Remifentanil 5mg Powder For Concentrate For Solution For Injection Or Infusion
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Remifentanil 1 mg powder for concentrate for solution for injection or infusion Remifentanil 2 mg powder for concentrate for solution for injection or infusion Remifentanil 5 mg powder for concentrate for solution for injection or infusion
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
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 you get any of the side effects talk to your doctor. This includes any possible side effects not listed in this leaflet.
In this leaflet:
1. What Remifentanil is and what it is used for
2. What you need to know before you are given Remifentanil
3. How Remifentanil is given
4. Possible side effects
5. How to store Remifentanil
6. Contents of the pack and any other information
1. WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR
Remifentanil belongs to a group of medicines known as opioids. These medicines are used widely to cause anaesthesia and or/ to relieve pain during an operation.
Remifentanil is used:
• as an analgesic, which helps to relieve pain, for use at the onset or during anaesthesia in conjunction with anaesthetic agents
• as an analgesic for patients 18 years of age or older who are mechanically ventilated in the intensive care unit.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN REMIFENTANIL Remifentanil must not be given
- if you are allergic (hypersensitive) to Remifentanil or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to any medicine used in operations or if you had a side effect during an operation.
- Remifentanil must not be administered by epidural or intrathecal injection, because this medicine contains glycine.
- as sole medicine to initiate anaesthesia.
Warnings and precautions
Tell your doctor before you are given Remifentanil:
- If you have had breathing problems
- If you have had a slow or irregular heart rate
- If you have lower than normal blood pressure
- If you are over 65 years of age
- If the patient is an infant younger than one year of age
- If you are debilitated
- If you are hypovolaemic (decrease of blood volume)
- If you have had experienced loss of blood or dehydration
- If you were feeling generally unwell
Other medicines and Remifentanil
Tell your doctor if you are taking or have recently taken any other medicines.
If you are taking or have recently taken some medicine such as beta-blockers or calcium channel blockers, it may increase the cardiovascular effects. In addition tell your doctor if you take or have recently taken other narcotic substances.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Your doctor will assess if having this medicine is necessary during pregnancy or breastfeeding.
In case of having this medicine, breast-feeding must be stopped during the following 24 hours.
Driving and using machines
After anaesthesia with Remifentanil you should not drive or operate machinery. The physician should decide when these activities may be resumed. It is advisable that you are accompanied when returning home and that alcoholic drink is avoided.
This medicine can affect your ability to drive.
Do not drive whilst taking this medicine until you know how this medicine affects you.
It may be an offence to drive if your ability to drive safely is affected.
There is further information for patients who are intending to drive in Great Britain - go to http://www.gov.uk/drug-driving-law
3. HOW REMIFENTANIL IS GIVEN
This medicine will always be given to you by a person who is qualified to do so. You will never be expected to give yourself this medicine.
Before giving it, the powder must be dissolved and then diluted by qualified person in order to have an appropriate liquid to be given intravenously.
The dose you are given will depend on the operation you have.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Remifentanil Injection can cause side effects although not everybody gets them. These effects are normally mild to moderate.
Some people can be allergic to medicines. If you have noticed some of the following symptoms immediately after an operation, tell you doctor immediately.
- sudden wheeze 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
Tell your doctor immediately if you notice some of the following symptoms:
Very common: (affects more than 1 user in 10)
- Muscle stiffness
- Nausea
- Vomiting
- Decreased blood pressure
Common: (affects 1 to 10 users in 100)
- Slow heart rate
- Increased blood pressure after the operation procedure
- Problems breathing
- Shivers
- Itching
The information provided in this section are the instructions for the preparation of Remifentanil powder for concentrate for solution for injection or infusion prior to administration and the guidelines for infusion rates for manually-controlled infusion.
For the Medical Profession
Refer to the Summary of Product Characteristics for the complete prescribing information.
Preparation guide for:
|
Drug Delivery Rate (pg/kg/min) |
Infusion Rate (ml/kg/h) for Solution Concentrations of | |||
|
20pg/ml 1mg/50ml |
25pg/ml 1mg/40ml |
50pg/ml 1mg/20m |
250pg/ml 10 mg/40ml | |
|
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 |
Remifentanil 1 mg powder for concentrate for solution for injection or infusion
Remifentanil 2 mg powder for concentrate for solution for injection or infusion
Remifentanil 5 mg powder for concentrate for solution for injection or infusion
Remifentanil Injection is a white to off-white powder, to be reconstituted before use. Remifentanil Injection is available in glass vials containing 1mg, 2mg or 5mg of remifentanil base.
Remifentanil 1mg Injection should not be stored above 25°C. Remifentanil 2mg and 5mg Injections do not require any special storage conditions.
When reconstituted as directed, solutions of Remifentanil Injection are clear, colourless and practically free from particulate material and contain 1mg/ml of remifentanil base as remifentanil hydrochloride. Remifentanil Injection should not be administered without further dilution after reconstitution of the lyophilised powder.
It is important that you read this guide prior to the preparation of Remifentanil Injection. This information can also be found under sections 6.4 and 6.6 of the Summary of Product Characteristics.
Reconstitution of the lyophilised powder
Remifentanil Injection should be prepared for intravenous use by adding, as appropriate 1, 2 or 5ml of diluent (see list of diluents under ‘Further Dilution') to give a reconstituted solution with a concentration of approximately 1 mg/ml remifentanil. The reconstituted solution is clear, colourless and practically free from particulate material. After reconstitution the solution should be visually inspected on contaminations, colour or a defective container. The solution should be discarded, if any of these modifications should appear. The reconstituted solution should be used immediately and is for single use only.
Further Dilution
After reconstitution, Remifentanil Injection 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 in paediatric patients aged 1 year and over when used in maintenance of anaesthesia).
Table 2: Remifentanil Injection Infusion Rates (ml/h) for a 20pg/ml Solution
|
Infusion Rate (pg/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 Injection Infusion Rates (ml/h) for a 25 pg/ml Solution
|
Infusion Rate (pg/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 |
After reconstitution, Remifentanil Injection should not be administered by target-controlled infusion (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 intravenous fluids listed below should be used for dilution:
Water for Injections
Glucose 50 mg/ml (5%) solution for injection
Glucose 50 mg/ml (5%) and Sodium Chloride 9 mg/ml (0.9%) solution for injection Sodium Chloride 9 mg/ml (0.9%) solution for injection Sodium Chloride 4.5 mg/ml (0.45%) solution for injection
After dilution, the solution should be inspected visually to ensure it is clear, colourless, practically free from particulate matter and the container is undamaged. Any solution where such defects are observed must be discarded.
The reconstituted and further diluted solution of Remifentanil Injection should be used immediately.
Remifentanil Injection 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 50 mg/ml (5%) solution for injection
Remifentanil Injection has been shown to be compatible with propofol when administered into a running IV catheter.
Guidelines for Infusion Rates
The tables below give guidelines for infusion rates of Remifentanil Injection for manually-controlled infusion:
Table 1: Remifentanil Injection Infusion Rates (ml/kg/h)
|
Drug Delivery Rate (pg/kg/min) |
Infusion Rate (ml/kg/h) for Solution Concentrations of | |||
|
20pg/ml 1mg/50ml |
25pg/ml 1mg/40ml |
50pg/ml 1mg/20m |
250pg/ml 10 mg/40ml | |
|
0.0125 |
0.038 |
0.03 |
0.015 |
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 |
Table 4: Remifentanil Injection Infusion Rates (ml/h) for a 50 pg/ml Solution
|
Infusion Rate (pg/kg/min) |
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 |
|
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 Injection Infusion Rates (ml/h) for a 250 pg/ml Solution
|
Infusion Rate (pg/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 |
This leaflet was last revised in
March 2014
Uncommon: (affects 1 to 10 users in 1,000)
- Aches following your operation
- Constipation
- Decrease of oxygen in blood
Rare: (affects 1 to 10 users in 10,000)
- Drowsiness once the operation is over
- Allergic reaction, including anaphylaxis (allergic general reaction)
- Heart function disorders (cardiac arrest)
Not known: (frequency cannot be estimated from the available data)
- Drug dependence
- Convulsions
- Atrioventricular block (heart block)
- Drug tolerance
If you get any side effects, talk to your doctor. This includes any side effects not listed in this leaflet.
5. HOW TO STORE REMIFENTANIL
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and on the carton. The expiry date refers to the last day of the month.
Remifentanil 1 mg: Do not store above 25°C.
Remifentanil 2 mg and 5 mg: This medicinal product does not require any special storage conditions. Shelf life after reconstitution:
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 has taken place in controlled and validated aseptic conditions.
Shelf life after dilution:
All mixtures with infusion fluids should be used immediately.
After reconstitution the solution must not be used, if it is not clear, colourless and free of visible particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Remifentanil contains
The active substance is Remifentanil. Each vial contains 1 mg, 2 mg or 5 mg of Remifentanil (as hydrochloride).
After reconstitution the solution contains 1 mg/ml if prepared as recommended.
The other ingredients are: glycine and hydrochloric acid 37% (for pH-adjustment).
What Remifentanil looks like and contents of the pack
Remifentanil is a white to off-white powder for concentration for solution for injection or infusion.
Each carton of Remifentanil 1 mg contains 5 vials of 5 ml.
Each carton of Remifentanil 2 mg contains 5 vials of 5 ml.
Each carton of Remifentanil 5 mg contains 5 vials of 10 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer: Laboratorio Reig Jofre, S.A., Gran Capitan, 10, 08970 Sant Joan Despf, Barcelona, Spain.
Other formats:
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For the Republic of Ireland please call 052 6186000
Please be ready to give the following information:
|
Product Name |
Reference Number |
|
Remifentanil 1 mg powder for concentrate |
PL29831/0482 |
|
for solution for injection or infusion |
PA1339/30/1 |
|
Remifentanil 2 mg powder for concentrate |
PL29831/0483 |
|
for solution for injection or infusion |
PA1339/30/2 |
|
Remifentanil 5 mg powder for concentrate |
PL29831/0484 |
|
for solution for injection or infusion |
PA1339/30/3 |
This medicinal product is authorised in the Member States of the EEA under the following names:
DE/H/2471/001 -003/DC:
|
DE |
Remifentanil -PAION 1/ 2/ 5mg Pulver fur ein Konzentrat zur Herstellung einer Injektionslosung / Infusionslosung |
|
UK |
Remifentanil 1/ 2/ 5mg powder for concentrate for solution for injection or infusion |
|
IE |
Remifentanil 1/ 2/ 5mg powder for concentrate for solution for injection or infusion |
|
IT |
Remifentanil Accord 1/ 2/ 5mg polvere per concentrato per soluzione iniettabile o per infusione |
|
GR |
Remifentanil 1/ 2/ 5mg |
This leaflet was last revised in
March 2014
105394/3
fwOCKHARDT
105394/3
Twockhardt