1. Name Of The Medicinal Product
Catacrom 2% w/v eye drops, solution.
2. Qualitative And Quantitative Composition
Sodium cromoglicate 2.0% w/v.
Each individual single-dose-unit contains 6mg of sodium Cromoglicate in 0.3ml of solution
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Eye drops, solution (eye drops)
Clear, colourless solution drops in a single dose container.
The eye drops are sterile and preservative free.
4. Clinical Particulars
4.1 Therapeutic Indications
Indicated for the relief and treatment of seasonal and perennial allergic conjunctivitis.
4.2 Posology And Method Of Administration
Topical ophthalmic use.
Adults, children and the elderly: one or two drops into each eye four times per day, or as directed by the doctor.
4.3 Contraindications
Known hypersensitivity to sodium cromoglicate.
4.4 Special Warnings And Precautions For Use
Catacrom 2% w/v eye drops are sterile, preservative free and presented in a single use container which should be discarded after use.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Catacrom 2% w/v eye drops should be used with caution in pregnancy, especially during the first trimester. Extensive experience with sodium cromoglicate suggests that there are no adverse effects on fetal development. Nevertheless, it should only be used in pregnancy where there is a clinical need.
It is not known whether sodium cromoglicate is excreted in breast milk; however, on the basis of its physicochemical properties, it is considered unlikely. There is no evidence that the use of sodium cromoglicate has any undesirable effects on the baby.
4.7 Effects On Ability To Drive And Use Machines
As with all eye drops, transient blurring of vision may occur on instillation. Do not drive or operate machinery until normal vision is restored.
4.8 Undesirable Effects
On instillation, transient stinging or burning may occur. Rarely, other symptoms of local irritation have been reported.
4.9 Overdose
Medical supervision only should be necessary.
If the solution is accidentally ingested, as sodium cromoglicate is only poorly absorbed, no action other than medical supervision should be necessary.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Other antiallergics; Cromoglicate acid
ATC-code: SO1G X01
The solution exerts its effect locally in the eye. Sodium cromoglicate has been shown to inhibit the degranulation of sensitised mast cells occurring after exposure to specific antigens. Sodium cromoglicate inhibits release of histamine and various membrane derived mediators from mast cells.
Sodium cromoglicate has no intrinsic antihistaminic or vasoconstrictor activity.
5.2 Pharmacokinetic Properties
Limited systemic absorption may be expected via ocular instillation.
In normal volunteers, analysis of drug excretion has shown that approximately 0.03% of sodium cromoglicate is absorbed following ocular administration.
5.3 Preclinical Safety Data
There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Purified water
Sodium chloride
6.2 Incompatibilities
None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
Unopened: 3 years.
After opening the sachet: use contents within 28 days.
After opening the single-dose unit: Use immediately after opening the single-dose unit. Discard any unused contents.
6.4 Special Precautions For Storage
Do not store above 25°C. Store in the original package.
6.5 Nature And Contents Of Container
Catacrom 2% w/v eye drops is available in 0.3 ml low density polyethylene single-dose containers. The single dose containers are packed into laminate sachets, within a cardboard carton.
Pack sizes: 10, 12, 18, 20, 24, 30 or 90 single doses
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
For single use only. Discard immediately after first use. Any unused product or waste material should be disposed of in accordance with the local requirements.
7. Marketing Authorisation Holder
Moorfields Eye Hospital NHS Foundation Trust
Trading as Moorfields Pharmaceuticals
34 Nile Street
London N1 7TP
8. Marketing Authorisation Number(S)
PL11412/0002
9. Date Of First Authorisation/Renewal Of The Authorisation
06/08/2009
10. Date Of Revision Of The Text
06/08/2009
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