1.3.1.1 Proposed Professional Information (PI) LINE
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PROFESSIONAL INFORMATION
SCHEDULING STATUS S0
1. NAME OF THE MEDICINE
Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
Respiclear® Nebs (Micro-emulsion for nebulisation)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
Each 2,5 ml unit dose contains:
Active ingredients: Menthol (Mentha arvensis) oil1,25 mg, Camphor (Cinnamomum camphora) oil 1,25 mg, White thyme (Thymus vulgaris) oil 1,25 mg, Eucalyptus (Eucalyptus globulus) oil 1,25 mg, Cinnamon leaf (Cinnamomum zeylanicum) oil 1,25 mg, Pine (Pinus sylvestris) oil 1,25 mg, Caffeine Anhydrous 25 mg, Lavender (Lavandula latifolia) oil
As per SAHPRA schedules
In accordance with Module 1.2.1 Application Form
3.2.P.1 3.2.P.3.2
Module 4.2.1
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1,25 mg, Peppermint (Mentha piperita) oil 1,25 mg, Olive (Olea europaea) oil 2,5 mg, Moringa seed (Moringa oleifera) oil 5 mg. CONTAINS CAFFEINE.
Inactive Ingredients: Saline, Propylene Glycol and EDTA2Na (0,1%)
3. PHARMACEUTICAL FORM
Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
Respiclear Nebs is a single unit dosage form each containing 2,5 mL clear solution (microemulsion) with a characteristic
“herbal” odour for inhalation via nebulisation.
4. CLINICAL PARTICULARS
Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
4.1. Therapeutic Indications
For symptomatic relief in nasal congestion, coryza (head colds) and bronchitis.
4.2. Posology and method of administration Posology
4.2.1.4, Pg 1 4.2.2.6
4.2.3 Toxicology
As per Regulation 9
As per Regulation 9
Module 4.2.1
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Adults and Older Children: Use 2,5 ml to 5 ml (one to two single dose units) of Respiclear® Nebs solution up to four times per day.
Children (4 to 11 years of age): Use 2,5ml (one single dose unit) of Respiclear® Nebs solution up to three times per day.
Method of administration
Respiclear® Nebs is for inhalation use only, to be breathed in through the mouth, using a suitable nebuliser. The solution should not be injected or swallowed.
4.3. Contraindications
Avoid if allergic or sensitive to any of the listed ingredients. If pregnant or breastfeeding, consult your doctor or pharmacist before use. Do not exceed recommended dosage(s) unless on the advice of a healthcare practitioner.
4.4. Special warnings and precautions for use
Discontinue use immediately should any adverse reaction occur due to hypersensitivity to any of the ingredients of Respiclear® Nebs. Not to be ingested or injected. Avoid contact with eyes.
4.5. Interaction with other medicines and other forms of interaction
Since Respiclear® Nebs are nebulised, there is a low probability of medicinal interactions. Patients are however advised to contact their doctor or healthcare provider before using Respiclear® Nebs. Use with lithium or other medicines
4.2.1.4, Pg 1 4.2.2.6
4.2.3 Toxicology
4.2.3 Toxicology
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(e.g. bitter orange extract, synephrine, octopamine, ephedra, ephedrine) which increase blood pressure is not recommended. Use with other caffeine- containing products (e.g. medications, coffee, tea, colas, cocoa, mate) is not recommended.
4.6. Fertility, pregnancy and lactation
Safety in pregnancy and lactation has not yet been established.
4.7. Effects on ability to drive and use machines
No effects on the ability to drive and use machines has been reported.
4.8. Undesirable effects
Possible side effects are nausea, vomiting, increased heart rate, insomnia and headache.
4.9. Overdose
An overdose incurred by inhalation is treated by taking the patient into fresh air. Accidental oral intake by mouth may cause diarrhoea, stomach-ache, nausea, and sweating.
5. PHARMACOLOGICAL PROPERTIES
Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
5.1. Pharmacodynamic properties
4.2.3.5
4.2.3 Toxicology
3.2.P.5.1, Pg 1
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33.7 Combination Product. The aromatic vapours of the active compounds have a decongestant and anti-inflammatory action on the upper respiratory tract, giving symptomatic relief in nasal congestion, coryza and bronchitis. Humectant properties of saline, together with mucolytic properties of some essential oils may aid the body by providing an alleviating mucolytic effect. Caffeine has been shown to act as a bronchodilator and may thus alleviate a tight chest in patients suffering from the symptom.
5.2. Pharmacokinetic properties
There is no pharmacokinetic data available on the active ingredients via the route of administration described.
5.3. Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections.
6. PHARMACEUTICAL PARTICULARS
Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
6.1. List of excipients
Inactive Ingredients: Saline, Propylene Glycol and EDTA2Na (0,1%), RO Water
6.2. Incompatibilities
3.2.P.5.1, Pg 1
3.2.P.1
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6.3. Shelf life 2 years
6.4. Special precautions for storage
Store below 30 °C in a cool, dry place. KEEP OUT OF REACH OF CHILDREN.
6.5. Nature and contents of container
Respiclear® Nebs is a clear, oily, aqueous liquid with menthol odour packed in single dose units each containing 2,5 mL of solution. Each carton contains 3 strips of 5 units (15 single dose units in total) each marked “Respiclear Nebs” with a Patient Information Leaflet.
6.6. Special precautions for disposal No special requirements.
7. HOLDER OF CERTIFICATE OF REGISTRATION Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
Microbel Laboratories (Pty) Ltd
86 Gazelle Avenue, Corporate Park South Midrand, South Africa, 1685
Email: [email protected]
8. REGISTRATION NUMBER(S)
3.2.P.8.1, Pg 1
3.2.P.7, Pg 1
In accordance with Module 1.2.1 Application form
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Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
TBA by SAHPRA
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
TBA by SAHPRA
10. DATE OF REVISION OF THE TEXT
Category D: human complementary medicine. This medicine has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat, cure or prevent any disease.
TBA by SAHPRA
AFRIKAANS TRANSLATION LINE
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CONTENT REFERENCES
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PROFESSIONELE INLIGTING
SKEDULERING STATUS S0
1. Naam van medikasie
Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie
Respiclear® Nebs (Mikro-emulsie vir inhalasie)
2. Kwalitatiewe en kwantitatiewe samestelling
Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie
Elke 2.5ml eenheid dosis bevat:
Aktiewe bestanddele: Mentol (Mentha arvensis) olie 1,25 mg, Kamfer (Cinnamomum camphora) olie 1,25 mg, Bloekom (Eucalyptus globulus) olie 1,25 mg, Kaneelblaar (Cinnamomum zeylanicum) olie 1,25 mg, denne (Pinus sylvestris) olie 1,25 mg, Anhidriese kaffeïen 25 mg, Laventel
As per English references.
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(Lavandula latifolia) olie 1,25 mg, Peperment (Mentha piperita) olie 1,25 mg, Olyf (Olea europaea) olie 2,5 mg, Moringa saad (Moringa oleifera) olie 5 mg. Tieme (thymus vulgaris) olie 1,25 mg. Bevat kaffeïen
Onaktiewe bestanddele: Soutwater , Propileen glikool en EDTA2Na (0,1%), gesuiwerde water.
3. Farmaseutiese doseervorm:
Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie
Respiclear Nebs is ‘n enkel eenheid doseervorm wat elk 2,5 ml van ‘n helder deursigtige mikro-emulsie bevat met ‘n karakteristieke kruie reuk vir inhalasie en nebulisering .
4. Kliniese besonderhede
Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie
4.1. Terapeutiese indikasie
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Vir die simptomatiese verligting van nasale kongestie, kopverkoue en brongitis simptome
4.2. Posologie en toedieningsmetode Posologie
Volwassenes en ouer kinders: Gebruik 2,5 ml tot 5 ml (een tot twee enkel dosis eenhede) Respiclear® Nebs oplossing tot en met 4 keer per dag.
Kinders (4-11 jaar): gebruik 2.5ml (een enkel eenheid dosis) Respiclear® Nebs oplossing tot en met drie keer per dag.
Metode van toediening
Respiclear® Nebs is slegs vir inhalasie bedoel, om ingeasem te word deur die mond deur van ‘n geskikte nebuliseereder gebruik te maak. Hierdie oplossing moet nie ingespuit of gesluk word nie.
4.3. Kontra-indikasie
Vermy indien allergies of hipersensitief is vir enige van die gelyste bestanddele. Indien swanger of borsvoedend, raadpleeg eers jou dokter voor gebruik. Moet nie die aanbevole dosisse oorskry behalwe anders voorgeskryf deur
‘n gesondheidsorgpraktisyn.
4.4. WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS
Staak onmiddellik die gebruik indien enige ongewensde newe- effekte voorkom a.g.v. van allergie of hipersensitiwiteit vir
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enige van die gekyste bestanddele in Respiclear® Nebs. Nie vir inwendige gebruik nie. Vermy kontak met die oë.
4.5. Interaksies met ander medisyne en ander vorme van interaksies
Aangesien Respiclear® Nebs genebuliseer word is daar lae waarskynlikheid vir enige medisinale interaksies. Pasiënte word aangemoedig om eers hul dokter te raadpleeg voor die gebruik van Respiclear® Nebs. Die gesamentlike gebruik van litium of ander medisyne (bitter lemoen ekstrak, sinepfrien, oktapamien, efedra en efedrien)wat die bloeddruk verhoog, word nie aanbeveel nie. Gesamentlike gebruik van ander kaffeïen bevattende produkte (soos medisyne, koffie, tee, kola, en kakao) word nie aanbeveel nie
4.6. Vrugbaarheid, swangerskap en laktasie
Veiligheid in swangerskap en laktasie is nog nie bevestig nie.
4.7. Effek op die vermoë om te bestuur en masjinerie te gebruik
Geen effekte op die vermoë om te bestuur of om masjinerie te gebruik is aangemeld nie
4.8. Ongewensde newe-effekte
Moontlike newe-effekte sluit in naarheid, braking, verhoogde harttempo insomnie en hoofpyn.
4.9. Oordosering
‘n Oordosering deur inhalasie kan behandel word deur die pasiënt te neem na ‘n area waar daar vars lug is. Indien per
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ongeluk oraal ingeneem word kan maagpyn, diarree, naarheid, braking en perspirasie voorkom.
5. Farmakologiese eienskappe
Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie
5.1. Farmakodinamiese eienskappe
33.7 Kombinasie produk. Die aromatiese dampe van die aktiewe verbindings het ‘n dekongestiewe en anti-
inflammatoriese werking op die boonste lugweë wat lei tot die simptomatiese verligting van nasale kongestie, verkoue en brongitis. Soutoplossing se Humektant-eienskappe, saam met die mukolitiese eienskappe van sekere essensiële olies kan bydra om ‘n verligtende effek teweeg bring. Kafeïen het brongodilatoriese eienskappe en kan dus help om verligting te bied vir ‘n stywe bors in pasiënte.
5.2. Farmakokinetiese eienskappe
Geen data beskikbaar vir die farmakokinetiese eienskappe van die aktiewe bestanddele via die toedieningsroete nie.
5.3. Pre-kliniese gesondheidsdata
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Geen pre-kliniese data beskikbaar wat belangrik is vir die voorskrywer wat nie in ander afdelings reeds bespreek is nie.
6. Farmaseutiese besonderhede
Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie.
6.1. Lys van vulstowwe
Onaktiewe bestanddele: Soutwater, Propileenglikool en EDTA2Na (0,1%) gesuiwerde water.
6.2. Onversoenbaarhede 6.3. Rak leeftyd
2 jaar
6.4. Spesiale voorsorg en bewaring
Bewaar onder 30 °C in ‘n koel droë plek. HOU BUITE BEREIK VAN KINDERS.
6.5. Samestelling inhoud van die houer
Respiclear® is ‘n deursigtige olierige oplossing met ‘n mentol geur en is verpak in ‘n enkel dosis eenheid wat 2,5 ml oplossing bevat. Elke karton boksie bevat 3 repies met 5 eenhede (totaal van 15 enkel-dosis eenhede) elk gemerk met
“Respiclear Nebs” met ‘n pasiënt inligtingspamflet
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6.6. Spesiale voorsorg om van Respiclear Nebs ontslae te raak
Geen spesiale vereistes
7. Houer van die sertifikaat van registrasie
Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie.
Microbel Laboratories (Pty) Ltd 86 Gazelle Avenue,
Midrand, Suid-Afrika, 1685 Epos: [email protected]
8. REGISTRASIE NOMMER(S)
Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie.
Moet nog aangekondig word deur SAPHRA
9. DATUM VAN EERSTE GOEDKEURING/HERNUWING VAN GOEDKEURING
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Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie.
Moet nog aangekondig word deur SAPHRA
10. Datum van teks hersiening
Kategorie D: Menslike komplimentêre medisyne. Hierdie medisyne is nog nie deur SAPHRA gevalueer nie . Hierdie medikasie is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie.
Moet nog aangekondig word deur SAPHRA
