PENTHROX Inhalation vapour (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
PENTHROX 99.9%, 3 ml inhalation vapour, liquid.
Qualitative and quantitative composition
Each bottle contains 3 ml of methoxyflurane 99.9%. Excipients with known effect: Butylated hydroxytoluene (E321) (0.01% w/w).
Pharmaceutical form
Inhalation vapour, liquid. Clear, almost colourless, volatile liquid, with a characteristic fruity odour.
Therapeutic indications
Emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain.
Posology and method of administration
PENTHROX should be self-administered under supervision of a person trained in its administration, <and> <or> <physician,> <and> <or> <doctor,> <and> <or> <nurse>, <and> <or> <paramedic>, using the hand ...
Contraindications
Use as an anaesthetic agent. Hypersensitivity to methoxyflurane, any fluorinated anaesthetic or to any of the excipients listed in section 6.1. Malignant hyperthermia: patients who are known to be or genetically ...
Special warnings and precautions for use
Renal disease To ensure the safe use of PENTHROX as an analgesic the following precautions should be observed. Use the lowest effective dose to control pain Use with caution in the elderly or other patients ...
Interaction with other medicinal products and other forms of interaction
There are no reported drug interactions when used at the analgesic dosage (3–6 mL). The metabolism of methoxyflurane is mediated by the CYP 450 enzymes particularly CYP 2E1 and to some extent CYP 2A6. ...
Fertility, pregnancy and lactation
Fertility No clinical data on effects of methoxyflurane on fertility are available. Limited data from animal studies do not indicate any effects on sperm morphology. Pregnancy Animal studies do not indicate ...
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 ...
Undesirable effects
Summary of safety profile The common non-serious reactions are CNS type reactions such as dizziness, and somnolence, and are generally easily reversible. Tabulated list of adverse reactions 'Serious dose-related ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics, other analgesics and antipyretics ATC code: N02BG09 Mechanism of action The mechanism by which methoxyflurane exerts its analgesic activity has not been fully elucidated. ...
Pharmacokinetic properties
Absorption 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 ...
Preclinical safety data
Genotoxicity and carcinogenicity Methoxyflurane is not considered mutagenic as indicated in an in vitro Ames study and an in vivo micronucleus study in rats. There is no clear evidence that methoxyflurane ...
List of excipients
Butylated hydroxytoluene E321 (stabiliser)
Incompatibilities
Not applicable.
Shelf life
36 months.
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. ...
Nature and contents of container
PENTHROX is supplied in the following presentations: One bottle with a tear off tamper-evident seal (packs of 10) Combination pack with one bottle of 3 ml PENTHROX, one PENTHROX Inhaler and one Activated ...
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.
Marketing authorization holder
Medical Developments UK Limited, c/o Price Bailey LLP, Causeway House, 1 Dane Street, Bishops Stortford, Herts CM23 3BT, United Kingdom
Marketing authorization number(s)
PL 42467/0001
Date of first authorization / renewal of the authorization
27/10/2015
Date of revision of the text
31/12/2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
