Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Agilus 120 mg powder for solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Dantrolene sodium hemiheptahydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Agilus contains dantrolene sodium. It is a type of medicine called a direct-acting muscle relaxant. It attaches to a target within muscle cells and helps the muscles of the body to relax when they have become over-stimulated. Together with other supportive measures, this medicine is used for the treatment of malignant hyperthermia in adults and children of all ages. Malignant hyperthermia is a life-threatening emergency condition in which the skeletal muscles of the body are over-stimulated and are unable to relax. This can cause a very fast increase of your body temperature and/or a build-up of waste products in the body (metabolic acidosis), which can stop vital organs from working properly. 2.
What you need to know before you take it
Agilus
You should not be given Agilus • if you are allergic to dantrolene sodium or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions You will probably have been given this medicine before you read this leaflet. Talk to your doctor or nurse if:
- you are currently taking medicines for high blood pressure or angina called "calcium channel blockers". Taking these medicines at the same time as Agilus may increase the amount of potassium in your blood, which could cause you to experience irregular heart rhythms or an inability to move some of your muscles.
- if you think any medicine has been spilt on your skin – this should be washed off with water. Liver damage has been observed in patients exposed to long term oral use of dantrolene sodium. Tell your doctor if you think you have symptoms of liver damage (e.g. if your skin and eyes appear yellowish or you have abdominal pain and swelling.
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Other medicines and Agilus Tell your doctor if you are taking, have recently taken, or might take, any other medicines. The following medicines may affect the way Agilus works or Agilus may affect the way they work:
- medicines for high blood pressure and angina called "calcium channel blockers" such as verapamil or diltiazem may result in heart failure if given at the same time as Agilus (see warnings and precautions).
- muscle relaxants, such as vecuronium may enhance the muscle relaxing effect of Agilus if given at the same time. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you are pregnant or are planning to have a baby, tell your doctor or nurse if possible before receiving this medicine. Pregnancy Agilus will not be used if you are pregnant unless considered necessary. After you have been given Agilus, the muscles of your uterus (womb) may be weak. If you receive Agilus during a caesarean section, your new-born baby may experience muscle weakness. Breast-feeding You should not breast-feed whilst you are receiving Agilus, or for 60 hours after your last dose. Tell your doctor if you are breast-feeding. Driving and using machines After you have been given Agilus, your hand and leg muscles may be weak, and you may also have a feeling of dizziness or "light headedness". These effects may last for up to 48 hours after you have been given Agilus. Do not drive or operate machinery during this time. Agilus contains cyclodextrin and sodium This medicine contains 3,530 mg hydroxypropylbetadex (a cyclodextrin) in each vial, which is equivalent to 156.2 mg/mL when reconstituted. Some cases of hearing impairment have been observed from hearing tests in other clinical settings, in patients taking cyclodextrin. Tell your doctor if you have had problems with your hearing in the past e.g. if you are prone to ear infections. The potential risk associated with cyclodextrin may be increased if your kidneys are not working properly. This medicine contains 6.9 mg of sodium (main component of cooking/table salt) in each vial. This is less than 0.5% of the recommended maximum daily dietary intake of sodium for an adult. 3.
How to take it
This injection is given to you by a healthcare professional, into a vein. The dose of Agilus you are given depends on your body weight. The dose will be repeated every 10 minutes until your symptoms improve. If you experience a relapse, your healthcare professional will inject Agilus again. If you have been given too much Agilus If you have received more Agilus than you should have, side effects may occur. Severe muscle weakness can occur, which might affect your breathing. Your doctor will monitor you closely If you have any further questions on the use of this medicine, ask your doctor or nurse.
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4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed with the active ingredient of Agilus; The frequency of the below side effects is not known (frequency cannot be estimated from the available data). Serious side effects – your doctor will stop giving you Agilus straight away. •
sudden, severe allergic reaction with breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating and loss of consciousness (anaphylactic reaction).
Other side effects The following side effects have been observed with the active ingredient of Agilus: • allergic reactions (hypersensitivity) • high blood potassium levels (hyperkalaemia), which can cause tiredness, muscle weakness, feeling sick and heart rhythm disturbances • dizziness, drowsiness, seizure, difficulty speaking (dysarthria), headache • altered vision • heart failure, slow heart rate (bradycardia), rapid heartbeat (tachycardia) • inflammation in a vein leading to a blood clot and blockage (thrombophlebitis) • difficulty breathing (respiratory failure), breathing that is too slow and shallow (respiratory depression) • pain in the belly (abdominal pain), nausea (feeling sick), vomiting, bleeding in the gut and stomach with symptoms of blood in stools or vomit (gastrointestinal haemorrhage), diarrhoea, difficulty swallowing (dysphagia) • yellow eyes and skin (jaundice)*, inflammation of the liver (hepatitis)*, liver failure that may be fatal*, changes in blood test of liver function, liver disease due to an unknown cause or allergic reaction • itchy rash (urticaria), reddening of the skin (erythema), excessive sweating (hyperhidrosis) • muscle weakness, tired muscles • crystal particles in the urine (crystalluria) • weak contractions when giving birth (uterine hypotonus) • feeling tired (fatigue), general weakness (asthenia), reactions at the injection site *These side effects were observed in situations where dantrolene treatment has been given by mouth for a long time.
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: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
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5.
How to store it
Agilus
Keep this medicine out of the sight and reach of children. This medicine will be stored in the hospital and these instructions are intended for health care staff only. Unopened vial: does not require any special temperature storage conditions. Keep the vial in the original carton to protect from light. Reconstituted solution: Use within 6 hours. Reconstituted solution must be protected from light. Do not store above 25°C and do not refrigerate. Do not use this medicine after the expiry date which is stated on the label and on the outer carton of the vials after "EXP". The expiry date refers to the last day of that month. For single use only. Discard any residual reconstituted solution. 6.
Contents of the pack and other information
What Agilus contains The active substance is dantrolene sodium hemiheptahydrate. One vial contains 120 mg dantrolene sodium hemiheptahydrate. After reconstitution with 20 mL water for injections, each millilitre of solution contains 5.3 mg dantrolene sodium hemiheptahydrate. The other ingredients are hydroxypropylbetadex (a cyclodextrin) and macrogol 3350 (E1521). See section 2 "Agilus contains cyclodextrin and sodium". What Agilus looks like and contents of the pack Glass vials, with a rubber stopper and seal, containing 120 mg of yellow-orange powder for solution for injection. Carton of 6 or 10 vials. Not all pack sizes may be marketed Marketing Authorisation Holder Norgine Pharmaceuticals Limited ARC Uxbridge, Building 01, Sanderson Road, Uxbridge, UB8 1DH, UK Manufacturer Norgine B.V. Antonio Vivaldistraat 150 1083 HP Amsterdam The Netherlands
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This leaflet was last revised in March 2025. Other sources of information If you need the information on this leaflet in an alternative format, such as large print, or Braille please ring 0800 198 5000. ———————————————————————————————————————–The following information is intended for healthcare professionals only: Posology and method of administration Treatment with Agilus should be started as soon as a malignant hyperthermia crisis is suspected. Posology Agilus should be administered rapidly by intravenous injection at an initial dose of 2.5 mg/kg body weight for adult and paediatric patients. As long as the main clinical symptoms of tachycardia, hypoventilation, sustained hyperacidity (pH and partial pressure of carbon dioxide (pCO2) monitoring required) and hyperthermia persist, a bolus injection of 2.5 mg/kg should be repeated every 10 minutes. If a cumulative dose of 10 mg/kg or above is considered, the diagnosis of malignant hyperthermia should be re-examined. The volume of Agilus to be administered (in mL) for a 2.5 mg/kg dose is calculated as follows: Volume (mL) = Patient's body weight (kg) x 2.5 mg/kg x 22.6 mL 120 mg The following table provides examples of dosing based on the number of vials needed for the initial 2.5 mg/kg dose, required immediately by rapid injection: Table 1: Dosing examples Dosing examples by body weight to achieve a loading dose of 2.5 mg/kg for both adults and children Number of vials to be prepareda
1
Body weight range
Up to 48 kg
2
From 49 kg to 96 kg
3
From 97 kg
Example dosing recommendation Body weight
Dose to be administered
Volume to be administereda
3 kg
7.5 mg
1.4 mL
6 kg
15 mg
2.8 mL
12 kg
30 mg
5.6 mL
24 kg
60 mg
11.3 mL
48 kg
120 mg
22.6 mL
72 kg
180 mg
33.9 mL
96 kg
240 mg
45.2 mL
120 kg
300 mg
56.5 mL
144 kgb
300 mgb
56.5 mL
5
a
Total volume of one reconstituted vial is 22.6 mL For all bodyweights, the initial dose and any repeat doses should not exceed 300 mg, equivalent to 2.5 vials. b
Treatment of recrudescence (recurrence) It should be noted that the hypermetabolic features of malignant hyperthermia may recur within the first 24 hours after initial resolution. If a recrudescence occurs, Agilus should be re-administered at a dose of 2.5 mg/kg every 10 minutes until the signs of malignant hyperthermia regress once more. Paediatric population No dose adjustment required. Method of administration For intravenous use. Special precautions for storage, preparation and handling Preparation Each vial should be reconstituted by adding 20 mL water for injections and shaking for approximately 1 minute, before inspecting for particulates. Further shaking may be necessary. The reconstituted solution should be a yellow-orange colour and free from particulates. The volume of solution in a reconstituted vial is 22.6 mL. Chemical and physical in-use stability after reconstitution has been demonstrated for 6 hours at 25°C. From a microbiological point of view, unless the method of opening/reconstitution precludes the risk of microbial contamination, the reconstituted product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and should not exceed 6 hours at 25°C. Storage The unopened vial does not require any special temperature storage conditions. Keep the vial in the outer carton in order to protect from light. Reconstituted solution must be protected from light. Do not store above 25°C and do not refrigerate. Handling In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Reconstituted Agilus solution must not be mixed with other solutions or given via the same venous access. Spill of solution on skin should be avoided. If solution gets on the skin, it must be removed with sufficient water. This medicinal product is for single use only and any residual reconstituted solution should be discarded. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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Frequently asked questions about Agilus 120 mg powder for solution for injection
How do I take Agilus 120 mg powder for solution for injection?
Agilus 120 mg powder for solution for injection comes as injection containing 120mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Agilus 120 mg powder for solution for injection?
The active substance in Agilus 120 mg powder for solution for injection is dantrolene sodium hemiheptahydrate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Agilus 120 mg powder for solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Agilus 120 mg powder for solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dantrolene sodium hemiheptahydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
In combination with adequate support measures, Agilus is indicated for the treatment of malignant hyperthermia in adults and children.
4.2. Posology and method of administration
Treatment with Agilus should be started as soon as a malignant hyperthermia crisis is suspected.
Posology
Agilus should be administered rapidly by intravenous injection at an initial dose of 2.5 mg/kg body weight for adult and paediatric patients.
As long as the main clinical symptoms of tachycardia, hypoventilation, sustained hyperacidity (pH and partial pressure of carbon dioxide (pCO2) monitoring required) and hyperthermia persist, a bolus injection of 2.5 mg/kg should be repeated every 10 minutes.
If a cumulative dose of 10 mg/kg or above is considered, the diagnosis of malignant hyperthermia should be re-examined.
The volume of Agilus to be administered (in mL) for a 2.5 mg/kg dose is calculated as follows:
The following table provides examples of dosing based on the number of vials needed for the initial 2.5 mg/kg dose, required immediately by rapid injection:
Table 1. Dosing examples
Dosing examples by body weight to achieve a loading dose of 2.5 mg/kg for both adults and children
Number of vials to be prepareda
Body weight range
Example dosing recommendation
Body weight
Dose to be administered
Volume to be administereda
1
Up to 48 kg
3 kg
7.5 mg
1.4 mL
6 kg
15 mg
2.8 mL
12 kg
30 mg
5.6 mL
24 kg
60 mg
11.3 mL
48 kg
120 mg
22.6 mL
2
From 49 kg to 96 kg
72 kg
180 mg
33.9 mL
96 kg
240 mg
45.2 mL
3
From 97 kg
120 kg
300 mg
56.5 mL
144 kgb
300 mgb
56.5 mL
aTotal volume of one reconstituted vial is 22.6 mL.
bFor all bodyweights, the initial dose and any repeat doses should not exceed 300 mg, equivalent to 2.5 vials.
Treatment of recrudescence (recurrence)
It should be noted that the hypermetabolic features of malignant hyperthermia recur within the first 24 hours after initial resolution. If a recrudescence occurs, Agilus should be re-administered at a dose of 2.5 mg/kg every 10 minutes until the signs of malignant hyperthermia regress once more.
Paediatric population
No dose adjustment required.
Method of administration
For intravenous use.
Each vial should be prepared by adding 20 mL of water for injections and the vial shaken until the solution is dissolved. Reconstituted Agilus is a yellow-orange solution with a final volume of 22.6 mL.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
The use of Agilus in the management of malignant hyperthermic crisis is not a substitute for other supportive measures. These must be individually continued in their various forms.
Caution should be exercised if hyperkalaemia symptoms occur (muscular paralysis, electrocardiogram changes, bradycardic arrhythmias) or in cases of pre-existing hyperkalaemia (renal insufficiency, digitalis intoxication etc.), as an increase in serum potassium has been demonstrated in animal studies as a result of the co-administration of dantrolene with verapamil. Concomitant use of Agilus and calcium channel blockers is not recommended (see section 4.5).
Agilus is only for intravenous use. Due to the high pH value of the solution (pH 9.5), extravascular injection must be avoided as it can lead to tissue necrosis. Due to the risk of vascular occlusion, intraarterial injections must be avoided.
Spill of solution on skin should be avoided. If solution gets on the skin, it must be removed with sufficient water (see section 6.6).
Liver damage may occur during dantrolene therapy. This has been observed during longer term, oral administration and may run a lethal course.
Excipients
Hydroxypropylbetadex
Agilus contains 3530 mg hydroxypropylbetadex (a cyclodextrin) in each vial, which is equivalent to 156.2 mg/mL in the reconstituted solution. Hydroxypropylbetadex increases solubility of dantrolene and thereby reduces preparation time and fluid volume.
Hydroxypropylbetadex has been associated with ototoxicity in animal studies (see section 5.3); and cases of hearing impairment (identified by audiometric assessment) have been observed in studies in other clinical settings. Cases of hearing impairment have been observed at hydroxypropylbetadex exposure levels comparable to the higher range of recommended Agilus doses. In most cases the hearing impairment has been transient and of slight to mild severity. For patients requiring high Agilus doses (above 10 mg/kg) the diagnosis should be re-evaluated (see section 4.2).
The potential risk for hearing impairment may be of particular concern in patients with increased risk for hearing loss, e.g. recurring/chronic ear infections. Exposure to hydroxypropylbetadex from Agilus is expected to be higher in patients with renal impairment. The potential risks associated with hydroxypropylbetadex may be higher in these patients.
Sodium
This medicinal product contains 6.9 mg sodium per vial, equivalent to 0.345% of the World Health Organisation recommended maximum daily intake of 2 g sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
Isolated case reports and animal studies indicate an interaction between dantrolene and calcium channel blockers, such as verapamil and diltiazem, in the form of heart failure. Concomitant use of Agilus and calcium channel blockers is not recommended (see section 4.4).
Concomitant administration of Agilus with non-depolarising muscle relaxants, such as vecuronium, can enhance their effect.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited data for the use of dantrolene in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Postpartum uterine atony has been reported after intravenous dantrolene therapy. The risk of floppy child syndrome in neonates has also been described when intravenous dantrolene was administered to the mother during caesarean section. Dantrolene crosses the placenta and should only be used during pregnancy when the potential benefits have been weighed against the possible risk to mother and child.
Breastfeeding
No information is available on the use of dantrolene during breastfeeding. According to its safety profile, a risk to a breastfed infant cannot be excluded as dantrolene is excreted in breastmilk. Therefore breastfeeding should be discontinued during administration of Agilus. Based on elimination half-life of dantrolene, breastfeeding can be restarted 60 hours after the last dose.
Fertility
Data on the effects of dantrolene on fertility in humans are not available. In animal studies, no adverse effects on fertility were observed (see section 5.3).
4.7. Effects on ability to drive and use machines
Agilus has a major influence on the ability to drive and use machines, as it can lead to skeletal muscle weakness, dizziness and light-headedness. Since some of these symptoms may persist for up to 48 hours, patients must not drive or use machines.
4.8. Undesirable effects
Agilus is a skeletal muscle relaxant. The most commonly reported adverse event of intravenous dantrolene administration, skeletal muscle weakness, is related to this mode of action.
The adverse reactions observed are linked to dantrolene and its formulations for acute, intravenous use and for chronic, oral use. Some of the adverse reactions listed may also be observed as a result of the underlying malignant hyperthermia crisis. Adverse reactions are presented below according to system organ class and frequency.
Frequencies are defined according to:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1000 to < 1/100)
Rare (≥ 1/10000 to < 1/1000)
Very rare (< 1/10000)
Not known: frequency could not be estimated due to the present data.
Table 2: List of adverse drug reactions
System Organ Class
Frequency
Adverse Drug Reactions
Immune system disorders
Not known
Hypersensitivity, Anaphylactic reaction
Metabolism and nutrition disordersa
Not known
Hyperkalaemia
Nervous system disorders
Not known
Dizziness, Somnolence, Seizure, Dysarthria, Headache
Eye disorders
Not known
Visual impairment
Cardiac disordersa
Not known
Cardiac failure, Bradycardia, Tachycardia
Vascular disorders
Not known
Thrombophlebitis
Respiratory, thoracic and mediastinal disorders
Not known
Respiratory failure, Respiratory depression
Gastrointestinal disorders
Not known
Abdominal pain, Nausea, Vomiting, Gastrointestinal haemorrhage, Diarrhoea, Dysphagia
Hepatobiliary disorders
Not known
Jaundiceb, Hepatitisb, Hepatic function abnormal, Hepatic failure including fatal outcomeb, Idiosyncratic or hypersensitive liver diseases
Skin and subcutaneous tissue disorders
Not known
Urticaria, Erythema, Hyperhidrosis
Musculoskeletal and connective tissue disorders
Not known
Muscle weakness, Muscle fatigue
Renal and urinary disordersa
Not known
Crystalluria
Reproductive system and breast disorders
Not known
Uterine hypotonus
General disorders and administration site conditions
Not known
Fatigue, Administration site reaction, Asthenia
aThese adverse reactions were observed in nonclinical studies
bThese adverse reactions have been observed with chronic, oral treatment
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Malignant hyperthermia is an emergency situation where rapid injection of a high dose of Agilus may be necessary (see section 4.2).
Dantrolene acts as a muscle relaxant. Severe muscle weakness with resultant respiratory depression can occur. Therefore, in cases of accidental overdose, symptomatic and general supportive measures should be employed.
The value of dialysis in dantrolene overdose is not known. There is no specific antidote for dantrolene.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Dantrolene sodium hemiheptahydrate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Agilus partial — not the same combinationDantroleni natricum · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Agilus 120 mg powder for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.