Gynotal® Obstetric Gel for Safe Childbirth Facilitation...
Product Information:
It must be used and applied by the professionals (midwives and physicians) who are competent in obstetric area
Please read the leaflet insert before using Gynotal® obstetric gel. Application & Package Content:
Gynotal® Obstetric Gel Kit: Single use, sterile injectors containing 12 ml of obstetric gel:
2 x Injectors Stage A
1 x Injectors Stage B
3 x Applicators
Specifications:
Other Specifications:
Gynotal Stage A: High degree bioadhesive
Gynotal Stage B: Medium-degree bioadhesive
Composition:
12 ml of obstetric gel contained in one single-use injector contains the following contents: deionized water, propylene glycol, carbomer, hydroxyethylcellulose, and sodium hydroxide.
Indications and Use:
Gynotal Obstetric Gel is developed for specially aiding the vaginal birth. It is highly bioadhesive and has a high water binding capacity. Gynotal Obstetric Gel is used to making the facilitation easier for mother and the baby and protecting the perineum during the delivery. Gynotal obstetric gel can be used for both in primigravidas and in multigravidas and also in status post Caesarean section procedures.
Gynotal Obstetric Gel is used for the following situations:
-Easing the vaginal birth and reducing the friction vvhich impedes birth in primiparous women.
-To ease vaginal birth and protect the mother and the baby by reducing the friction which impedes birth in multiparous women, in water births and in women with Caesarean history.
-To prevent protracted or challenging deliveries (results of the observations).
-to make vaginal operative procedures (vacuum/forceps) easier.
-to protect the perineum and vagina in vaginal births.
-To reduce vaginal-urethral burning sense after birth.
Special Recommendations on Use:
Only for local application to the birth channel.
Gynotal Stage A: Suitable for use during the first stage of birth.
Gynotal Stage B: Suitable for use during the second stage of birth and for manual placenta separation.
Dosing and Application:
Gynotal Obstetric Gel is used during vaginal examination during childbirth, starting from the first vaginal examination. At each vaginal examination, about 3 ml gel is i is introduced into the vaginal birth canal using a sterile glove and is spread equally. To improve application, an elastic vaginal applicator can be used; about 3 ml gel is applied in the area in front of the presented section. In order to obtain the best possible lubricating film, care should be taken to ensure that sufficient fluid is added when the vagina is dry. Standard solutions such as sodium chloride or aseptic solutions can be used for this purpose. More gel should be applied 15 to 30 minutes after rupturing the amniotic sac. Gynotal Obstetric Gel accelerates both the first and second stages of the birth. Gynotal® Obstetric Gel should therefore be used throughout the entire duration of labour. Gynotal® Stage A is recommended for use especially during the first stage and Gynotal® Stage B during the second stage. The average dose required is between 10-30 ml Gynotal Obstetric Gel per birth. The experiments show that the maximum dose for Gynotak® Obstetric Gel should be 30 ml. The gel must be applied only by the professionals who are competent in obstetric area.
Precautions:
It is sterile as long as the blister packing is not opened. If the packaging is damaged or opened or the expiry date has passed, do not use the obstetric gel. After opening the blister package, the injectors must be treated according to the rules for using sterile materials in order to maintain the injectors in sterile condition. When the head of the baby appears, the face (including the eyes and the nose) of the baby should be wiped with a dry cloth. Where appropriate, cleaning should be performed on the mouth/nose surface. It is recommended to use a dry cloth, when the baby is coming in order the prevent the sliding. Since the Gynotal Obstetric Gel is electroconductive, electro surgery can be applied anytime, for example during the anytime Caesarean procedure or for hemostasis while fixing the birth channel, after the application of the gel. Therefore the GynotalⓇ Obstetric Gel must not be used in combination with other gels as they may overturn the electrical conductivity of Gynotal® Obstetric Gel.
Biocompatibility and Use In Pregnancy:
Gynotal Obstetric Gel has been tested in accordance with international guidelines in relation to biocompatibility. Based on the results of these tests, there are no indications of a harmful effect for the mother or the new born infant.
Side Effects: No side effect has been reported to date.
Interaction:
No case related to any interaction reported to date.
Contraindications:
Gynotal Obstetric Gel must not be used for the women have allergic history against any of the ingredient of this product.
Storage and Shelf Life:
The shelf life of Gynotal Obstetric Gel is 3 years. It must be stored in a temperature between 5°C and 30°C, avoid exposure to direct sunlight. The expiry date is written on the outer packaging. Do not use the expired products
