Alvedon Suppositories
2. Qualitative and quantitative composition
Alvedon Suppositories sixty mg: every medication contains Paracetamol sixty mg.
Alvedon Suppositories one hundred twenty five mg: every medication contains Paracetamol one hundred twenty five mg.
Alvedon Suppositories 250 mg: every medication contains Paracetamol 250 mg.
For the complete list of excipients, see section half dozen.1.
3. Pharmaceutical kind
Suppositories.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of gentle to moderate pain and symptom in children:
Alvedon sixty mg is indicated in youngsters aged up to one year.
Alvedon one hundred twenty five mg is indicated in youngsters aged one to five years.
Alvedon 250 mg is indicated in youngsters aged half dozen to twelve years.
Alvedon suppositories is also particularly helpful in patients unable to require oral types of paracetamol, e.g. post-operatively or with nausea and reflex.
4.2 materia medica and technique of administration
Posology
Children underneath three months aged (60 mg suppositories)
One medication (60 mg) is appropriate for babies WHO develop a fever following protection at two months. Otherwise solely use in babies aged but three months on a doctor's recommendation.
Children three months to one year (60 mg suppositories)
The dose ought to be supported age and weight i.e.
3 months (5 kg)
60mg (1 suppository)
1 year (10 kg)
-
120mg (2 suppositories)
Children one to five years (125 mg suppositories)
The dose ought to be supported age and weight i.e.
1 year (10 Kg)
125mg (1 suppository)
5 years (20 Kg)
250mg (2 suppositories)
Children half dozen to twelve years (250 mg suppositories)
The dose ought to be supported age and weight i.e.
6 years (20 Kg)
250mg (1 suppository)
12 years (40 Kg)
500mg (2 suppositories)
Method of administration
These doses is also continual up to a most of four times in twenty four hours. The dose shouldn't be continual a lot of often than each four hours. The counseled dose shouldn't be exceeded. Higher doses don't manufacture any increase in analgesic result. solely whole suppositories ought to be administered – don't break medication before administration.
4.3 Contraindications
Hypersensitivity to paracetamol or to any of the excipients listed in section half dozen.1.
4.4 Special warnings and precautions to be used
Alvedon Suppositories shouldn't be combined with alternative analgesic medications that contain paracetamol. Paracetamol ought to be with care to patients with impaired urinary organ or liver operate.
Doses on top of those counseled involve a risk of terribly severe liver harm. Liver harm additionally|is additionally} related to bound risk factors (see also Section four.5 Interaction with alternative healthful product and alternative types of interaction, and Section four.9 Overdose). If liver harm is suspected then liver operate tests ought to be performed.
Do not exceed the counseled dose. If symptoms persist consult your doctor. prevent of the sight and reach of youngsters.
Label and Leaflet can state the subsequent warnings:
Label:
“Immediate medical recommendation ought to be wanted within the event of Associate in Nursing drug, although the kid looks well”.
“Do not provide with the other paracetamol-containing product.”
Leaflet:
“Immediate medical recommendation ought to be wanted within the event of Associate in Nursing drug, although the kid looks well, due to the chance of delayed, serious liver harm.”
4.5 Interaction with alternative healthful product and alternative types of interaction
Drugs that induce viscus granule enzymes like alcohol, barbiturates and alternative anticonvulsants, might increase the hepatotoxicity of paracetamol, significantly when overdosage.
The anti-coagulant result of Coumadin and alternative coumarins is also increased by prolonged regular use of paracetamol with raised risk of trauma. The result seems to extend because the dose of paracetamol is raised, however will occur with doses as low as one.5–2 g paracetamol per day for a minimum of 5–7 days. Occasional doses don't have any important result.
Probenicid inhibits the glucuronidation of paracetamol which may have an effect on the clearance of paracetamol. this could be thought-about once these medicines ar administered concomitantly.
Paracetamol might have an effect on the pharmacological medicine of antibiotic. This interaction ought to be thought-about once these medications ar administered concomitantly, particularly in underfed patients.
Enzyme-inducing medicines, like some antiepileptic drug medicine (phenytoin, sodium thiopental, carbamazepine, primidone) are shown in pharmacokinetic studies to scale back the plasma United Self-Defense Force of Colombia of paracetamol to approx. 60 %. alternative substances with enzyme-inducing properties, e.g. rifampicin and St. John's wort (hypericum) are suspected of inflicting lowered concentrations of paracetamol. additionally, the chance of liver harm throughout treatment with most counseled doses of paracetamol are higher in patients being treated with enzyme-inducing agents.
4.6 Fertility, physiological state and lactation
A large quantity of knowledge on pregnant girls indicate neither malformative, nor feto/neonatal toxicity. medicine studies on neurodevelopment in youngsters exposed to paracetamol in utero show inconclusive results. If clinically required, paracetamol is used throughout physiological state, however, it ought to be used at rock bottom effective dose for the shortest attainable time and at rock bottom attainable frequency.
Paracetamol is excreted in breast milk however not in clinically important amounts.
Available revealed information don't advise breast-feeding.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Side-effects at therapeutic doses ar rare.
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