Dianatal® obstetric gel - For an easier birth

For use by qualified obstetric professionals (midwifes and physicians) only.

Pharmaceutical form and contents:
Dianatal® obstetric gel kit: sterile single-use syringes containing 11ml obstetric gel:
2 syringes Dianatal® stage 1: white plunger
syringe Dianatal® stage 2: blue plunger
2 Dianatal® obstetric gel applicators

Properties, galenic form and ingredients
Dianatal® obstetric gel is sterile and packed in sterile single-use syringes. It is non-allergenic, bioadhesive, electroconductive, isotonic, slightly acidic, latex-free, free of preservatives, and kind on mucous membranes and on the eyes.
Dianatal® obstetric gel does not contain any pharmaceutically active ingredients. Dianatal® obstetric gel is an odourless, almost colourless gel, packed in sterile (autoclave) single-use packaging. The gel is highly viscous, isotonic, with a slightly acidic pH of 5.5 - 6.5 and electrical con¬ductivity of 5.0 - 9.0 mS cm-1

Special properties:
Dianatal® stage 1: highly bioadhesive: white plunger Dianatal® stage 2: moderately bioadhesive: blue plunger

Ingredients:
One single-use syringe of 11 ml obstetric gel contains the following active ingredients: Propylene glycol, carbomer, hydroxyethylcellulose, purifed water

Indication and uses of Dianatal® obstetric gel
Dianatal® obstetric gel has been developed specifically to assist with vaginal delivery. It is highly bioadhesive and has a high water binding capacity. Dianatal® obstetric gel is used during vaginal delivery to make the birth easier for both mother and child, and to protect the perineum. Dianatal® obstetric gel forms a low-friction bioadhesive film in the vaginal birth canal, reducing the friction between the child and the vaginal birth canal which can make delivery more difficult.
Dianatal® obstetric gel is sterile, non-allergic, electro-conductive, slightly acidic, isotonic, kind on mu¬cous membranes and on the eyes.
Dianatal® obstetric gel can be used both for first-timer mothers and for women who have already given birth, following Caesarean section or for completion of delivery by means of vaginal surgery.
Dianatal® obstetric gel eases and shortens both the first and second stages of labour and protects mother and child, in particular protecting the vagina, the pelvic floor and the perineum.

Dianatal® obstetric gel is used specifically:
- to make vaginal delivery easier to protect both mother and child by reducing the friction which can hinder delivery for both first-timer mothers and women who have already given birth, following Caesarean section, for water births, for premature delivery, following rupture of the amniotic sac
- to treat prolonged delivery
- to ease vaginal surgery
- to protect the perineum during vaginal delivery
- to make manual detachment of the placenta easier

Special recommendations for use:
Dianatal® stage 1: for use during the fist stage of labour
Dianatal® stage 2: for use during the second stage of labour and for manual detachment of the placenta

Dosage and application
Dianatal® obstetric gel is applied during the vaginal examinations during delivery, beginning with the first vaginal examination. 3-5 ml gel is evenly distributed in the vaginal birth canal at each vaginal examination using a sterile glove. A flexible vaginal applicator can be used to improve application; 2-3 ml gel is applied ahead of the presenting part.
In order to achieve the optimum low-friction film, care should be taken to ensure that sufficient fluid is added when the gel is applied. The standard solutions such as NaCl or aseptic solution can be used for this. An additional application of gel should be made 15-30 minutes after rupture of the amniotic sac. Dianatal® obstetric gel shortens both the first and second stages of labour. It should therefore be used throughout the entire delivery.
Dianatal® stage 1 is particularly used during the first stage of labour, Dianatal® stage 2 during the second stage. The necessary dosage is on average between 10 ml and 30 ml Dianatal® obstetric gel per delivery Experience has shown the maximum required amount to be 30 ml Dianatal® obstetric gel.
The gel should only be applied by qualified obstetric professionals.

Method of use
For local application in the vaginal birth canal only

Precautions
Content is sterile as long as the blister pack has not been opened. You should not use the Obstetric Gel if the packaging is damaged or if the packaging has been opened or after the expiry date. Once the sterile blister pack has been opened the syringes must be handled in accordance with sterile regula¬tions in order to ensure that they remain sterile. Once the baby’s head has emerged his/her face area (including eyes and nose) should be wiped with a dry cloth. Superficial aspiration of the mouth/nose area should also be carried out if appropriate. It is advisable to use a dry cloth as the child emerges to prevent the baby from slipping.
Because Dianatal® obstetric gel is electro-conductive, electro-surgery can be employed for haemostasis at any time after the use of Dianatal® obstetric gel, for example when performing a Caesarean section or revision of the birth canal. Dianatal® obstetric gel should therefore not be used in combination with other gels as this may impair the electrical conductivity of Dianatal®

Biocompatibility and use during pregnancy
Dianatal® obstetric gel has been tested with regard to biocompatibility in line with international guideli¬nes. These tests have not produced any evidence of any harmful effect for mother or baby.

Adverse effects
No adverse effects have been reported to date.

Interaction
No cases involving interaction have been reported to date.

Contraindications
Dianatal® obstetric gel should not be used if:
• amniotic infection syndrome is suspected
• there are signs of fetal asphyxia
• there is a known allergy to any of the ingredients
• vaginal delivery is contra-indicated

Storage and shelf-life
Dianatal® obstetric gel should be stored at room temperature and should be protected from light.
The expiry date is printed on the outer wrapping and the packaging. Dianatal® obstetric gel should not
be used after the expiry date.

Manufacturer:
MPC INTERNATIONAL S A
26, Boulevard Royal
L-2449 Luxembourg

Dianatal is a Trademark of HCB Happy Child Birth Holding AG, Basel Switzerland