MEDI-KEEL A® THROAT GARGLE - Adcock Ingram | Colds & Flu

SCHEDULING STATUS: S1
PROPRIETARY NAME: MEDI-KEEL A ® THROAT GARGLE
(AND DOSAGE FORM) (SOLUTION)
COMPOSITION:
Each 15 ml of solution contains :
Dibucaine hydrochloride 5 mg
Benzocaine 30 mg
Cetylpyridinium chloride 3,713 mg
Benzyl alcohol 60 mg
Alcohol
Sugar free
15,3 % v/v added as preservative
PHARMOCOLOGICAL CLASSIFICATION:
A 16.3 Surface anaesthetics.
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PHARMOCOLOGICAL ACTION:
Dibucaine and benzocaine have a mild local anaesthetic action which alleviates sore throat.
Cetylpyridinium chloride is a quaternary ammonium compound. In vitro findings show
cetylpyridinium chloride to have a rapid and prolonged bactericidal and fungicidal action. It is
germicidal in high dilutions against a wide variety of Gram-positive and Gram-negative
bacteria which include haemolytic Streptococci, Staphylococcus aureus, Escherichia coli and
Lactobacillus acidophilus. Fungicidal action has been demonstrated against Monilia albicans,
the cause of oral thrush.
INDICATIONS:
MEDI-KEEL A THROAT GARGLE is indicated for rapid and temporary relief of pain and
discomfort in: sore throats due to colds, throat irritations (and accompanying tickling cough)
due to dust, allergy, smoke or excessive use of the voice. MEDI-KEEL A THROAT GARGLE
is also recommended for minor mouth irritations due to stomatitis, dental procedures and
minor surgery of the mouth.
CONTRA-INDICATIONS:
MEDI-KEEL A THROAT GARGLE is contra-indicated in patients with a history of
hypersensitivity to local anaesthetics.
DOSAGE AND DIRECTIONS FOR USE:

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15-30 ml (3-6 medicine measuresful) every 3-4 hours as needed. Depending upon location of
the pain, the solution should be swished around the mouth and/or used as a gargle. .
Do not swallow.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Persons with a high fever, severe sore throat or persistent cough should not use this
preparation unless directed by a physician. MEDI-KEEL A THROAT GARGLE should be
used with caution in patients with severely traumatized mucosa and sepsis in the region of the
proposed application.
This preparation must not be administered to persons who are allergic to benzocaine or
related substances.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No cases of overdosage have been reported to date. Stomach washout and supportive
therapy are advised.
IDENTIFICATION:
Clear orange/red liquid with characteristic odour.
PRESENTATION:
100 ml and 200 ml bottles.
STORAGE INSTRUCTIONS:
Store in a cool, dark place below 25 °C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
H/16.3/199
NAME AND ADDRESS OF HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited
3011 William Nicol Drive
Bryanston
Private Bag X69, Bryanston 2021
www.adcock.co.za
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18/02/76

SKEDULERINGSTATUS: S1
EIENDOMSNAAM MEDI-KEEL A ® THROAT GARGLE
(EN DOSEERVORM): (OPLOSSING)
SAMESTELLING:
Elke 15 ml van die oplossing bevat :
Dibukaïenhidrochloried 5 mg
Bensokaïen 30 mg
Setielpiridiniumchloried 3,713 mg
Bensielalkohol 60 mg
Alkohol
Suikervry
15,3 % v/v bygevoeg as preserveermiddel.
FARMAKOLOGIESE KLASSIFIKASIE:
A 16.3 Oppervlakverdowingsmiddels.
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FARMAKOLOGIESE WERKING:
Dibukaïen en bensokaïen het 'n ligte plaaslike verdowende werking wat seerkeel verlig.
Setielpiridiniumchloried is 'n kwaternêre ammoniumverbinding. In vitro bevindings bewys dat
setielpiridiniumchloried 'n vinnige en langdurige kiem-en swamdodende werking het, en in
hoë verdunnings kiemdodend is teen 'n wye verskeidenheid Gram-positiewe en Gramnegatiewe
bakterieë met inbegrip van hemolitiese Streptococcus, Stafilococcus aureus,
Escherichia coli en Lactobacillus acidophilus. Swamdodende werking is aangetoon teen
Monilia albicans, die oorsaak van mondsproei.
INDIKASIES:
MEDI-KEEL A THROAT GARGLE is aangewese vir snelle en tydelike verligting van pyn en
ongemak in: seerkeel te wyte aan verkoues, keelirritasies (en gepaardgaande kielierige hoes)
te wyte aan stof, allergie, rook of oormatige gebruik van die stem. MEDI-KEEL A THROAT
GARGLE word ook aanbeveel vir geringe mondirritasies te wyte aan mondontsteking,
tandheelkundige prosedures en kleinere mondichirurgie.
KONTRA-INDIKASIES:
MEDI-KEEL A THROAT GARGLE is teenaangewese vir pasiënte met 'n geskiedenis van
oorgevoeligheid vir plaaslike verdowingsmiddels.
DOSIS EN GEBRUIKSAANWYSINGS:
15 - 30 ml (3 - 6 medisynemate) elke 3 - 4 uur soos nodig. Afhangende van ligging van pyn,
moet die oplossing in die mond gespoel en/of as 'n gorrelmiddel gebruik word.

Moenie insluk nie.
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NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:
Persone met 'n hoë koors, ernstige seerkeel of aanhoudende hoes behoort nie hierdie
preparaat te gebruik tensy deur 'n geneesheer voorgeskryf nie. MEDI-KEEL A THROAT
GARGLE moet met sorg gebruik word deur pasiënte met ernstige troumatiese mukosa en
sepsis in die deel wat behandel moet word. Hierdie preparaat moet nie aan persone wat
allergies is vir bensokaïen en verwante stowwe toegedien word nie.
BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN BEHANDELING
DAARVAN:
Geen gevalle van 'n oordosis is tot op datum aangemeld nie. Maagspoelling en
ondersteunende terapie word aangeraai.
IDENTIFIKASIE:
Helder oranje/rooi vloeistof met karakteristieke reuk.
AANBIEDING:
100 ml en 200 ml bottles.
BERGINSAANWYSINGS:
Bêre op 'n koel donker plek benede 25 °C. Beskerm teen lig.
HOU BUITE BEREIK VAN KINDERS.
REGISTRASIENOMMER:
H/16.3/199
NAAM EN ADRES VAN HOUER VAN DIE REGISTRASIESERTIFIKAAT:
Adcock Ingram Limited
William Nicolrylaan 3011
Bryanston
Privaatsak X69, Bryanston 2021
www.adcock.co.za
DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
18/02/76