0.5 mg / ml injection solution 
alfentanil

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Alfentanil Hameln is and what it is used for 
2. What you need to know before you use Alfentanil Hameln 
3. How to use Alfentanil Hameln 
4. Possible side effects 
5. How to store Alfentanil Hameln 
6. Contents of the packaging and other information 

1. What Alfentanil Hameln is and what it is used for

Alfentanil Hameln belongs to a group of medicines called opioid analgesics. It is used to relieve or prevent pain. Alfentanil Hameln is used as an anesthetic in various types of surgery.

Alfentanil Hameln is used in adults in:

  • short operations and day surgery (then you can go home the same day).
  • medium and long operations, when given as an injection followed by additional doses or as a continuous infusion (drip).

Alfentanil Hameln can be used in newborns, infants, and children such as:

  • anesthetic.
  • painkillers for anesthesia and for both short and long operations.

Alfentanil contained in Alfentanil Hameln may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Alfentanil Hameln

Do not use Alfentanil Hameln

  • if you are allergic (hypersensitive) to alfentanil, other strong painkillers ( opioids ), or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or nurse before using Alfentanil Hameln. This is especially true if you have:

  • any head or brain injury. Alfentanil Hameln may affect the symptoms in patients with head injuries.
  • any lung disease or other breathing difficulties.
  • kidney or liver problems.
  • thyroid problems.
  • alcohol problem.

Newborns, children, and adolescents

Alfentanil can cause breathing difficulties, especially in newborns and very young children. When Alfentanil Hameln is given to newborns and very young children:

  • the breathing should be closely monitored during the operation and for some time afterward.
  • your doctor may provide muscle relaxants to prevent muscle stiffness.

Other medicines and Alfentanil Hameln

Concomitant use of Alfentanil Hameln and sedatives or medicines for sleep disorders such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

If your doctor prescribes Alfentanil Hameln at the same time as sedatives, your dose and treatment time should be limited by your doctor.

Tell your doctor if you are taking any sedatives and follow the doctor’s close

dose recommendations. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines.

It is especially important that you do not receive this medicine and that you tell your doctor or nurse if you have taken:

  • Antidepressants are known as monoamine oxidase inhibitors ( MAOIs ) for the past two weeks.

If you have done this, you should not be given Alfentanil.

It is important that you talk to your doctor or nurse if you take any of the following:

  • Selective serotonin reuptake inhibitors ( SSRIs ) or serotonin and norepinephrine reuptake inhibitors ( SNRIs ).

The effects of Alfentanil may be longer if you take:

  • Cimetidine – for stomach ulcers, stomach pain, and heartburn
  • Erythromycin – antibiotic
  • Diltiazem – for heart problems/angina

Talk to your doctor before taking Alfentanil if you are taking any of these medicines.

The effects of Alfentanil or any of these medicines may be more powerful when taken together

  • Other strong painkillers, e.g. opioid analgesics such as morphine or codeine
  • Medicines for high blood pressure or heart problems, so-called beta-blockers
  • Anesthetics as anesthetics
  • Medicines for anxiety/sleeping pills or sedatives such as sedatives or sleeping pills
  • Medicines that affect your central nervous system ( CNS suppressants) as medicines for mental disorders/diseases
  • Epilepsy medicines such as clobazam, clonazepam or phenobarbital

Talk to your doctor before taking Alfentanil if you are taking any of these medicines. Your doctor may need to adjust your dose for Alfentanil or the other medicines you are taking.

Some medicines may affect the way Alfentanil works

  • Medicines for fungal infections such as fluconazole , voriconazole, ketoconazole or itraconazole
  • Drugs that treat HIV – infection (so-called antiviral protease inhibitors ) to ritonavir, indinavir, or saquinavir

Talk to your doctor before taking Alfentanil if you are taking any of these medicines. Your doctor may need to adjust the dose for Alfentanil.

Alfentanil and alcohol

Talk to your doctor or nurse if you drink alcohol regularly, as alcohol can increase the risk of side effects.

Pregnancy and breastfeeding

Alfentanil Hameln should not be given to pregnant women unless your doctor considers it necessary.

Breast-feeding is not recommended until 24 hours after treatment with alfentanil.

Ask your doctor or pharmacist for advice before taking any medicine.

Alfentanil should not be used during childbirth as it may affect the baby’s ability to breathe.

Driving and using machines

You should not drive or use machines for at least 24 hours after treatment with Alfentanil Hameln.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Alfentanil contains sodium

Alfentanil Hameln 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 . This should be considered by patients on a low-salt diet.

How to use Alfentanil Hameln

Alfentanil Hameln is provided by specially trained medical personnel and the necessary equipment will be available.

Alfentanil Hameln is given as an injection or by infusion (drip) into a vein, usually on the back of the hand or in the forearm.

Dosage for adults

How much Alfentanil Hameln you receive depends on your age, weight, physical condition, your medical condition, concomitant use of other medicines, and the type and duration of anesthesia required.

The physician will make an assessment of the appropriate dose based on the type of surgery and the patient’s individual needs. 

The initial dose of Alfentanil Hameln should be reduced in elderly and weak patients.

Dose one may need to be adjusted for patients with hypothyroidism or liver, kidney, or lung problems, or alcohol problems.

Dosage for newborns, infants, and children

Your child is given Alfentanil Hameln by a nurse or doctor. For newborns, a lower dose of alfentanil may be necessary. The doctor will assess what is the right dose for your child and how and when an injection should be given. All children will be closely monitored when administering one of alfentanil.

If you have any further questions on the use of this medicine, talk to your doctor or nurse who is giving you an injection.

If you have been given too much Alfentanil Hameln or if a dose has been missed

Because Alfentanil Hameln is usually given by a doctor or nurse under close supervision, it is unlikely that you will receive too much or that you will miss a dose. If you have received too much or are suspected of receiving too much Alfentanil Hameln, the necessary measures will be taken immediately by the specialist team. In rare cases where an overdose has occurred, the following symptoms may occur difficulty breathing, muscle stiffness, and decreased blood pressure and heart rate. Tell your doctor or nurse immediately if you notice any signs of overdose.


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

4. Possible side effects

Like all medicines, Alfentanil Hameln can cause side effects, although not everybody gets them.

Sometimes Alfentanil Hameln can cause allergic reactions (hypersensitivity) such as rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue. Immediately inform a doctor or nurse if one or more of these reactions occur.

The following side effects have been reported:

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

  • nausea and vomiting

Common (may affect up to 1 in 10 people)

  • low blood pressure ( hypotension )
  • injection site pain
  • temporary respiratory arrest ( apnea )
  • dizziness
  • drowsiness
  • muscle stiffness
  • visual impairment
  • slow heart rate ( bradycardia )
  • fast heart rate ( tachycardia )
  • high blood pressure ( hypertension )
  • fatigue
  • overindulge
  • pain from the procedure
  • the feeling of well-being and euphoria
  • involuntary movements

Uncommon (may affect up to 1 in 100 people)

  • hiccup
  • headache
  • somnolence
  • asthma-like symptoms (eg difficulty breathing, respiratory cramps)
  • lack of response to stimuli (ie irritation of nerves)
  • irregular heartbeat
  • increased carbon dioxide content in the blood
  • allergic dermatitis
  • increased sweating
  • pain
  • confusion (shortly after surgery)
  • restlessness (shortly after surgery)
  • breathing difficulties (shortly after surgery)

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

  • restlessness
  • crying
  • pain in the veins
  • nosebleed
  • skin itching ( pruritus )
  • complications of anesthesia (related to the nervous system)
  • complications during treatment
  • complications during intubation (insertion of tubes into the trachea during anesthesia)
  • breathing difficulties due to respiratory cramps

Very rare (may affect up to 1 in 10,000 people)

  • hypersensitivity reaction
  • disorientation (unclear perception of time and space)
  • loss of consciousness (shortly after surgery)
  • seizures
  • muscle twitching
  • pupil reduction
  • cardiac arrest
  • respiratory arrest
  • cough
  • redness ( erythema )
  • rash
  • fever

Additional side effects are in children and adolescents

The frequency and type of adverse reactions in children and adolescents are similar to those in adults, with the exception of the following:

  • severe muscle stiffness (muscle stiffness)
  • muscle twitching
  • breathing difficulties

Reporting of side effects ar

If you get any side effects, talk to your doctor or nurse. This also applies to any side effects that are not mentioned in the information. You can also report side effects directly to (see details below).

By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

5. How to store Alfentanil Hameln

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

Doctors and pharmacists are responsible for the correct storage, use, and disposal of Alfentanil Hameln.

Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiration date is the last day of the specified month.

Do not use Alfentanil Hameln if you find that the liquid is not clear, colorless, and free of particles or if the packaging is damaged.

6. Contents of the packaging and other information

Content declaration

The active substance is alfentanil.

1 ml of solution contains 543.8 micrograms of alfentanil hydrochloride hydrate, equivalent to 500 micrograms of alfentanil.

The other ingredients are water for injections, sodium chloride, and hydrochloric acid.

What the medicine looks like and the contents of the pack

Alfentanil Hameln is a clear and colorless solution for injection.

Pack sizes:

Ampoules with 5×2 ml and 10×2 ml

Ampoules with 5×10 ml and 10×10 ml

Vials with 1×50 ml, 5×50 ml and 10×50 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Hameln pharma gmbh

Inselstraße 1

31787 Hameln

Germany

Manufacturer

Siegfried Hameln GmbH

Langes Feld 13

31789 Hameln

Germany

HBM Pharma sro

Sklabinská 30

03680 Martin

Slovakia

hameln rds as

Horná 36

900 01 Modra

Slovakia

This medicinal product is authorized under the European Economic Area under the names:

Austria Alfentanil-hameln 0.5 mg / ml solution for injection
Finland Alfentanil Hameln 0.5 mg / ml injection test, liuos
Norway Alfentanil Hameln
Portugal Alfentanilo Hameln
Netherlands Alfentanil-hameln 0.5 mg / ml solution for injection

This leaflet was last modified on 7 July 2020

The following information is intended for healthcare professionals only:

PREPARATION INSTRUCTIONS FOR:

Alfentanil Hameln 0.5 mg / ml injection solution

This is a summary of the information on the preparation, storage, and administration of Alfentanil Hameln 0.5 mg/ml solution for injection.

It is important that you read the entire contents of this manual before preparing the medical product.

See the Summary of Product Characteristics for complete prescription information and other information.

Packaging and contents

Alfentanil Hameln is supplied as a clear and colorless solution for injection in 2 or 10 ml colorless glass ampoules (type I) or in 50 ml colorless glass vials (type I) with a bromobutyl rubber stopper.

Incompatibilities

This medicinal product must not be mixed with other medicinal products other than those mentioned in the section “Dilution instructions”.

Dilution instructions

Dilutions of Alfentanil Hameln should be prepared under controlled and validated aseptic conditions.

Alfentanil Hameln can be diluted with sodium chloride 0.9% solution, glucose 5% solution, glucose 5% + sodium chloride 0.9% solution or Ringer lactate to a concentration of 25‑80 micrograms / ml. Such solutions are compatible with infusion bags and plastic infusion sets.

Chemical and physical in-use stability has been demonstrated for 48 hours. From a microbiological point of view, the dilutions should be used immediately.

Storage

No special precautions apply when storing.

The product should be used immediately after opening the package.

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 under controlled and validated aseptic conditions.

Any unused solution from opened ampoules or vials should be discarded.

Dosage and route of administration

Method of administration

Alfentanil Hameln is administered intravenously as bolus injections (for short procedures) or bolus injections supplemented with additional doses or by infusion(for long painful procedures) and should only be given by healthcare professionals trained in anesthesia administration and management of the effects of potent opioids on the respiratory tract.

Dosage for adults

Alfentanil Hameln should be dosed individually taking into account age, body weight, physical status, underlying medical conditions, other medications, and type of surgery and anesthesia.

The initial dose should be reduced in elderly and weak patients. The effect of the initial dose should be taken into account in the calculation of additional doses.

To avoid bradycardia, a small intravenous dose of anticholinergic should be given just before induction. Postoperative nausea is usually relatively short-lived and can be easily controlled with conventional methods.

Dosage for children

Assistive ventilation equipment should be available for use in children of all ages, even during short interventions where children breathe spontaneously.

Information on use in children, in the age group 1 month to 1 year, is limited (see section 5.2 of the SPC).

Due to the large variation in how younger children respond to alfentanil, it is difficult to establish dosage recommendations for younger children. For older children, a bolus dose of 10 to 20 micrograms/kg alfentanil is considered suitable for induction of anesthesia (ie as an adjunct to propofol or inhalation anesthesia) or as an analgesic. Additional bolus doses of 5 to 10 micrograms/kg alfentanil may be given at appropriate intervals.

To maintain analgesia in children during surgery, Alfentanil Hameln Hameln can be given at an infusion rate between 0.5 to 2 micrograms/kg/min. Dose one must be titrated up or down according to the needs of the individual patient. When combined with an intravenous anesthetic, a dose rate of approximately 1 microgram/kg/min is recommended.

There may be a higher risk of respiratory complications and muscle rigidity when alfentanil is administered to newborns and very young children. Necessary precautions are described in section 4.4 of the Summary of Product Characteristics.

Muhammad Nadeem

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