The doctor or hospital pharmacist will work out the dose you need based on your height and weight.

Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after

the infusion of Armisarte has finished. The infusion of cisplatin will last approximately 2 hours.

You should usually receive your infusion once every 3 weeks.

Additional medicines:

Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of

dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day

after Armisarte treatment. This medicine is given to you to reduce the frequency and severity of skin

reactions that you may experience during your anticancer treatment.

Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin

containing folic acid (350 to 1000 micrograms) that you must take once a day while you are receiving

Armisarte. You must take at least 5 doses during the seven days before the first dose of Armisarte.

You must continue taking the folic acid for 21 days after the last dose of Armisarte. You will also

receive an injection of vitamin B

(1000 micrograms) in the week before administration of Armisarte

and then approximately every 9 weeks (corresponding to 3 courses of Armisarte treatment). Vitamin

and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.

Your condition will be closely monitored during treatment. This routinely involves blood tests,

including checks on your liver and kidney function. Your dose may be changed or treatment delayed

depending on results from these tests.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must contact your doctor immediately if you notice any of the following:

Fever or infection (common): if you have a temperature of 38°C or greater, sweating or other

signs of infection(since you might have less white blood cells than normal which is very

common). Infection (sepsis) may be severe and could lead to death

If you start feeling chest pain (common) or having a fast heart rate (uncommon)

If you have pain, redness, swelling or sores in your mouth (very common)

Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation

(common), or fever (common). Rarely, skin reactions may be severe and could lead to death.

Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson

Syndrome or Toxic epidermal necrolysis)

If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since

you might have less haemoglobin than normal which is very common)

If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop,

reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal

which is very common)

If you experience sudden breathlessness, intense chest pain or cough with bloody sputum

(uncommon)(may indicate a blood clot in the blood vessels of the lungs)

Side effects with Armisarte may include:

Very common (may affect more than 1 in 10 people)

Low white blood cells

Low haemoglobin level (anaemia)

Low platelet count

Diarrhoea

Vomiting

Pain, redness, swelling or sores in your mouth

Nausea

Loss of appetite

Fatigue (tiredness)

Skin rash, peeling of the skin

Hair loss

Constipation

Loss of sensation

Kidney: abnormal blood tests

Common (may affect up to 1 in 10 people)

Allergic reaction: skin rash / burning or prickling sensation

Infection including sepsis

Fever

Dehydration

Kidney failure

Irritation of the skin and itching

Hives

Chest pain

Muscle weakness

Conjunctivitis (inflamed eye)

Upset stomach

Pain in the abdomen

Taste change

Liver: abnormal blood tests

Watery eyes

Dizziness

Uncommon (may affect up to 1 in 100 people)

Acute renal failure

Fast or irregular heart rate

Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed/

radiation therapy

Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal

or rectal bleeding)

Interstitial pneumonitis (scarring of the air sacs of the lung)

Oedema (excess fluid in body tissue, causing swelling)

Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving

pemetrexed usually in combination with another anticancer therapy

Pancytopenia- combined low counts of white cells, red cells and platelets

Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy)

may occur in patients who are also treated with radiation before, during or after their

pemetrexed therapy

Extremity pain, low temperature and discolouration have been reported

Blood clots in the lung blood vessels (pulmonary embolism)

Rare (may affect up to 1 in 1,000 people)

Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously

been exposed to radiotherapy, from days to years after the radiation.

Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic

epidermal necrolysis

Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells)

Hepatitis (inflammation of the liver)

Anaphylactic shock (severe allergic reaction)

Not known (frequency cannot be estimated from the available data)

Lower limb swelling with pain and redness

Increased urine output

Thirst and increased water consumption

Hypernatraemia – increased sodium in blood

You might have any of these symptoms and/or conditions. You must tell your doctor as soon as

possible when you start experiencing any of these side effects.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not

listed in this leaflet. You can also report side effects directly via the national reporting system listed in

Appendix V. By reporting side effects you can help provide more information on the safety of this

medicine.

5.

How to store Armisarte

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP’. The

expiry date refers to the last day of that month.

Store and transport refrigerated (2°C to 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Infusion Solution: Chemical and physical in-use stability of infusion solution of pemetrexed was

demonstrated for 3 days at room temperature and 21 days at refrigerated temperature. 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 not be longer

than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic

conditions.

Armisarte should not been used if there are any signs of particles.

This medicine is for single use only; any unused solution must be disposed of in accordance with local

requirements.

6.

Contents of the pack and other information

What Armisarte contains

The active substance is pemetrexed. One ml of concentrate contains 25 mg pemetrexed (as pemetrexed

diacid). Further dilution by a healthcare provider is required prior to administration.

One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid)

One vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diacid)

One vial of 34 ml concentrate contains 850 mg pemetrexed (as pemetrexed diacid)

One vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid)

The other ingredients are trometamol (for pH adjustment), anhydrous citric acid, methionine and water

for injection.

What Armisarte looks like and contents of the pack

Armisarte concentrate for solution for infusion (sterile concentrate) is a clear, colourless to slightly

yellowish or yellow-greenish solution.

Armisarte is provided in a colourless glass vial with rubber stopper and an aluminium cap with

polypropylene disk. Vials may or may not be sheathed in a protective sleeve.

Each pack of Armisarte contains one vial.

Pack sizes

1 x 4 ml vial (100 mg/4 ml)

1 x 20 ml vial (500 mg/20 ml)

1 x 34 ml vial (850 mg/34 ml)

1 x 40 ml vial (1000 mg/40 ml)

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Iceland

Manufacturer

PLIVA CROATIA Ltd.

10000 Zagreb

Prilaz baruna Filipovića 25

Croatia

Actavis Italy S.p.A.

Viale Pasteur 10

20014 Nerviano (Milan)

Italy

S.C. Sindan-Pharma S.R.L.

11 Ion Mihalache Blvd.

011171 Bucharest

Romania

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tel/Tél: + 32 (0)38 20 73 73

Lietuva

UAB "Sicor Biotech"

Tel: +370 5 266 0203

България

Актавис ЕАД

Teл.: +359 2 489 95 85

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG

Tel/Tél: + 32 (0)38 20 73 73

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Magyarország

Teva Gyógyszergyár Zrt.

Tel.: +36 1 288 6400

Danmark

Teva Denmark A/S

Tlf: +45 44 98 55 11

Malta

Actavis Ltd.

Tel: +35621693533

Deutschland

ratiopharm GmbH

Tel: +49 731 402 02

Nederland

Teva Nederland B.V.

Tel: +31 (0) 800 0228 400

Eesti

UAB "Sicor Biotech" Eesti filiaal

Tel: +372 661 0801

Norge

Teva Norway AS

Tlf: +47 66 77 55 90

Ελλάδα

Specifar ABEE

Τηλ: +30 210 5401500

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43(0)1 97007 0

España

Teva Pharma, S.L.U.

Tél: +(34) 91 387 32 80

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 22 345 93 00

France

Teva Santé

Tél: +(33) 1 55 91 78 00

Portugal

Teva Pharma - Produtos Farmacêuticos Lda

Tel: +351 21 476 75 50

Hrvatska

Pliva Hrvatska d.o.o.

Tel: +385 1 37 20 000

România

Teva Pharmaceuticals S.R.L

Tel: +4021 230 65 24

Ireland

Actavis Ireland Limited

Tel: +353 (0)21 4619040

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Ísland

Actavis Group PTC ehf.

Sími: +354 550 3300

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o

Tel: +421 2 57 26 79 11

Italia

Teva Italia S.r.l.

Tel: +(39) 028917981

Suomi/Finland

ratiopharm Oy

Puh/Tel: +358 (0) 20 180 5900

Κύπρος

Specifar ABEE

Τηλ: +30 210 5401500

Ελλάδα

Sverige

Teva Sweden AB

Tel: +46 42 12 11 00

Latvija

UAB "Sicor Biotech" filiāle Latvijā

Tel: +371 673 23 666

United Kingdom

Actavis UK Limited

Tel: +44 1271 385257

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for medical or healthcare professionals only:

Instructions for use, handling and disposal

Use aseptic techniques during dilution of pemetrexed for intravenous infusion administration.

Calculate the dose and the number of Armisarte vials needed.

Armisarte must only be diluted with 5% glucose solution, without preservative. The appropriate

volume of pemetrexed concentrate must be diluted to 100 ml with 5% glucose solution and

administered as an intravenous infusion over 10 minutes.

Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl

chloride and polyolefin lined administration sets and infusion bags. Pemetrexed is incompatible

with diluents containing calcium, including lactated Ringer’s Injection and Ringer’s Injection.

Armisarte contains trometamol as an excipient. Trometamol is incompatible with cisplatin

resulting in degradation of cisplatin. This medicinal product must not be mixed with other

medicinal products. Intravenous lines should be flushed after administration of Armisarte.

Parenteral medicinal products should be inspected visually for particulate matter and

discolouration prior to administration. If particulate matter is observed, do not administer.

Pemetrexed solutions are for single use only. Any unused product or waste material should be

disposed of in accordance with local requirements.

Preparation and administration precautions

As with other potentially toxic anticancer agents, care should be exercised in the handling and

preparation of pemetrexed infusion solutions. The use of gloves is recommended. If a pemetrexed

solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If

pemetrexed solutions contact the mucous membranes, flush thoroughly with water. Pemetrexed is not

a vesicant. There is not a specific antidote for extravasation of pemetrexed. There have been a few

reported cases of pemetrexed extravasation, which were not assessed as serious by the investigator.

Extravasation should be managed by local standard practice as with other non-vesicants.

Diluted solution

Chemical and physical in-use stability of infusion solution of pemetrexed was demonstrated for 3 days

at room temperature and 21 days at refrigerated temperature. 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 not be longer than 24 hours at 2°C to 8°C,

unless dilution has taken place in controlled and validated aseptic conditions.