1. Name Of The Medicinal Product
LACRI-LUBE® Eye ointment
REFRESH NIGHT TIME® Eye ointment
2. Qualitative And Quantitative Composition
No pharmacologically active ingredient is present.
For excipients, see 6.1.
3. Pharmaceutical Form
Eye ointment.
Smooth, homogeneous, off-white, preservative-free ointment.
4. Clinical Particulars
4.1 Therapeutic Indications
As adjunctive therapy to lubricate and protect the eye in conditions such as exposure keratitis, decreased corneal sensitivity, recurrent corneal erosions, keratitis sicca, ophthalmic and non-ophthalmic surgery.
4.2 Posology And Method Of Administration
For topical ocular administration.
Pull lower eye lid down to form a pocket and apply small amount as required.
There is no variation in dosage for age.
4.3 Contraindications
Hypersensitivity to wool alcohols.
4.4 Special Warnings And Precautions For Use
To avoid contamination during use, do not touch the tube tip to any surface.
If irritation, pain, redness and changes in vision occur or worsen, treatment discontinuation should be considered and a re-evaluation of the patient's condition should be made.
Contact lenses should not be worn during instillation of the drug. After instillation there should be an interval of at least 30 minutes before reinsertion.
In circumstances where concomitant topical ocular medication is necessary, there should be an interval of at least 5 minutes between the two medications. LACRI-LUBE® / REFRESH NIGHT TIME® should always be the last medication instilled.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interactions have been observed with LACRI-LUBE® / REFRESH NIGHT TIME®. Since the constituents have a well-established medicinal use, no interactions are anticipated.
4.6 Pregnancy And Lactation
The constituents of LACRI-LUBE® / REFRESH NIGHT TIME® have been used as pharmaceutical agents for many years with no untoward effects. No special precautions are therefore necessary for the use of LACRI-LUBE® / REFRESH NIGHT TIME® in pregnancy and lactation.
Women of child-bearing potential: suitable for use.
Fertility: no known implications.
4.7 Effects On Ability To Drive And Use Machines
May cause transient blurring of vision. Do not drive or use machinery unless vision is clear.
4.8 Undesirable Effects
Local (ocular) effects:
Transient blurring of vision (typically lasting 1-15 minutes) may occur.
|
|
|
|
Isolated reports of oedema, and pruritus.
4.9 Overdose
Accidental topical ocular overdosage will present no hazard, apart from a transient effect on vision (see 4.7).
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group (ATC code) = S01X A 20.
The ingredients of LACRI-LUBE® / REFRESH NIGHT TIME® are pharmacologically inert, bland oleaginous substances for lubrication and to maintain hydration of the ocular surfaces by occlusion.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
No information.
6. Pharmaceutical Particulars
6.1 List Of Excipients
White soft paraffin (white petroleum jelly)
Liquid paraffin
Wool alcohols
6.2 Incompatibilities
None known.
6.3 Shelf Life
Shelf life of the medicinal product as packaged for sale = 36 months.
Shelf life after first opening of container = 1 month.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Epoxy-phenolic lined collapsible aluminium tube with a black polyethylene screw cap. The tube contains 3.5 g or 5.0g of eye ointment.
Dispensing under medical prescription or sale from registered pharmacies.
6.6 Special Precautions For Disposal And Other Handling
Discard any unused product 1 month after first opening.
7. Marketing Authorisation Holder
Allergan Ltd
Marlow International
The Parkway
Marlow
Bucks
SL7 1YL
United Kingdom
8. Marketing Authorisation Number(S)
PL 00426/0041
9. Date Of First Authorisation/Renewal Of The Authorisation
23rd July 2003
10. Date Of Revision Of The Text
16th Dec 2010
No comments:
Post a Comment