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ALFENTANIL 5MG/ML SOLUTION FOR INJECTION

Active substance(s): ALFENTANIL HYDROCHLORIDE

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Packager: hameln pharmaceuticals gmbh

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

hameln

Alfentanil 5 mg/ml solution for injection
Important information about your medicine
► Your doctor or nurse will give you the injection.
► If this injection causes you any problems talk to your doctor, nurse or pharmacist.
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine.
► Please tell your doctor or pharmacist, if you are taking any other medicines.
Read all of this leaflet carefully before you start using 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 nurse.
• 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 side effects, talk to your doctor or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Alfentanil 5 mg/ml
solution for injection, which will be referred to as
Alfentanil throughout this leaflet.
What is in this leaflet
1. What Alfentanil is and what it is used for
2.
What you need to know before you use
Alfentanil
3. How to use Alfentanil
4. Possible side effects
5. How to store Alfentanil
6. Contents of the pack and other information

1. WHAT ALFENTANIL IS AND WHAT IT
IS USED FOR
Alfentanil belongs to a group of medicines called
opioid analgesics, which relieve or prevent pain.
Alfentanil is a strong painkiller which has a
very rapid effect. Alfentanil is used for surgical
procedures.
Alfentanil is used to:
- prevent pain during painful operations
- prevent pain during brief painful procedures
(suction
through
a
breathing
tube,
physiotherapy etc.)
- prevent pain and depress breathing activity in
artificially ventilated patients in intensive care
- help patients tolerate artificial breathing and the
placement of an endotracheal (wind-pipe) tube
Artificially ventilated patients may remain awake if
they have appropriate pain control.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE ALFENTANIL
Do not use Alfentanil if:
- you are allergic (hypersensitive) to Alfentanil,
other strong painkillers, or any of the other
ingredients (see list of ingredients in Section
6).
- you suffer from any illness causing
breathing difficulties and your breathing is
not assisted during and/or after surgery
- you are taking any of the antidepressant
medicines known as monoamine oxidase
inhibitors (MAOIs) or have taken them
during the last two weeks
Alfentanil should not be given during labour or
before the cord is clamped during Caesarean
section.
Warnings and precautions
Before you receive Alfentanil, tell your doctor if
you have:
- a head injury - Alfentanil may influence the
clinical signs of patients with head injuries
- lung disease or other breathing difficulties
- a liver or kidney disorder
- a thyroid disorder
Other medicines and Alfentanil
Please tell your doctor or nurse if you are taking,
or have recently taken, any other medicines,
including medicines you can get without a
prescription. This is especially important with the

following medicines as they may interact with
your Alfentanil:
- fluconazole, ketoconazole (treatments of fungal
diseases)
- erythromycin (an antibiotic drug)
- diltiazem (treatment of high blood pressure or
angina)
- cimetidine (treatment of heartburn or ulcers)
- ritonavir (treatment of HIV-AIDS)
- barbiturates (sleeping tablets)
- tranquilizers (treatment of anxiety)
- opioids (strong painkillers)
- inhalation general anaesthetics
- beta-blockers (treatment of high blood pressure
and irregular heart rhythms)
- drugs affecting liver blood flow or liver enzymes
(your doctor will know what these are)
It may still be all right for you to receive Alfentanil
and your doctor will be able to decide what is
suitable for you.
Children
Alfentanil is not recommended for use in children
in intensive care.
Elderly
The initial dose of Alfentanil should be
appropriately reduced in elderly and debilitated
patients.
Pregnancy and breast-feeding
Alfentanil should not be given to pregnant women
unless medically justified.
Alfentanil should not be used during childbirth as it
can affect the baby’s breathing. Breast-feeding is
not recommended. Ask your doctor or pharmacist
for advice before taking any medicine.
Driving and using machines
After you have been given Alfentanil you must
not drive or operate machinery for the following
24 hours.
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.

Do not drive while taking this medicine until
you know how it affects you.

It is an offence to drive if this medicine
affects your ability to drive.

However, you would not be committing an
offence if:

The medicine has been prescribed to
treat a medical or dental problem and

You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and

It was not affecting your ability to drive
safely
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.
Alfentanil contains less than 1 mmol sodium
per dose.

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

hameln

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

Alfentanil 5 mg/ml solution for injection
This is a summary of the information regarding
the preparation, storage and administration of
Alfentanil 5 mg/ml solution for injection.
It is important that you read the entire contents of
this guide prior to the preparation of this medicinal
product. Please refer to the Summary of Product
Characteristics for full prescribing and other
information.
Nature and content of container
Alfentanil 5 mg/ml is supplied as a clear and
colourless solution for injection in clear glass
ampoules (Ph Eur Type I, one point cut) containing
5 mg/1 ml.
Original pack containing 5 or
10 ampoules of 1 ml each.
Incompatibilities
This medicinal product must not be mixed with
other medicinal products except those mentioned
in the following paragraph “Dilution instructions”.
Dilution instructions
Alfentanil 5 mg/ml solution for injection should
be diluted with sodium chloride intravenous
infusion BP, glucose intravenous infusion BP, or
compound sodium lactate intravenous infusion
BP (Hartmann’s solution). Such dilutions are
compatible with plastic bags and giving sets.
Chemical and physical in-use stability of the
dilutions has been demonstrated for 48 hours.

45465_03_14_Leaflet_Alfentanil 5 mg-ml_CM.indd 1

From the microbiological point of view, the
dilutions should be used immediately.
Storage
No special precautions for storage.
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 dilution has taken
place in controlled and validated aseptic
conditions.
Any unused solution from opened ampoules or
vials should be discarded.
Posology and method of administration
Method of administration
For intravenous infusion.
Alfentanil should be administered only by persons
specifically trained in the use of intravenous and
general anaesthetic agents and the management
of respiratory effects of potent opioids. An opioid
antagonist, resuscitative and intubation equipment
and oxygen should be readily available. Because
of the possibility of delayed respiratory depression,
monitoring of the patient must continue well after
surgery.
At the proposed doses, Alfentanil 5 mg/ml solution
for injection has no sedative activity. Therefore
supplementation with an appropriate hypnotic or

22/01/2014 09:56:43

3. HOW TO USE ALFENTANIL
Alfentanil will be given to you by specifically
trained health care professionals and emergency
equipment will be available.
Alfentanil is given as an injection into a vein,
usually on the back of the hand or in the forearm.
Dosage
The amount of Alfentanil you need depends on
your age, body weight, fitness, your condition, the
use of other drugs and the type of surgery and
level of anaesthesia that is needed.
-
The
recommended
starting
dose
for
mechanically ventilated adult patients is 2 mg
per hour of Alfentanil. For a 70 kg patient, this is
about 30 micrograms per kilogram body weight
per hour.
- Adolescents and young adults will require
higher than average doses.
- Elderly and those patients with liver disease and
hypothyroidism (under-active thyroid gland) will
require lower doses.
- Obese patients may need a dose based on
their ideal body weight.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Alfentanil can cause side
effects, although not everybody gets them.
Occasionally, Alfentanil may cause allergic
reactions such as rash, itching, difficulty of
breathing or swelling of the face, lips, throat
or tongue. Please inform your doctor or nurse
immediately if one or more of these reactions
occur.
The following side effects have been reported:
Very common (more than 1 in 10 patients)
- feeling sick (nausea)
Common (in less than 1 in 10 patients, but
more than 1 in 100 patients)
- headache
- low blood pressure (hypotension)
- pain at injection site
- pruritus (itching)
- shallow breathing (respiratory depression/
hypoxemia)
- sleepiness
- dizziness
- drowsiness
- vomiting
Uncommon (in less than 1 in 100 patients, but
more than 1 in 1000 patients)
- slow heartbeat (bradycardia)
- coughing
- excitation
- high blood pressure (hypertension)
-
asthma-like
symptoms
(e.g.
breathing
difficulties, spasm of the airway)
- rigid muscles
- shivering/feeling cold
- rapid heartbeat (tachycardia)
- unable to urinate (urinary retention)
- visual disturbances

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

5. HOW TO STORE ALFENTANIL
Keep out of the sight and reach of children.
Your doctor and pharmacist are responsible for
the correct storage, use and disposal of Alfentanil.
Do not use Alfentanil after the expiry date which
is stated on the carton and label after “EXP.”. The
expiry date refers to the last day of that month.
Do not use Alfentanil if you notice the solution is
not clear, colourless and free of particles or if the
container is damaged.

6.
CONTENTS OF THE
OTHER INFORMATION

PACK

AND

What Alfentanil contains
The active substance is alfentanil hydrochloride.
1 ml of Alfentanil contains 5.44 mg alfentanil
hydrochloride monohydrate, equivalent to 5 mg
alfentanil base.
The other ingredients are: water for injections,
sodium chloride and hydrochloric acid
What Alfentanil looks like and contents of the
pack
Alfentanil is a clear and colourless solution for
injection.
Pack containing 5 or 10 clear glass ampoules of
1 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
hameln pharma plus gmbh
Langes Feld 13
31789 Hameln, Germany
Manufacturer
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln, Germany
HBM Pharma s.r.o.
Sklabinská 30
03680 Martin, Slovakia
hameln rds a.s.
Horná 36
900 01 Modra, Slovakia
Distributor
hameln pharmaceuticals ltd
Gloucester
United Kingdom
For any information about this medicine,
please contact the Distributor.
This leaflet was last revised in January 2014

Rare (in less than 1 in 1000 patients, but more
than 1 in 10 000 patients)
- hiccups (singultus)
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
Yellow Card Scheme - Website: www.mhra.
gov.uk/yellowcard. Alternatively you can call
Freephone 0808 100 3352 (available from 10
a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.

45465/03/14

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------sedative agent is recommended. Admixture is not
advisable due to the need to individually titrate
both agents.
Alfentanil should only be prescribed by physicians
familiar with the use of potent opioids when given
by continuous i.v. infusion.
Dosage
Once the patient has been intubated, mechanical
ventilation can be initiated using the following
dosage regimen:
The recommended initial infusion rate for
mechanically ventilated adult patients is 2 mg per
hour (equivalent to 0.4 ml per hour) of undiluted
Alfentanil 5 mg/ml solution for injection. For a
70 kg patient, this corresponds to approximately
30 micrograms per kilogram per hour.
More rapid control may initially be gained by
using a loading dose. For example, a dose of
5 mg may be given in divided doses over a period
of 10 minutes, during which time careful monitoring
of blood pressure and heart rate should be
performed. If hypotension or bradycardia occurs,
the rate of administration should be reduced
accordingly and other appropriate measures
instituted.
The dose to produce the desired effects should
then be individually determined and reassessed
regularly to ensure that the optimum dose is being
used.
In clinical trials, patient requirements have
generally been met with doses of 0.5 to 10 mg
alfentanil per hour.
Additional bolus doses of 0.5-1.0 mg alfentanil
may be given to provide analgesia during short
painful procedures.
The elderly and those patients with liver
impairment and hypothyroidism will require lower
doses. Obese patients may require a dose based
on their lean body mass.

45465_03_14_Leaflet_Alfentanil 5 mg-ml_CM.indd 2

Paediatric patients
Data in children, particularly those aged 1 month
to 1 year are limited (see section 5.2). Alfentanil is
not recommended for use in children in intensive
care.
The maximum recommended duration of
treatment with alfentanil infusions is 4 days.
Present data suggest that clearance of alfentanil
is unaltered in renal failure. However there is
an increased free fraction and hence dosage
requirements may be less than in the patient with
normal renal function.
For more information regarding recommended
dose modifications please refer to the SPC.
Marketing Authorisation Holder
hameln pharma plus gmbh
Langes Feld 13
31789 Hameln
Germany
Distributor
hameln pharmaceuticals ltd
Gloucester
United Kingdom
For any information about this medicine,
please contact the Distributor.
This part of the leaflet was last revised in
June 2013.

45465/03/14

22/01/2014 09:56:43

PACKAGER: HBM Pharma s.r.o.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

hameln

Alfentanil 5 mg/ml solution for injection
Important information about your medicine
► Your doctor or nurse will give you the injection.
► If this injection causes you any problems talk to your doctor, nurse or pharmacist.
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine.
► Please tell your doctor or pharmacist, if you are taking any other medicines.
Read all of this leaflet carefully before you start using 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 nurse.
• 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 side effects, talk to your doctor or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Alfentanil 5 mg/ml
solution for injection, which will be referred to as
Alfentanil throughout this leaflet.
What is in this leaflet
1. What Alfentanil is and what it is used for
2.
What you need to know before you use
Alfentanil
3. How to use Alfentanil
4. Possible side effects
5. How to store Alfentanil
6. Contents of the pack and other information

1. WHAT ALFENTANIL IS AND WHAT IT
IS USED FOR
Alfentanil belongs to a group of medicines called
opioid analgesics, which relieve or prevent pain.
Alfentanil is a strong painkiller which has a
very rapid effect. Alfentanil is used for surgical
procedures.
Alfentanil is used to:
- prevent pain during painful operations
- prevent pain during brief painful procedures
(suction
through
a
breathing
tube,
physiotherapy etc.)
- prevent pain and depress breathing activity in
artificially ventilated patients in intensive care
- help patients tolerate artificial breathing and the
placement of an endotracheal (wind-pipe) tube
Artificially ventilated patients may remain awake if
they have appropriate pain control.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE ALFENTANIL
Do not use Alfentanil if:
- you are allergic (hypersensitive) to Alfentanil,
other strong painkillers, or any of the other
ingredients (see list of ingredients in Section
6).
- you suffer from any illness causing
breathing difficulties and your breathing is
not assisted during and/or after surgery
- you are taking any of the antidepressant
medicines known as monoamine oxidase
inhibitors (MAOIs) or have taken them
during the last two weeks
Alfentanil should not be given during labour or
before the cord is clamped during Caesarean
section.
Warnings and precautions
Before you receive Alfentanil, tell your doctor if
you have:
- a head injury - Alfentanil may influence the
clinical signs of patients with head injuries
- lung disease or other breathing difficulties
- a liver or kidney disorder
- a thyroid disorder
Other medicines and Alfentanil
Please tell your doctor or nurse if you are taking,
or have recently taken, any other medicines,
including medicines you can get without a
prescription. This is especially important with the

following medicines as they may interact with
your Alfentanil:
- fluconazole, ketoconazole (treatments of fungal
diseases)
- erythromycin (an antibiotic drug)
- diltiazem (treatment of high blood pressure or
angina)
- cimetidine (treatment of heartburn or ulcers)
- ritonavir (treatment of HIV-AIDS)
- barbiturates (sleeping tablets)
- tranquilizers (treatment of anxiety)
- opioids (strong painkillers)
- inhalation general anaesthetics
- beta-blockers (treatment of high blood pressure
and irregular heart rhythms)
- drugs affecting liver blood flow or liver enzymes
(your doctor will know what these are)
It may still be all right for you to receive Alfentanil
and your doctor will be able to decide what is
suitable for you.
Children
Alfentanil is not recommended for use in children
in intensive care.
Elderly
The initial dose of Alfentanil should be
appropriately reduced in elderly and debilitated
patients.
Pregnancy and breast-feeding
Alfentanil should not be given to pregnant women
unless medically justified.
Alfentanil should not be used during childbirth as it
can affect the baby’s breathing. Breast-feeding is
not recommended. Ask your doctor or pharmacist
for advice before taking any medicine.
Driving and using machines
After you have been given Alfentanil you must
not drive or operate machinery for the following
24 hours.
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.

Do not drive while taking this medicine until
you know how it affects you.

It is an offence to drive if this medicine
affects your ability to drive.

However, you would not be committing an
offence if:

The medicine has been prescribed to
treat a medical or dental problem and

You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and

It was not affecting your ability to drive
safely
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.
Alfentanil contains less than 1 mmol sodium
per dose.

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

hameln

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

Alfentanil 5 mg/ml solution for injection
This is a summary of the information regarding
the preparation, storage and administration of
Alfentanil 5 mg/ml solution for injection.
It is important that you read the entire contents of
this guide prior to the preparation of this medicinal
product. Please refer to the Summary of Product
Characteristics for full prescribing and other
information.
Nature and content of container
Alfentanil 5 mg/ml is supplied as a clear and
colourless solution for injection in clear glass
ampoules (Ph Eur Type I, one point cut) containing
5 mg/1 ml.
Original pack containing 5 or
10 ampoules of 1 ml each.
Incompatibilities
This medicinal product must not be mixed with
other medicinal products except those mentioned
in the following paragraph “Dilution instructions”.
Dilution instructions
Alfentanil 5 mg/ml solution for injection should
be diluted with sodium chloride intravenous
infusion BP, glucose intravenous infusion BP, or
compound sodium lactate intravenous infusion
BP (Hartmann’s solution). Such dilutions are
compatible with plastic bags and giving sets.
Chemical and physical in-use stability of the
dilutions has been demonstrated for 48 hours.

57515_08_14_Leaflet_Alfentanil 5 mg-ml_HBM.indd 1

From the microbiological point of view, the
dilutions should be used immediately.
Storage
No special precautions for storage.
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 dilution has taken
place in controlled and validated aseptic
conditions.
Any unused solution from opened ampoules or
vials should be discarded.
Posology and method of administration
Method of administration
For intravenous infusion.
Alfentanil should be administered only by persons
specifically trained in the use of intravenous and
general anaesthetic agents and the management
of respiratory effects of potent opioids. An opioid
antagonist, resuscitative and intubation equipment
and oxygen should be readily available. Because
of the possibility of delayed respiratory depression,
monitoring of the patient must continue well after
surgery.
At the proposed doses, Alfentanil 5 mg/ml solution
for injection has no sedative activity. Therefore
supplementation with an appropriate hypnotic or

17/02/2014 09:49:58

3. HOW TO USE ALFENTANIL
Alfentanil will be given to you by specifically
trained health care professionals and emergency
equipment will be available.
Alfentanil is given as an injection into a vein,
usually on the back of the hand or in the forearm.
Dosage
The amount of Alfentanil you need depends on
your age, body weight, fitness, your condition, the
use of other drugs and the type of surgery and
level of anaesthesia that is needed.
-
The
recommended
starting
dose
for
mechanically ventilated adult patients is 2 mg
per hour of Alfentanil. For a 70 kg patient, this is
about 30 micrograms per kilogram body weight
per hour.
- Adolescents and young adults will require
higher than average doses.
- Elderly and those patients with liver disease and
hypothyroidism (under-active thyroid gland) will
require lower doses.
- Obese patients may need a dose based on
their ideal body weight.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Alfentanil can cause side
effects, although not everybody gets them.
Occasionally, Alfentanil may cause allergic
reactions such as rash, itching, difficulty of
breathing or swelling of the face, lips, throat
or tongue. Please inform your doctor or nurse
immediately if one or more of these reactions
occur.
The following side effects have been reported:
Very common (more than 1 in 10 patients)
- feeling sick (nausea)
Common (in less than 1 in 10 patients, but
more than 1 in 100 patients)
- headache
- low blood pressure (hypotension)
- pain at injection site
- pruritus (itching)
- shallow breathing (respiratory depression/
hypoxemia)
- sleepiness
- dizziness
- drowsiness
- vomiting
Uncommon (in less than 1 in 100 patients, but
more than 1 in 1000 patients)
- slow heartbeat (bradycardia)
- coughing
- excitation
- high blood pressure (hypertension)
-
asthma-like
symptoms
(e.g.
breathing
difficulties, spasm of the airway)
- rigid muscles
- shivering/feeling cold
- rapid heartbeat (tachycardia)
- unable to urinate (urinary retention)
- visual disturbances

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

5. HOW TO STORE ALFENTANIL
Keep out of the sight and reach of children.
Your doctor and pharmacist are responsible for
the correct storage, use and disposal of Alfentanil.
Do not use Alfentanil after the expiry date which
is stated on the carton and label after “EXP.”. The
expiry date refers to the last day of that month.
Do not use Alfentanil if you notice the solution is
not clear, colourless and free of particles or if the
container is damaged.

6.
CONTENTS OF THE
OTHER INFORMATION

PACK

AND

What Alfentanil contains
The active substance is alfentanil hydrochloride.
1 ml of Alfentanil contains 5.44 mg alfentanil
hydrochloride monohydrate, equivalent to 5 mg
alfentanil base.
The other ingredients are: water for injections,
sodium chloride and hydrochloric acid
What Alfentanil looks like and contents of the
pack
Alfentanil is a clear and colourless solution for
injection.
Pack containing 5 or 10 clear glass ampoules of
1 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
hameln pharma plus gmbh
Langes Feld 13
31789 Hameln, Germany
Manufacturer
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln, Germany
HBM Pharma s.r.o.
Sklabinská 30
03680 Martin, Slovakia
hameln rds a.s.
Horná 36
900 01 Modra, Slovakia
Distributor
hameln pharmaceuticals ltd
Gloucester
United Kingdom
For any information about this medicine,
please contact the Distributor.
This leaflet was last revised in January 2014

Rare (in less than 1 in 1000 patients, but more
than 1 in 10 000 patients)
- hiccups (singultus)
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
Yellow Card Scheme - Website: www.mhra.
gov.uk/yellowcard. Alternatively you can call
Freephone 0808 100 3352 (available from 10
a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.

57515/08/14

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------sedative agent is recommended. Admixture is not
advisable due to the need to individually titrate
both agents.
Alfentanil should only be prescribed by physicians
familiar with the use of potent opioids when given
by continuous i.v. infusion.
Dosage
Once the patient has been intubated, mechanical
ventilation can be initiated using the following
dosage regimen:
The recommended initial infusion rate for
mechanically ventilated adult patients is 2 mg per
hour (equivalent to 0.4 ml per hour) of undiluted
Alfentanil 5 mg/ml solution for injection. For a
70 kg patient, this corresponds to approximately
30 micrograms per kilogram per hour.
More rapid control may initially be gained by
using a loading dose. For example, a dose of
5 mg may be given in divided doses over a period
of 10 minutes, during which time careful monitoring
of blood pressure and heart rate should be
performed. If hypotension or bradycardia occurs,
the rate of administration should be reduced
accordingly and other appropriate measures
instituted.
The dose to produce the desired effects should
then be individually determined and reassessed
regularly to ensure that the optimum dose is being
used.
In clinical trials, patient requirements have
generally been met with doses of 0.5 to 10 mg
alfentanil per hour.
Additional bolus doses of 0.5-1.0 mg alfentanil
may be given to provide analgesia during short
painful procedures.
The elderly and those patients with liver
impairment and hypothyroidism will require lower
doses. Obese patients may require a dose based
on their lean body mass.

57515_08_14_Leaflet_Alfentanil 5 mg-ml_HBM.indd 2

Paediatric patients
Data in children, particularly those aged 1 month
to 1 year are limited (see section 5.2). Alfentanil is
not recommended for use in children in intensive
care.
The maximum recommended duration of
treatment with alfentanil infusions is 4 days.
Present data suggest that clearance of alfentanil
is unaltered in renal failure. However there is
an increased free fraction and hence dosage
requirements may be less than in the patient with
normal renal function.
For more information regarding recommended
dose modifications please refer to the SPC.
Marketing Authorisation Holder
hameln pharma plus gmbh
Langes Feld 13
31789 Hameln
Germany
Distributor
hameln pharmaceuticals ltd
Gloucester
United Kingdom
For any information about this medicine,
please contact the Distributor.
This part of the leaflet was last revised in
June 2013.

57515/08/14

17/02/2014 09:49:58

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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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