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Package leaflet
Information for use, please, read carefully!
HYPROMEL® 2,5%
sterile viscoelastic solution
Manufacturer: UNIMED PHARMA Ltd, Bratislava, Slovak republic
Composition: Hydroxypropylmethylcellulosum (hypromellosum) 25 mg in 1 ml
Excipients: Natrii chloridum, Kalii chloridum, Calcii chloridum, Magnesii chloridum,
Natrii acetas, Natrii citras, Aqua ad iniectabilia.
Properties:
HYPROMEL® 2,5% is a viscoelastic, transparent, isotonic, sterile solution of
hydroxypropylmethylcellulose without preservative used as an adjuvant in ocular
surgery. Injected into the anterior chamber of the eye, it provides a mechanical
protection of sensitive tissues of the eye, more specifically of the corneal
endothelium.
HYPROMEL® 2,5% is inert and non toxic for any living tissues. It does not provoke
any inflammation nor does it have any immunogenic, teratogenic or mutagenic
characteristics.
Elimination of the product:
HYPROMEL® 2,5% must be thoroughly removed after surgery from anterior chamber
of the eye by irrigation and /or aspiration moreover nevertheless, that traces that
may remain after surgery will almost totally dissipate (98%) through Schlemm´s
cannal within 24 hours.
Indication:
The eye microsurgery. The intraocular surgeries in the front segment of the eye,
where HYPROMEL® 2,5% maintain deep anterior chamber and reduce risk demage
of corneal endothelium cells and others sensitive tissues.It also may be use to coat
the artificial lens and the surgical instruments.
Precautions:
Instilling excessive amounts of HYPROMEL® 2,5% into the anterior or posterior
chamber of the eye may increase intraocular pressure temporarely. An excessive
intraocular pressure may also be caused by a pre-existing glaucoma condition or by
operative procedures and sequelae. Because these factors vary from case to case
and are difficult to predict, the following precautions are recommended:
- do not overfill the eye with HYPROMEL® 2,5%
- at the end of surgery all remaining HYPROMEL® 2,5% should be remove by
irrigation and /or aspiration
- carefully monitoring the intraocular pressure, especially during the immediate
post-operative period.
If a significant increase in pressure is observed, treat appropriately.
Also,
Do not use if sterile pouch is damaged.
Do not use after the expiration date.
Single use only.
Instructions for use:
1. Take a pack with a sterile-packed syringe out from a paper cardboard.
2. Holding it above a sterile tray remove the syringe from a protection cover.
3. Put the syringe on the sterile tray.
4. Remove a rubber cap from the syringe and slip an enclosed sterile cannula
on. Make sure the cannula is firmly linked with the syringe.
5. By gentle pushing on the syringe piston remove air from the cannula and
make sure the syringe functions correctly.
6. The syringe is ready to use.
Dosage:
Dosage varies with type of surgery. Usually a dose of 0.5 to 1.0 ml is injected into
the anterior segment.
Ophathalmic surgical application:
CATARAC SURGERY: before lens extraction HYPROMEL® 2,5% is introduced into
the anterior chamber to protect the corneal endothelium and to maintain a deep
anterior chamber. Additional amounts may also be introduced prior to the
implantation of an intraocular lens, and to coat the artificial lens and the surgical
instruments.
CORNEAL TRANSPLANT SURGERY: prior to cornea trepanation, the anterior
chamber is filled with HYPROMEL® 2,5%. The donor draft should be placed into the
proper position without removing HYPROMEL® 2,5%. Then suturing can begin.
Additional amounts of HYPROMEL® 2,5% may also be used to protect the exposed
endothelium layer of the donor buton during preparation of the recipient eye.
GLAUCOMA SURGERY: HYPROMEL® 2,5% may be used before trabeculectomy.
Adverse reactions:
Transient rises of post-operative intraocular pressure have been reported in some
cases. It could be controlled using appropriate medication.
Interactions:
None currently known.
Incompatibilities:
None currently known.
Packaging:
1 x 2 ml solution in syringe , 1  cannula
Storage:
Store at temperature from 10 – 25 OC . Protect from freezing.
Oriešková 11, 821 05 Bratislava
Slovak Republic