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REMIFENTANIL NORIDEM 2MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): REMIFENTANIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Remifentanil Noridem 1 mg Powder for Concentrate for Solution for Injection or Infusion
Remifentanil Noridem 2 mg Powder for Concentrate for Solution for Injection or Infusion
Remifentanil Noridem 5 mg Powder for Concentrate for Solution for Injection or Infusion

Remifentanil
Read all of this leaflet carefully before you are given this medicine.

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

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

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Remifentanil Noridem 1mg, 2mg, 5 mg Powder for Concentrate for Solution for Injection or Infusion
In the rest of this leaflet Remifentanil Noridem 1m, 2mg, 5 mg Powder for Concentrate for Solution for Injection or Infusion is called Remifentanil.
In this leaflet:
1.
What Remifentanil is and what it is used for
2.
Before you are given Remifentanil
3.
How to use Remifentanil
4.
Possible side effects
5.
How to store Remifentanil
6.
Further information
1.
What Remifentanil is and what it is used for
Remifentanil belongs to a group of medicines known as opioids.
It is used:

to help put you to sleep before an operation

to keep you asleep and stop you feeling pain during an operation

to make you feel sleepy and stop you feeling pain while you receive treatment in an Intensive Care Unit.
2.
Before you are given Remifentanil
Do not use Remifentanil:

if you are allergic (hypersensitive) to remifentanil or any of the other ingredients of Remifentanil (See section 6: Further information)

if you are allergic (hypersensitive) to any other opioid medicines, such as morphine.

as a sole agent for induction of anaesthesia

for epidural or intrathecal (spinal) administration
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before having Remifentanil.
Take special care with Remifentanil:

if you are over 65 years of age

if you are dehydrated or have lost a lot of blood

if you have been feeling unwell
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse, before having Remifentanil.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a
prescription. This includes herbal medicines. This is because Remifentanil can work with other medicines to cause side effects.
In particular tell your doctor or pharmacist if you are taking:

Medicines for your heart or blood pressure, such as beta-blockers (these include atenolol, metoprolol and bisoprolol) or calcium channel
blockers (these include amlodipine, diltiazem and nifedipine).
Pregnancy and breast-feeding
Talk to your doctor if you are pregnant, planning to get pregnant or breast-feeding.
Driving and using machines
If you are only staying in hospital for the day, your doctor will tell you how long to wait before leaving the hospital or driving a car. It can be dangerous
to drive too soon after having an operation.
3.
How to use Remifentanil
You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.
Remifentanil can be given:

as a single injection into your vein

as a continuous infusion into your vein. This is where the drug is slowly given to you over a longer period of time.
The way you are given the drug and the dose you receive will depend on:

the operation you have

how much pain you will be in

how sleepy the medical staff want you to be in the Intensive Care Unit.
The dose varies from one patient to another.
After your operation
Tell your doctor or nurse if you are in pain. If you are in pain after your procedure, they will be able to give you other painkillers.
4.
Possible side effects
Like all medicines, Remifentanil can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Some people can be allergic to Remifentanil. You must tell your doctor or nurse immediately if you have:
Rare (affects less than 1 in 1,000 people)

sudden wheeziness and chest pain or chest tightness

swelling of your eyelids, face, lips, mouth or tongue

a lumpy skin rash or ‘hives’ anywhere on the body

a collapse.
Tell your doctor as soon as possible if you notice any of the following:
Very common (affects more than 1 in 10 people)

muscle stiffness
Common (affects less than 1 in 10 people)

difficulty breathing

dizziness, tiredness or fainting
Your doctor or nurse will then adjust your dose accordingly.
Other side effects that can happen when you wake up after having an anaesthetic include:
Very common (affects more than 1 in 10 people)

feeling sick (nausea) and being sick (vomiting)

low blood pressure
Common (affects less than 1 in 10 people)

shivering

increases or decrease in heart rate or blood pressure

itching
Uncommon (affects less than 1 in 100 people)

aches

constipation

problems breathing

seizures/convulsions
Rare (affects less than 1 in 1,000 people)

feeling very calm or drowsy (sedation)

feeling restless or agitated
Unknown frequency

drug dependence

uncontrollable muscle contractions

loss of consciousness

drug tolerance
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.
How to store Remifentanil
Keep out of the reach and sight of children.
Do not use Remifentanil after the expiry date (EXP) which is stated on the vial and carton. The expiry date refers to the last day of the month.
Do not use the reconstituted product unless it is clear, colourless and practically free from particulate material.
Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. The nurse or pharmacist will dispose of medicines no longer required.
These measures will help to protect the environment.
6.
Further information
What Remifentanil contains
The active substance is remifentanil hydrochloride. The other ingredients are glycine and hydrochloric acid.
What Remifentanil looks like and contents of the pack
Remifentanil is a sterile, bacteria-free, freeze-dried white to off-white powder. The powder will be mixed with an appropriate fluid before being
injected. When mixed to form a solution, Remifentanil is clear and colourless.
Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion is available in glass vials with bromobutyl rubber stoppers, each
containing 1 mg, 2 mg or 5 mg of remifentanil (as remifentanil hydrochloride)
Each strength of Remifentanil is supplied in cartons containing 5 vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.
Manufacturer: DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Remifentanil Noridem 1mg/2mg/5mg Powder for Concentrate for Solution for Injection or Infusion
Ireland: Remifentanil Noridem 1mg/2mg/5mg Powder for Concentrate for Solution for Injection or Infusion
Germany: Remifentanil Noridem 1mg/2mg/5mg Pulver für ein Konzentrat zur Herstellung einer Injektionslösung / Infusionslösung
Austria: Remifentanil/Noridem Pulver zur Injektion 1mg/2mg/5mg
Greece: Remifentanil/Noridem Κόνις για Ενέσιμο Διάλυμα 1mg/2mg/5mg
Spain: Remifentanilo Noridem 1mg/2mg/5mg Polvo para concentrado para solución inyectable o perfusión
This leaflet was last approved in 11/2011
The following information is intended for medical or healthcare professionals only
Remifentanil should be prepared for intravenous use by adding, as appropriate 1, 2, or 5 ml of diluent to give a reconstituted solution with a concentration of 1mg/ml
remifentanil. The reconstituted solution is clear, colourless, and practically free from particulate material. After reconstitution, visually inspect the product (where the
container permits) for particulate material, discolouration or damage of container. Discard any solution where such defects are observed. Reconstituted product is for
single use only. Any unused material should be discarded.
Remifentanil should not be administered by manually-controlled infusion without further dilution to concentrations of 20 to 250 micrograms/ml (50 micrograms/ml is the
recommended dilution for adults and 20 to 25 micrograms/ml for paediatric patients aged 1 year and over).
Remifentanil should not be administered by TCI without further dilution (20 to 50 micrograms/ml is the recommended dilution for TCI).
The dilution is dependent upon the technical capability of the infusion device and the anticipated requirements of the patient.
One of the following IV fluids listed below should be used for dilution:

Water for Injections
Glucose 5% solution for injection
Glucose 5% and Sodium Chloride 0.9% solution for injection
Sodium Chloride 0.9% solution for injection
Sodium Chloride 0.45% solution for injection
After dilution, visually inspect the product to ensure it is clear, colourless, practically free from particulate matter and the container is undamaged. Discard any solution
where such defects are observed.
Remifentanil has been shown to be compatible with the following intravenous fluids when administered into a running IV catheter:
Lactated Ringer's solution for injection
Lactated Ringer's and Glucose 5% solution for injection
Remifentanil has been shown to be compatible with propofol when administered into a running IV catheter.
The following tables give guidelines for infusion rates of Remifentanil for manually-controlled infusion:
Table 1. Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion Rates (ml/kg/h)
Drug Delivery Rate
(micrograms/kg/min)

Infusion Delivery Rate (ml/kg/h) for Solution Concentrations of
20 micrograms /ml 1 mg/50
ml

0.0125

0.038

25 micrograms /ml 1 mg/40
ml

50 micrograms /ml 1 mg/20
ml

0.03

0.015

250 micrograms /ml 10 mg/40
ml
Not recommended

0.025

0.075

0.06

0.03

Not recommended

0.05

0.15

0.12

0.06

0.012

0.075

0.23

0.18

0.09

0.018

0.1

0.3

0.24

0.12

0.024

0.15

0.45

0.36

0.18

0.036

0.2

0.6

0.48

0.24

0.048

0.25

0.75

0.6

0.3

0.06

0.5

1.5

1.2

0.6

0.12

0.75

2.25

1.8

0.9

0.18

1.0

3.0

2.4

1.2

0.24

1.25

3.75

3.0

1.5

0.3

1.5

4.5

3.6

1.8

0.36

1.75

5.25

4.2

2.1

0.42

2.0

6.0

4.8

2.4

0.48

Table 2. Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion Rates (ml/h) for a 20 micrograms/ml Solution
Infusion Rate
(micrograms/kg/min)

Patient Weight (kg)
5

10

20

30

40

50

60

0.0125

0.188

0.375

0.75

1.125

1.5

1.875

2.25

0.025

0.375

0.75

1.5

2.25

3.0

3.75

4.5

0.05

0.75

1.5

3.0

4.5

6.0

7.5

9.0

0.075

1.125

2.25

4.5

6.75

9.0

11.25

13.5

0.1

1.5

3.0

6.0

9.0

12.0

15.0

18.0

0.15

2.25

4.5

9.0

13.5

18.0

22.5

27.0

0.2

3.0

6.0

12.0

18.0

24.0

30.0

36.0

0.25

3.75

7.5

15.0

22.5

30.0

37.5

45.0

0.3

4.5

9.0

18.0

27.0

36.0

45.0

54.0

0.35

5.25

10.5

21.0

31.5

42.0

52.5

63.0

0.4

6.0

12.0

24.0

36.0

48.0

60.0

72.0

Table 3. Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion Rates (ml/h) for a 25 micrograms/ml Solution
Infusion Rate
(micrograms/kg/min)

Patient Weight (kg)
10

20

30

40

50

60

70

80

90

100

0.0125

0.3

0.6

0.9

1.2

1.5

1.8

2.1

2.4

2.7

3.0

0.025

0.6

1.2

1.8

2.4

3.0

3.6

4.2

4.8

5.4

6.0

0.05

1.2

2.4

3.6

4.8

6.0

7.2

8.4

9.6

10.8

12.0

0.075

1.8

3.6

5.4

7.2

9.0

10.8

12.6

14.4

16.2

18.0

0.1

2.4

4.8

7.2

9.6

12.0

14.4

16.8

19.2

21.6

24.0

0.15

3.6

7.2

10.8

14.4

18.0

21.6

25.2

28.8

32.4

36.0

0.2

4.8

9.6

14.4

19.2

24.0

28.8

33.6

38.4

43.2

48.0

Table 4. Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion Rates (ml/h) for a 50 micrograms/ml Solution
Infusion Rate

Patient Weight (kg)
30

40

50

60

70

80

90

100

0.025

0.9

1.2

1.5

1.8

2.1

2.4

2.7

3.0

0.05

1.8

2.4

3.0

3.6

4.2

4.8

5.4

6.0

0.075

2.7

3.6

4.5

5.4

6.3

7.2

8.1

9.0

0.1

3.6

4.8

6.0

7.2

8.4

9.6

10.8

12.0

0.15

5.4

7.2

9.0

10.8

12.6

14.4

16.2

18.0

(micrograms/kg/min)

0.2

7.2

9.6

12.0

14.4

16.8

19.2

21.6

24.0

0.25

9.0

12.0

15.0

18.0

21.0

24.0

27.0

30.0

0.5

18.0

24.0

30.0

36.0

42.0

48.0

54.0

60.0

0.75

27.0

36.0

45.0

54.0

63.0

72.0

81.0

90.0

1.0

36.0

48.0

60.0

72.0

84.0

96.0

108.0

120.0

1.25

45.0

60.0

75.0

90.0

105.0

120.0

135.0

150.0

1.5

54.0

72.0

90.0

108.0

126.0

144.0

162.0

180.0

1.75

63.0

84.0

105.0

126.0

147.0

168.0

189.0

210.0

2.0

72.0

96.0

120.0

144.0

168.0

192.0

216.0

240.0

Table 5. Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion Rates (ml/h) for a 250 micrograms/ml Solution

Infusion Rate
(micrograms/kg/min)

Patient Weight (kg)
30

40

50

60

70

80

90

100

0.1

0.72

0.96

1.20

1.44

1.68

1.92

2.16

2.40

0.15

1.08

1.44

1.80

2.16

2.52

2.88

3.24

3.60

0.2

1.44

1.92

2.40

2.88

3.36

3.84

4.32

4.80

0.25

1.80

2.40

3.00

3.60

4.20

4.80

5.40

6.00

0.5

3.60

4.80

6.00

7.20

8.40

9.60

10.80

12.00

0.75

5.40

7.20

9.00

10.80

12.60

14.40

16.20

18.00

1.0

7.20

9.60

12.00

14.40

16.80

19.20

21.60

24.00

1.25

9.00

12.00

15.00

18.00

21.00

24.00

27.00

30.00

1.5

10.80

14.40

18.00

21.60

25.20

28.80

32.40

36.00

1.75

12.60

16.80

21.00

25.20

29.40

33.60

37.80

42.00

2.0

14.40

19.20

24.00

28.80

33.60

38.40

43.20

48.00

The following table provides the equivalent blood remifentanil concentration using a TCI approach for various manually-controlled infusion rates at steady state:
Table 6. Remifentanil Blood Concentrations (nanograms/ml) estimated using the Minto (1997) Pharmacokinetic Model in a 70 kg, 170 cm, 40 Year Old Male
Patient for Various Manually-Controlled Infusion rates (micrograms /kg/min) at Steady State.
Remifentanil Infusion Rate
(micrograms /kg/min)

Remifentanil Blood Concentration

0.05

1.3

0.10

2.6

0.25

6.3

0.40

10.4

0.50

12.6

1.0

25.2

2.0

50.5

(nanograms/ml)

After reconstitution/dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. 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/dilution has taken place in controlled and validated aseptic conditions.

If this leaflet is difficult to see or read please contact the following address for help: Fannin
Limited, Fannin House, South County Business Park, Leopardstown, Dublin 18, Ireland Tel
+353-1-2907000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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