Mydriasert 5.4mg/0.28mg ophthalmic inserts

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Tropicamide; Phenylephrine hydrochloride

Inapatikana kutoka:

Thea Pharmaceuticals Ltd

INN (Jina la Kimataifa):

Tropicamide; Phenylephrine hydrochloride

Kipimo:

.28mg ; 5.4mg

Dawa fomu:

Ophthalmic insert

Njia ya uendeshaji:

Ocular

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 11050000; GTIN: 0793573718860

Tabia za bidhaa

OBJECT 1
MYDRIASERT
Summary of Product Characteristics Updated 16-Jul-2015 | Thea
Pharmaceuticals Ltd
1. Name of the medicinal product
Mydriasert 0.28 mg/5.4 mg ophthalmic insert
2. Qualitative and quantitative composition
Each ophthalmic insert contains 0.28 mg of tropicamide and 5.4 mg of
phenylephrine hydrochloride.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Ophthalmic insert.
White to yellowish-white, oblong, 4.3 mm x 2.3 mm insert.
4. Clinical particulars
4.1 Therapeutic indications
Mydriasert is indicated:
- to obtain pre-operative mydriasis,
- or for diagnostic purposes when monotherapy is known to be
insufficient.
4.2 Posology and method of administration
Restricted use to health-care professionals.
This medicine is reserved to adults.
There are no data in children and adolescents. Mydriasert is not
recommended in these patients.
POSOLOGY
One ophthalmic insert per operated eye, a maximum of 2 hours before
surgery or the investigative
procedure (see also 5.1).
METHOD OF ADMINISTRATION
Cut the sealed edge along the dotted line, open the sachet and locate
the insert.
Hold the insert with disposable sterile forceps with rounded ends
provided in the packaging, making sure
not to damage it.
Pull down the lower eyelid by pinching it between the thumb and index
finger (A), and apply the
ophthalmic insert, using the disposable sterile forceps, in the lower
conjunctival sac (B).
INSTRUCTIONS FOR USE
Do not leave the ophthalmic insert for more than two hours in the
lower conjunctival sac. The practitioner
can remove the ophthalmic insert as soon as mydriasis is deemed
sufficient for the operation or procedure
to be carried out, and at the latest within the next 30 minutes.
In the event of discomfort, ensure that the insert has been placed
correctly at the base of the lower
conjunctival sac.
Manipulate aseptically. It is recommended to avoid excessive
manipulation of eyelids.
CAUTION: REMOVAL OF THE OPHTHALMIC INSERT
Before an operation or procedure, and as soon as the required
mydriasis h