CALPROFEN Oral suspension (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Calprofen 100mg/5ml Oral Suspension Ibuprofen.
Qualitative and quantitative composition
Ibuprofen 100 mg/5 ml. Also contains maltitol syrup (E965), sodium methylhydroxybenzoate (E219), sodium propylhydroxybenzoate (E217), propylene glycol (E1520) and ethanol. For excipients – see section ...
Pharmaceutical form
Oral Suspension. Sugar Free, Colour Free and Strawberry Flavour.
Therapeutic indications
Children aged 3 months to 12 years: Mild to moderate pain, post-immunisation pyrexia, rheumatic or muscular pain, headache, reduction of fever, sore throat, teething pain, toothache, minor aches and pains, ...
Posology and method of administration
To be taken orally. For short term use only. Children aged 3 months to 12 years Not recommended for children weighing less than 5 kg. For pain and fever – 20mg/kg/day in divided doses. Infants 3-6 months: ...
Contraindications
Hypersensitivity to Ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin ...
Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below). The elderly have an increased frequency ...
Interaction with other medicinal products and other forms of interaction
Ibuprofen should be avoided in combination with Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (See section 4.4). ...
Fertility, pregnancy and lactation
While no teratogenic effects have been demonstrated in animal experiments, the use of Ibuprofen should, if possible, be avoided during the first 6 months of pregnancy. During the 3<sup>rd</sup> trimester, ...
Effects on ability to drive and use machines
It is not expected that Calprofen 100 mg/5 ml Oral Suspension would interfere with the ability to drive or operate machinery at the recommended dose and duration of therapy.
Undesirable effects
Hypersensitivity reactions have been reported and these may consist of: Non-specific allergic reactions and anaphylaxis. Respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm or dyspnoea. ...
Overdose
In children, ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear-cut. The half-life in overdose is 1.5–3 hours. Symptoms Most patients who have ingested ...
Pharmacodynamic properties
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans Ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ...
Pharmacokinetic properties
Ibuprofen is rapidly absorbed from the gastro-intestinal tract and rapidly distributed throughout the whole body. Peak plasma concentrations occur about 1 to 2 hours after ingestion with food or in 45 ...
Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
List of excipients
Glycerol (E422) Xanthan gum Maltitol syrup (Lycasin 80/55 (E965)) Polysorbate 80 Saccharin sodium (E954) Citric acid monohydrate Sodium methylhydroxybenzoate (E219) Sodium propylhydroxybenzoate (E217) ...
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C. Keep out of reach and sight of children.
Nature and contents of container
Amber glass bottle sealed with a child resistant, tamper evident cap. A syringe with a 2.5 ml and 5 ml measure is supplied with this pack. Pack sizes: 100ml.
Special precautions for disposal and other handling
Shake well before use. Return any left over medicine to the Pharmacist.
Marketing authorization holder
McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom
Marketing authorization number(s)
PL 15513/0147
Date of first authorization / renewal of the authorization
21<sup>st</sup> July 2006
Date of revision of the text
24 April 2018
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