Zovirax 4.5g of 3% ophthalmic ointment

The instruction for medical use

of Zoviraks® medicine

the Trade name
of Zoviraks®

the International unlicensed


name Acyclovir Dosage Form
oculentum of 3% 4.5 g

Structure
of 1 g of ointment contains
active agent - acyclovir of 30 mg,
excipient - vaseline white.

The description
Ointment of white or almost white color, soft, uniform, slightly transparent, oily, with a slight characteristic smell, not containing grains, lumps and foreign particles.

Pharmacotherapeutic group
Drugs for treatment of diseases of eyes.
Antiviral drugs. Acyclovir.
The ATX S01AD03 code

the Pharmacological

Pharmacokinetics Acyclovir properties is quickly absorbed by an epithelium of a cornea and near-eye fabrics therefore in intraocular liquid the concentration of drug necessary for suppression of a virus is created. Acyclovir at external use gets to a system blood stream in insignificant quantity.
The pharmacodynamics
of Zoviraks® – antiviral drug which is highly effective concerning the herpes simplex virus (HSV) of the 1st and 2nd types and a virus of chicken pox at the same time its toxicity for cells of mammals is very small.
After receipt in the cells infected with a virus acyclovir is phosphorylated to active agent of acyclovir of triphosphate by means of a virus thymidinekinase. Acyclovir triphosphate works as nonspecific inhibitor and substrate for virus DNA of a polymerase and prevents synthesis of virus DNA without damage of cells of the owner.

Indications
- the keratitis caused by a herpes simplex virus

the Route of administration and doses
For topical administration (in the lower conjunctival sac).
Ointment should be applied 5 times a day with an interval about 4 hours, except for night time.

IInstruktsiya on
ointment 1 use. Carefully wash up hands.

2. A finger gently delay a lower eyelid of the affected eye.

3. Slightly incline the head of a kzada and look up.

4. The strip of ointment 10 mm long should be placed along the inner edge of a lower eyelid. It is necessary to avoid contact of a tip of a tuba with an eye.

5.





sec. Close eyes for 30 seconds.

6. The sight can be indistinct within from 5 to 10 minutes after putting Zoviraks® ointment. Wait before driving before restoration of clearness of sight.

7. Wash up hands after ointment imposing.

Treatment needs to be continued within 3 days after healing.


Side effects
the Frequency of side effects was established on the basis of the conducted clinical trials: very often (& gt, 1/10), it is frequent (from & gt, 1/100 to & lt, 1/10), sometimes (from & gt, 1/1000 to & lt, 1/100), is rare (from & gt, 1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000).
Very often
- a dot superficial keratopathy which does not demand the termination of treatment and disappears without consequences
Often
- the easy burning which is taking place over time
- conjunctivitis (dacryagogue)
It is rare
- blepharitis
Very seldom
- reaction of immediate hypersensitivity, including a Quincke's disease and a small tortoiseshell
the Providing data on expected side reactions of drug is very important point allowing to carry out continuous monitoring of a ratio risk/advantage of medicine. Health workers should provide information on any expected adverse reactions on the contacts specified at the end of the instruction and also through the national system of collection of information.


Contraindications
- the known hypersensitivity to acyclovir, a valatsiklovir or to any of excipients


Medicinal interactions
No, of data


Special instructions
during drug treatment it is not necessary to carry contact lenses.
Use in pediatric practice
there are no Age limits.
Pregnancy and the period of a lactation
Use of drug at pregnancy is possible in case the potential advantage for mother exceeds possible risk for a fruit. Drug is found in breast milk after receipt in a system blood stream of mother (for example, after intake), however, the amount of drug which will be received by the child, will be extremely insignificant.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during use of drug should be careful in connection with possible decrease in visual acuity.


The overdose
Overdose by drug at an intraocular method of administration is improbable. No adverse effects were observed at intake of all contents of the tuba containing 135 mg of acyclovir.
However, in case of repeated administration of drug inside within several days the development of symptoms from digestive tract (nausea, vomiting) is possible and from nervous system (headache, confusion of consciousness).
Acyclovir is removed with a hemodialysis.


The form of release and packing
oculentum of 3%
On 4.5 g of ointment place in a tuba from polyolefin polyolefin/aluminium/laminate, with a polyethylene nozzle and the screwing-up cap. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard pack.



To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach!




To Use a period of storage of 5 years within one month after packing opening.
Not to use after expiry date.


Prescription status
According to the prescription



Jubilant HollisterStier General Partnership Producer, Canada
(16751 route Transcanadienne, Kirkland, Quebec, H9H 4J4, Canada)


the Owner of the registration certificate
of The Wellcome Foundation Limited, Great Britain
(980 Great West Road, TW8 9GS, UK)

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Predstavitelstvo kompanii GlaksoSmitKlyayn Export Ltd in Kazakhstane050059, Almaty, Furmanov St., 273 Phone number: +7 727 258 28 92, +7 727 259 09 96 Fax number: + 7 727 258 28 90 E-mail address: kaz.med@gsk.com