Medicinal Products

ANTARENE Ge Enf Nour s / s 20 mg / mL

Generic drug of the therapeutic class: Analgesics
active ingredients: Ibuprofen
laboratory: Elerte

Oral suspension
Bottle (+ syringe for oral administration) of 150 ml
All forms

Indication

Symptomatic treatment of painful and / or febrile conditions.

Symptomatic treatment of juvenile chronic arthritis.

Dosage ANTARENE Gé Enf Nour s / s 20 mg / mL Oral suspension Bottle (+ syringe for oral administration) of 150 ml

Dosage and frequency of administration

The occurrence of side effects can be minimized by using the lowest possible dose for the shortest duration of treatment required to relieve symptoms (see Warnings and Precautions section ).

Painful and / or febrile conditions:

The usual dosage is 20 to 30 mg / kg / day in 3 doses per day (without exceeding 30 mg / kg / day).

Systematic catches, spaced 8 hours apart, prevent pain or fever oscillations.

Juvenile chronic arthritis:

The usual dosage is 30 to 40 mg / kg / day in 4 doses per day.

Administration mode

Reserved for infants and children, from 3 months to 12 years (about 30 kg).

Oral way.

Shake the bottle well before use.

The drug is administered by means of the 5 ml or 10 ml oral syringe (graduated in kg) which delivers a dose of 10 mg / kg per dose.

ADMINISTRATION WITH SYRINGE FOR ORAL ADMINISTRATION

The syringe for oral administration is graded in kg of body weight.

The use of the syringe for oral administration is strictly reserved for the administration of this pediatric suspension of ibuprofen. The oral syringe should be disassembled, rinsed and dried after each use.

The dose to be administered for 1 shot is obtained by aspirating the suspension by pulling the plunger of the oral syringe to the graduation corresponding to the weight of the child.

For each take:

· Up to 10 kg:
use the 5 ml graduated syringe up to 10 kg or the 10 ml graduated syringe up to 20 kg provided.

· More than 10 kg:
use the 10 ml graduated syringe up to 20 kg supplied.

· More than 20 kg:
use the 10 ml graduated syringe up to 20 kg supplied.
fill the syringe for the first time until the 20 kg graduation, then a second time until reaching a total equal to the weight of the child.
(example for a child of 30 kg: fill a first time the syringe until graduation 20 kg then a second time up to 10 kg).

· Above 30 kg (ie around 12 years): there are more suitable pharmaceutical forms.

Elderly

This drug is intended for infants and children, but when used in the elderly, it should be noted that the age does not change the kinetics of ibuprofen, the dosage should not have to be changed depending on this setting. However precautions must be taken (see section Warnings and precautions for use ).

Against indications

This medicine is contraindicated in the following situations:

· Beyond 24 weeks of amenorrhea (5 months pregnant) (see section on Pregnancy and breastfeeding ),

· Hypersensitivity to ibuprofen or any of the excipients of the product,

· History of asthma triggered by ibuprofen or other substances of similar activity such as: other NSAIDs, acetylsalicylic acid,

· History of bleeding or digestive perforation during previous NSAID treatment,

· Gastrointestinal haemorrhage, cerebrovascular hemorrhage or other progressive haemorrhage,

· Progressive peptic ulcer, history of peptic ulcer or recurrent haemorrhage (2 or more episodes, or more, of haemorrhage or ulceration objectivized),

· Severe liver failure,

· Severe renal insufficiency,

· Severe heart failure,

· Systemic lupus erythematosus.

Side effects Antarene GE Enf Nour S / S

RELATED TO IBUPROFEN

Clinical studies and epidemiological data suggest that the use of ibuprofen, especially when used at high doses (2400 mg per day) over a long course of treatment, may be associated with a slight increase in the risk of arterial thrombotic event (eg, myocardial infarction or stroke) (see Warnings and Precautions for Use section ).

The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, can occur, especially in the elderly (see section Warnings and precautions for use ).

Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melena, hematemesis, exacerbation of rectocolitis or Crohn's disease (see Warnings and Precautions for Use section ) reported following administration of NSAIDs. Less frequently, gastritis has been observed.

Edema, hypertension and heart failure have been reported in combination with NSAID therapy.

Gastrointestinal effects

Gastrointestinal disorders such as nausea, vomiting, gastralgia, dyspepsia, transit disorders, digestive ulcerations with or without haemorrhage, occult or non-occult haemorrhage have usually been reported. These are all the more frequent as the dosage used is high and the duration of treatment extended.

Hypersensitivity reactions

· Dermatological: rashes, rash, pruritus, edema, aggravation of chronic urticaria.

· Respiratory: The onset of asthma attacks in some subjects may be related to an allergy to acetylsalicylic acid or a nonsteroidal anti-inflammatory drug (see section 4.3 ).

· General: anaphylactic shock, Quincke's edema.

Skin effects

Very rarely, bullous reactions (Stevens-Johnson syndrome, Lyell syndrome) have been observed.

Exceptionally occurrence of severe infectious skin and soft tissue complications during chickenpox (see Warnings and Precautions for Use section ).

Effects on the central nervous system

Ibuprofen may exceptionally be responsible for vertigo and headache.

Other

· Some rare cases of visual disturbances have been reported,

· Oliguria, renal failure,

· The discovery of aseptic meningitis with ibuprofen should result in systemic lupus erythematosus or connective tissue disease.

Some biological modifications could be observed

· Hepatic: transient increase in transaminases, exceptional cases of hepatitis,

· Haematological: agranulocytosis, haemolytic anemia.

RELATED TO EXCIPIENTS

· Risk of allergic reactions due to the presence of Red Cochineal A (E124).

· Possibility of digestive disorders and diarrhea, due to the presence of sorbitol.

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