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ALFENTANIL 500 MICROGRAM/ML SOLUTION FOR INJECTION

Active substance(s): ALFENTANIL HYDROCHLORIDE

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hameln

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Alfentanil 500 micrograms/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
500 micrograms/ml solution for injection, which
will be referred to as Alfentanil throughout this
leaflet.

- 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 (treatment 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)

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 in adults for:
- Short procedures and outpatient surgery (day
case)
- Medium and long procedures when given as
an injection and followed by additional doses
or by continuous infusion

It may still be all right for you to be given
Alfentanil and your doctor will be able to decide
what is suitable for you.

Alfentanil is used in neonates, infants and
children:
- for induction of anaesthesia
- as a pain killer during anaesthesia and for both
short and long surgical procedures
At very high doses, Alfentanil may be used
to induce unconsciousness (anaesthesia) in
patients with assisted breathing (artificially
ventilated patients).

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.

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.

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

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

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

hameln

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

PREPARATION GUIDE FOR:

Alfentanil 500 micrograms/ml solution for injection
This is a summary of the information regarding
the preparation, storage and administration
of Alfentanil 500 micrograms/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 500 micrograms/ml is supplied as a
clear and colourless solution for injection in clear
glass ampoules (Ph Eur Type I, one point cut)
containing 1 mg/2 ml or 5 mg/10 ml and in clear
glass vials (Ph Eur Type I) containing 1 mg/2 ml,
5 mg/10 ml or 25 mg/50 ml.
Incompatibilities
This medicinal product must not be mixed with
other medicinal products except those mentioned
in the following paragraph “Dilution instructions”.
Dilution instructions
Dilutions of Alfentanil 500 micrograms/ml should
be prepared under controlled and validated
aseptic conditions.
Alfentanil 500 micrograms/ml solution for
injection may be diluted with sodium chloride
injection BP, glucose injection BP, or Ringer
Lactate injection BP (Hartmann’s solution) to a
concentration of 25-80 µg/ml. 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.

From the microbiological point of view, the
dilutions should be used immediately.
Storage
No special precautions for storage.
The product should be used immediately after
opening the container.
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
Alfentanil is administered intravenously by
injection or infusion and should only be given
by individuals trained in the administration of
general anaesthetics and the management
of the respiratory effects of potent opioids.
Alfentanil 500 micrograms/ml should be used
as bolus injections (short procedures) or bolus
supplemented by increments or by infusion (long
painful surgical procedures).
Pulse oximetry or some other means for
measuring respiratory function is recommended.
Visually inspect parenteral products for
particulate matter and discoloration prior to
administration.
Infuse i.v. slowly over 3 minutes. Injections rates
of <1 minute are associated with an increased
incidence of hypotension.

Leaflet Alfentanil 500µg/ml sol inj UK
Quality

SAP No

500189

Artwork No

N500189.01-UK Dimensions

DMcode

500189

Folded leaflet size

white paper, 50 g/m²
148x440 mm

Prepared

L.Hnilica/30.11.2017

Checked

Z.Kakackova/30.11.2017

148x220 mm / DMcodes outside

Leaflets must comply with PNOM-OD 9 Leaflets developed by HBM Pharma.

Colours

Replaces 59673
Approved

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 sodium
Alfentanil contains 0.31 mmol (or 7.1 mg)
sodium per 2 ml ampoule, 1.54 mmol (35.4 mg)
sodium per 10 ml ampoule and 7.70 mmol (or
177 mg) sodium per 50 ml vial. To be taken into
consideration by patients on a controlled sodium
diet.

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 infusion 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, bodyweight, fitness, your condition, the
use of other drugs and the type of surgery and
level of anaesthesia that is needed.
In Adults
The usual recommended dosage is as follows:
Starting dose
Breathing
normally
Assisted
breathing

Additional doses

500 micrograms 250 micrograms
(1 ml)
(0.5 ml)
30-50
15 micrograms/kg
micrograms/kg

In Neonates, Infants and Children
Your child will be given Alfentanil by a nurse
or doctor. Your doctor will decide the correct
dosage for your child and how and when the
injection will be given.
If you have any further questions or concerns
on the use of this medicine for your child ask the
doctor or nurse giving the injection.
Obese patients may need a dose based on their
ideal body weight.
Patients with a liver disorder may need a dose
adjustment.

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
reported:

side

effects

have

been

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
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.
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 PACK AND
OTHER INFORMATION
What Alfentanil contains
The active substance is alfentanil hydrochloride.
1 ml of Alfentanil contains 543.8 micrograms
alfentanil hydrochloride, equivalent to 500
micrograms 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
containing 1 mg in 2 ml
Pack containing 5 or 10 clear glass ampoules
containing 5 mg in 10 ml
Pack containing 5 or 10 clear glass vials
containing 1 mg in 2 ml
Pack containing 5 or 10 clear glass vials
containing 5 mg in 10 ml
Pack containing 1, 5 or 10 clear glass vials
containing 25 mg in 50 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder
hameln pharma plus gmbh
Langes Feld 13
31789 Hameln, Germany
Manufacturer
Siegfried Hameln 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 2018.
500189/48/17

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