El fármaco, que está pensado para aliviar a los pacientes de urgencias de traumatología, se administra mediante un inhalador, y sus efectos son superiores a los obtenidos con los tratamientos habituales para estos casos. Su efectividad es mayor incluso que la que otorgan los analgésicos intravenosos más utilizados, que principalmente son antiinflamatorios y opioides.
El bálsamo es un líquido que tiene que ser vertido por un profesional sanitario en un dispositivo pequeño, portátil y ligero, en un inhalador. El paciente simplemente se lleva el dispositivo a la boca y respira normalmente, inhalando la medicación que necesite para obtener el nivel correcto de alivio del dolor, bajo la supervisión de un profesional sanitario.
Una novedad europea, estudiada en españoles
El medicamento está basado en el metoxiflurano, una sustancia que fue sintetizada en la década de 1940 por el químico orgánico estadounidense William T. Miller y que se reveló como un atenuante del dolor muy efectivo. "Es un éter halogenado que se utiliza como analgésico inhalado desde hace más de 40 años en Australia y Nueva Zelanda, pero hasta ahora la licencia europea no había sido solicitada", explica Alberto Borobia, quien está al frente del ensayo de este medicamento, que en Europa se comercializará con el nombre de Penthrox, y que es miembro del grupo SEMES Dolor y de la Plataforma de Unidades de Investigación Clínica y Ensayos Clínicos (SCReN), los responsables del diseño y gestión del ensayo, respectivamente.
Los resultados de su trabajo son prometedores. "El tiempo de efecto del metoxiflurano inhalado es menos de la mitad que el de los analgésicos habituales. Se notan los primeros efectos a los 3 minutos y a los 10 minutos los pacientes reducen su dolor en un 50%", añade. El estudio clínico que lo demuestra, que apunta a que cada dispositivo tiene un efecto analgésico que dura entre 25 y 60 minutos, tiene tintes patrios: ha sido desarrollado íntegramente en 14 servicios de urgencias y emergencias en España (esos lugares a los que uno no siempre tiene claro si debe acudir).
Eficaz, rápido y autoadministrado: un analgésico único
Penthrox no formará parte del botiquín doméstico sino que se administrará siempre bajo control de personal sanitario, tanto en hospitales como en el ámbito extrahospitalario (en ambulancias, servicios de rescate, urgencias de atención primaria…). Además, se reservará para las situaciones que requieran un alivio urgente del dolor, como fracturas, fisuras, luxaciones, esguinces, contusiones y quemaduras.
En cuanto a efectos secundarios, los mareos y la somnolencia, aunque casi siempre son leves y transitorios, son los más frecuentes. Por otra parte, el hecho de que es idóneo para aliviar de forma rápida el dolor de origen traumático y su efecto es de corta duración implica que no es adecuado para mitigar los dolores crónicos. En todo caso, se trata de una interesante aportación al botiquín.
Para Borodia, el medicamento tiene tres características que hacen que sea único: "Su eficacia analgésica en el tratamiento del dolor traumático moderado a severo; su rápido inicio de acción, muy superior a los analgésicos estándar utilizados en la actualidad, y su autoadministración por parte de los pacientes, utilizando la vía inhalada, a través de un dispositivo pequeño, ligero y portátil, sin necesidad de ventilación en el lugar de su administración", concluye.
"No os espante el dolor: o tendrá fin o acabará con vosotros", decía Séneca. Parece que ahora, en muchas de sus modalidades, terminará antes siquiera de que empecemos a asustarnos; la primera opción es la más probable.
¿PARA QUÉ SIRVE EL DOLOR?
El dolor es una señal que emite el organismo a través de unas fibras nerviosas, cuando detecta un daño en algún tejido. La sensación llega a través de un proceso neuronal llamado nocicepción, mediante el cual unas terminaciones nerviosas especializadas, llamadas nociceptores o receptores del dolor, envían una señal al cerebro con el objetivo de que reaccionemos y evitemos daños mayores.
El dolor es nuestro guardián más fiel. Si no, ¿qué sucedería si pusieras la mano en el fuego y no sintieras la imperiosa -y dolorosa- necesidad de apartarla de la llama?
Eso es lo que le pasa a los afectados por un raro conjunto de enfermedades hereditarias que conforman lo que se conoce como insensibilidad congénita al dolor. No solo no lo perciben sino que tampoco sienten la temperatura. Esa mutación bloquea el canal que comunica con los nocireceptores, con lo que los pacientes que sufren esa dolencia deben estar muy atentos para evitar cualquier situación de riesgo.Pueden lastimarse sin querer, por ejemplo, al morderse la lengua o los labios.
https://elpais.com/elpais/2018/12/11/buenavida/1544549365_789580.html
En resumen, Penthrox®:
EN PACIENTES TRAUMÁTICOS ATENDIDOS EN URGENCIAS
Mudipharma anuncia los resultados sobre un nuevo analgésico inhalado by www.actasanitaria.com
MADRID 14 JUN, 2018 - 12:31 PM
La compañía farmacéutica Munidpharma ha anunciado la realización en España del primer ensayo europeo de un “nuevo” analgésico inhalado comparado con el tratamiento habitual, que muestra su superioridad en la rapidez y el alivio del dolor de los pacientes traumáticos atendidos en Urgencias.
by Alberto Borobia
El ensayo clínico aleatorizado europeo, diseñado y coordinado por el Grupo de Dolor de la Sociedad Española de Medicina de Urgencias y Emergencias (SEMES), fue presentado durante su Congreso anual, en el que se mostraron sus resultados sobre un medicamento todavía no disponible en España, el metoxiflurano inhalado, autoadministrado por el paciente con un pequeño dispositivo, comparado con el tratamiento habitual que los investigadores utilizan para los pacientes con dolor por trauma en urgencias.
El metoxiflurano inhalado a dosis bajas, autoadministrado por los pacientes, es un analgésico ampliamente utilizado en Australia y Nueva Zelanda desde hace décadas, y recientemente aprobado en Europa. Cada dispositivo ofrece una analgesia de entre 25 y 60 minutos.
En este estudio, se incluyeron 310 pacientes con dolor por trauma de intensidad moderada-severa. Según Mundipharma, los pacientes tratados con metoxiflurano obtuvieron el primer alivio del dolor en la mitad de tiempo que los tratados con los analgésicos utilizados por los investigadores de forma habitual.
Tiempo de respuesta
Desde la primera evaluación, tres minutos después de iniciar el tratamiento, las personas tratadas con metoxiflurano tuvieron un alivio significativamente superior al obtenido por los pacientes tratados con los analgésicos habituales. Diez minutos después de iniciar el tratamiento con metoxiflurano, estos redujeron cuatro puntos, el 50 por ciento, la intensidad de su dolor.
A la vista de los resultados, el investigador principal del ensayo y miembro del grupo SEMES Dolor, el doctor Alberto Borobia, subrayó que “metoxifluorano sería una buena opción como tratamiento analgésico de primera línea para el manejo del dolor agudo en los Servicios de Urgencias”.
https:///mudi-pharma-anuncia-los-resultados-nuevo-analgesico-inhalado-dolor/
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
PENTHROX 3mL inhalation vapour, liquid
2. Qualitative and quantitative composition
Each vial contains 3 mL of methoxyflurane 99.9%.
For full list of excipients see, section 6.1.
Inhalation vapour, liquid.
Clear, almost colourless, volatile liquid, with a characteristic fruity odour.
4.1 Therapeutic indications
Emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain. See sections 4.2 and 5.1.
4.2 Posology and method of administration
One bottle of 3 mL PENTHROX to be vaporised in a PENTHROX inhaler. On finishing the 3 mL dose, another 3 mL may be used. Dose of PENTHROX should not exceed 6 mL in a single administration. Methoxyflurane may cause renal failure if the recommended dose is exceeded. The lowest effective dosage of PENTHROX to provide analgesia should be used.
Onset of pain relief is rapid and occurs after 6 – 10 inhalations. Patients should be instructed to inhale intermittently to achieve adequate analgesia. Patients are able to assess their own level of pain and titrate the amount of PENTHROX inhaled for adequate pain control. Continuous inhalation provides analgesic relief for up to 25-30 minutes. Intermittent inhalation may provide longer analgesic relief. Patients should be advised to take the lowest possible dose to achieve pain relief.
The frequency at which PENTHROX can be safely used is not established. Administration on consecutive days is not recommended and the total dose to a patient in a week should not exceed 15 ml (see section 4.4).
PENTHROX should not be used in children under 18 years.
Method of Administration
https://www.penthrox.co.uk/content/uploads/sites/2/2017/01/PEN-15-036-A3-How-to-Administer-Poster.pdf
Instructions on the preparation of the PENTHROX Inhaler and correct administration are provided in the Figures below.
Ensure the Activated Carbon (AC) Chamber is inserted into the dilutor hole on the top of the PENTHROX Inhaler.
Remove the cap of the bottle by hand. Alternatively, use the base of the PENTHROX Inhaler to loosen the cap with a ½ turn. Separate the Inhaler from the bottle and remove the cap by hand.
Tilt the PENTHROX Inhaler to a 45° angle and pour the total contents of one PENTHROX bottle into the base of the Inhaler whilst rotating.
Place wrist loop over patient's wrist. Patient inhales through the mouthpiece of the PENTHROX Inhaler to obtain analgesia. First few breaths should be gentle and then breathe normally through Inhaler.
Patient exhales into the PENTHROX Inhaler. The exhaled vapour passes through the AC Chamber to adsorb any exhaled methoxyflurane.
If stronger analgesia is required, patient can cover dilutor hole on the AC chamber with finger during use.
Patient should be instructed to inhale intermittently to achieve adequate analgesia. Continuous inhalation will reduce duration of use. Minimum dose to achieve analgesia should be administered.
Replace cap onto PENTHROX bottle. Place used PENTHROX Inhaler and used bottle in sealed plastic bag and dispose of responsibly.
How to administer Penthrox® (metoxiflurano)?
Healthcare professional administering PENTHROX must provide and explain the Product Information Leaflet to the patient.
Use as an anaesthetic agent.
Hypersensitivity to PENTHROX or any fluorinated anaesthetic.
Malignant hyperthermia: patients with known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
Patients who have a history of showing signs of liver damage after previous methoxyflurane use or halogenated hydrocarbon anaesthesia.
Clinically significant renal impairment.
Altered level of consciousness due to any cause including head injury, drugs, or alcohol.
Clinically evident cardiovascular instability.
Clinically evident respiratory depression.
4.4 Special warnings and precautions for use
Methoxyflurane causes significant nephrotoxicity at high doses. Nephrotoxicity is also related to the rate of metabolism. Therefore factors that increase the rate of metabolism such as drugs that induce hepatic enzymes can increase the risk of toxicity with methoxyflurane as well as sub-groups of people with genetic variations that may result in fast metaboliser status (see section 4.5). Nephrotoxicity is thought to be associated with inorganic fluoride ions, a metabolic break-down product. Toxicity in the past when used as an anaesthetic agent has been determined to be associated with serum levels greater than 40 μmol/L. Following a single dose of 3 mL serum levels did not exceed 10 μmol/L.
Despite this safety margin the lowest effective dose of methoxyflurane should be administered, especially in the elderly or patients with other known risk factors of renal disease. In addition, methoxyflurane should be cautiously used in patients diagnosed with clinical conditions that would pre-dispose to renal injury.
Methoxyflurane is metabolised in the liver, therefore increased exposures in patients with hepatic impairment can cause toxicity. PENTHROX must not be used in patients who have a history of showing signs of liver damage after previous methoxyflurane use or halogenated hydrocarbon anaesthesia. PENTHROX should be used with care in patients with underlying hepatic conditions or with risks for hepatic dysfunction (such as enzyme inducers - see also section 4.5).
It has been reported that previous exposure to halogenated hydrocarbon anaesthetics (including methoxyflurane when used in the past as an anaesthetic agent), especially if the interval is less than 3 months, may increase the potential for hepatic injury.
Cautious clinical judgement should be exercised when PENTHROX is to be used more frequently than on one occasion every 3 months.
Cardiovascular system depression / Use in elderly
Potential effects on blood pressure and heart rate are known class-effects of high dose methoxyflurane used in anaesthesia and other anaesthetics. They do not appear to be significant at the analgesic doses. There is no particular pattern to the patients' systolic BP levels after methoxyflurane administration as an analgesic across age groups. However, as the risk may potentially be increased for older people with hypotension and bradycardia, caution should be exercised in the elderly due to possible reduction in blood pressure.
Central nervous system effects
Secondary pharmacodynamic effects including potential CNS effects such as sedation, euphoria, amnesia, ability to concentrate, altered sensorimotor co-ordination and change in mood are also known class-effects. Self-administration of methoxyflurane in analgesic doses will be limited by occurrence of CNS effects, such as sedation.
Additionally, the CNS effects can be a risk factor for potential abuse.
Healthcare professionals who are regularly exposed to patients using PENTHROX inhalers should be aware of any relevant occupational health and safety guidelines for the use of inhalational agents. To reduce occupational exposure to methoxyflurane, the PENTHROX Inhaler should always be used with the Activated Carbon (AC) Chamber which adsorbs exhaled methoxyflurane. Multiple use of PENTHROX Inhaler without the AC Chamber creates additional risk. Elevation of liver enzymes, blood urea nitrogen and serum uric acid have been reported in exposed maternity ward staff in delivery wards when methoxyflurane was used in the past in obstetric patients at the time of labour and delivery.
Due to the limitations on the dose of PENTHROX (maximum - 6ml) and the duration of pain relief, PENTHROX is not appropriate for providing relief of break-through pain/exacerbations in chronic pain conditions. PENTHROX is also not appropriate for relief of trauma related pain in closely repeated episodes for the same patient.
PENTHROX contains the excipient, butylated hydroxytoluene (E321), a stabiliser. Butylated hydroxytoluene may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. See section 6.1.
4.5 Interaction with other medicinal products and other forms of interaction
The metabolism of methoxyflurane is mediated by the CYP 450 enzymes particularly CYP 2E1 and to some extent CYP 2A6. It is possible that enzyme inducers (such as alcohol or isoniazid for CYP 2E1 and phenobarbital or rifampicin for CYP 2A6) which increase the rate of methoxyflurane metabolism might increase its potential toxicity and they should be avoided concomitantly with methoxyflurane.
Concomitant use of PENTHROX with CNS depressants, such as opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects. If opioids are given concomitantly with PENTHROX, the patient should be observed closely, as is normal clinical practice with opioids.
Concomitant use of methoxyflurane with medicines (e.g. contrast agents and some antibiotics) which are known to have a nephrotoxic effect should be avoided as there may be an additive effect on nephrotoxicity. Antibiotics with known nephrotoxic potential include tetracycline, gentamicin, colistin, polymyxin B and amphotericin B. It is advisable to avoid using sevoflurane anaesthesia following methoxyflurane analgesia, as sevoflurane increases serum fluoride levels and nephrotoxicity of methoxyflurane is associated with raised serum fluoride.
There are no reported drug interactions when used at the analgesic dosage (3 – 6 mL).
When methoxyflurane was used for anaesthesia at the higher doses of 40 – 60 mL, there were reports of:
a) Drug interaction with hepatic enzyme inducers (eg barbiturates) increasing metabolism of methoxyflurane and resulting in a few reported cases of nephrotoxicity. There is insufficient information to show whether enzyme induction affects liver damage after an analgesic dose of methoxyflurane.
b) Reduction of renal blood flow and hence anticipated enhanced renal effect when used in combination with drugs (eg barbiturates) reducing cardiac output.
c) Class effect on cardiac depression which may be enhanced by other cardiac depressant drugs, eg intravenous practolol during cardiac surgery.
4.6 Fertility, pregnancy and lactation
No clinical data on effects of methoxyflurane on fertility are available. Limited data from animal studies do not indicate any effects on sperm morphology.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Where methoxyflurane has been used for obstetric analgesia in pregnant women, there has been a single report of neonatal respiratory depression associated with a high fetal level of methoxyflurane. However, when low concentrations were administered, or the duration of higher concentrations was kept short, per recommended posology, methoxyflurane was found to have little effect on the fetus. No fetal complications were reported to result from methoxyflurane analgesia in the mother in all the studies completed in obstetric analgesia.
As with all medicines care should be exercised when administered during pregnancy especially the first trimester.
There is insufficient information on the excretion of methoxyflurane in human milk. Caution should be exercised when methoxyflurane is administered to a nursing mother.
4.7 Effects on ability to drive and use machines
Methoxyflurane may have a minor influence on the ability to drive and use machines. Dizziness, somnolence and drowsiness may occur following the administration of methoxyflurane (see section 4.8). Patients should be advised not to drive or operate machinery if they are feeling drowsy or dizzy.
Summary of safety profile
The most common non-serious reactions are CNS type reactions such as dizziness, and somnolence (≥1/100 to <1 and="" are="" easily="" font="" generally="" reversible.="">
Serious dose-related nephrotoxicity has only been associated with methoxyflurane when used in large doses over prolonged periods during general anaesthesia. Methoxyflurane is therefore no longer used for anaesthesia. See section 4.4 under renal disease. The recommended maximum dose for PENTHROX should therefore not be exceeded.
Tabulated list of adverse reactions
The adverse drug reactions observed in PENTHROX clinical studies in analgesia are listed in the table below, classified according to frequency (common ≥1/100 to <1 font="" to="" uncommon="">
MedDRA System Organ Class
Respiratory, thoracic and mediastinal disorders
Gastrointestinal disorders
Skin and subcutaneous tissue disorders
Post-marketing experience
Rare (≥1/10,000 to <1 analgesic="" been="" failure="" font="" have="" hepatic="" hepatitis="" methoxyflurane.="" observed="" of="" reports="" use="" with="">
Other events linked to the methoxyflurane use in analgesia (in addition to the reactions from clinical trials listed above), including reports from the literature include:
- Nervous system disorders: drowsiness, agitation, restlessness, dissociation, affect lability, disorientation, altered state of consciousness
- Respiratory system: choking, hypoxia, oxygen saturation decreased
- Cardiovascular system: blood pressure fluctuation
- Gastrointestinal: vomiting
- Hepatic: hepatitis, increased liver enzymes, jaundice, liver injury
- Renal: increased serum uric acid, urea nitrogen and creatinine, renal failure
- Eyes: blurred vision, nystagmus
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Patients should be observed for signs of drowsiness, pallor and muscle relaxation following methoxyflurane administration.
High doses of methoxyflurane cause dose related nephrotoxicity. High output renal failure has occurred several hours or days after the administration of repeated high analgesic or anaesthetic doses of methoxyflurane.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Methoxyflurane vapour provides analgesia when inhaled at low concentrations. After methoxyflurane administration, drowsiness may occur. During methoxyflurane administration, the cardiac rhythm is usually regular. The myocardium is only minimally sensitised to adrenaline by methoxyflurane. At analgesic therapeutic doses pain relief may lead to some decrease in blood pressure. This may be accompanied by bradycardia.
Clinical efficacy and safety
The efficacy and safety of PENTHROX was demonstrated in MEOF-001, a randomised, double-blind, multi-centre, placebo controlled study in the treatment of acute pain in patients with minor trauma presenting to an Emergency Department. 300 patients were recruited (149 received methoxyflurane and 149 received placebo in a 1:1 ratio). Patients with a pain score of ≥ 4 to ≤ 7 on the Numerical Rating Scale were eligible for the study. The mean pain scores (Visual Analogue Scale) observed at baseline were similar in the methoxyflurane (64.8) and placebo (64.0) groups. The primary efficacy variable, the estimated mean change in VAS pain from Baseline to 5 min, 10 min, 15 min and 20 min, was greater for the methoxyflurane group (-23.1, -28.9, -34.0 and -35.0 respectively) when compared to the placebo group (-11.3, -14.8, -15.5 and -19.0 respectively). Overall, there was a highly significant difference between the methoxyflurane and placebo group (estimated treatment effect -15.1; 95% CI -19.2 to -11.0; p<0 -18.5="" .0001="" 0.0001="" 1-10="" 10="" 126="" 15="" 20="" 30.9="" 30="" 33.6="" 37.6="" 57.7="" 5="" 63.8="" 76="" a="" after="" an="" analysis="" and="" as="" at="" baseline="" compared="" comparison="" defined="" each="" effect="" estimated="" experienced="" first="" font="" for="" from="" greater="" greatest="" group.="" group="" improvement="" in="" indicated="" inhalations="" least="" methoxyflurane="" mins="" minutes="" of="" p="" pain="" patient="" patients="" percentage="" placebo="" relief="" responder="" responders="" results="" score.="" seen="" significantly="" that="" the="" their="" this="" time-point.="" to="" total="" treatment="" undertaken="" vas="" was="" when="" where="" who="" with="">
5.2 Pharmacokinetic properties
Methoxyflurane has the following partition coefficients:
• a water/gas coefficient of 4.5,
• a blood/gas coefficient of 13 and
• an oil/gas coefficient of 825
Methoxyflurane enters the lungs in the form of a vapour and is rapidly transported into the blood, therefore there is a rapid onset of analgesic action.
Methoxyflurane has a high oil/gas coefficient hence methoxyflurane is highly lipophilic. Methoxyflurane has great propensity to diffuse into fatty tissues where it forms a reservoir from which it is released slowly over days.
Biotransformation of methoxyflurane occurs in man. Methoxyflurane is metabolised by dechlorination and o-demethylation in the liver, mediated by CYP 450 enzymes particularly CYP 2E1 and CYP 2A6. Methoxyflurane is metabolised to free fluoride, oxalic acid, difluoromethoxyacetic acid, and dichloroacetic acid. Both free fluoride and oxalic acid can cause renal damage at concentrations higher than those achievable with single analgesic dose use. Methoxyflurane is more susceptible to metabolism than other halogenated methyl ethyl ethers and has greater propensity to diffuse into fatty tissues. Hence methoxyflurane is released slowly from this reservoir and becomes available for biotransformation for many days.
Approximately 60% of methoxyflurane uptake is excreted in the urine as organic fluorine, fluoride and oxalic acid; the remainder is exhaled unaltered or as carbon dioxide. Higher peak blood fluoride levels may be obtained earlier in obese than in non-obese people, and in the elderly.
5.3 Preclinical safety data
In studies in mice and rats, methoxyflurane crossed the placenta but demonstrated no evidence of embryotoxic or teratogenic properties. However, delayed fetal development (reduced fetal body weight and decreased ossification) was observed following repeated dosing over 9 days. The no observed adverse effect level (NOAEL) for embryo-fetal development was 0.006% - 4h/day in mice and close to 0.01% - 8 h/day in rats. The NOAELs in mouse and rat represent a 1- to 2-fold margin on a mg/kg basis and a 0.1- to 0.3-fold margin on a mg/m2 basis versus the proposed maximum clinical dose. As PENTHROX is not intended for daily use, the risk of delayed fetal development is considered to be very low.
Repeated intermittent or continuous administration of subanaesthetic concentrations of methoxyflurane has been associated with limited and commonly reversible hepatic changes (fatty metamorphosis, elevated ALT/AST) in several species. A NOAEL has not been established. These effects were seen at exposures considered sufficiently in excess of those anticipated through normal clinical use of the product.
6. Pharmaceutical particulars
Butylated hydroxytoluene E321 (stabiliser).
6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions. For storage, PENTHROX combination pack should be kept in a locked cabinet, and should not be left on an open shelf.
6.5 Nature and contents of container
PENTHROX is supplied in the following presentations:
3 mL bottle with a tear off tamper-evident seal (packs of 10)
Combination pack with one 3 mL bottle, one PENTHROX Inhaler and one Activated Carbon (AC) chamber (packs of 1 or 10).
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
After loading the PENTHROX Inhaler, replace cap onto PENTHROX bottle. After use, place used PENTHROX Inhaler and used bottle in plastic bag provided, seal and dispose of responsibly.
7. Marketing authorisation holder
Medical Developments UK Limited
1 Dane Street, Bishop's Stortford
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
22/12/2016
Penthrox Administration Checklist-HCP use Further copies of the educational materials and training on the administration of Penthrox are available from Galen on request (tel 028 38334974 or email customer.services@galen-pharma.com).
Penthrox Administration Guide-HCP use Further copies of the educational materials and training on the administration of Penthrox are available from Galen on request (tel 028 38334974 or email customer.services@galen-pharma.com).
Penthrox Patient Alert Card-Patient Use
http://www.insht.es/InshtWeb/Contenidos/Documentacion/FichasTecnicas/NTP/Ficheros/601a700/ntp_606.pdf
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